The U.S. Office of Personnel Management (OPM) is issuing final regulations to implement a provision of the National Defense Authorization Act for Fiscal Year 2008 (Pub. L. 110-181, January 28, 2008) which provides a higher limit on the accumulation of annual leave for certain senior-level employees covered by 5 U.S.C. 5376 and 10 U.S.C. 1607(a).

Section 1112 of the Act amends 5 U.S.C. 6304(f)(1) to provide that the annual leave carryover ceiling for employees in senior-level (SL) and scientific and professional (ST) positions compensated under 5 U.S.C. 5376, and for employees serving in positions designated under 10 U.S.C. 1607(a) as Intelligence Senior Level positions, is 90 days (720 hours)—the same 90-day annual leave ceiling that applies to members of the Senior Executive Service.

Pursuant to section 553(b)(B) of title 5 of the United States Code, OPM finds good cause exists for waiving the general notice of proposed rulemaking. Also, pursuant to 5 U.S.C. 553(d)(3), OPM finds good cause exists for making this rule effective in less than 30 days. These regulations implement section 1112 of Public Law 10X-181, which became effective on the date of enactment, January 28, 2008. The statutory change is unambiguous and does not require interpretation, because it only extends coverage under a particular provision of law to additional categories of employees. These regulations merely incorporate the statutory change. Thus, a notice of proposed rulemaking and a delayed effective date are unnecessary. This waiver will facilitate timely implementation of the law as intended by Congress.

This rule has been reviewed by the Office of Management and Budget in accordance with E.O. 12866.

I certify that these regulations will not have a significant economic impact on a substantial number of small entities because they will apply only to Federal agencies and employees.

The MSPB published, with OGE concurrence, an interim rule at 72 FR 26533, on May 10, 2007, governing the conduct of MSPB employees and requested comments. No comments were received. The MSPB has determined, with OGE concurrence, to adopt the interim rule as final without change. The interim rule being adopted as final provides that an MSPB employee, other than a special Government employee, must obtain approval before engaging in outside employment. The rule defines outside employment and sets out the procedures for seeking approval. The rule also provides that the Designated Agency Ethics Official (DAEO) or alternate DAEO may exempt certain categories of employment from the prior approval requirement.

For a detailed section analysis of this final rule, see the preamble of the interim rule as published at 72 FR 26533.

The MSPB has determined, pursuant to the Regulatory Flexibility Act, 5 U.S.C. chapter 6, that this rulemaking will not have a significant economic impact on a substantial number of small entities because it primarily affects MSPB employees.

The Paperwork Reduction Act, 44 U.S.C. chapter 35, does not apply because this rulemaking does not contain information collection requirements subject to the approval of the Office of Management and Budget.

The Merit Systems Protection Board has determined that this rule is not a rule as defined in 5 U.S.C. 804, and thus, does not require review by Congress.

Section 101(a)(15)(F)(i) of the Immigration and Nationality Act of 1952, as amended (INA), 8 U.S.C. 1101(a)(15)(F)(i), establishes the F-1 nonimmigrant classification for individuals who wish to come to the United States temporarily to attend an academic or language training institution certified by the Student and Visitor Exchange Program (SEVP) for U.S. Immigration and Customs Enforcement (ICE). F-1 students may remain in the United States for the duration of their educational programs if they otherwise maintain status. 8 CFR 214.2(f)(5). Once an F-1 student has completed his or her course of study, and any authorized practical training following completion of studies, the student must either transfer to another SEVP-certified school to continue studies, change to a different nonimmigrant status, otherwise legally extend their period of authorized stay in the United States, or leave the United States. 8 CFR 214.2(f)(5)(iv). F-1 students are allowed 60 days after the completion of such studies and practical training to prepare for departure from the United States. 8 CFR 214.2(f)(5)(iv).

F-1 students generally are not authorized to work in the United States during the term of their educational program, with limited exceptions. Currently, students in F-1 nonimmigrant status who have been enrolled on a full-time basis for at least one full academic year in a college, university, conservatory, or seminary certified by SEVP, and have otherwise maintained status, are eligible to apply for up to 12 months of optional practical training (OPT) to work for a U.S. employer in a job directly related to the student's major area of study. 8 CFR 214.2(f)(10). F-1 students may obtain OPT either during their educational program (“pre-completion OPT”) or after the student graduates (“post-completion OPT”). The student remains in F-1 status throughout the OPT period.

An F-1 student in post-completion OPT, therefore, does not have to leave the United States within 60 days after graduation, but is authorized to remain in the United States for the entire post-completion OPT period. If the student has not used any pre-completion OPT, then the student's post-completion OPT period could be up to 12 months. Once the post-completion OPT period has concluded, the student must depart the United States within 60 days, unless he or she changes status or otherwise legally extends his or her stay in the United States ( e.g. , starts a graduate program).

During his or her authorized period of stay, a qualified F-1 student may receive a change of nonimmigrant status to H-1B nonimmigrant status if an employer has timely filed, and USCIS grants, a petition on behalf of that student. The employer must submit a Form I-129, Petition for a Nonimmigrant Worker to USCIS. The Form includes a section for the employer to indicate whether change of status is being requested for the beneficiary (if eligible), or whether the beneficiary will instead apply for a visa outside of the United States at a U.S. consulate. USCIS may grant H-1B status to eligible nonimmigrants employed in or offered a job by the petitioner in a specialty occupation. 8 CFR 214.2(h)(1)(ii)(B). A specialty occupation is one that requires the theoretical and practical application of a body of specialized knowledge and a bachelor's or higher degree in the specific specialty as a minimum qualification. INA Section 214(i).

Congress, however, has prohibited USCIS from granting H-1B status to more than 65,000 nonimmigrant aliens during any fiscal year (referred to as the “cap”). 1 See INA Section 214(g). The H-1B category is greatly oversubscribed. When USCIS determines that the cap will be reached for that fiscal year, based on the number of H-1B petitions received, it announces to the public the final day on which USCIS will accept such petitions for adjudication in that fiscal year. USCIS refers to this day as the “final receipt date.” See 8 CFR 214.2(h)(8)(ii)(B). USCIS then randomly selects from among the petitions received on the final receipt date the number of petitions necessary to reach the 65,000 cap. Id. If the final receipt date falls within the first five business days on which petitions subject to the applicable cap may be filed, USCIS will randomly select the number of petitions necessary to reach the 65,000 cap from among those filed during the acceptance period.

There is a significant amount of competition among employers of highly-skilled workers for the limited number of H-1B visas available each fiscal year. Each year, the cap has been reached earlier in the year. For FY05, the cap was reached on October 1, 2004, the first day of that fiscal year. In FY06, the cap was reached on August 10, 2005; and in FY 07, the cap was reached on May 26, 2006. Last year, the cap was reached on April 2, 2007, the first business day for filing. On that single day, USCIS received more than twice the number of petitions needed to reach the cap for that fiscal year. 2

Many employers who hire F-1 students under the OPT program eventually file a petition on the students' behalf for classification as an H-1B worker in a specialty occupation. If the student is maintaining his or her F-1 nonimmigrant status, the employer may also include a request to have the student's nonimmigrant status changed to H-1B. Because the H-1B category is greatly oversubscribed, however, OPT employees often are unable to obtain H-1B status within their authorized period of stay in F-1 status, including the 12-month OPT period, and thus are forced to leave the country. The inability of U.S. employers, in particular in the fields of science, technology, engineering and mathematics, to obtain H-1B status for highly skilled foreign students and foreign nonimmigrant workers has adversely affected the ability of U.S. employers to recruit and retain skilled workers and creates a competitive disadvantage for U.S. companies.

The National Science Foundation (NSF), in its Science and Engineering Indicators 2008 (SEIND08), 3 took note of these trends. NSF observed that globalization of science and technology has proceeded at a quick pace since the early 1990s. Increased international travel coincided with the development of the Internet as a tool for unfettered worldwide information dissemination and communication. “By the late 1990s,” the report continues “many governments had taken note of these developments. They increasingly looked to the development of knowledge-intensive economics for their countries' economic competitiveness and growth.” SEIND08 at 0-4. NSF further reports that “twenty-five percent of all college-education science and engineering occupations in 2003 were foreign born, as were [forty percent] of doctorate holders in science and engineering.” According to the Task Force on the Future of American Innovation, Measuring the Moment: Innovation, National Security and Economic Competitiveness (November 2006), 4 the proportion of American students in the United States obtaining degrees in STEM fields has fallen from 32% to 27%. Later, the report reveals that since 2000, there have been more foreign graduate students studying engineering and the physical, computer and mathematical sciences in U.S. graduate schools than U.S. citizens and permanent residents.

The NSF goes on to say that “U.S. [Gross Domestic Product] growth is robust but cannot match large, sustained increases in China and other Asian economies.” And because of this globalization, the United States, while still the leading producer of scientific knowledge, faces a labor market in which it must increasingly compete with these countries. The economies of the Organization of Economic Cooperation and Development (OECD) countries, particularly Australia, Canada, and certain European countries, are also providing increased opportunities for STEM scientists. And STEM graduates from the growing economies of China, India, and Russia, for example, have increased employment opportunities in their native countries. Thus, the Task Force on the Future of American Innovation reports “the impact of China and India on global R&D [research and development] is significant and growing rapidly: In 1990, these two countries accounted for 3.4% of foreign R&D staff, which increased to 13.9% by 2004. By the end of 2007, China and India will account for 31% of global R&D staff, up from 19% in 2004.” See Measuring the Moment: Innovation, National Security and Economic Competitiveness (November 2006). In short, with their large and growing populations of STEM-graduate scientists, high-tech industries in these three countries and others in the OECD now compete much more effectively against the U.S. high technology industry.

DHS has received communications from a wide range of concerned stakeholders, including companies in the high-tech industry, members of Congress, and U.S. educational institutions, about the adverse impact on the U.S. economy and the ability of U.S. schools to attract talented foreign students for STEM study programs due to the immigration and employment practices in the United States. Representatives of high-tech industries in particular have raised significant concerns that the inability of U.S. companies to obtain H-1B visas for qualified F-1 students in a timely manner continues to result in the loss of skilled technical workers to countries with more lenient employment visa regimes, such as Canada and Australia. See Testimony of Bill Gates, Chairman, Microsoft Corporation, before the U.S. Senate Committee on Health, Education, Labor & Pensions, “Strengthening American Competitiveness for the 21st Century” (Washington, D.C.; March 7, 2007). 5

Notably, the European Union recently proposed a “Blue Card” program, similar to the U.S. H-1B visa program, under which skilled workers would be able to obtain a temporary work visa for employment in the European Union. Unlike the H-1B program, the European Union's Blue Card program proposal would not have a cap. The European Union estimates that workers would usually be able to obtain their visas in 90 days or less. If the Blue Card proposal is adopted, U.S. employers could be at a competitive disadvantage to employers in the European Union when recruiting foreign national candidates. U.S. high-tech employers are particularly concerned about the H-1B cap because of the critical shortage of domestic science and engineering talent and the degree to which high-tech employers are as a consequence necessarily far more dependent on foreign workers than other industries. See The National Science Foundation, Rising Above the Gathering Storm: Energizing and Employing America for a Brighter Economic Future (2007), pp. 78-83 (describing the critical shortages of science, math, and engineering talent in the United States) . 6

Many F-1 students who graduated last spring will soon be concluding their 12-month periods of OPT. Unless employers for those students are able to obtain H-1B visas when the filing period commences on April 1, 2008 for FY09 (October 1, 2008), many of these students will need to leave the United States when their current post-completion OPT period concludes.

This interim final rule addresses the immediate competitive disadvantage faced by U.S. high-tech industries, and thus may quickly ameliorate some of the adverse impacts on the U.S. economy. It does this by allowing an F-1 student already in a period of approved post-completion OPT to apply to extend that period by up to 17 months (for a maximum total period of 29 months of OPT) if the student received a STEM degree. As discussed in Section II below, this extension is only available to F-1 students with STEM degrees who have accepted employment with an employer registered and in good standing with USCIS' E-Verify employment verification program. In addition, employers of F-1 students who qualify for this 17-month extension of post-completion OPT must report to the student's school DSO within 48 hours if the student's employment ends prior to the end of the student's authorized OPT employment period.

As discussed above, nonimmigrant F-1 students on post-completion OPT maintain valid F-1 status until the expiration of the OPT period and the subsequent 60-day departure preparation period. Employers of students already working for the employer under OPT often file petitions to change the students' status to H-1B so that these nonimmigrant aliens may continue working in their current or a similar job. Many times, however, an F-1 student's OPT authorization will expire prior to the student being able to assume the employment specified in the approved H-1B petition.

Currently, an employer may not file, and USCIS may not approve, an H-1B petition submitted earlier than six months before the date of actual need for the beneficiary's services or training. 8 CFR 214.2(h)(9)(i)(B). As a result, the earliest date that an employer can file an H-1B petition for consideration under the next fiscal year cap is April 1, for an October 1 employment start date. If that H-1B petition and the accompanying change of status request are approved, the earliest date that the student may start H-1B employment is October 1. Consequently, F-1 students who are the beneficiaries of approved H-1B petitions, but whose period of authorized stay (including authorized periods of post-completion OPT and the subsequent 60-day departure preparation period) expires before the October 1 H-1B employment start date, would have a gap in authorized stay and employment. This situation is commonly referred to as the “cap-gap.”

An F-1 student in a cap-gap situation would have to leave the United States and return at the time his or her H-1B status becomes effective at the beginning of the next fiscal year. This gap creates a hardship to a number of students and provides a disincentive to remaining in the United States for employment. The cap-gap therefore creates a recruiting obstacle for U.S. employers interested in obtaining F-1 students for employment and submitting H-1B petitions on their behalf. Moreover, when the student is already working for a U.S. company on OPT and has to leave the United States, frequently for several months, during the cap-gap period, the employer suffers a major disruption.

USCIS is already authorized to extend the status of F-1 students caught in a cap-gap between graduation and the start date on his or her approved H-1B petition. 8 CFR 214.2(f)(5)(vi). However, before USCIS can offer students any relief from the cap-gap, it must first determine that the cap has been reached for the current fiscal year, or is likely to be reached prior to the end of the current fiscal year, and then publish a notice in the Federal Register announcing that status is extended for students with pending H-1B petitions. Significantly, the existing regulations do not take into account the fact that the H-1B category is now oversubscribed to such a degree that USCIS' final receipt date for petitions is now announced even before the start of the fiscal year for which the petitions are being submitted and, in the absence of an expansion of the 65,000 cap by Congress, this state of affairs will likely continue indefinitely. The existing regulations, therefore, are not an effective means of addressing the cap-gap problem suffered by student beneficiaries of pending H-1B petitions (and their employers).

This interim rule amends USCIS procedures by eliminating the requirement that USCIS issue a Federal Register notice. Instead, this rule extends the authorized period of stay, as well as work authorization, of any F-1 student who is the beneficiary of a timely-filed H-1B petition that has been granted by, or remains pending with, USCIS. The extension of status and work authorization terminates on October 1 of the fiscal year for which the H-1B visa has been requested. This amendment better reflects the reality of the current situation, where demand for H-1B visas is so high that USCIS regularly receives enough petitions to reach the cap before the beginning of the fiscal year for which petitions are filed, and offer more substantial cap gap relief to both students and employers.

This interim rule will allow F-1 students who have received a degree in a STEM field to obtain an extension of their existing post-completion OPT period for up to 17 months, for a maximum period of post-completion OPT of 29 months. The extension, however, is only available to students who are employed, or will be employed, by an employer enrolled (and determined by USCIS to be in good standing) in USCIS' E-Verify employment verification program at the time the student applies for the 17-month extension. A student seeking an extension must agree to report to a DSO at his or her school the following: Changes to the student's name, the student's residential and mailing address, the student's employer, and the address of the student's employer. The student must also report to a DSO every six months from the date the OPT extension starts to verify this information. In addition, the employer of a student under extended OPT must report to the student's school DSO within 48 hours after the student leaves employment with that employer. The DSO must report all of this information in SEVIS.

This interim final rule will allow qualified F-1 students who currently have approved post-completion OPT to apply for a 17-month extension of OPT. The student's degree, as shown is SEVIS, must be a bachelor's, master's, or doctorate degree with a degree code that is on the current STEM Designated Degree Program List.

The STEM Designated Degree Program List is based on the “Classification of Instructional Programs” (CIP) developed by the U.S. Department of Education's National Center for Education Statistics (NCES). See Classification of Instructional Programs—2000: (NCES 2002-165) U.S. Department of Education, National Center for Education Statistics. Washington, DC: U.S. Government Printing Office. 7 To be eligible for the 17-month OPT extension, a student must have received a degree in the following:

• Actuarial Science. NCES CIP Code 52.1304

• Computer Science: NCES CIP Codes 11.xxxx (except Data Entry/Microcomputer Applications, NCES CIP Codes 11.06xx)

• Engineering: NCES CIP Codes 14.xxxx

• Engineering Technologies: NCES CIP Codes 15.xxxx

• Biological and Biomedical Sciences: NCES CIP Codes 26.xxxx

• Mathematics and Statistics: NCES CIP Codes 27.xxxx

• Military Technologies: NCES CIP Codes 29.xxxx

• Physical Sciences: NCES CIP Codes 40.xxxx

• Science Technologies: NCES CIP Codes 41.xxxx

• Medical Scientist (MS, PhD): NCES CIP Code 51.1401

DHS will announce any future changes to the list on this Web site. Note that catch-all NCES CIP codes ending in “99” are not considered STEM designated degrees.

Students who wish to extend OPT must request that their DSO recommend the 17-month OPT extension. DSOs recommending the extension must verify the student's eligibility, certify that the student's degree is on the STEM Designated Degree Program List, and ensure that the student is aware of his or her responsibilities for maintaining status while on OPT. The DSO must make the recommendation to extend OPT for the student through SEVP's Student and Exchange Visitor Information System (SEVIS), a Web-enabled database for the collection of information related to F, M and J nonimmigrants, certified schools, and State Department approved exchange visitor programs. SEVP will implement an interim update to SEVIS to ensure schools can recommend extending the authorized OPT period for 17 months for qualified students. The changes will be minimal due to the short time for planning and the reduced testing cycle. SEVP is also planning a major SEVIS release in the first part of FY 2009 to more fully support the new regulatory requirements. SEVP will publish interim instructions for the period between the interim update and the major release and provide training opportunities for DSOs. SEVIS help desk personnel will provide assistance with the proper interim procedures.

Once the DSO recommends a student for the extension, the student must submit a Form I-765 and appropriate fees (as indicated in the form instructions) to USCIS. Instructions for filing the Form I-765 can be found at USCIS' Web site at http://www.uscis.gov.

This interim final rule also extends EADs for students with pending requests for extension of post-completion OPT. An F-1 student who has properly filed Form I-765 prior to the end date of his or her post completion OPT is allowed to maintain continuous employment for up to 180 days while USCIS adjudicates the request for the extension.

To implement the changes discussed in this rulemaking, USCIS is making conforming amendments to Form I-765 to ensure that that the F-1 students seeking a 17-month extension of their post-completion OPT are, in fact, eligible to do so. USCIS is amending this form to add, among other things, a new question #17 asking students to identify the degree they have received, so that USCIS may determine that the student has received a degree in a STEM field. The new Form I-765 also will ask the student seeking the extension to provide the name of their employer (as listed in E-Verify), and their employer's E-Verify Company I.D. number or, if the employer is using a Designated Agent to perform the E-Verify queries, a valid E-Verify Client Company I.D. number

As discussed above, only students who are employed by employers who have enrolled, and are determined by USCIS to be in good standing, in USCIS' E-Verify program will be eligible for the 17-month extension of post-completion OPT. The E-Verify program is an Internet-based system operated by USCIS, in partnership with the Social Security Administration (SSA). E-Verify is currently free to employers and is available in all 50 states, the District of Columbia, Puerto Rico, Guam, and the U.S. Virgin Islands. E-Verify electronically compares information contained on the Employment Eligibility Verification Form I-9 (herein Form I-9) with records contained in SSA and DHS databases to help employers verify identity and employment eligibility of newly-hired employees. This program currently is the best means available for employers to determine employment eligibility of new hires and the validity of their Social Security Numbers.

Before an employer can participate in the E-Verify program, the employer must enter into a Memorandum of Understanding (MOU) with DHS and SSA. This memorandum requires employers to agree to abide by current legal hiring procedures and to ensure that no employee will be unfairly discriminated against as a result of the E-Verify program. Violation of the terms of this agreement by the employer is grounds for immediate termination of its participation in the program.

Employers participating in E-Verify must still complete a Form I-9 for each newly hired employee, as required under current law. Following completion of the Form I-9, the employer must enter the newly hired worker's information into the E-Verify Web site, and that information is then checked against information contained in SSA and USCIS databases. E-Verify compares employee information against more than 425 million records in the SSA database and more than 60 million records stored in the DHS database. Currently, 93 percent of all employer queries are instantly verified as work authorized.

It is important to note that, once an employer enrolls in E-Verify, that employer is responsible for verifying all new hires, including newly hired OPT students with 17-month OPT extensions, at the hiring site(s) identified in the MOU executed by the employer and DHS. New hires must be verified to be authorized to work in the United States through E-Verify within three days of hire. If, however, an employer enrolls in E-Verify to retain the employment of an OPT student, the employer may not verify the employment eligibility of the OPT employee in E-Verify as the MOU prohibits the verification of existing employees. Additional information on enrollment and responsibilities under E-Verify can be found at http://www.uscis.gov/E-Verify.

Employers can register for E-Verify on-line at http://www.uscis.gov/E-Verify. The site provides instructions for completing the MOU needed to officially register for the program.

SEVP's ability to track nonimmigrant students in the United States relies on reporting by the students' DSOs. DSOs obtain the needed information from the school's recordkeeping systems and contact with the students. Students on OPT, however, are often away from the academic environment, making it difficult for DSOs to ensure proper and prompt reporting on student status to SEVP. While DHS regulations currently require DSOs to update SEVIS, the current reporting requirements depend entirely on the student's timely compliance. DSOs are not currently required to review and verify information reported by students on a recurring basis. This combination of factors hinders systematic reporting and SEVP's ability to track F-1 students during OPT.

Accordingly, DHS will only extend post-completion OPT for students employed by employers that agree to report when an F-1 student on extended OPT terminates or otherwise leaves his or her employment with the employer prior to end of the authorized period of OPT. The employer must report this information to the DSO of the student's school no later than 48 hours after the student leaves employment. Employers must report this information to the DSO at the student's school unless DHS announces another means to report such information through a Federal Register notice. The contact information for the DSO is on the student's Form I-20. DHS welcomes comments on possible means for directly reporting to DHS, such as through electronic means similar to or associated with the E-Verify platform.

Currently, F-1 students who are the beneficiaries of approved H-1B petitions, but whose period of admission (including authorized periods of post-completion OPT and the subsequent 60-day departure preparation period) expires before the H-1B employment start date, have a gap in authorized stay and employment between the end of their F-1 status and the beginning of their H-1B employment. This situation is commonly referred to as the “cap-gap.”

USCIS is authorized to extend the status of F-1 students caught in a cap gap between the end of the student's F-1 status and the start date on his or her approved H-1B petition. 8 8 CFR 214.2(f)(5)(vi). The current regulations, however, do not provide for a commensurate extension of students' employment authorization to cover the gap period. Additionally, the regulations currently provide that USCIS must determine that the H-1B cap will be met prior to the end of the “current” fiscal year before it may authorize an extension of stay for students subject to the cap gap for that fiscal year by means of a notice published in the Federal Register .

This interim rule expands the relief offered by the existing cap gap provision by first eliminating the limitation that cap gap relief be authorized only when the H-1B cap is likely to be reached prior to the end of the current fiscal year. This interim rule also removes the requirement that USCIS issue a notice in the Federal Register to announce the extension of status and instead allows an automatic extension of status and employment authorization for F-1 students with pending H-1B petitions. If USCIS denies a pending H-1B petition, the student will have the standard 60-day period (from notification of the denial or rejection of the petition) before they have to leave the United States.

Unlike the extension of post-completion OPT, which is limited to F-1 students who have obtained STEM degrees, the extension of status for ­F-1 students in a cap-gap applies to all ­F-1 students with pending H-1B petitions during a fiscal year.

Currently, students must apply for post-completion OPT prior to completing their course requirements. 8 CFR 214.2(f)(10)(ii)(A). This is inconsistent with other regulatory provisions allowing students to transfer, apply for a new degree program, or change to another nonimmigrant status during their 60-day post-completion departure preparation period. Problems also arise if students fail to complete their program after receiving authorization for post-completion OPT. Therefore, this rule allows students to apply for post-completion OPT during the 60-day departure preparation period.

DHS regulations currently define the period of an F-1 student's status as the time the student is pursuing a full course of study at an SEVP-certified school or engaging in authorized post-completion OPT. 8 CFR 214.2(f)(5). They do not specify how much time the student may be unemployed, making it difficult to determine when an unemployed student on post-completion OPT violates the requirements for remaining in ­F-1 status. As status during OPT is based on the premise that the F-1 student is working, there must be a limit on unemployment, just as the ­F-1 student's period in school is based on the premise that he is actually pursuing a full-time course of study, and there are limits on how often the student can reduce his course load. An F-1 student who drops out of school or does not pursue a full-time course of study loses status; an F-1 student with OPT who is unemployed for a significant period should similarly put his status in jeopardy. Therefore, this rule specifies an aggregate maximum allowed period of unemployment of 90 days for students on 12-month OPT. This maximum period increases by 30 days for F-1 students who have an approved 17-month OPT period. In addition to clarifying the student's status, this measure allows time for job searches or a break when switching employers.

To avoid a loss of skilled students through the next round of H-1B filings in April 2008, DHS is implementing this initiative as an interim final rule without first providing notice and the opportunity for public comment under the “good cause” exception found under the Administrative Procedure Act (APA) at 5 U.S.C. 553(b). The APA provides that an agency may dispense with notice and comment rulemaking procedures when an agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” See 5 U.S.C. 553(b)(B). The exception excuses notice and comment, however, in emergency situations, or where “the delay created by the notice and comment requirements would result in serious damage to important interests.” Woods Psychiatric Institute v. United States, 20 Cl. Ct. 324, 333 (1990), aff'd 925 F.2d 1454 (Fed. Cir. 1991); see also National Fed'n of Fed. Employees v. National Treasury Employees Union, 671 F.2d 607, 611 (D.C. Cir. 1982).

Currently, DHS estimates, through data collected by SEVP's Student and Visitor Exchange Information System (SEVIS), that there are approximately 70,000 F-1 students on OPT in the United States. About one-third have earned a degree in a STEM field. Many of these students currently are in the United States under a valid post-completion OPT period that was granted immediately prior to the conclusion of their studies last year. Those students soon will be concluding the end of their post-completion OPT and will need to leave the United States unless they are able to obtain an H-1B visa for FY09 or otherwise maintain their lawful nonimmigrant status. DHS estimates that there are 30,205 F-1 students with OPT expiring between April 1 and July 31 of this year. The 17-month extension could more than double the total period of post-completion OPT for F-1 students in STEM fields. Even if only a portion of these students choose to apply for the extension, this extension has the potential to add tens of thousands of OPT workers to the total population of OPT workers in STEM occupations in the U.S. economy.

This interim rule also provides a permanent solution to the “cap-gap” issue by an automatic extension of the duration of status and employment authorization to the beginning of the next fiscal year for F-1 students who have an approved or pending H-1B petition. This provision allows U.S. employers and affected students to avoid the gap in continuous employment and the resulting possible violation of status. This increases the ability of U.S. employers to compete for highly qualified employees and makes the United States more competitive in attracting foreign students. Based on the historical numbers of “cap-gap” students taking advantage of a Federal Register Notice extending F-1 status, ICE estimates that up to 10,000 students will have approved H-1B petitions with FY09 start dates. At the end of their OPT, these students must terminate employment and either depart the United States within 60 days or extend their F-1 status by enrolling in another course of study. Unless this rule, and the cap gap relief it affords, is implemented this Spring, all these students must interrupt their employment and those who leave the United States will not be allowed to return until the October 1, 2008 start date on their H-1B petitions.

The ability of U.S. high-tech employers to retain skilled technical workers, rather than losing such workers to foreign business, is an important economic interest for the United States. This interest would be seriously damaged if the extension of the maximum OPT period to twenty-nine months for F-1 students who have received a degree in science, technology, engineering, or mathematics is not implemented early this spring, before F-1 students complete their studies and, without this rule in place and effective, would be required to leave the United States.

Accordingly, DHS finds that good cause exists under 5 U.S.C. 553(b) to issue this rule as an interim final rule. DHS nevertheless invites written comments on this interim rule. Further, because this interim final rule relieves a restriction by extending the maximum current post-completion OPT period for certain students from 12 months to up to 29 months, DHS finds that this rule shall become effective immediately upon publication of this interim final rule in the Federal Register . 5 U.S.C. 553(d).

The Regulatory Flexibility Act (RFA) (5 U.S.C. 605(b)), as amended by the Small Business Regulatory Enforcement and Fairness Act of 1996 (SBRFA), requires an agency to prepare and make available to the public a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small governmental jurisdictions). RFA analysis is not required when a rule is exempt from notice and comment rulemaking under 5 U.S.C. 553(b). DHS has determined that this rule is exempt from notice and comment rulemaking pursuant to 5 U.S.C. 553(b)(B). An RFA analysis, therefore, is not required for this rule.

This is not a major rule, as defined by Section 804 of the Small Business Regulatory Enforcement Act of 1996. This rule will not result in an annual effect on the United States economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreign- based companies in domestic and export markets.

This proposed rule has been designated as a “significant regulatory action” under Executive Order 12866. This rule therefore has been submitted to OMB for review. In addition, under section 6(a)(3)(C) of the Executive Order, DHS has prepared an assessment of the benefits and costs anticipated to occur as a result of this regulatory action and provided the assessment to OMB for review. This assessment is as follows:

Recent numbers: This rule will have an impact on a small percentage of international students in the United States. According to the DHS Office of Immigration Statistics, an average of approximately 642,000 F-1 academic students, at all grade levels, have entered the United States per year in fiscal years 2004, 2005, and 2006. 9 According to the Institute of International Education, approximately 583,000 of these students are college students. 10 Of those, SEVP records indicate that close to 70,000 students currently participate in OPT and, of those, only about 23,000 are OPT participants who are studying in designated STEM fields. Thus, about 3.6 percent of F-1 students could potentially benefit from this rule. Nonetheless, as shown below, this may be a sufficient number to significantly benefit employers who are in need of workers in STEM-related fields.

OPT extension volume estimate: A reasonable estimate of the number of students who will participate in this new OPT 17-month extension program is difficult for a number of reasons, but DHS estimates that about 12,000 students will apply for an OPT extension after this rule takes effect. Of the 23,000 OPT students, however, about 4,000 have bachelor's degrees, 13,000 have master's degrees, and 6,000 have a doctorate. Anecdotal evidence indicates that foreign students with a master's or bachelor's degrees often continue as students and pursue more advanced degrees. DHS experience indicates that many of these students will be granted H-1B status and will not need an OPT extension, although actual records do not exist on the rates at which F-1 OPT participants actually receive an H-1B position. Additionally, some students will not request an OPT extension because they are returning to their home country, while many students will want to stay. According to a report from the Oak Ridge Institute for Science and Education, 65 percent of 2000 U.S. science and engineering doctoral degree recipients with temporary visas were still in the United States in 2005, up from a 61 percent 5-year stay rate found in 2003. 11 This implies that STEM students stay in the U.S. at a relatively high rate. And, finally, the changes made by this rule are expected to increase the attractiveness of the OPT program. Although a precise estimate of the effect is impossible, the OPT application volume is likely to increase at least a slight amount because of the impact of this rule on program flexibility, length of stay, and students' quality of life. Therefore, after considering these factors, DHS estimates that about 12,000 of the 23,000 students who could apply for the OPT extension allowed by this rule, will apply in an average year after this rule takes effect.

Fees. The fee for Form I-765 is $340. 8 CFR 103.7(b)(1). Thus, the new filing fees to be collected by USCIS from students requesting an employment authorization document as a result of this rule will be about $4.1 million. 12

Paperwork burden. The public reporting burden for completion of the Form I-765 information is estimated at 3 hours and 25 minutes per response, including the time for reviewing instructions, completing and submitting the form. As discussed below in the Paperwork Reduction Act section of this rule, this form is being amended to add a space for STEM students to provide their degree, the name of their employer, and their employer's E-Verify Company I.D. number or, if the employer is using a Designated Agent to perform the E-Verify queries, a valid E-Verify Company Client Company I.D. Number. Therefore, the 12,000 students requesting OPT will expend approximately 3.42 hours per application for a total of 41,040 burden hours per year. 13 Based on the private industry employer average compensation costs of $28.03 per hour worked, 14 this requirement will result in an estimated total cost of $1.15 million. 15

New burden. This rule adds to the current regulation's DSO and student reporting requirements. A student with a 17-month extension to post-completion OPT must also make a validation report to the DSO every six months starting from the date of the extension, within 10 business days, and ending when the student's F-1 status ends, if the student changes educational levels at the same school or the student transfers to another school or program. The validation is a confirmation that the student's information in SEVIS is current and accurate. The DSO is responsible for updating the student's record with SEVIS within 21 days. The DSO must also report in SEVIS when the employer of a student with the 17-month OPT extension reports that the student no longer works for that employer.

Also, this rule makes failure to report a basis for terminating the student's status and provides that failure to report can impact the future visa program and OPT eligibility of the school, employer, and student. Further, the school is required by this rule to report to SEVIS whether there have been any changes in the student's circumstances or not. Although the student is already required to report to the school DSO any changes in their address and their OPT employer's name and address, and the school is then required to report this information to SEVIS, program familiarity and anecdotal evidence indicates that full compliance is lacking. The increased incentives to comply with the reporting requirements provided in this rule will result in about 2.5 additional reports per student per extension period from students to schools and schools to SEVIS. Each report or update will require an estimated 10 minutes. Thus, for the 12,000 students and graduates expected to benefit from this rule, an additional reporting burden of 5,000 hours (12,000 × .42 hours) is estimated to occur for both the student and school for a total of 5,000 additional hours of burden. Based on the private industry employer average compensation costs of $28.03 per hour worked, 16 this requirement will result in an estimated total cost of $140,150 (5,000 hours × $28.03).

DHS has determined that the currently approved information collection burden for SEVIS contains a high enough estimate of that program's paperwork burden on program participants to encompass this rule's requirements because reporting requirements were already imposed, although not with the utmost clarity. Also, current regulations do not impose any penalty on a school or student for failure to report. SEVP will work with schools on the best way to implement this new reporting requirement so as to maximize its benefit while minimizing its burden on participating students and schools. SEVP is making conforming amendments to its approved information collection for SEVIS and has included the updated burden estimates. Public comments are especially welcome on these changes.

E-Verify Registration. This rule requires employers of F-1 students participating in the 17-month OPT extension to enroll in E-Verify. That will require the employer to register for E-Verify if they wish to hire an employee under the extended OPT. Less than 1 percent of the total number of employers in the United States are currently enrolled in E-Verify and a similar percentage of enrollment in E-Verify would be expected for OPT employers. Thus, DHS anticipates that most employers who would want to employ these students under the 17-month extension would need to register for E-Verify. 17

The time and cost associated with registering for E-Verify largely depends on the access method a company chooses. The vast majority of companies will sign up for employer access which requires approximately 3 to 4 hours for a person to register online, read and review the Memorandum of Understanding, and take the tutorial. A recent cost analysis for the E-Verify program looked at the associated costs for an organization to undertake the above tasks based on an average salary and the time required. According to this analysis, a company would spend an average of $170 per registration for the Employer Access method. This cost could increase if an employer chose to use a Designated Agent or Web Services as their access method. The Designated Agent costs can vary greatly and would be difficult to estimate as many employers contract with a Designated Agent to perform a variety of human resources related tasks. Web Services would also likely involve a significant cost and time to the employer as they would need to design their own software to interface with the E-Verify system.

DHS has no record of the numbers or identity of employers hiring students under OPT, no figures on those that hire students and also participate in E-Verify, no data on the average number of employees in such firms, and no data on the average number of employees hired by such firms for which the immigration status will have to be verified. However, since this rule is applicable only to STEM students and recent graduates, it is estimated that the employers and positions will be similar in characteristics to those hiring employees in the H-1B specialty worker program. In that program, USCIS records show that in FY 2007, about 29,000 different employers employed at least one of the 65,000 initial H-1B employees (based on employer identification number) with about 20,000 employing only one H-1B employee. Thus, employers hiring new H-1B employees in FY 2007 hired an average of 2.24 each. If the 12,000 students per year that DHS is estimating will receive an OPT extension are distributed along those same lines, as is expected, they will work for approximately 5,357 employers (12,000/2.24). Since about 1.0 percent of employers are already enrolled in E-Verify already, 5,300 employers are estimated to have to enroll in E-Verify as a result of this rule. At $170 per registration for the Employer Access method, the total initial enrollment costs from this rule would be $901,000. 18

At the end of registration, the company is required to read and sign a Memorandum of Understanding (MOU) that provides the terms of agreement between the employer, SSA, and USCIS. It is expected that each company will have a Human Resources manager review the MOU and that many companies will also have a lawyer and or a general manager review the MOU. Using the Bureau of Labor Statistics (BLS) estimates for the average hourly labor rate, plus a multiplier of 1.4 to account for fringe benefits, DHS calculated a labor rate of $48.33 for an HR manager, $60.93 per hour for a general manager, and $76.09 for legal counsel. 19 Based on the amount of time that company employees are expected to spend reviewing and approving the MOU, DHS estimates this rule will cost the 5,300 establishments that must enroll in E-Verify in order to hire OPT students about $64 each or a total of $339,200 to review, approve, and sign the MOU.

New hire verification. This rule will require the affected employers of students to verify the status of every new employee they hire using E-Verify. 20 To calculate this annual cost, DHS estimated the number of new employees hired by these employers in an average year. While there is no record of the average size of an employer of OPT students, it is assumed that the average monthly and annual employee hire rate for these employers is consistent with the average. An estimate of the average number of employees may be made based on the average number of employees per firm in industries where STEM employment is prevalent. The 2002 Economic Census  21 indicates that, as of 2002, in industries where STEM employment is most prevalent, 1.7 million firms have 26.5 million employees, or an average of 16 employees per firm. 22 According to the Bureau of Labor Statistics, the new hires rate (number of hires to the payroll during the month as a percent of total employment) in the industries where STEM employment is believed to be most prevalent was about 2.5 percent in February 2008. 23 Therefore, for 12 months, newly hired and rehired employees amount to about 30 percent (12 months × 2.5 percent monthly hire rate) of the total number of current employees in the STEM related industries. For an establishment with 16 employees, that hire rate would result in about 5 new hires per year.

To verify new hires, the E-Verify participant company must submit a query before the end of three business days after the new hire's actual start date. Based on the number of queries and case resolutions for the current E-Verify program from January through June of 2007, the time required to enter this information into the computer and submit the query, and the costs incurred by an employee to challenge occurrences of tentative nonconfirmation, DHS has calculated the combined costs incurred by an employer and prospective employee to verify each new hire to be about $6.36 per new hire. Thus, the annual public cost incurred for verification of new hires for the 5,300 employers affected by this rule is around $168,540 (5,300 × 5 × $6.36).

In summary, the total public cost of this rule requiring employers of F-1 students participating in the 17-month OPT extension to enroll in E-Verify will be $1,240,000 ($901,000 + $339,200) up front and $168,540 per year thereafter.

This rule requires no additional outlays of DHS funds. The requirements of this rule and the associated benefits are funded by fees collected from persons requesting these benefits. The fees are deposited into the Immigration Examinations Fee Account. These fees are used to fund the full cost of processing immigration and naturalization benefit applications and petitions and associated support services.

Improved U.S. competitive position for STEM students and employees. The primary benefits to be derived from allowing the extension of OPT relates to maintaining and improving the United States competitive position in the market. Over the past 20 years, there has been a sustained globalization of the STEM labor force, according to the National Science Board's “Science and Engineering Indicators 2008.” Increased globalization has turned the labor market for STEM workers into a worldwide marketplace. 24 Today, investment crosses borders in search of available talent, talented people cross borders in search of work, and employers recruit internationally. Slowing of the growth of the science and engineering labor force in the United States could affect both technological change and economic growth. As a result, the United States must be successful in the increasing international competition for immigrant and temporary nonimmigrant scientists and engineers. The employment-based immigrant visa ceiling makes it difficult for foreign students to stay in the United States permanently after their studies because long delays in the immigrant visa process usually makes it impractical to be directly hired with an immigrant visa. Though obtaining a nonimmigrant work visa like an H-1B is a much quicker process, the oversubscription of the H-1B program makes obtaining even temporary work authorization an uncertain prospect. Studies show that the most talented employees worldwide are increasingly unwilling to tolerate the long waits and uncertainty entailed in coming to work temporarily in or immigrating to the United States. Instead, they are going to Europe, Canada, Australia and other countries where knowledge workers face fewer immigration difficulties. 25 This rule will help ease this difficulty by adding an estimated 12,000 OPT students to the STEM-related workforce. With only 65,000 H-1B visas available annually, this number represents a significant expansion of the available pool of skilled workers.

Student's quality of life. The most significant qualitative improvement made by this rule is the enhancement related to improving the quality of life for participating students by making available an extension of OPT status for up to 17 months for certain students following post-completion OPT. Additionally, the changes to the cap gap provision for F-1 students will allow up to 10,000 students to remain in the United States and work while waiting to become an H-1B worker. These and similar changes made by this rule will significantly enhance the experience of the student who participates in the program by potentially allowing them more time and flexibility while considering employment in the United States. Students should experience much less stress about their need to comply with tight time frames or risk being out of status. These changes will result an increase in the attractiveness of the program.

This rule will cost students approximately $1.49 million per year in additional information collection burdens, $4,080,000 in fees, and cost employers $1,240,000 to enroll in E-Verify and $168,540 per year thereafter to verify the status of new hires. However, this rule will increase the availability of qualified workers in science, technology, engineering, and mathematical fields; reduce delays that place U.S. employers at a disadvantage when recruiting foreign job candidates; increase the quality of life for participating students, and increase the integrity of the student visa program. Thus, DHS has determined that the benefits of this rule to the public exceed its costs.

This rule 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. Therefore, in accordance with section 6 of Executive Order 13132, DHS has determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

Under the Paperwork Reduction Act of 1995, Public Law 104-13, all departments are required to submit to OMB, for review and approval, any reporting requirements inherent in a rule. To implement the changes discussed in this rulemaking, USCIS is making conforming amendments to Form I-765, Application for Employment Authorization (current OMB Control No. 1615-0040), which is used by students to apply for pre- and post-completion OPT. Specifically, this form is being amended to add a new question #17, asking STEM students to provide their degree, the name of their employer (as listed in E-Verify), and their employer's E-Verify Company identification number or, if the employer is using a Designated Agent to perform the E-Verify queries, a valid E-Verify Client Company identification number. The collection of this information is necessary to ensure that F-1 students seeking a 17-month extension of their post-completion OPT are, in fact, eligible to do so. E-Verify has been approved by OMB under OMB Control No. 1615-0092. USCIS will submit an OMB Correction Worksheet (OMB 83-C), increasing the number of respondents, for both Form I-765 and E-Verify (OMB Control No. 1615-0092).

To implement the changes discussed in this rulemaking, SEVP is making conforming amendments to its information collection for the Student and Exchange Visitor Information System (SEVIS; current OMB Control No. 1653-0038). This authorization encompasses all data collected to meet the requirements of the Student and Exchange Visitor Program (SEVP). This further includes completion of Forms I-20, Certificate of Eligibility for Nonimmigrant Student Status, which are updated and generated by SEVIS in the recommendation for employment authorization and tracking of activity. The reporting requirements in this rule will impact 3% of the total number of F-1 students, those who are eligible for the 29-month OPT option. Additions to the reporting burden include:

• DSO verification of student qualification for OPT and issuance of a Form I-20 recommending the 17-month extension of OPT for STEM students (five minutes per student applicant);

• Semiannual verification of student and employment information in SEVIS for all students with an approved 17-month extension of OPT (five minutes for both the student and a DSO per verification); and

• Updates to SEVIS records of about 25% of the students with an approved 17-month OPT who report a change in student name, student address, employer name, or employer address (five minutes for both the students and a DSO per verification).

• Updates by the DSO to SEVIS based on an estimated 600 reports by an employer that the student's employment has ended (five minutes for the reporting DSO).

On December 18, 2007, the FAA published in the Federal Register a notice of proposed rulemaking to establish Class D airspace at Georgetown, Texas (72 FR 71608). This action would improve the safety of IFR aircraft at Georgetown Municipal Airport, Georgetown, Texas. 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 D airspace designations are published in paragraph 5000 of FAA Order 7400.9R, signed August 15, 2007, and effective September 15, 2007, which is incorporated by reference in 14 CFR 71.1. The Class D 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 establishing Class D airspace at Georgetown, Texas. A new air traffic control tower has been installed at Georgetown Municipal Airport, making this action necessary for the safety and management of IFR aircraft operations at the airport.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. 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 that 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, describes 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 establishes controlled airspace at Georgetown Municipal Airport, Georgetown, Texas.

On January 18, 2008, the FAA published in the Federal Register a notice of proposed rulemaking to establish Class E airspace at Pagosa Springs, CO, (73 FR 3430). This action would improve the safety of IFR aircraft executing a new RNAV GPS SIAP approach procedure at Stevens Field, Pagosa Springs, CO. 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 7400.9R signed August 15, 2007, and effective September 15, 2007, which is incorporated by reference in 14 CFR part 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 establishing Class E airspace at Pagosa Springs, CO. Additional controlled airspace is necessary to accommodate IFR aircraft executing a new RNAV (GPS) approach procedure at Stevens Field, Pagosa Springs, CO.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. 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 that 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 FAAs 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 establishes controlled airspace at Stevens Field, Pagosa Springs, CO.

Intervet Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, DE 19966, filed NADA 141-280 that provides for use of ZILMAX (zilpaterol hydrochloride), and RUMENSIN (monensin USP), TYLAN (tylosin phosphate), and MGA (melengestrol acetate) Type A medicated articles to make dry and liquid four-way combination Type B and Type C medicated feeds used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii ; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium ( Actinomyces ) pyogenes ; and suppression of estrus (heat) in heifers fed in confinement for slaughter during the last 20 to 40 days on feed. The NADA is approved as of February 29, 2008, and the regulations in 21 CFR 558.342 and 558.665 are amended to reflect the approval.

In addition, FDA has noticed that the codified indications for use of tylosin in combination with melengestrol and lasalocid are not consistent with the conditions of use approved for an abbreviated new animal drug application (71 FR 39204, July 12, 2006). At this time, the indications for use are revised to include the associated pathogens. This action is being taken to improve the accuracy of the regulations.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(2) 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.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

The U.S. Army Rock Island Arsenal requested a temporary deviation for the Rock Island Railroad and Highway Drawbridge, Mile 482.9, at Rock Island, Illinois, across the Upper Mississippi to remain in the closed-to-navigation position as the drawbridge is part of the Annual Quad City Marathon route. The Rock Island Railroad and Highway Drawbridge currently operates in accordance with 33 CFR 117.5, which states the general requirement that drawbridges shall open promptly and fully for the passage of vessels when a request to open is given in accordance with the subpart. In order to facilitate the annual event, the drawbridge must be kept in the closed-to-navigation position. This deviation allows the bridge to remain in the closed-to-navigation position for four hours from 7:30 a.m. until 11:30 a.m., September 28, 2008.

There are no alternate routes for vessels transiting this section of the Upper Mississippi River.

The Rock Island Railroad and Highway Drawbridge, in the closed-to-navigation position, provides a vertical clearance of 23.8 feet above normal pool. Navigation on the waterway consists primarily of commercial tows and recreational watercraft. This temporary deviation has been coordinated with waterway users. No objections were received.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The U.S. Army Rock Island Arsenal requested a temporary deviation for the Rock Island Railroad and Highway Drawbridge, mile 482.9, at Rock Island, Illinois across the Upper Mississippi to remain in the closed-to-navigation position as the drawbridge is part of the Annual Quad Cities Heart Walk. The Rock Island Railroad and Highway Drawbridge currently operates in accordance with 33 CFR 117.5, which states the general requirement that drawbridges shall open promptly and fully for the passage of vessels when a request to open is given in accordance with the subpart. In order to facilitate the annual event, the drawbridge must be kept in the closed-to-navigation position. This deviation allows the bridge to remain in the closed-to-navigation position for two and one half hours from 8:30 a.m. until 11 a.m., May 17, 2008.

There are no alternate routes for vessels transiting this section of the Upper Mississippi River.

The Rock Island Railroad and Highway Drawbridge, in the closed-to-navigation position, provides a vertical clearance of 23.8 feet above normal pool. Navigation on the waterway consists primarily of commercial tows and recreational watercraft. This temporary deviation has been coordinated with waterway users. No objections were received.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Caltrans requested a temporary change to the operation of the Tower Drawbridge, mile 59.0, Sacramento River, at Sacramento, CA. The Tower Drawbridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw opens on signal from May 1 through October 31 from 6 a.m. to 10 p.m. and from November 1 through April 30 from 9 a.m. to 5 p.m. At all other times the draw shall open on signal if at least four hours notice is given, as required by 33 CFR 117.189. Navigation on the waterway is commercial and recreational.

The drawspan will be secured in the closed-to-navigation position 11 a.m. through 3 p.m. on April 12, 2008 to allow the public to participate in the Grand Opening Celebration of the newly refurbished drawbridge. This temporary deviation has been coordinated with waterway users. There are no scheduled river boat cruises or anticipated levee maintenance during this deviation period. No objections to the proposed temporary deviation were raised.

Vessels that can transit the bridge, while in the closed-to-navigation position, may continue to do so at any time.

In the event of an emergency the drawspan can be opened with 45 minutes advance notice.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

On February 7, 2008, we published a notice of proposed rulemaking (NPRM) entitled Safety zone, Colorado River, Parker, AZ in the Federal Register (73 FR 7231). We received no letters commenting on the proposed rule. No public hearing was requested, and none was held.

RPM Racing Enterprises is sponsoring the Bluewater Resort and Casino APBA National Tour/Regional Championship, which is held on the Lake Moolvalya region on the Colorado River in Parker, AZ. This temporary safety zone is necessary to provide for the safety of the participants, crew, spectators, sponsor vessels, and other users of the waterway.

This event involves powerboats racing along a circular track. The size of the boats varies from eight to 15 feet. Approximately 130 to 150 boats will participate in this event. The sponsor has provided two water rescue and two patrol vessels to patrol this event.

No changes will be made to the rule, since no comments were received.

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

We expect the impact of this rule to be so minimal that a full Regulatory Evaluation is unnecessary. The safety zone is of a limited duration, and is limited to a relatively small geographic area. A race Patrol Commander will be on-scene and will authorize recreational traffic when vessel movement is safe.

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 will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in a portion of the Colorado River, Parker, AZ from 6 a.m. to 6 p.m. on May 4, 2008. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons. This rule will be in effect for only twelve (12) hours in the day for a period of three (3) days. Before the effective period, we will submit an inclusion in the Local Notice to Mariners (LNM).

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), 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. If your small business or organization is affected by this rule, or if you have questions concerning its provisions or options for compliance, please contact MST3 Kristen Beer, Waterways Management, U.S. Coast Guard Sector San Diego at (619) 278-7233.

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).

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.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g) of the Instruction, from further environmental documentation.

A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES .

Table of Contents I. What Action Is EPA Taking? II. What Is the Background for EPA's Action? III. What Is the Effect of This Action? IV. What Is EPA's Analysis of North Carolina's Subarea VOC and NO X for the Triad Area? V. Final Action VI. Statutory and Executive Order Reviews I. What Action is EPA Taking?

EPA is taking direct final action to approve North Carolina's SIP revision submitted on February 4, 2008, which includes revisions to the subarea  1 2010, 2012, and 2015 MVEBs for VOC and NO X for the Triad Area because it meets all requirements of section 110 of the Clean Air Act (“CAA” or “Act”). These new MVEBs revise those established in a September 20, 2004 (69 FR 56163) direct final rulemaking entitled “Approval and Promulgation of Implementation of Plans; North Carolina: Raleigh/Durham Area and Greensboro/Winston-Salem/High Point Area Maintenance Plan Updates.” The revised subarea MVEBs are in the below tables:

This direct final rulemaking is in response to North Carolina's February 4, 2008, SIP submittal which supersedes North Carolina's December 20, 2007, submittal that included a request for parallel processing.

Under the CAA, states are required to submit, at various times, control strategy SIPs and maintenance plans for ozone attainment areas. These control strategy SIPs (reasonable further progress and attainment demonstration, etc.) and maintenance plans establish MVEBs for criteria pollutants and/or their precursors to address pollution from cars and trucks. Pursuant to 40 CFR part 93, an MVEB is established for the last year of the maintenance plan. A state may adopt MVEBs for other years as well. States also have the option to revise MVEBs at any time through a SIP revision. The MVEB is the portion of the total allowable emissions in the maintenance demonstration that is allocated to highway and transit vehicle use and emissions. See, 40 CFR 93.101. The MVEB serves as a ceiling on emissions from an area's planned transportation system. The MVEB concept is further explained in the preamble to the November 24, 1993, transportation conformity rule (58 FR 62188). The preamble also describes how to establish the MVEB in the SIP and how to revise the MVEB.

The Triad Area was designated as a nonattainment area for the 1-hour ozone national ambient air quality standard (“NAAQS” or “standard”) on November 6, 1991 (56 FR 56694). In 1993, after the area had three consecutive years, 1990-1992, of air quality data showing attainment of the standard, the State of North Carolina, through NCDENR, submitted a redesignation request and a maintenance plan for the Triad Area for the 1-hour ozone NAAQS. On September 9, 1993, EPA redesignated the Triad Area to attainment for the 1-hour ozone NAAQS and approved the 1-hour ozone maintenance plan (58 FR 47391).

Consistent with the CAA, ozone reductions are achieved by establishing NAAQS, such as the 1-hour and subsequent 8-hour ozone standard, and implementing the measures necessary to reduce ozone and its precursors. In the April 30, 2004, rulemaking entitled “Air Quality Designations and Classifications for the 8-Hour Ozone National Ambient Air Quality Standards; Early Action Compact Areas with Deferred Effective Dates” (69 FR 23858), EPA designated every county in the United States unclassifiable/attainment or nonattainment for the new 8-hour ozone standard. The Triad Area was designated as nonattainment with a deferred effective date as part of the Early Action Compact program. (For more information on the Early Action Compact—or EAC—Program, see, http://www.epa.gov/ttn/naaqs/ozone/eac/index.htm#RMNotices. ) One year after the effective date of these designations, June 15, 2005, the 1-hour ozone standard was revoked in most areas. However, the 1-hour ozone standard was not revoked for previous 1-hour nonattainment areas that are currently 8-hour EAC areas, such as the Triad Area, even if those areas were designated as attainment for the 1-hour ozone standard prior to the 8-hour ozone designations. 2

Currently, the Triad EAC Area is attaining the 8-hour ozone standard with a design value of 0.083 parts per million (ppm) using the latest three years of quality assured data for the years of 2005-2007. On February 6, 2008 (73 FR 6863), EPA proposed that 13 nonattainment areas, including the Triad Area, with deferred effective dates be designated attainment for the 8-hour ozone standard, because they have met all of the milestones of the EAC program and have demonstrated that they were in attainment of the 8-hour ozone NAAQS as of December 31, 2007. A final decision will be made on designations by April 15, 2008. EPA also proposed that one year after the effective date of these designations, the 1-hour ozone standard be revoked and the transportation conformity requirements no longer remain in effect.

On June 4, 2004, NCDENR submitted revisions to North Carolina's SIP to provide a 10-year update to the Triad Area's 1-hour ozone maintenance plan as required by section 175A(b) of the CAA. In addition to meeting the requirements of 175A(b), the revisions established subarea MVEBs for the Triad Area for the years 2004, 2007, 2010, 2012, and 2015. Some of these subarea MVEBs are currently being used by the transportation partners to demonstrate conformity, as approved in the September 20, 2004, rulemaking. The subarea MVEBs that are currently being used by transportation partners in the Triad Area are noted in the tables below:

The tables above showing the currently approved subarea MVEBs for the Triad Area reflect the total on-road emissions for 2010, 2012 and 2015, plus an allocation from the available VOC and NO X safety margins for each year. Pursuant to 40 CFR 93.101, the term “safety margin” is the difference between the attainment level (from all sources) and the projected level of emissions (from all sources) in the maintenance area. The safety margin can be allocated to the transportation sector; however, the total emissions must remain below the attainment level. These subarea MVEBs and the allocations from the safety margin were developed in consultation with the transportation partners and were added to account for uncertainties in population growth, changes in model vehicle miles traveled and new emission factor models. The allocated portion of the safety margins for the Triad Area that was approved in the September 20, 2004, rulemaking are as follows:

The total remaining VOC safety margins after allocating a portion of the safety margin to the subarea MVEBs for the Triad Area are 26.59 tons per day (tpd) in 2010, 26.41 tpd in 2012, and 25.50 tpd in 2015. The total remaining NO X safety margins after allocating a portion of the safety margin to the subarea MVEBs for the Triad Area is 58.61 tpd in 2010, 66.09 tpd in 2012, and 74.21 tpd in 2015. For more information on the total remaining safety margins, see the September 20, 2004, direct final rulemaking.

On February 4, 2008, the State of North Carolina, through NCDENR, submitted a request to revise the subarea MVEBs for the Triad 1-hour ozone maintenance area for the years 2010, 2012, and 2015. The new allocation of the safety margins to the subarea MVEBs is discussed in section IV of this direct final rulemaking.

Through the Triad Area's Interagency Consultation Group, which includes the North Carolina transportation and air quality partners, NCDENR identified a need for revised subarea MVEBs to allow for growth in the transportation sector. NCDENR, a partner of the Interagency Consultation Group, evaluated the option of revising the subarea MVEBs for the Triad Area and prepared a February 4, 2008, SIP revision to effectuate that option. The February 4, 2008, SIP revision was submitted to EPA for approval and requested a change to the subarea MVEBs by allocating a portion of the available safety margins to the subarea MVEBs. This allocation is discussed further in section of IV of this direct final rulemaking.

The subarea MVEBs for the Triad Area are established for each metropolitan planning organization (MPO), and in some instances, counties that are “donut areas.” The conformity rule defines a donut area as the portion of a metropolitan nonattainment or maintenance area that is located outside an MPO's planning boundary (40 CFR 93.101). Donut areas are not considered isolated rural nonattainment and maintenance areas under the transportation conformity rule.

The transportation conformity rule, specifically, 40 CFR 93.124(c) and (d), provide the regulatory mechanism for establishing and implementing subarea SIP MVEBs. In July 2004, EPA released a guidance document that provided additional details for implementing conformity in multi-jurisdictional areas, including establishing subarea SIP MVEBs in areas with multiple MPOs, entitled “Companion Guidance for the July 1, 2004 Final Transportation Conformity Rule Conformity Implementation in Multi-Jurisdictional Nonattainment and Maintenance Areas for Existing and New Air Quality Standards,” EPA 420A-B-04-012 (2004 Guidance). Although this guidance did not address the situation where subarea MVEBs are established for a donut area, such MVEBs may be established in a manner consistent with the requirements of the CAA that ensures that conformity determinations in the Triad Area will continue to meet federal conformity requirements.

Statutory and regulatory requirements regarding conformity may be met for the entire nonattainment or maintenance area if conformity is determined for every subarea SIP MVEBs at least every four years. Only by meeting all subarea SIP MVEBs can the SIP's overall purpose be met. CAA section 176(c) states that the federal government and MPOs cannot approve transportation activities unless they conform to the SIP and its SIP-approved MVEBs. See also, page 21 of the 2004 Guidance. In a nonattainment or maintenance area with more than one MPO, all MPOs must conform even if the SIP has established subarea MVEBs. EPA believes that this same legal standard applies in the case where the SIP establishes a subarea MVEBs for a donut area.

With regard to the February 4, 2008, revisions to the Triad 1-hour ozone maintenance area subarea MVEBs have been established for the Area's MPOs and donut areas. As a result, conformity determinations must be completed for all subarea MVEBs according to the statutory requirement to determine conformity at least every four years in areas with MPOs, transportation plans, and Transportation Improvement Programs (TIPs). MPOs must determine conformity to their respective transportation plans and TIPs every four years, and the interagency consultation process for the Triad Area should ensure that conformity is demonstrated for any subarea MVEBs for a donut area at least every four years as well. In the event that an MPO or donut area cannot demonstrate conformity on a four-year cycle, the other subareas cannot complete a conformity determination until all subareas conform. For further information regarding the conformity implications of not meeting subarea MVEBs, see pages 20-21 of the 2004 Guidance. The effect of this action will make new subarea MVEBs available to transportation partners in North Carolina.

In a June 4, 2004, SIP submittal, NCDENR, after interagency consultation with the transportation partners for the Triad Area, elected to develop county-level subarea MVEBs for VOC and NO X . In addition to other years, North Carolina developed these MVEBs, for the years 2010, 2012, and 2015 of its maintenance plan. The aforementioned MVEBs reflect the total on-road emissions for 2010, 2012 and 2015, plus an allocation from the available VOC and NO X safety margins for each year. Refer to the section II entitled “What is the Background for EPA's Proposed Actions?” of this rulemaking for further explanation of the safety margin. These MVEBs were approved into the SIP in the September 20, 2004, direct final rulemaking. On February 4, 2008, NCDENR submitted a SIP revision seeking to change the MVEBs that were approved in the September 20, 2004, SIP revision. The February 4, 2008, change is consistent with the CAA. The revised subarea VOC and NO X MVEBs for the Triad Area are defined in the revised MVEBs tables, Tables 1 through 4, in section I of this direct final rulemaking.

North Carolina has chosen to allocate a portion of the available safety margin to the 2010, 2012 and 2015 subarea VOC and NO X MVEBs. The following table identifies the amount of the safety margin that was allotted to the 2010, 2012 and 2015 VOC and NO X subarea MVEBs per the February 4, 2008, submittal:

The total remaining VOC safety margin after allocation of some of the safety margin to the subarea MVEBs for the Triad Area is 25.47 tpd in 2010, 25.67 tpd in 2012, and 24.43 tpd in 2015. The total remaining NO X safety margin after allocation of some of the safety margin to the subarea MVEBs for the Triad Area is 56.97 tpd in 2010, 63.48 tpd in 2012, and 71.84 tpd in 2015.

Through this rulemaking, EPA is approving the revised 2010, 2012 and 2015 subarea MVEBs for VOC and NO X for the Triad Area because EPA has determined that the Area maintains the 1-hour ozone standard with the emissions at the levels of the MVEBs and demonstrates that based upon expected emissions for all other source categories, the Triad Area will continue to maintain the 1-hour ozone standard.

As mentioned above, these MVEBs are subarea MVEBs for each individual county in the Triad Area. Once the new subarea MVEBs for the Triad Area (the subject of this rulemaking) are approved they must be used for future conformity determinations.

EPA is approving revisions to the 1-hour ozone maintenance plan for the Triad Area submitted by NCDENR on February 4, 2008. Tables 1-4, above, list the new MVEBs for VOC and NO X being approved in this action. Table 10, above, lists the new available safety margins being approved in this action. The safety margin was reallocated as described in section IV of this action.

Within 24 months from the effective date of this direct final rule or the date of publication for the final rule for this action, the transportation partners will need to demonstrate conformity to the new subarea MVEBs pursuant to 40 CFR 93.104(e). See, 73 FR 4419 (January 24, 2008).

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective June 9, 2008 without further notice unless the Agency receives adverse comments by May 8, 2008.

If EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on June 9, 2008 and no further action will be taken on the proposed rule.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will 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, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 9, 2008. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See, section 307(b)(2).)

I. Background

Section 129(a)(5) of the Clean Air Act (the Act) requires EPA to conduct a 5-year review of the solid waste incinerator new source performance standards (NSPS) and emission guidelines (EG) and revise both, as appropriate. Accordingly, in the May 10, 2006 edition of the Federal Register , EPA promulgated revised LMWC rules under sections 111 and 129 of the Act. EG for existing affected facilities are not federally enforceable. However, section 129(b)(2) of the Act requires States to submit to EPA for approval State Plans and revisions that implement and enforce the amended EG, in this case, 40 CFR part 60, subpart Cb. State Plans and revisions must be at least as protective as the EG, and become federally enforceable as a section 111(d)/129 plan revision upon approval by EPA. The procedures for adoption and submittal of State Plans and revisions are codified in 40 CFR Part 60, subpart B.

The required Maryland 111(d)/129 plan revision (#07-15) was submitted to EPA on October 24, 2007. EPA has reviewed the plan revision for existing LMWC units in the context of the requirements of 40 CFR part 60, and subparts B and Cb, as amended. State plans must include the following essential elements: (1) Identification of legal authority, (2) identification of mechanism for implementation, (3) inventory of affected facilities, (4) emissions inventory, (5) emissions limits, (6) compliance schedules, (7) testing, monitoring, recordkeeping, and reporting, (8) public hearing records, and (9) annual state progress reports on facility compliance.

Title 40 CFR 60.26 requires the plan to demonstrate that the State has legal authority to adopt and implement the emission standards and compliance schedules. The initial LMWC plan submittal demonstrates that the MDE has the legal authority to adopt and implement a plan.

The subpart B provision at 40 CFR 60.24(a) requires that state plans include emissions standards, defined in 40 CFR 60.21(f) as “* * * a legally enforceable regulation setting forth an allowable rate of emissions into the atmosphere, or prescribing equipment specifications for control of air pollution emissions.” The MDE Code of Maryland Regulations (COMAR) for LMWC units has been amended to incorporate revisions to subpart Cb. These amendments to Regulations .01, .02 and .08 under COMAR 26.11.08, Control of Incinerators, were adopted September 12, 2007 and became effective on October 8, 2007. Other applicable and effective supporting air program rules were identified in EPA's initial plan approval. (64 FR 19919). These rules collectively met the requirement of 40 CFR 60.24(a) to have a legally enforceable emission standard.

Title 40 CFR 60.25(a) requires the plan to include a complete source inventory of all LMWC units. The MDE has identified two (2) affected facilities—Wheelabrator Baltimore, L.P., and Montgomery County Resource Recovery Facility. An unknown affected facility is not exempt from applicable 111(d)/129 requirements because it is not listed in the source inventory.

Title 40 CFR 60.25(a) requires that the plan include an emissions inventory that estimates emissions of the pollutant regulated by the EG. Emissions from MWC units contain organics (dioxin/furans), metals (cadmium, lead, mercury, particulate matter, opacity), and acid gases (hydrogen chloride, sulfur dioxide, and nitrogen oxides). For each affected MWC facility, the MDE plan revision contains MWC unit emissions rates for each regulated pollutant based on 2006 and 2007 stack test and continuous emission monitoring data. This meets the emission inventory requirements of 40 CFR 60.25(a).

Title 40 CFR 60.24(c) specifies that the State plan or revision must include emission standards that are no less stringent than the EG, except as specified in 40 CFR 60.24(f) which allows for less stringent emission limitations on a case-by-case basis if certain conditions are met. This exception clause is superseded by section 129(b)(2) of the Act which requires that state plans be “at least as protective” as the EG. A review of COMAR 26.11.08.08 emissions limitations shows that all are “at least as protective” as those in the EG, subpart Cb, as amended.

Under 40 CFR 60.24(c) and (e), a state plan must include an expeditious compliance schedule that owners and operators of affected MWC units must meet in order to comply with the requirements of the plan. The plan revision and related COMAR 26.11.08.08 rule amendments contain a compliance schedule, consistent with subpart Cb requirements, with specific increments of progress for meeting the revised and more stringent emission limitations. § 60.24(e)(1) requires that compliance schedules extending more than 12 months from the date required for submittal of the plan must include legally enforceable increments of progress. The required state plan revision was due at EPA on May 10, 2007. Accordingly, the submitted plan revision contains increments of progress which require full facility compliance by a date no later than April 28, 2009, assuming an extensive emission control system upgrade is not required. This requirement does not preclude an affected facility from demonstrating full compliance prior to April 28, 2009. In the case where an extensive emission control system upgrade is required, the facility's first increment of progress is to complete a control system and cost analysis by April 1, 2008; if that is the case, full compliance is then required by March 10, 2011. The state plan revision meets applicable Federal requirements.

The provisions of subpart B, 40 CFR 60.24(b) and 60.25(b), stipulate facility testing, monitoring recordkeeping and reporting requirements for state plans. COMAR 26.11.08.08 has also been amended to be consistent with EPA's May 10, 2006 EG amendments, subpart Cb, relating to source testing, monitoring, recordkeeping and reporting requirements.

A public hearing on the plan revision was held August 8, 2007. Applicable portions of COMAR 26.11.08.01, .02, and .08 amendments became effective on October 8, 2007. The state provided evidence of complying with public notice and other hearing requirements, including a record of public comments received. The MDE has met the requirement of 40 CFR 60.23 for a public hearing.

The MDE will submit to EPA on an annual basis a report which details the progress in the enforcement of the plan in accordance with 40 CFR 60.25. Accordingly, the MDE will submit annual reports on progress in plan enforcement to EPA on an annual (calendar) basis, commencing with the first full report period after plan revision approval.

Based upon the rationale discussed above and in further detail in the technical support document (TSD) associated with this action, EPA is approving the Maryland plan revision and related COMAR 26.11.08 Regulation, Control of Incinerators, amendments to .01, .02, and .08, as adopted September 12, 2007. This approval excludes certain authorities retained by EPA, and as stated in 40 CFR 60.30b(b) and 60.50b(n). As required by 40 CFR 60.28(c), any revisions to the Maryland plan or supporting regulations will not be considered part of the applicable plan until submitted by the MDE in accordance with 40 CFR 60.28(a) or (b), as applicable, and until approved by EPA in accordance with 40 CFR part 60, Subpart B, requirements.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. This action simply reflects already existing Federal requirement for state air pollution control agencies and existing LMWC units that are subject to the provisions of 40 CFR part 60, subpart Cb and related subpart Eb. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the section 111(d)/129 plan revision should relevant adverse or critical comments be filed. This rule will be effective June 9, 2008 without further notice unless EPA receives adverse comments by May 8, 2008. If EPA receives adverse comments, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule did not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

Under the Clean Air Act, the Administrator is required to approve a 111(d)/129 plan submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing 111(d)/129 plan submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

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

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

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

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

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

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

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

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

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

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the 111(d)/129 plan is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 9, 2008 . Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Entities Potentially Affected by This Rule. Categories and entities potentially affected by this rule include:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be impacted by this rule. This table lists examples of the types of entities EPA is now aware could potentially be regulated by this action. Other types of entities not listed could also be affected. To determine whether your facility, company, business, organization, etc., is affected by this rule, you should examine the applicability criteria in 40 CFR 63.1200. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

How Do I Obtain a Copy of This Document and Other Related Information? In addition to being available in the docket, an electronic copy of today's rule will also be available on the on the World Wide Web. Following the Administrator's signature, a copy of this document may be posted at http://www.epa.gov/hwcmact . This Web site also provides other information related to the NESHAP for hazardous waste combustors including the NESHAP issued on October 12, 2005 (70 FR 59402).

Judicial Review. Under section 307(b)(1) of the Clean Air Act, judicial review of the final action is available only by filing a petition for review in the United States Court of Appeals for the District of Columbia Circuit by June 9, 2008. Section 307(d)(7)(B) of the CAA provides that “[o]nly an objection to a rule or procedure which was raised with reasonable specificity during the period for public comment (including any public hearing) may be raised during judicial review.” This section also provides a mechanism for us to convene a proceeding for reconsideration, “[i]f the person raising an objection can demonstrate to the EPA that it was impracticable to raise such objection within [the period for public comment] or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule.” Any person seeking to make such a demonstration to us should submit a Petition for Reconsideration to the Office of the Administrator, U.S. EPA, Room 3000, Ariel Rios Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460, with a copy to both the person listed in the preceding FOR FURTHER INFORMATION CONTACT section, and the Associate General Counsel for the Air and Radiation Law Office, Office of General Counsel (Mail Code 2344A), U.S. EPA, 1200 Pennsylvania Ave., NW., Washington, DC 20004. Moreover, under section 307(b)(2) of the CAA, the requirements established by the final action may not be challenged separately in any civil or criminal proceedings brought by EPA to enforce these requirements.

Organization of This Document. The information presented in this preamble is organized as follows:

Section 112(c) of the Clean Air Act requires EPA to list categories and subcategories of major sources and area sources of hazardous air pollutants (HAP) and to establish NESHAP for the listed source categories and subcategories. Hazardous waste combustors include incinerators, cement kilns, lightweight aggregate kilns, boilers, and hydrochloric acid production furnaces that burn hazardous waste. EPA's initial list of categories of major and area sources of HAP was published on July 16, 1992 (57 FR 31576). Hazardous waste incinerators, Portland cement manufacturing, clay products manufacturing (including lightweight aggregate kilns), industrial/commercial/institutional boilers and process heaters, and hydrochloric acid production furnaces were among the listed categories of sources. Major sources of HAP are those sources that have the potential to emit at least 10 tons per year of any one HAP or 25 tons per year of any combination of HAP.

The final rule was published on October 12, 2005 (70 FR 59402) and codified in 40 CFR part 63, subpart EEE. Following publication of the final rule, two industry trade associations identified a number of typographical errors and suggested several potential compliance and monitoring amendments and clarifications to the rule. 1 On September 6, 2006, we published proposed amendments (71 FR at 52639) to address these issues and sought public comment on the proposed amendments. 2 EPA received comments from five entities. Today's action presents EPA's responses to those comments and promulgates amendments to Subpart EEE of 40 CFR part 63.

In today's notice, we are announcing our final action on several amendments to Subpart EEE of 40 CFR part 63. The amendments revise several compliance and monitoring provisions in response to questions and issues raised by entities affected by the rule. The revised provisions are effective immediately, and today's final rule does not change the October 14, 2008 compliance date established by the October 12, 2005 final rule. See also Section III (Time Lines for compliance activities) in today's action. Sources can readily comply with the revised provisions promulgated today within the compliance time frames established by the October 12, 2005 final rule. See § 63.1206(a).

In the September 6, 2006 proposal, we proposed several corrections and clarifications to the NESHAP for hazardous waste combustors. 71 FR at 52639-642, 52645-646. We received no adverse comments on the majority of the corrections and clarifications (see Table 1 below). Therefore, we are promulgating those provisions, as proposed, without further discussion. 3 The reader is referred to the September 2006 proposed rule for background on these changes.

We also received no adverse comment on the proposed amendments described in Section V.G (Calculating Rolling Averages for Averaging Periods in Excess of 12 Hours) of the September 6, 2006 preamble citation. That discussion described our intent to simplify the monitoring requirements for sources that select mercury or semivolatile metal feedrate limits averaged over periods greater than 12 hours. As described in the preamble, this would require identical changes to four paragraphs of the regulation: §§ 63.1209(n)(2)(v)(A)( 2 )( iv ), 63.1209(n)(2)(v)(A)( 3 )( v ), 63.1209(l)(1)(ii)(B)( 5 ), and 63.1209(l)(1)(ii)(C)( 5 ). However, corresponding regulatory changes to the latter three paragraphs were inadvertently omitted from the September 2006 proposed rule. In today's rule, we are correcting this oversight by promulgating the language proposed for § 63.1209(n)(2)(v)(A)( 2 )( iv ) in all four paragraphs.

a. Summary of the Final Action. We are revising §§ 63.1209(n)(2)(v)(B)( 1 ), 63.1209(n)(2)(v)(B)( 2 ), and 63.1209(o)(1)(ii)(A)( 3 ) as proposed on September 6, 2006. 71 FR at 52640. These changes are intended to clarify that data for demonstrating compliance with feed rate limits of up to a 12-hour rolling average must be updated each minute. In addition, § 63.1209(n)(2)(v)(B)( 1 )( i ) is modified to confirm that the chromium feed rate limit for boilers burning liquid hazardous waste with a heating value of 10,000 Btu/lb or greater is a 12-hour rolling average limit.

b. What Are the Responses to Major Comments?

Comment: We received two comments on this topic. One supported the changes as proposed. The other commenter objected to updating the 12-hour average every minute rather than every hour, arguing that this complicates data management and could require increased data storage.

Response: We believe that complications to data management or increases in data storage requirements, if any, are negligible. Phase I sources—incinerators, cement kilns, and lightweight aggregate kilns—have been complying with 12-hour averages updated each minute for several years without significant problems. Furthermore, data storage is not measurably affected. These continuous monitors are required to record a data point at least once each minute, regardless of the whether the rolling average value for determining compliance is updated each minute or each hour. Consequently, the amount of recorded data is not significantly affected under either approach to calculating the rolling average.

Phase I sources have been required to update their 12-hour rolling average feed rate data each minute ever since the hazardous waste combustor MACT rule was first promulgated in 1999. A “rolling average” was defined in that rule as “the average of all one-minute averages over the averaging period.” That definition has remained the same through the interim standards (for Phase I sources) and the replacement standards. We have consistently interpreted the definition to require that a new rolling average be calculated each minute. See, for example, the preamble discussion in the September 30, 1999 rule which says, while discussing how to calculate rolling averages upon initial startup, “Given that the one-hour, and 12-hour rolling averages for limits on various parameters must be updated each minute * * *” 64 FR at 52924.

In the 2004 replacement standards proposed rule, we first introduced the concept of hourly updates to rolling averages, but only in the context of monitoring compliance with annual rolling average feed rate limits. See 69 FR at 21312. At no time did we discuss or propose any change to the long-standing requirement that rolling averages of 12 hours or less be updated each minute. In fact, we reiterated the requirement for one-minute updates in discussing how compliance with the 12-hour thermal feed rate limits would be monitored. In that discussion we said that “For compliance, you would continuously monitor the feed rate of hazardous waste on a 12-hour rolling average updated each minute or, for standards based on normal emissions, on an annual rolling average updated each hour.” Id. at 21312.

Given that we have consistently required rolling averages of 12 hours or less to be updated each minute and we have never discussed or proposed any changes to that approach, we find ample evidence that the addition of hourly updates for these parameters in the final replacement standards were, as we asserted in the proposed rule, inadvertent. Furthermore, we find no support for the commenter's claim that data management or data storage requirements are significantly affected under either approach. Therefore, we have removed the references to hourly updates, as proposed.

a. Summary of the Final Action. We proposed to revise the particulate matter standards expressed in English units (gr/dscf) in §§ 63.1216 through 63.1221 by converting and expressing the standards using the International System of Units (SI). 71 FR at 52641. However, after considering the comments received in response to the proposed rule, we are not revising the standards as proposed. Thus, we are retaining the format of the particulate matter standards as promulgated in the October 12, 2005 final rule.

b. What Are the Responses to Major Comments?

Comment: We received three comments on this topic. One supported revising the particulate matter standards by expressing all particulate matter standards in SI units as proposed. Two other commenters opposed the proposed revisions because converting a standard from gr/dscf to mg/dscm and rounding to two significant figures can increase (and apparently does for at least one affected source) the stringency of the standard.

Response: Given that the proposed conversion to SI units can increase the stringency of the promulgated standard in some instances, we are not revising the particulate matter standards as proposed. We do not believe the proposed revisions are appropriate because a source currently complying with the standard expressed in English units could find itself suddenly out of compliance if the standard were converted to SI units, after rounding the result to two significant figures. We believe this would be an inappropriate outcome for this “housekeeping” amendment.

a. Summary of the Final Action. We proposed several corrections to the NIC regulatory provisions for new units to accurately reflect the time frames for holding the informal public meeting and submitting a final NIC. See 71 FR at 52645-646. Specifically, we made corrections to the time line (Figure 2; 71 FR at 52644), and proposed to revise § 63.1210(b)(3) and (c)(1), which are the core requirements for the informal public meeting and final NIC. We explained that it was our intent to clarify that existing units' NIC deadlines were based upon the effective date of the rule (e.g., “* * * no later than one year following the effective date * * *”), whereas new units” NIC deadlines were based upon a set number of days between NIC compliance activities (e.g., “* * * or 60 days following the informal public meeting”). This was necessary because the final rule effective date has no bearing on new units. We further explained that since the public meetings for the NIC and the RCRA pre-application are to occur simultaneously for new units, we anticipate new units will plan accordingly and work with their permitting authorities to determine the most suitable time to begin the NIC compliance process.

Today we are amending § 63.1210(b)(3) and (c)(1) to accurately reflect the time frames for holding the informal public meeting and submitting a final NIC for new units. However, the amendments are not finalized as proposed, but rather were revised to reflect a comment we received (see below). We are now further subdividing the paragraphs to explicitly differentiate between “existing units” and “new units.” Also, to further clarify that new units are subject to the same NIC requirements, we have added a new paragraph (b)(5) to § 63.1212 with respect to the final NIC. While it essentially mirrors § 63.1210(b)(3), we believe it is important to clearly indicate all applicable NIC provisions for new units in § 63.1212.

b. What Are the Responses to Major Comments?

Comment: One comment was received in response to the proposed amendments. The commenter noted that the proposed § 63.1210(c)(1) language retains the 10 month deadline, but also requires that the meeting must be held no later than 30 days following the notice. The 30 day advance notice language of § 63.1210(c)(3) was retained. This puts the facility in a position of having to issue the public notice precisely 30 days before the public meeting (i.e., facilities have two 30 day deadlines, one working backward from the meeting date and one working forward from the notice date). The commenter suggested that the requirements for new units and existing units be presented as two separate paragraphs to better represent the timelines for each.

Response: We agree with the commenter. The few words added to § 63.1210(c)(1) do not clearly differentiate between existing and new units' NIC deadlines. The reference in § 63.1210(c)(1) to the “* * * no later than 10 months after the effective date * * *” was intended only for existing units and the proposed reference to “* * * or 30 days following notice * * *” was intended only for new units. The way the paragraph reads gives the appearance that both references may be applicable to all units. Therefore, if one reads the 30 day reference in § 63.1210(c)(1) to also apply to existing units, along with the 30 day reference which was retained in § 63.1210(c)(3), it creates the situation which the commenter correctly identifies.

We have subdivided § 63.1210(c)(1) (as well as § 63.1210(b)(3)) to clearly designate applicability for existing and new units as the commenter suggests. Section 63.1210(c)(1) is revised to require the informal public meeting for new units to be held no earlier than 30 days following notice of the informal meeting, as opposed to no later than 30 days following the notice. Also, we have revised § 63.1212(b)(4) to state that the informal public meeting must be held no earlier than 30 days following notice of the meeting, so that it is consistent with § 63.1210(c)(1). Finally, as noted above, a new paragraph (b)(5) is added to § 63.1212 regarding submission of the final NIC.

This action also corrects a ministerial error by EPA that lead to inadvertent revision of § 63.1206(c)(2)(v). In a 2006 final rule amending the Part 63 general provisions, EPA made conforming changes to many individual MACT standards that merely incorporate the startup, shutdown and malfunction (SSM) requirements of the general provisions. 71 FR 20446 (April 20, 2006). In doing so, EPA inadvertently revised the SSM provisions tailored specifically for HWC facilities. Today, we are correcting that inadvertent error. Accordingly, we are revising § 63.1206(c)(2)(v)(A)( 2 ) and (c)(2)(v)(B)( 4 ) so that they read as they did before the April 20, 2006 revisions.

In the September 2006 proposed rule, we noted several errors in the time lines published in the October 12, 2005 final rule. See 70 FR 59524-525 and 71 FR at 52642-644. Consequently, we revised the time lines, Figures 1 and 2, to reflect the correct dates and time frames associated with compliance activities for Phase 1 (i.e., incinerators, cement kilns, and lightweight aggregate kilns) and Phase 2 sources (i.e., liquid and solid fuel boilers and hydrochloric acid production furnaces). In addition, we discussed the time line revisions and why the changes were necessary, as well as providing some clarifying remarks.

We did not receive any public comments on the revised time lines that were published in the proposed rule. For the reader's convenience, we are publishing the time lines again in today's final rule. Please refer to the proposal for the accompanying discussion of the time lines. 71 FR at 52642-643.

A description of the affected source categories is discussed in the April 20, 2004 proposed rule. 69 FR at 21207-09. In the October 12, 2005 final rule, we estimated that there are a total of 267 sources subject to the rule requirements, including 116 boilers (104 liquid fuel boilers and 12 solid fuel boilers), 92 on-site incinerators, 25 cement kilns, 15 commercial incinerators, 9 lightweight aggregate kilns, and 10 hydrochloric acid production furnaces. 70 FR at 59530. While we are aware of several changes to the universe of operating hazardous waste combustors, these estimates remain a reasonable representation of existing operating sources. 4

The rule amendments do not change any of the impacts presented in the preamble to the October 12, 2005 final rule. See 70 FR at 59529-35.

This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to OMB review.

This action does not impose any new information collection burden because there is no additional burden on affected sources as a result of the final rule. However, the Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations (see 40 CFR part 9) under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2050-0171, EPA ICR number 1773.08. A copy of the OMB approved Information Collection Request (ICR) may be obtained by writing to: Director, Collection Strategies Division; U.S. Environmental Protection Agency (2822T); 1200 Pennsylvania Ave., NW., Washington, DC 20460 or by calling (202) 566-1700.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. As discussed in the October 12, 2005 final rule (which today's final rule amends), we determined that hazardous waste combustion facilities are not owned by small governmental jurisdictions or nonprofit organizations. 70 FR at 59538. Therefore, in that rule only small businesses were analyzed for small entity impacts (a small entity was defined either by the number of employees or by the dollar amount of sales). We found that few—a total of eight out of 145 facilities—of the sources affected by the October 2005 rule were owned by small businesses. Finally, our analysis indicated that none of these facilities are likely to incur annualized compliance costs greater than one percent of gross annual corporate revenues. Cost impacts were found to range from less than 0.01 percent to 0.46 percent of annual gross corporate revenues. 70 FR at 59538.

Although this final rule will not have a significant economic impact on a substantial number of small entities, EPA nonetheless has tried to reduce the impact of this rule on small entities. We note that today's final rule does not alter the number or type of small businesses that were discussed in the October 12, 2005 final rule. Additionally today's rule does not have any significant new regulatory requirements as compared to the requirements discussed in the October 12, 2005 final rule.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

EPA has determined that this rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. This is because today's final rule does not add new requirements that would increase the costs of the original NESHAP for hazardous waste combustors. The NESHAP was published on September 30, 1999, and October 12, 2005, and had aggregated annualized social costs between $50 to $63 million (64 FR at 53022) and $22.6 million (70 FR at 59538), respectively. Thus, today's final rule is not subject to the requirements of sections 202 and 205 of the UMRA. In addition, EPA has determined that this final rule does not significantly or uniquely affect small governments because it contains no requirements that apply to such governments or impose obligations upon them. Therefore, this final rule is not subject to section 203 of the UMRA.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

This final rule does not have federalism implications. The final rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because State and local governments do not own or operate any sources that would be subject to the requirements of the final rule and as such would not bear substantial costs of effects. Thus, Executive Order 13132 does not apply to this rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have tribal implications, as specified in Executive Order 13175, because tribal governments do not own or operate any sources subject to today's action. Thus, Executive Order 13175 does not apply to this rule.

Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any rule that: (1) is determined to be “economically significant” as defined under EO 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

EPA interprets Executive Order 13045 as applying to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Order has the potential to influence the regulation. This final rule is not subject to Executive Order 13045 because it is based solely on technology performance and not on health or safety risks. Furthermore, this final rule is not considered “economically significant” as defined under EO 12866.

This rule is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Further, we have concluded that this rule is not likely to have any adverse energy effects.

As noted in the proposed rule, Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This action involves technical standards. During the development of the final rule, EPA searched for voluntary consensus standards that might be applicable. EPA adopted the following standards as practical alternatives to specified EPA test methods in the final rule: (1) American Society for Testing and Materials (ASTM) D6735-01, “Standard Test Method for Measurement of Gaseous Chlorides and Fluorides from Mineral Calcining Exhaust Sources—Impinger Method,” and (2) American Society of Mechanical Engineers (ASME) standard QHO-1-2004, “Standard for the Qualification and Certification of Hazardous Waste Incinerator Operators.”

Section 63.1208 lists the test methods to determine compliance with the emission standards in the final rule. Under § 63.7(f) of the general provisions, a source may apply to EPA for permission to use alternative test methods in place of any required testing method, performance specification, or procedure.

Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because the provisions contained within do not affect the level of protection to human health of the environment. The final amendments to the hazardous waste combustor NESHAP (40 CFR part 63 subpart EEE) are comprised of clarifications and revisions to current compliance and monitoring provisions that do not affect the current level of control at facilities subject to these rules.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This final rule will be effective on April 8, 2008.

All sea turtles that occur in U.S. waters are listed as either endangered or threatened under the Endangered Species Act of 1973 (ESA). The Kemp's ridley ( Lepidochelys kempii ), leatherback ( Dermochelys coriacea ), and hawksbill ( Eretmochelys imbricata ) sea turtles are listed as endangered. The loggerhead ( Caretta caretta ) and green ( Chelonia mydas ) sea turtles are listed as threatened, except for breeding populations of green turtles in Florida and on the Pacific coast of Mexico that are listed as endangered. Due to the inability to distinguish between these populations of green turtles away from the nesting beach, NMFS considers green sea turtles endangered wherever they occur in U.S. waters. Kemp's ridley, hawksbill, loggerhead, and green sea turtles are hard-shelled sea turtles. The incidental take, both lethal and non-lethal, of loggerhead, Kemp's ridley, and unidentified hard-shelled sea turtles has been documented in the sea scallop dredge fishery, as well as a non-lethal take of a green sea turtle (NEFSC FSB, Observer Database). In addition, an unconfirmed take of a leatherback sea turtle was reported during the experimental fishery to test the chain-mat modified dredge gear (DuPaul et al. , 2004).

This action is being taken under the ESA provisions authorizing the issuance of regulations to conserve threatened species and for enforcement purposes (sections 4(d) and 11(f), respectively). The requirement to use chain-mat modified dredge gear is necessary to provide for the conservation of threatened loggerhead sea turtles, and will have ancillary benefits for other sea turtle species that have been taken in the sea scallop dredge fishery, albeit to a lesser extent than loggerheads. Under the ESA and its implementing regulations, taking endangered sea turtles—even incidentally—is prohibited. The incidental take of endangered species may only legally be exempted by an incidental take statement (ITS) or an incidental take permit issued pursuant to section 7 or 10 the ESA, respectively. Existing sea turtle conservation regulations at 50 CFR 223.206(d) exempt fishing activities and scientific research from the prohibition on takes of threatened species under certain conditions. Any incidental take of threatened loggerhead sea turtles in sea scallop dredge gear in compliance with this gear modification requirement and other applicable requirements is exempted from the prohibition against takes.

The chain-mat modified dredge is expected to benefit sea turtles following an interaction in the water column. Based on the available information, NMFS has determined that the use of a chain-mat modified dredge will prevent most captures of sea turtles in the dredge bag as well as any ensuing injuries as a result of such capture (e.g., crushing in the dredge bag, crushing on deck, etc.). However, NMFS has made the conservative assumption that a turtle in a bottom interaction sustains significant injuries on the bottom, so, under this conservative assumption, there would not be a benefit from the chain mat for bottom interactions. This assumption, however, may be too conservative in that it is possible (although not likely) that turtles in a bottom interaction only receive minor injuries. In the unlikely scenario of a turtle receiving only minor injuries following a bottom interaction, the chain mat modification would prevent significant injuries that result from capture in the dredge bag (i.e, injuries from debris in the bag, drowning from forced submergence, dropping on deck, or crushing by the dredge). Additional information on the background, affected environment, and environmental consequences of this action is included in the preamble to the proposed rule (72 FR 63537, November 9, 2007) and in the Final Environmental Assessment (EA) for this aciton.

This final rule will (1) clarify the requirements related to the use of chain mats in the Atlantic sea scallop dredge fishery, (2) add a transiting provision, and (3) address a procedural error in the August 2006 rulemaking (71 FR 50361, August 25, 2006) that required the use of chain-mat modified dredges in the Atlantic sea scallop fishery.

Specifically, this action requires any vessel with a sea scallop dredge and required to have a Federal Atlantic sea scallop fishery permit, regardless of dredge size or vessel permit category, that enters waters south of 41° 9.0′ N. latitude from the shoreline to the outer boundary of the EEZ, to modify their dredge(s) with a chain mat. The chain mat must be composed of horizontal and vertical chains configured such that the openings formed by the intersecting chains have no more than four sides. The length of each side of the openings created by the intersecting chains, including the sweep, must be less than or equal to 14 inches (35.5 cm). Any vessel that enters the waters described above and that is required to have a Federal Atlantic sea scallop fishery permit must have the chain mat configuration installed on all dredges for the duration of the trip, unless it meets the terms of the transiting provision. Vessels may transit through the regulated area provided that the dredge gear is stowed and there are no scallops on board. These requirements are in place from May 1 though November 30 each year.

Since the requirement for the chain-mat modified gear became effective in the fall of 2006, there have been five takes of sea turtles in the scallop dredge fishery. Four of the takes, all loggerhead sea turtles, occurred south of the current northern boundary of the chain mat regulation, while one take, a Kemp's ridley sea turtle, was documented north of this line. Of the four takes south of the line, one of the turtles was observed on top of the dredge frame, swimming away before the dredge came on deck; two were observed in the dredge bag; and one turtle was reported between the chain mat and the dredge. These takes occurred in June (1), August (1), September (2), and October (2). While information on the incidental take that occurred in June was available for the proposed rule, the data on the remaining takes were considered preliminary at that time. Detailed information on these takes and the implications these takes may have regarding the chain-mat modified gear are discussed in the response to Comment 1.

On November 9, 2007, NMFS published a proposed rule to clarify the requirements regarding chain-mat modified dredges in the Atlantic sea scallop fishery and to add a transiting provision to these requirements (72 FR 63537, November 9, 2007). Comments on this proposed action were requested through December 10, 2007. Six comment letters from individuals or organizations were received during the public comment period. Two commenters were generally supportive of the action but provided comments on particular aspects of the proposed rule, three commenters were opposed to the proposed action, and one provided neither support nor opposition to the proposed action. A complete summary of the comments and NMFS( responses, grouped according to general subject matter in no particular order, is provided here. In their comment letter on the proposed rule, Oceana incorporated comments submitted previously on the Biological Opinion for the Atlantic sea scallop fishery and on the August 2006 chain mat regulation. Those comments included in the submission and relevant to this action will be addressed in the comment/response section below. This submission also included comments that are not relevant to this particular action. These include comments on the original rulemaking related to the economic analysis for the seasonal closure (a non-preferred alternative), other comments on alternatives not considered in this action, and reinititation of consultation based on a letter dated March 13, 2005 received from Dr. Heppell addressing the December 2005 Biological Opinion and a statement on cumulative effects included in the Draft EA (NMFS 2006a) for that action. These comments are addressed in the August 2006 final rule (71 FR 50361, August 25, 2006). Additional comments not relevant to this action are related to the jeopardy analysis included in the Biological Opinion, and the model used for the analysis, and turtle excluder devices for the sea scallop trawl fishery.

Comment 1: The purported benefit of chain mats was that, even though most sea turtles are probably severely injured or killed as a result of seafloor collisions, some small number that collide with dredges in the water column are saved because they are prevented from entering the dredge bag. This benefit may be illusory since five turtles were observed captured in 2007, a large number given the low levels of observer coverage in the fishery.

Response: Since the requirement for the chain-mat modified gear became effective, the Northeast Fisheries Science Center (NEFSC) Fisheries Sampling Branch (FSB) has documented five takes of sea turtles in the scallop dredge fishery. These takes occurred in June (1), August (1), September (2), and October (2). Four of the takes, all loggerhead sea turtles, occurred south of the 41°9.0′ N. latitude line (the northern boundary of the regulation); while one take, a Kemp's ridley (fresh dead), was documented north of this line. Chain mats were not required, nor were they used, on the trip that occurred north of 41°9.0′ N. latitude. Of the four takes south of the line, one of the turtles was reported by the crew on top of the dredge frame; two were reported in the dredge bag; and one was reported by the captain on the outside of the chains, between the chains and the dredge. All four of the turtles were alive and the observers' comments indicated that the turtles were injured (NEFSC, FSB, Observer Database).

One of the turtles was reported on the top of the dredge frame, possibly held by water pressure. This turtle swam away before the gear was hauled above the waterline. Sea turtles have been documented on the dredge frame previously and have swum away as the gear nears/reaches the surface, indicating that the turtle may have been held by water pressure. NMFS has no indication that this type of interaction would result in significant injury. The chain mat gear is designed to prevent sea turtles from being captured in the dredge bag, not to prevent this type of interaction, which can occur regardless of whether a chain mat is used.

One turtle was reported by the vessel captain to be on the outside of the chain mat, caught between the dredge and the chains. However, it is unclear exactly how and where the turtle was caught/hung up on the dredge frame and/or the chains. The observer did not see the turtle until it was brought on-board. The captain reported that the turtle hit between the dredge and the vessel and then again while lowering the gear to deck. This type of interaction could result in injuries that occur during hauling and emptying of the gear. In 2005 and 2006, NMFS worked with industry to test a dredge with a modified frame designed to guide sea turtles up and over the dredge frame (see response to Comment 3). The video work conducted during this project did show that sea turtles may become caught on the chains following an interaction on the bottom. However, this likely follows the turtle being struck by the dredge, during which it is likely to have become injured. It is not known whether the interaction in 2007 occurred in the water column or on the bottom. From the available information, it is not known whether the chain mat contributed to the take or the nature of the injuries sustained by the turtle. NMFS is not aware of any other interactions of this nature and it is possible that this is a unique event. NMFS will continue to monitor the sea scallop dredge fishery to determine whether this is indeed a unique event.

The chain-mat modified gear is expected to prevent most sea turtles from entering the dredge bag and injuries that result from such capture. However, two turtles were documented in the dredge bag by the NEFSC FSB in 2007. NMFS investigated whether this may mean that the gear was not functioning as expected and as described in the proposed rule for this action. For one of the interactions resulting in capture in the dredge bag, the openings in the chain mat were measured by the observer at the start of the trip and following the take. After the tow in which the turtle was observed, some openings in the chain mat, particularly at the top of the bag and near the sweep, measured from 16 to 20 inches (40.6-50.8 cm). The turtle captured on this trip measured 65.2 cm (25.7 inches) curved carapace length from notch to tip and 61.5 cm (24.2 inches) curved carapace width (NEFSC, FSB, Observer database). Using the formulas in Teas (1993) and Coles (1999), respectively, this is a straight carapace length of 60.4 cm (23.8 inches) and a straight carapace width of 50.2 cm (19.8 inches). Given the larger openings recorded in the chain mat, a sea turtle of the size observed captured would be small enough to pass through the observed openings.

The second turtle reported captured in the dredge bag measured 89 cm (35.0 inches) from notch to tip and 83 cm (32.7 inches) curved carapace width (NEFSC, FSB, Observer database). Using the formulas in Teas (1993) and Coles (1999), respectively, this is a straight carapace length of 82.9 cm (32.6 inches) and a straight carapace width of 66.2 cm (26.1 inches). No measurements were taken of the openings in the chain mat. However, the observer's comments indicate that there were breaks in, or problems with, the chain mat that allowed the turtle to be captured in the bag. There were several comments in the observer's log about chains/shackles being broken, but none specifically on the tow in which the turtle was taken. On tows prior to the one on which the turtle was taken, there were several instances of large (500 pound (227 kg) and 800 pounds (363 kg)) rocks being caught inside the dredge. The rocks were larger than the turtle that was taken, and too large to fit through a chain mat that was operating correctly. The observer also stated that the horizontal chain closest to the cutting bar may not have been attached to the vertical chain, so the grid was not fixed, which would allow for larger openings (memo from Pasquale Scida to The File, March 11, 2008). For both interactions that resulted in the capture of the sea turtle in the dredge bag, the observers' comments indicate that there were openings in the gear larger than the openings required, allowing the sea turtles to pass into the dredge bag.

This information shows that non-compliant chan mats may result in failure to achieve the intended conservation benefits. However, it does not indicate that the gear, when properly implemented, does not function as expected. NMFS believes that when the gear is properly implemented, it will prevent most sea turtles from being captured in the dredge bag. NMFS is developing a plan to collect information on and to monitor the degree/frequency of stretch and breakage that is occurring in order to better understand the impacts of the wear of the gear. NMFS will also continue to use observer data to gain a better understanding of how sea turtles may be interacting with other parts of the dredge gear (i.e., outside of the dredge bag).

The observer coverage in the Atlantic sea scallop dredge fishery in 2007 is comparable to that over the preceding 5 years (memo from Ellen Keane to The File, February 27, 2007). The number of observed hauls May 1 through November 30 in waters south of 41°9.0′ N. latitude was 4617 in 2002, 5877 in 2003, 10609 in 2004, 7601 in 2005, and 5176 in 2006. From May 1 through October 31, 2007, 8317 hauls were observed. Data on the number of hauls observed in November 2007 is not yet available, but will increase the total number of observed hauls in 2007. The number of hauls observed in 2007 is greater than all but one of the preceding 5 years.

Comment 2: Two comments addressed the spatial extent of the proposed rule. One supported using a longitudinal line at 70° W. longitude (long.) as the boundary of the rule as, according to the comment, this is the area in which the gear was tested and is far northward of the area where takes are likely to occur, or where they have occurred with rare exceptions. A second commenter supported the action and the northern boundary as proposed, but noted that the boundary needs to be monitored closely for any changes in the distribution of sea turtles or sea scallops, and therefore, fishing effort, due to environmental change.

Response: Sea turtle species that are found off the northeastern coast of the United States north of Cape Hatteras, North Carolina are, in order of frequency of occurrence, loggerhead, leatherback, Kemp's ridley, and green sea turtles (Shoop, 1980; Shoop and Kenney, 1992). The distributions of all four species overlap in part with the distribution of scallop dredge gear. Loggerhead, leatherback, Kemp's ridley, and green sea turtles occur seasonally in southern New England and mid-Atlantic continental shelf waters north of Hatteras. The occurrence of these species in these waters is temperature dependent (Keinath et al. , 1987; Shoop and Kenney, 1992; Musick and Limpus, 1997; Morreale and Standora, 1998; Braun-McNeill and Epperly, 2002; James et al. , 2005b; Morreale and Standora, 2005). In general, turtles move up the coast from southern wintering areas as water temperatures warm in the spring. The trend is reversed in the fall as water temperatures cool. By December, turtles have passed Cape Hatteras, returning to more southern waters for the winter (Keinath et al. , 1987; Shoop and Kenney, 1992; Musick and Limpus, 1997; Morreale and Standora, 1998; Braun-McNeill and Epperly, 2002; James et al. , 2005b; Morreale and Standora, 2005). Hard-shelled species are typically observed as far north as Cape Cod whereas more cold-tolerant leatherbacks are observed in more northern Gulf of Maine waters in the summer and fall (Shoop and Kenney, 1992; STSSN database). Extensive survey effort on the continental shelf from Cape Hatteras, North Carolina to Nova Scotia, Canada in the 1980s (CeTAP, 1982) revealed that loggerheads were observed in waters from the beach to depths of up to 4481 m (14,701 ft). However, they were, in general, more commonly found in waters from 22-49 m (72.2-160.8 ft) deep (Shoop and Kenney, 1992). The overall depth range of leatherback sightings in the CeTAP study (1982) was comparable to loggerheads. Leatherbacks were sighted in water depths ranging from 1-4151 m (3.3-13,619 ft) (Shoop and Kenney, 1992). However, leatherback depth distribution was broader than that of loggerheads with 84.4 percent of the sightings in waters less than 180 m (590.6 ft) (Shoop and Kenney, 1992). By comparison, 84.5 percent of loggerhead sightings were in waters less than 80 m (262.5 ft) (Shoop and Kenney, 1992). The CeTAP study did not include Kemp's ridley and green turtle sightings given the difficulty of sighting these smaller species.

Sixty-five turtles have been observed taken in the sea scallop dredge fishery from 1996 through December 2007. An additional 16 turtles were reported captured on an off-watch or unobserved haul. Prior to 2005, no sea turtle takes had been observed in the sea scallop dredge fishery outside the mid-Atlantic region. In the 1999 and 2000 scallop fishing years, relatively high levels of observer coverage (22 percent-51 percent) occurred in portions of the Georges Bank Multispecies Closed Areas that were conditionally opened to scallop fishing (memo from M. Sissenwine to P. Howard, November 1, 2000). Despite this high level of observer coverage and operation of scallop dredge vessels in the area during June-October, no sea turtles were observed captured in scallop dredge gear in these years. From 2001 through 2004, observer coverage was low in the Gulf of Maine (<1 percent in 2001, 2002, and 2004) and Georges Bank regions (<1 percent in 2001, 2002, and 2003; <2 percent from September through November 2004, with most of the coverage occurring in November) (Murray, 2004a, 2005).

Two takes have been documented in the sea scallop dredge fishery on Georges Bank. In August 2005, a Kemp's ridley sea turtle was taken at approximately 40° 58′ N. lat./67° 16′ W. long., just south of the northern boundary of the chain-mat requirements, by a dredge vessel operating on the southern portion of Georges Bank demonstrating that takes in this area are possible. In 2007, a second Kemp's ridley was taken on Georges Bank at approximately 41° 24′ N. lat./68° 30′ W., just north of the northern boundary of the requirements.

The NEFSC FSB has documented interactions between sea turtles and other commercial fisheries operating in the Georges Bank region. NMFS examined the observer database for sea turtle-fishery interactions in statistical areas 521, 522, 525, 526, 561, and 562. These areas overlap Georges Bank and are east of 70° W. long. From 1989 through 2006, the NEFSC FSB documented 166 sea turtles (excluding moderately and severely decomposed turtles) taken in these areas (memo from John Boreman to Patricia A. Kurkul, March 16, 2006). Of these, only one interaction was documented north of 41°9.0′ N lat. It should be noted that these numbers include all of the turtle data contained in the NEFSC observer database, even though fisheries and turtle bycatch information in the early years is not necessarily reflective of current conditions, nor necessarily analyzed by the NEFSC (such as pelagic longline data) (memo from John Boreman to Patricia A. Kurkul, March 16, 2006). These data show that sea turtles are present on the southern portion of Georges Bank and would be vulnerable to capture by sea scallop dredge gear operating in this area.

As described in the Final EA, the variables associated with sea turtle bycatch in the sea scallop dredge gear are inconclusive (Murray 2004a, 2004b, 2005). Sea surface temperature (SST), depth, time-of-day, and tow time were identified as variables affecting observed bycatch rates of sea turtles with scallop dredge gear (Murray, 2004a, 2004b, 2005). However, the variable(s) associated with the highest bycatch rates changed from one year to another (e.g., SST, depth) or could not be further analyzed (e.g., time-of-day and tow time) because the information is not collected for the entire fishery (Murray, 2004a, 2004b, 2005). Therefore, a single variable has not yet been found for forecasting sea turtle bycatch in sea scallop dredge gear. Intense biological activity is usually associated with oceanographic fronts because they are areas where water masses of different densities converge (Robinson and Hamner; www.mbari.org/muse/Participants/Robinson-Hamner.html posted February 18, 2004). A review of the data associated with the 11 sea turtles captured by the scallop dredge fishery in 2001 concluded that the turtles appeared to have been near the shelf/slope front (memo from David Mountain to Cheryl Ryder and Paul Rago, March 22, 2002). Such oceanographic features occurring in the same area as the operation of scallop dredge gear may increase the risk of interactions between scallop dredge gear and sea turtles.

While these geographic and oceanographic factors may increase the risk of sea turtle interactions with scallop gear, evidence for these is presently lacking. Interactions of sea turtles with scallop dredge gear are likely where sea turtle distribution overlaps with the fishery. Based on the known distribution of sea turtles and the observed take of sea turtles in fisheries operating on Georges Bank, NMFS expects the take of sea turtles by dredge vessels operating north of 41°9.0′ N. lat. to be rare. However, it is known that sea turtles are present on southern Georges Bank and may be vulnerable to capture in sea scallop dredge gear operating in this area. Therefore, based on: (1) the known distribution of sea turtles, (2) sea scallop dredge fishing effort, and (3) the observed take of sea turtles, this rule maintains the eastern boundary at the EEZ and the northern boundary at 41°9.0′ N. lat. NMFS will continue to evaluate new information as it becomes available and continue to assess the appropriateness of these boundaries. This action does not preclude NMFS from modifying these boundaries at a future time.

Comment 3: One commenter supported the changes to the chain mat requirement but noted that the changes do not address the operation of the dredge on the bottom and that further efforts, such as modifications to the dredge design, are needed. NMFS has expended major effort addressing sea turtle interactions with “dredge trawls”, but has paid insufficient attention to the dredges themselves where turtles can get lodged in the gear and run over by the dredge. The commenter urges NMFS to increase funding and research to determine the extent of interactions and address them as soon as possible.

Response: NMFS continues to be concerned about sea turtle takes in the scallop fishery and is working to minimize them. The chain-mat modification has been shown to reduce the capture of sea turtles in the scallop dredge bag and injuries resulting from such capture. As described in the response to Comment 24, it is likely that sea turtles interact with sea scallop dredge gear on the sea floor and in the water column. However, it is not known what proportion of sea turtles interact with the gear on the sea floor or the water column. NMFS believes the chain mat will prevent serious injury leading to death or failure to reproduce caused by crushing from debris in the dredge bag, dumping of turtles on the vessel's deck, and crushing them by the falling gear. NMFS recognizes that interactions may still occur on the sea floor and may result in serious injury or mortality. Therefore, NMFS is continuing to work to address this type of interaction.

In 2005 and 2006, NMFS worked with industry to test a dredge with a modified cutting bar and bail designed to minimize impacts to turtles that may be encountered on the bottom by guiding the sea turtle over the dredge frame (NMFS, 2005; Milliken et al. , 2007). The project used turtle carcasses and model turtles to simulate a worst case scenario of a dredge overtaking a sea turtle lying on the bottom. During the 2005 study, the turtle carcasses were observed lodged in front of the cutting bar and pushed along, eventually going under the cutting bar and getting caught on the chain mat. The model turtle was deployed on one tow with the modified dredge in 2005. During this tow, the model turtle was deflected over the bail of the modified dredge (NMFS, 2005). Based on the results of the 2005 study, the dredge was further modified and additional trials were conducted in 2006. In 8 of the 12 successful trials, the carcasses went over the dredge (n=7) or were deflected to the side (n=1), indicating that the design may be effective in guiding turtles up and over the dredge (Milliken et al. , 2007). It is important to note that the project was limited in that behavioral responses of a live turtle encountering a dredge could not be assessed. The results of these studies indicate that this modification may be effective at guiding sea turtles up and over the dredge frame. NMFS is continuing to test this modification to assess whether it will be effective in reducing the severity of injuries to sea turtles interacting with sea scallop dredges on the bottom.

In addition, research using video has been conducted to better understand the nature of the interactions. Three recent projects have used video to try to document sea turtle behavior and interactions with sea scallop dredges. In addition to the work conducted in 2005 and 2006 on the modified dredge frame, researchers used video during the 2003-2004 study of the chain-mat modified dredge. During this study, one trip was designated as a research camera cruise where underwater video was taken of the modified dredge during normal fishing operations (DuPaul et al. , 2004). Video was also used on two other cruises. No sea turtles were documented by video on the three cruises that utilized cameras (R. Smolowitz, pers. comm.).

In 2004 and 2005, the NEFSC also worked with researchers and commercial fishermen to conduct approximately 80 hours of videotaping of dredges as they are fished. These studies were designed to observe sea turtle behavior around sea scallop dredge gear. In 2004, 7 hours of video was taken on a 3-day trip. During this project, video techniques and tools were developed to document the behavior of sea turtles. However, no sea turtles were recorded (Smolowitz et al. , 2005). In 2005, video was collected over 2 trips, one in August and one in September (Smolowitz and Weeks, 2006). Approximately 80 hours of video were collected during these trips. This video has been reviewed and no sea turtles were documented (Smolowitz and Weeks, 2006).

It is evident from these studies that using video to document the specific nature of sea turtle-sea scallop dredge interactions, in general, and sea turtle-chain mat interactions specifically, is logistically difficult. Despite the challenges associated with using video to document interactions between sea turtles and sea scallop dredges, NMFS plans to continue collecting video in conjunction with other gear projects in an effort to gain a better understanding of interactions between sea scallop dredge gear and sea turtles.

NMFS is also investigating gear modifications to minimize impacts to sea turtles resulting from interactions in the sea scallop trawl fishery. In 2006, the use of a turtle excluder device (TED) in the scallop trawl fishery was investigated (Lawson and DeAlteris, 2006). This research is on-going. NMFS is considering amendments to the regulatory requirements for TEDs, including requiring the use of TEDs in the trawl component of the Atlantic sea scallop fishery (72 FR 7382, February 15, 2007).

Comment 4: One commenter believes the solution is to create hatcheries for turtles that release more turtles than have interactions with commercial fishing gear. The hatchery could raise the turtles to two or more years before releasing them.

Response: Headstarting is used to describe the process whereby turtles are maintained in captivity for a period following hatching (USFWS and NMFS, 1992). The premise behind headstarting is that sea turtles will be larger and less susceptible to predators upon their release; thus, increasing their chances of survival. Sea turtles have been captive reared in a number of projects, including green sea turtles in Florida (Huff, 1989) and Kemp's ridley sea turtles in Texas (USFWS and NMFS, 1992). Generally, this has been considered experimental as a management technique (NRC, 1990; USFWS and NMFS, 1992) and has been controversial for a number of reasons, including that it is unproven, removes turtles from their natural environment, and does not reduce the threats that cause population declines (NRC, 1990; Shaver and Wibbels, 2007). The effectiveness of headstarting is dependent on the survival, adaptation, and eventual breeding of sea turtles after their release (Shaver and Wibbels, 2007). Some headstarted sea turtles have been documented nesting (Shaver and Calliouet, 1998; Bell et al. , 2005; Shaver, 2005). However, data are often limited and it is not clear how many documented nestings are required to indicate success of a program. Although headstarted sea turtles have been shown to successfully nest, it is not known that such a program increases the size of the wild breeding stock of sea turtles.

In addition, it is important to protect in-water populations of sea turtles. Based on the size of Atlantic loggerheads at various life stages and the measurements of sea turtles captured in the sea scallop dredge fishery, NMFS anticipates that both benthic immature and sexually mature loggerhead sea turtles are captured in the fishery (NMFS, 2008). This is a different size class than would be released from the head-starting program. Population model analyses for loggerhead sea turtles indicated survival in the first year was less critical than survival in later life stages (Crouse et al. , 1987). Heppel et al. (1996) used a series of deterministic matrix models for yellow mud turtles and Kemp's ridley sea turtles to examine the effects of headstarting. This study showed that efforts focusing exclusively on improving survival in the first year of life are unlikely to be effective for long-lived species such as turtles. Across turtle species, analyses of growth rates have consistently shown that these rates depend strongly on survival of turtles nearing or reaching sexual maturity ( i.e. , large juveniles, sub-adults, and sexually mature animals) (Heppell, 1998). Benthic immature and sexually mature loggerhead sea turtles are the size classes that are impacted by the sea scallop dredge fishery.

Comment 5: Several comments were received on the ITS for the Atlantic sea scallop dredge fishery. One commenter states that NMFS has a history of failing to recognize the extent and impact of the scallop dredge fishery's impact on turtles as estimates of take have increased in the 2003 and 2004 Biological Opinions and that the current levels are unacceptably high. In addition, chain mats contribute to underestimates by not bringing sea turtles out of the water, and the failure to lower the ITS in the 2006 Biological Opinion leads them to believe that NMFS does not expect that the take and injury will be significantly reduced with the use of the chain mats. Comments on the original chain-mat rulemaking, and resubmitted with this rulemaking, stated that the proposed rule's estimated take was too low because the 2004 Biological Opinion did not include a number of ways that dredges can take sea turtles ( i.e. , being hauled up on top of the gear, being wedged in the forward parts of the dredge frame, being held against the dredge by the pressure of the flow of water, or by being run over by the dredge and chain bag). In addition, one commenter stated that the assumption that sea turtles are interacting with the dredges at the same rate as prior to 2006 is not sound science, as industry has fewer days.

Response: The most recent consultation on the continued authorization of the Atlantic sea scallop fishery, conducted under section 7 of the ESA, was completed in March 2008. The Biological Opinion for that consultation provides the consultation history, the past and anticipated future effects of the fishery on ESA-listed species, and measures to be taken by NMFS to address the taking of ESA-listed species in the scallop dredge and trawl fisheries (NMFS, 2008).

For the reasons stated in the background and in the response to comment 24, NMFS believes that the serious injury and mortality rate of sea turtles interacting with chain-mat modified gear will be less than that calculated for the Biological Opinion since fewer turtles will be subject to injuries occurring within the dredge bag or as a result of dumping the bag on deck. However, NMFS cannot quantify the reduction in mortality rate given that the proportion of sea turtles interacting with the dredge in the water column versus on the bottom is not known. For the section 7 consultation on the continued authorization of the scallop fishery, NMFS uses the best available information and provides the benefit of the doubt to the species where information is incomplete. Therefore, since the reduction in the mortality rate cannot be quantified, the anticipated number of lethal sea turtle interactions was not reduced as a result of the implementation of the chain-mat regulations.

The bycatch estimates completed by the NEFSC (Murray 2004a, 2004b, 2005, 2007), and the anticipated take level in the Biological Opinions, included any interaction occurring during an on-watch haul, that was not moderately or severely decomposed upon capture. This includes sea turtles hauled up on top of the gear, wedged in the forward parts of the dredge frame, held against the dredge by the pressure of the flow of water as observed from on deck, or turtles swimming at the surface that were observed “bumped” by the cables of the dredge. Sea turtles may interact with the gear and not be brought to the surface. These interactions cannot be quantified at this time.

The number of days available to industry would not change the bycatch rate (number of turtles taken per unit of effort) of sea turtles in the fishery, but would change the total estimated bycatch of sea turtles if the fishing effort has been reduced in areas and at times where turtle occur. NMFS recognizes that recent management measures have/will constrain effort in the mid-Atlantic sea scallop fishery. In Framework 18 to the Scallop FMP, open areas DAS allocations were lower than the 2004 levels (71 FR 2006, June 8, 2006). Amendment 11 to the Scallop FMP proposes to control the capacity of the general category scallop fishery and, if implemented, would limit the number of vessels that can participate in the fishery and the number of scallops that can be retained and landed by vessels in the general category fleet (72 FR 71315, December 17, 2007). As described above, in the section 7 consultation process under the ESA, NMFS uses the best available information and provides the benefit of the doubt to the species where information is incomplete. For the purpose of analyzing the effects of the sea scallop dredge fishery on loggerhead sea turtles, NMFS considers that the bycatch estimates in the 2003 and 2004 fishing years provide the best available information. NMFS believes that the serious injury and mortality rate of sea turtles interacting with chain-mat modified gear will be less than that calculated for the Biological Opinion since fewer turtles will be subject to injuries occurring within the dredge bag or as a result of dumping the bag on deck. However, NMFS cannot quantify the reduction in mortality rate at this time. Refer to the March 2008 Biological Opinion for additional information on the estimate of take in this fishery.

Comment 6: Sonar could be utilized to displace sea turtles from the areas where scallopers are working.

Response: The information on the hearing capabilities of sea turtles is limited, but suggests that the auditory capabilities are centered in the low-frequency range (<1kHz) (Ridgeway et al. , 1969; Lenhardt et al. , 1996; Bartol et al. , 1999). There is also very little information about sea turtle behavioral reactions to levels of sound below the thresholds suspected to cause injury or Temporary Threshold Shift (Ridgeway et al. , 1969; McCauley, 2000). Given the limited information on sea turtle hearing and behavior in response to sound, this type of mitigation is not feasible. The use of sonar could result in injury, affect sea turtle behavior, and displace sea turtles from a preferred habitat including foraging grounds, and would constitute a take under the ESA. The use of sonar could also impact other animals in the area in which it is utilized. Some of these species are protected under the Marine Mammal Protection Act and the ESA.

Comment 7: No dredging, trawling, or longlining should be allowed.

Response: As described in the response to Comment 2, sea turtle presence varies with season. The capture of sea turtles in sea scallop dredge gear has been documented in the mid-Atlantic from June through October and the potential for takes exists in May and November due to the overlap of the sea scallop dredge fishery with sea turtle distribution. As sea turtle distribution and sea scallop dredge effort are not expected to overlap from December 1 through April 30, banning dredging during these months is not expected to provide benefits to sea turtles. A seasonal closure of the mid-Atlantic was considered during the original rulemaking to require chain-mat modified dredges in the Atlantic sea scallop dredge fishery. This alternative was rejected given the uncertainty of the extent of the area in which interactions occur, the broad extent of the closure, and the potential displacement of effort to other fishing areas. Additional information on this alternative can be found in the August 2006 final rule (71 FR 50361, August 25, 2006) and its accompanying EA (NMFS, 2006). The comments regarding longline and trawl fisheries are not relevant to this action.

Comment 8: NMFS should consider additional methodologies to reduce sea turtle interactions with the dredge fleet, such as keeping discards on board during fishing operations as sea turtles may be attracted to the discards.

Response: It has been suggested that the discard of scallop viscera during fishing operations may be attracting sea turtles to the fishing area. White (2004) reported loggerhead sea turtles opportunistically feeding on discards from gillnet vessels docked at a quay in Greece and there are anecdotal reports of sea turtles opportunistically feeding on discards in the shrimp trawl fishery. It is unclear whether the turtles were drawn to the vessel because of the discards or just happened to be in the same place as the vessels at the same time. At this time, NMFS has no evidence to refute or support the possibility that discards may be attracting sea turtles to scallop vessels. Sea turtles that may be attracted to discarded viscera might disperse away from fishing vessels if the practice is prohibited. Alternatively, these turtles may remain in the fishing area and feed on natural prey in the benthos. Therefore, it is not clear that a prohibition on the discard of sea scallop viscera would reduce the risk of interaction.

NMFS is continuing to investigate additional modifications to reduce injury and mortality to sea turtles resulting from an interaction with sea scallop dredge gear. See the response to Comment 3 for additional information.

Comment 9: Regulations result in scallop fishing occurring in smaller areas which creates a non-natural food supply congregating sea turtles. Reduce the non-natural food supply by changing the regulations.

Response: The distribution of sea scallop fishing effort is a function of the condition of the resource. Vessels fish where the sea scallop catch is most efficient. Certain management measures may amplify this as with more restrictive measures, there is more interest in maximizing the yield compared to the effort. While vessels may fish the same areas, NMFS has no evidence to refute or support the possibility that discards from the sea scallop fishery may be attracting sea turtles to those areas (see response to Comment 8).

Comment 10: NMFS could substantially mitigate the impacts of the scallop dredge fishery on sea turtles through narrowly crafted time-area closures. An analysis of potential closure areas was submitted with the comment. Recommended closures include the Elephant Trunk Access Area from June 1 to October 31, the eastern portion of the Hudson Canyon Access Area and the area immediately east from July 1 to October 31, and the Delmarva Area from June to October. Time-area closures must be considered in this rulemaking.

Response: During the original rulemaking to require chain-mats in the Atlantic sea scallop dredge fishery, NMFS evaluated a seasonal closure of the mid-Atlantic in order to reduce the impacts on sea turtles from sea scallop dredge activity. However, given the uncertainty of the extent of the area in which interactions occur, the broad extent of the closure, and the potential displacement of effort to other fishing areas, this alternative was rejected at that time (71 FR 50361, August 25, 2006).

Framework 18 to the Scallop FMP implemented a closure of the Elephant Trunk Access Area (ETAA) during September and October to reduce potential interactions between the sea scallop fishery and sea turtles (71 FR 33211, June 8, 2006). On November 8, 2007, the New England Fishery Management Council (Council) submitted Framework 19 to the Scallop FMP to NMFS. In Framework 19, the Council recommends removing the seasonal closure for the ETAA. NMFS has published a proposed rule for Framework 19 that indicates that NMFS would disapprove the Council's recommended closure, thereby leaving the September through October closure in place (73 FR 14748). As there is no new information that justifies eliminating the seasonal closure, and due to concern relating to the potential bycatch of sea turtles if this closure were eliminated, the Council's recommendation to eliminate the ETAA seasonal closure will be disapproved. NMFS would continue to monitor the effectiveness of this closure and adjust management measures as appropriate.

As described in the Final EA, a consistent set of variables has not yet been found for forecasting sea turtle bycatch with sea scallop dredge gear. NMFS is continuing to work towards identifying “hot spots” of sea turtle bycatch in the mid-Atlantic. NMFS is currently conducting a study to examine various environmental variables in relation to sea turtle takes in multiple NER fisheries, including the sea scallop fishery. This project integrates data from a suite of satellite sensors, electronic tags, fishery observer logs, and high-resolution coupled physical-biological models to quantitatively characterize sea turtle habitat in a variety of oceanic environments. The end product will be a set of decision support tools that forecast the likelihood of sea turtle-fishery interactions.

Comment 11: NMFS should expeditiously issue new and adequate regulations to protect loggerhead sea turtles from sea scallop dredging before scallop dredging begins to take sea turtles in the spring.

Response: As described in the proposed rule and the EA for this final action, NMFS believes that the chain-mat modification will protect sea turtles from capture in the dredge bag and will, therefore, protect them from injury and mortality that results from such capture. Therefore, NMFS is issuing this final rule to minimize the impacts that would result from capture in the dredge bag. NMFS recognizes that sea turtles may be struck by the dredge gear as it is fished and that injuries and mortality may result from such an interaction. NMFS will continue to investigate and implement, as appropriate, measures to reduce interactions with sea turtles and/or the severity of interactions that do occur (see comment 3).

Comment 12: The reevaluation of the chain mat modification must be undertaken in the context that the south Florida nesting population is in perilous condition. The loggerhead sea turtle is no closer to recovery now than when it was originally listed.

Response: A detailed description of the status of the species can be found in the EA for this action, while a summary is provided here. A number of stock assessments (TEWG 1998, 2000; NMFS SEFSC, 2001; Heppell et al. , 2003) have examined the stock status of loggerhead sea turtles in the waters of the United States, but have been unable to develop any reliable estimates of absolute population size. Due to the difficulty of conducting comprehensive population surveys away from nesting beaches, nesting beach survey data are used to index the status and trends of loggerhead sea turtles (68 FR 53949, Sept. 15, 2003). There are at least five western Atlantic loggerhead nesting groups. These are the northern, south Florida, Dry Tortugas, Florida Panhandle, and Yucatan nesting groups. Genetic analyses conducted at the nesting sites indicate that they are distinct nesting groups (TEWG, 2000). The 5-year status review for loggerhead sea turtles (NMFS and USFWS, 2007) compiled the available information on mean number of loggerhead nests per year and, where available, the approximated counts of nesting females for each of the five identified nesting groups in the western North Atlantic.

Nesting survey data is important in that it provides information on the relative abundance of nesting, the estimated number of reproductively mature females in each nesting group, and the contribution of each nesting group to loggerhead nesting in the western Atlantic, overall. During the majority of the 1990s, the south Florida nesting group showed an increase in the number of nests of 3.6 percent annually from 1989-1998 (TEWG, 2000). However, in 2006, information was presented at an international sea turtle symposium (Meylan et al. , 2006) and in a letter to NMFS (letter to NMFS from the Director, Fish and Wildlife Research Institute, Florida Fish and Wildlife Conservation Commission, October 25, 2006) that the south Florida loggerhead nesting group was experiencing a decline in nesting. A trend analysis of the nesting data collected for Florida's Index Nesting Beach Survey program showed a decrease in nesting of 22.3 percent in the annual nest density of surveyed shoreline over the 17-year period and a 39.5-percent decline since 1998 (letter to NMFS from the Director, Fish and Wildlife Research Institute, Florida Fish and Wildlife Conservation Commission, October 25, 2006). Data collected in Florida in 2007 reveal that the decline in nest numbers has continued as 2007 had the lowest nest count in any year during the period of 1989-2007 (FWRI, 2007). Standardized ground surveys of 11 North Carolina, South Carolina, and Georgia nesting beaches showed a significant declining trend of 1.9 percent annually in loggerhead nesting from 1983-2005 (NMFS and USFWS, 2007). In addition, standardized aerial nesting surveys in South Carolina have shown a significant annual decrease of 3.1 percent from 1980-2002 (NMFS and USFWS, 2007). The South Carolina data represents approximately 59 percent of nesting by the northern nesting group (Dodd, 2003). No surveys of the Dry Tortugas nesting group have been conducted since 2004. No trend was detected in the number of nests laid from 1995 to 2004 (excluding 2002 when surveys were not conducted); however, because of the annual variability in nest totals, a longer time series is needed to detect a trend (NMFS and USFWS, 2007). The Florida Panhandle nesting group has shown a significant declining trend of 6.8 percent annually from 1995-2005 (NMFS and USFWS, 2007). The Yucatan nesting group is characterized as having declined since 2001 (NMFS and USFWS, 2007).

Unlike nesting beach data, in water studies of sea turtles typically sample both sexes and multiple age classes. As is the case with nesting data, there are caveats for using results from in water studies to assess sea turtles abundance and the trend of turtle populations, overall. Nevertheless, these can be useful for gaining information on the species away from the nesting beach. As was described in a 1999 report of the IUCN/SSC Marine Turtle Specialist Group, although sea turtles spend at most 1 percent of their lives in or on nesting beaches, approximately 90 percent of the literature on sea turtle biology is based on nesting beach studies (Bjorndal, 1999). In water studies have been conducted in some areas of the western Atlantic and provide some data by which to assess the relative abundance of loggerhead sea turtles and changes in abundance over time (Maier et al. , 2004; Morreale et al. , 2004; Mansfield, 2006). Maier et al. (2004) used fishery-independent trawl data to establish a regional index of loggerhead abundance for the southeast coast of the United States (Winyah Bay, South Carolina to St. Augustine, FL) during the period 2000-2003. A comparison of loggerhead catch data from this study with historical values suggested that in-water populations of loggerhead sea turtles along the southeastern United States appear to be larger, possibly an order of magnitude higher than they were 25 years ago (Maier et al. , 2004). However, reduced catch rates in the smaller size classes was also noted over the four year time period (Maier et al. , 2004). A long-term, on-going study of loggerhead abundance in the Indian River Lagoon System of Florida found a significant increase in the relative abundance of loggerheads over the last 4 years of the study, but there was no discernable trend in abundance over the 24-year time period of the study (1982-2006) (Ehrhart et al. , 2007). Sea turtles captured in pound nets in the fall and early winter in North Carolina were sampled from 1995-1997 and 2001-2003 to monitor trends in catch rates. The catch rates of loggerhead sea turtles increased significantly at a rate of 13 percent per year during the study period (Epperly et al. , 2007). There was also a significant increase in the size of loggerhead sea turtles over time (Epperly et al. , 2007).

In contrast to these studies, Morreale et al. (2004) observed a decline in the incidental catch of loggerhead sea turtles in pound net gear fished around Long Island, NY during the period 2002-2004 in comparison to the period 1987-1992. No changes in size distribution were noted but only two loggerheads were captured from 2002-2004 and these were comparable in size to the larger turtles captured during the 1987-1992 period (Morreale et al. , 2004). Using aerial surveys, Mansfield (2006) also found a decline in the densities of loggerhead sea turtles in Chesapeake Bay over the period 2001-2004 compared to aerial survey data collected in the 1980s. Significantly fewer turtles (p<0.05) were observed in both the spring (May-June) and the summer (July-August) of 2001-2004 compared to aerial surveys in the 1980s (Mansfield, 2006). A comparison of median densities from the 1980s to the 2000s suggested that there had been a 63.2 percent reduction in densities during the spring residency period and a 74.9 percent reduction in densities during the summer residency period (Mansfield, 2006).

NMFS is undertaking a number of efforts in order to determine the status of loggerhead sea turtles. In November 2007, NMFS initiated a review of the status of loggerhead sea turtles to determine whether a petitioned action to classify the North Pacific or Pacific loggerhead sea turtles as a Distinct Population Segment (DPS) with endangered status is warranted, and whether any additional changes to the current threatened listing for the loggerhead sea turtle are warranted (72 FR 64585, November 16, 2007). This review is expected to be completed in the summer of 2008. NMFS also received a petition in November 2007 to designate loggerhead sea turtles in the western North Atlantic as a DPS with endangered status and to designate critical habitat for this population. The petition also requested that if the western Atlantic loggerhead sea turtle is not determined to meet the DPS criteria that loggerheads throughout the Atlantic be designated as a DPS and listed as endangered and that critical habitat be designated for it (Petition from Oceana and The Center for Biological Diversity to Carlos M. Gutierrez, Dr. William Hogarth, Dirk Kempthorne, and H. Dale Hall, November 15, 2007). On March 5, 2008, NMFS published a response to the petition (73 FR 11851). NMFS has convened a biological review team to review the status of the species to determine whether the petitioned action is warranted and to determine whether any additional changes to the current listing of the loggerhead turtle are warranted (73 FR 11851, March 5, 2008). The Recovery Plan for loggerhead sea turtles is currently being revised, and NMFS has convened a new loggerhead Turtle Expert Working Group (TEWG) to review all available information on Atlantic loggerheads. The TEWG is continuing to explore several hypotheses as to the decline in nest numbers observed in Florida. A final report from the TEWG is anticipated in 2008.

The information on the decline in the south Florida nesting group is detailed and considered in the EA for this action. This action is expected to mitigate to some extent negative impacts to sea turtles by reducing injury and mortality resulting from capture in the sea scallop dredge bag.

Comment 13: Two comments were received regarding reinitiation of consultation under section 7 of the ESA. One commenter stated that NMFS should reinitiate on all major U.S. fisheries interacting with sea turtles given the recent nest numbers for Florida. A second commmenter stated that the new rule should be subject to formal consultation to ensure that the scallop dredge fishery does not jeopardize the continued existence and recovery of the loggerhead sea turtle.

Response: As provided in 50 CFR 402.16, reinitiation of formal consultation is required where discretionary Federal agency involvement or control over the action has been retained and if: (1) The amount or extent of incidental take is exceeded; (2) new information reveals effects of the agency action that affect listed species or critical habitat in a manner or to an extent not considered in the previous opinion; (3) the agency action is subsequently modified in a manner that causes an effect to listed species or critical habitat not considered in the previous opinion; or (4) a new species is listed or critical habitat designated that may be affected by the action. NMFS determined on November 2, 2007 that this action does not trigger the need to reinitiate consultation (memo from Patricia A. Kurkul to The Record, November 2, 2007).

Although this action does not trigger reinitiation of consultation, NMFS reinitiated ESA section 7 consultation on the Scallop FMP on April 3, 2007 as new information had become available on the take of sea turtles in the sea scallop trawl fishery (Murray, 2007). This consultation (March 2008) considered the effects of the sea scallop fishery as a whole, including the use of chain-mat modified gear. The comments related to reinitiating on other major U.S. fisheries that interact with sea turtles are not relevant to this action.

Comment 14: NMFS should consider ways for fishermen, working in conjunction with appropriate veterinary or rescue facilities, to bring injured turtles to these facilities for treatment.

Response: Currently, information regarding the transfer of injured turtles to appropriate rehabilitation facilities is included in the fishery observer training packets, including contacts for appropriate/authorized facilities from Maine to North Carolina. Observers are encouraged to make these arrangements for injured sea turtles as logistics and practicality allow, taking into account trip length and ability to transfer turtles quickly and safely. It is generally considered prohibitive if a turtle is taken during a multi-day trip, as a turtle with significant injuries would need to be transferred immediately, all resources to enable the transfer would be voluntary/donated, the receiving facility must be able to accept the case, and must agree to the transfer before a turtle is brought in. Vessels in the limited access fleet generally take extended trips of up to 12-20 days. Often, based on NMFS' experience with trained observers, the transportation of sea turtles to rehabilitation facilities is logistically challenging.

Regulations under 50 CFR 223.206(d) require fishermen who incidentally take turtles to return them to the water immediately (or after resuscitation) and prohibit the landing, offloading, or transhipping of incidentally caught sea turtles. At this time, fishermen should contact NMFS Northeast Regional Office to see if a Sea Turtle Stranding and Salvage Network member would meet the vessel and retrieve the turtle at sea or what other options may be available.

Comment 15: The requirement should be that the chain mat be created with ``any material'' to create openings of 14 inches (35.5 cm) or less. The chains are causing vessels to turn the engines harder using more fuel.

Response: The experimental fishery to test the modified gear used 3/8 inch hardened steel chain to create the chain mat (DuPaul et al. , 2004). This was the modification that was shown to be effective at preventing sea turtles from entering the dredge bag. As far as NMFS is aware, no other materials have been tested. NMFS cannot assume that all other materials would be as effective as chain at preventing sea turtles from entering the gear. Therefore, NMFS is requiring that chain be used over the opening to the dredge bag. The impacts of the chains on the efficiency of the dredge are discussed in the response to Comment 20.

Comment 16: Two comments were received on cumulative impacts. One commenter stated that there is a need to expeditiously address the cumulative impacts of U.S. fisheries on sea turtles given the recent nest numbers. The estimate of takes, and the authorized take, in fisheries has been revised upwards in recent year, and as new information becomes available increases in takes can be expected. NMFS must address these cumulative impacts if the decline of Atlantic loggerhead sea turtles is to be arrested. A second commenter stated that NMFS must ensure that the ESA and National Environmental Policy Act (NEPA) analysis considers cumulative impacts on loggerheads, including the threats from global climate change.

Response: The response to Comment 12 summaries the information on the recent nest numbers and the status of the species. Cumulative effects, including global climate change, on sea turtles were evaluated in the NEPA analysis for this action and under section 7 consultation on the continued authorization of the fishery. The EA for this action and the most recent Biological Opinion (NMFS 2008) should be referred to for the analysis.

NMFS continues to work to minimize negative impacts to sea turtles. NMFS has implemented measures to reduce fisheries impacts including restrictions on the use of gillnet gear and gear requirements in the Virginia pound net fishery, the pelagic longline fishery, and the shrimp and summer flounder trawl fisheries. As described in the response to Comment 3, NMFS is conducting research on gear modifications to minimize impacts from benthic interactions between sea turtles and sea scallop dredge gear. In addition, NMFS is considering amendments to the regulatory requirements for TEDs in the mid-Atlantic (72 FR 7382, February 15, 2007). NMFS continues to work to identify and address threats to sea turtles.

Comment 17: Two commenters stated that the configuration should be defined as a fixed number of chains based on dredge width for ease of compliance and enforcement. In addition, one commenter stated that the regulation can be only enforced by measuring all sides of the squares, the current configuration presents too great a risk of unintentional violations, and is a safety issue. To measure the chain mat at sea, enforcement must either disengage the mats and lay them out, measure a suspended dredge, which is unsafe for all, or disengage the dredge and turn it up. None of these are practicable and all take away from fishing opportunities.

Response: NMFS Office of Law Enforcement (OLE) and the United States Coast Guard (USCG) are confident that the regulation is enforceable regardless of whether the requirement is for a specified number of chains or for an opening of less than or equal to 14 inches (35.5 cm). We have discussed the issue of safety with both OLE and the USCG and they have not raised any concerns. Measurements may be taken with the gear on deck if measuring a suspended dredge is determined at the time to present a safety issue. As with any gear modification of this type (i.e., mesh size requirements), it is not necessary that enforcement measure each and every opening, but rather that they measure a subset of openings to determine whether the gear is in compliance.

NMFS recognizes that as the chains stretch and wear (“stretch”), they become longer and the openings may exceed 14 inches (35.5 cm), even if the gear was originally configured to meet the requirement. This may result in fishermen being concerned about unintentional violations resulting from larger openings due to this stretch. The degree of stretch depends on a number of factors including the area in which the vessel is fishing and the type/quality of chain that the vessel uses to configure the gear. NMFS has limited information on the degree of stretch that may occur. For one of the interactions resulting in the capture of a sea turtle in the dredge bag in 2007 (see response to Comment 1), the openings in the chain mat were measured by the observer at the start of the trip and following the take. At the start of the trip, the openings were 12 inches (30.5 cm) to 14 inches (35.5 cm), but by the tow in which the turtle was observed, some openings in the chain mat, particularly at the top of the bag and near the sweep, measured from 16 to 20 inches. The openings measured at the start of the trip and those measured after the take were not necessarily the same openings (memo from Pasquale Scida to The File, March 11, 2008). That is, the openings which measured 16 inches (40.6 cm) to 20 inches (50.8 cm) inches may have been greater than 12 inches (30.5 cm) to 14 inches (35.5 cm) measured at the start of the trip. This is the only trip on which measurements are available. However, there is anecdotal information from the observer program that indicates the stretch that may have occurred on this trip is not what is normally observed. Observers have noted that all the chains do stretch slightly. However, the stretch on this trip seemed excessive (memo from Pasquale Scida to The File, March 11, 2008). NMFS will continue to work with the observer program to get additional measurements with which to better assess the degree of stretch and to evaluate the implications of the observed stretch. NMFS has advised fishermen that they need to be aware of this stretch and take it into consideration when configuring the gear.

Comment 18: The design of the modified gear was driven by the desire to balance the need to protect turtles with an objective and easy to enforce standard and was structured to balance dredge efficiency with the prevention of turtles entering the dredge. There was no expectation of absolute uniformity in the rectangles created. There is no basis for the statement “As indicated in the final report, the number of chains in and of itself was not what drove the configuration tested. Rather it was the target size of the openings that drove the overall configuration.''

Response: According to the final report on the experimental fishery, the design criteria that were used in developing the chain mat were to: (1) Prevent turtles of greater than 24 inches (60.7 cm) from entering the dredge bag (6 ticklers by 11 or 13 up and downs); (2) decrease the size and weight of the chains to keep impacts low; (3) increase chain hardness (grade) to minimize wear and stretching; (4) place tickler chains on top of up and down chains (allows gear to slide rather than dig); (5) use rubber cookies at each shackle to prevent wear; and (6) minimize bottom impacts by keeping gear light (DuPaul et al. , 2004). The report does not include criteria related to enforcement. The first criterion in the gear design is to prevent turtles of a certain size from entering the dredge bag. This criterion notes a particular number of chains, presumably the number of chains needed to achieve this objective. During initial testing, the gear was hung in typical rock chain fashion which resulted in as much as a 32-inch (81.3-cm) diagonal between connection points. To correct for this, the design was modified to hang the horizontal chains straight across the opening (DuPaul et al. , 2004). This information indicates that the gear was designed to achieve a particular spacing between the chains. That is, the criteria was to create an opening sufficiently small enough to prevent sea turtles of a certain size from entering the gear. While there may not have been an expectation of uniform openings, it is clear that the openings need to be small enough to prevent sea turtles from passing through the chains into the dredge bag. Based on the information provided to NMFS on the size of the openings in the experiment to test the chain-mat modified gear and the species identification and size of sea turtles taken in this fishery, NMFS believes that openings of 14 inches (35.5 cm) or less will prevent most sea turtles from entering the dredge bag and will prevent the injury and mortality resulting from such capture. Under these requirements, the openings do not need to be uniform but cannot be larger than 14 inches (35.5 cm) per side.

The criteria also included decreasing the size and weight of the chains in order to keep impacts low (criteria 2 and 6). The report does not include information on the type of impacts being considered in criteria 2 and it is possible that this criteria included impacts related to dredge efficiency. However, as described in the response to Comment 20, the weight of the chain-mat modified gear is not substantially different than the unmodified gear. Therefore, NMFS does not anticipate that the additional weight of the chain mat will significantly impact the dredge efficiency. In addition, the openings required in the regulation are based on the experimental fishery to test the chain mat modified gear (see response to Comment 19).

Comment 19: A fixed number of chains based on dredge width is the only configuration that has been rigorously tested on a variety of dredge widths and has been proven effective in eliminating virtually all incidence of sea turtles becoming entrapped in the dredge. If the agency believes a different design would be more efficacious, it should test such gear to account for all factors relevant to turtle takes, and collect empirical data on other conservation or economic impacts. There is no data showing the impacts of chains configured to comply with the 14-inch (35.5-cm) requirement. The commenter urges NMFS to re-adopt a fixed number of chains based on dredge width as the change to the 14-inch (35.5-cm) requirement is based on a misinterpretation of the science upon which the gear is based, has unknown implications for sea turtle protection, conservation and economic impacts, and presents an enforcement concern.

Response: The size of the opening created by the chains is the important factor in preventing sea turtles from entering the dredge bag, not the number of chains. Although the size of the openings is not provided in the final report (DuPaul et al. , 2004), the information provided to NMFS during the development of the chain mat requirements was that the configuration tested during the experimental fishery had openings that were less than 14 inches.

The experimental fishery was conducted with 11-ft (3.35-m), 14-ft (4.27-m), and 15-ft (4.57-m) dredges. The 14-ft (4.27-m) and 15-ft (4.57-m) dredges had 11 vertical chains and 6 horizontal chains; while the 11-ft (3.35-m) dredge had 9 vertical chains and either 5 or 6 horizontal chains. The table included in the original rule included dredges binned into four groups: less than 10 ft (3.05 m), 10 ft (3.05 m) to less than 11 ft (3.35 m), 11 ft (3.35 m) to 13 ft (3.96 m), and greater than 13 ft (3.96 m). Dredges of several widths fall into each grouping. Therefore, only a subset of the dredge widths included in the table were actually tested in the experimental fishery. Two of these dredge widths tested fall into the bin for dredges greater than 13 ft (3.96 m). The number of horizontal chains included in the original chain-mat regulation for an 11-ft (3.35-m) dredge based on dredge width was 5. However, the 11-ft dredge tested in the experiment used 5 or 6 horizontal chains. If the 11-ft dredge in the experimental fishery used 5 horizontal chains, this configuration would also have been tested.

In addition, dredges of the same width may be configured differently. As such, the same number of chains on two dredges with the same width, may not result in the same size openings. For example, the distance between the cutting bar and the sweep is known to vary by up to 1.7 ft (0.5 m) for certain dredge widths (NMFS 2007). Given the variability in the distance between the cutting bar and the sweep, it would be difficult to specify a number of horizontal chains that would achieve the desired spacing. As noted above, the chains wear and become longer with time, and this wear depends on a number of factors including the chain used and the bottom habitat fished. This variability may be difficult to account for in a table. As a result of these factors, the rule does not define the configuration based on a number of vertical and horizontal chains required, but by the desired size of the opening, which is the important factor for sea turtle conservation. Based on the results of the experimental fishery and information on the sea turtles observed taken in this fishery, NMFS has determined that a spacing of 14 inches (35.5 cm) or less will prevent most sea turtles from being captured in the dredge bag. Enforcement and safety are addressed in the response to Comment 17 and conservation and economic impacts are addressed in the response to Comment 20.

Comment 20: As a precaution, fishermen are rigging the chain mats with rectangles with sides of no more than 11 inches (27.9 cm) or 12 inches (30.5 cm) to avoid being found in violation. As a result, the data collected during the experimental fishery is not applicable. The economic impact will greatly exceed that currently assumed due to greater loss of scallops, increased fuel consumption due to the heavier mat and increased drag, additional loss of fishing time while emptying the bags, and increased stretching/breaking of the chains. Vessels may tow longer to offset the loss of scallops, increasing bottom time which has habitat implications and may have unintended consequences on protected species.

Response: The total weight of a sea scallop dredge with a width of 15 ft (4.57 m) is approximately 4,500 lbs (2041 kg) for the dredge frame, chain bag, and club stick. Weights may vary slightly due to differences in materials and configuration. The weight of the chain mat is estimated to be between 56 lbs (25.4 kg) for a 10-ft (3.05-m) dredge and 147 lbs (66.7 kg) for a 15-ft dredge (4.57-m)(e-mail from Henry Milliken (NEFSC) to Richard Merrick (NEFSC), October 1, 2004). Assuming 20 percent additional chains and shackles would be required for some vessels to comply with the 14-inch (35.5-cm) requirement (a conservative overestimate) (memo from Ellen Keane (NERO) to The File, October 3, 2007), the range of weights would increase by 11 lbs (5 kg) for a 10-ft (3.05-m) dredge and 29 lbs (13 kg) for a 15-ft (4.57-m) dredge. The weight of the chain mat, and the additional chain required to configure the openings to the 14-inch (35.5-cm) requirement, is relatively small compared to the weight of the dredge. Some vessels that choose to rig their gear at 11 inches (27.9 cm) or 12 inches (30.5 cm) to account for stretch in the chains may need to use additional chain. However, this is not expected to substantially increase the weight of the chain-mat modified gear. As the weight of the modified dredge is not significantly different from an unmodified dredge, the additional chain is not expected to substantially impact the efficiency of the gear.

The economic costs of the chain mat requirements include costs required to configure and maintain the gear, costs due to loss of catch, and costs associated with a loss of efficiency. The costs to configure the gear result from the cost of materials and the cost of labor. The cost of materials and labor is estimated from approximately $200 for a dredge less than 10-ft (3.05-m) up to $460 for a 15-ft (4.57-m) dredge. These costs will vary depending on the type and size of chain used. Maintenance of the gear will be required as the chain mats wear. Vessels that configure the opening at or near the 14-inch (35.5 cm) requirement may need to readjust the gear more frequently than vessels that configure the opening less than 14 inches (35.5 cm) to allow for wear. In addition, the longevity of the chain is affected by numerous factors including the type of chain used, the bottom fished, and the configuration of the gear. All of these may affect the frequency with which the chains need to be replaced. Vessels fishing on sandy bottom will likely need to replace the gear less frequently than vessels fishing on rockier bottom. Information from the observer program indicates that the chains do stretch and break. One observer noted that the chains need to be re-adjusted once per a trip to once every three trips (memo from Pasquale Scida to The File, March 11, 2008). In addition, the observer logs indicate that the links/shackles connecting the chains break, but that these are relatively simple and quick repairs. If a high-quality chain is used, NMFS anticipates that the chain mat would need to be replaced in its entirety over the course of a fishing season. It is unlikely that the gear will be replaced all at once as broken links and shackles will be repaired as they occur over the course of the year. Nevertheless, the vessel would incur the costs associated with configuring gear each year. This replacement cost is considered in the EA/FRFA/RIR for this action.

In assessing the impacts of requiring this gear modification, the analysis of the cost due to a loss of catch is based on the average loss of scallops that was observed in the experimental fishery. Although measurements of the opening are not included in the final report on the experiment (DuPaul et al. , 2004), all of the information provided to NMFS during the rulemaking indicated that the size of the openings tested was less than or equal to 14 inches (35.5 cm), ranging from 11 to 14 inches (27.9 to 35.5 cm). The data from the experimental fishery shows that scallop catches were highly variable from vessel to vessel and trip to trip, ranging from a −30.88 percent to a 7.28 percent difference, with the average loss of sea scallop catch approximately 6.7 percent (DuPaul et al. , 2004). The researchers believe that this variability will decrease as vessels became more familiar with the gear (DuPaul et al. , 2004). The size of the openings tested in the experimental fishery is the size of the openings that are required under the current regulations and this final regulation. It is possible that the loss of scallops may vary if the openings in the chain mats are configured significantly smaller than those tested in the experiment. However, there is no data available at this time to evaluate this difference. Therefore, the loss of catch is based on the experimental fishery.

Other potential costs are those due to increased drag, weight, and tow times, as well as increased fuel consumption, which will result from adding chains to the dredge. As described above, the difference in weight between an unmodified dredge and a chain-mat modified dredge is not substantial and NMFS does not anticipate any significant costs resulting from extra weight on the gear. As described above, the size of the openings is based on the experimental fishery to test the modified gear. The final report on the study does not indicate that the dredge bag was more difficult to empty. It is expected that as fishermen become more familiar with the gear, difficulties that may be associated with dumping the bag will decrease. In general, the chain-mat modified dredge with openings of 14 inches (35.5 cm) or less has been required in the Atlantic sea scallop dredge fishery for one fishing season, with minimal reports of economic disruption that are described herein. More detailed information on the analysis can be found in the EA/RIR/IRFA for this action.

The area swept by the modified and the unmodified dredge gear is the same. However, as described in the Final EA, an increase in disturbance to bottom sediments is expected whenever the chain mats are used. Vessels are expected to continue to fish in the same areas, but a loss of scallops may be offset by increasing the tow time. The sediment type in the regulated area has a rapid recovery time and impacts to habitat are expected to be minimal. In addition, the researchers believe that this variability in catch retention will decrease as vessels became more familiar with the gear (DuPaul et al. , 2004). Thus, as vessels become more familiar with fishing the chain-mat modified gear, these impacts will be even further minimized. As described in the response to Comment 24, it is not known whether turtles interact on the bottom or in the water column. Therefore, it is not known whether the increased tow times would result in a greater risk of interaction. It is reasonable to assume that interactions are occurring both on the bottom and in the water column, but the proportion of interactions occurring in each of these cannot be quantified. While increased tow times may result in an increased risk for sea turtles, this risk is limited by the facts that the average loss of scallops was fairly small ~6.7 percent) and that as fishermen become more familiar with the gear, it is expected that the chain-mat modified dredge will be more comparable to the unmodified dredge. This will lessen the need to offset a loss of catch. While the loss of catch may be greater than that observed in the experiment if fishermen rig the gear significantly different than that tested in the experiment, NMFS cannot quantify what this loss would be. From the information available, it appears that vessels are rigging the gear in the same manner that was tested ( i.e. , approximately 11- to 14-inch (20.9-35.5 cm) openings).

Comment 21: Vessels have received violations for broken chains. We recommend that NMFS add a requirement that any broken chains be fixed immediately, but make it clear that a broken chain itself cannot support a violation. A violation could be given if a vessel deploys a dredge with a broken chain.

Response: NMFS recognizes that chains and links/shackles will break during normal fishing activity. These breaks must be repaired before redeploying the gear. In addition, the gear must be readjusted as necessary to ensure that the openings maintain a spacing of 14 inches (35.5 cm) or less. Broken chains have been noted during boardings by enforcement agents. NMFS enforcement agents and the USCG have discretion when conducting boardings and can take into account whether the captain or crew is in the process of repairing broken chains.

Comment 22: One commenter supported the transiting provision; while a second commenter was opposed to this provision. This commenter objected to the limitation that requires vessels that transit the area and fish exclusively north of the line to install chains before transiting home. The commenter stated that allowing vessels to stow their gear while in transit would not implicate any reasonable enforcement concern. It is unlikely that vessels fishing in the mid-Atlantic would undertake the labor intensive action of removing the chains to steam home, but in the event they did, no harm exists as long as the dredges are stowed and unavailable for use. Vessels fishing in the mid-Atlantic could be identified easily through Vessel Monitoring System (VMS) data.

Response : With the clarifications to the existing regulatory text, vessels that transit through areas south of 41° 9.0′ N. latitude would be required to use chain mats while fishing north of that line. That is not the intent of the regulation as sea turtle interactions north of the line are unlikely. Therefore, NMFS has added a transiting provision that would exempt vessels from the chain mat requirements provided that there are no scallops on board and the gear is stowed. NMFS recognizes that this provision requires vessels fishing north of the line to either land the catch north of the line or install chain mats before transiting back through the regulated area. This provision is necessary as vessels that fish north of the line on a trip cannot be distinguished from those that fish south of the line once they transit south. Some have suggested that VMS can be used to identify where these vessels were fishing for the purposes of enforcing this regulation. At this time, regulations require scallop vessels to be responsible for position reports ``at least twice per hour.'' Although it is sometimes possible to determine a vessel's activity (such as fishing) from half-hour polls, half-hour polls alone often do not provide a full picture of where the vessel was between polls. Therefore, increased polling would be necessary to determine where the vessel was fishing. Increased polling is not possible because the current technology provided by the VMS providers does not support changing the reporting rate by fishery declaration. Before a vessel starts a trip, it must declare through VMS whether the trip will be general category or limited access and the area in which it will fish. The vendors do not have the capacity to sort through the declarations and target polling intervals accordingly.

Comment 23 : NMFS must withdraw and re-evaluate the proposed rule, including revising the NEPA analysis, to take into account the status of loggerheads and the apparent failure of the turtle chains.

Response : As described in the response to Comment 1, the chain-mat modification has not failed, but rather has been improperly implemented in some cases. This has resulted in the capture of sea turtles in the dredge bag. The available information shows that, when properly implemented, the gear modification will prevent most captures and injuries resulting from such capture. In evaluating the impacts of this gear modification, the EA has taken into account the status of loggerheads (see response to Comment 12).

Comment 24 : It is not known what happens when turtles interact with the chain mat modified dredge and there is a significant risk that the chains do not reduce take, but simply change the nature of the interaction. The proposed action may do very little to reduce mortality and injury to sea turtles. NMFS admits that the chain mat configuration would not lessen the number of sea turtles taken, injured, or killed by the dredge on the sea floor. It stands to reason that a significant number of the sea turtles that are seriously injured and end up dying are caught on the sea floor as the dredge is towed on the sea floor for far more time than it is hauled up to the boat through the water column. The EA does not appear to analyze how often injuries occur from interactions with the dredge in the water column, but the implication is that even without the turtle chains, such interactions are unlikely.

Response : NMFS recognizes the uncertainty regarding whether sea turtles interact with sea scallop dredges as the dredge is dragged along the bottom, as the dredge is hauled back, or both. It takes approximately 1 minute to set a dredge and approximately 10 minutes to haul back, dump the catch, and reset the gear. For the remainder of the haul, the gear is on the bottom. However, it is not known where sea turtles are encountering the gear. It is likely that sea turtles are interacting with the gear both in the water column and on the bottom. Sea turtles have been observed in the area in which sea scallop gear operates and they have been seen near scallop vessels when they are fishing or hauling gear. In addition, sea turtles are known to forage and rest on the sea floor as part of their normal behavior. The condition of sea turtles observed taken in the sea scallop dredge fishery ranges from alive with no apparent injuries to alive and injured to fresh dead. Some of these injuries have been reported to occur after the gear has been brought on-board the vessel (DuPaul et al. , 2004; NEFSC, FSB, Observer Database). As described in the EA, NMFS believes that interactions between sea turtles and sea scallop dredge gear that occur on the bottom are likely to result in serious injury to the sea turtle. Based on this assumption, NMFS believes that the unharmed/slightly injured turtles observed captured in the sea scallop dredge bag follow an interaction with sea scallop dredge gear in the water column. The most recent Biological Opinion anticipates that up to 929 loggerhead sea turtles will be captured by sea scallop dredge gear biennially, and that up to 595 of these may sustain serious injury or mortality (as defined in the NMFS Northeast Region ``Serious Injury Determinations for Sea Turtles Taken in Scallop Dredge Gear—Working Guidance”).

Data do not exist on the percentage of sea turtles interacting with the chain mat-modified gear that will be unharmed, sustain minor injuries, or sustain serious injuries that will result in death or failure to reproduce. However, there are several assumptions that can be made to assess the degree of interaction. With the chain mat installed over the opening to the dredge bag, it is reasonable to assume that sea turtles, which would otherwise enter the dredge bag, will instead come into contact with the chain mat at least. NMFS recognizes that this modification may not reduce the number of sea turtles interacting with sea scallop dredge gear, but it is reasonable to assume that the modification will reduce mortality and the severity of injury following interactions that occur in the water column. Some of the seriously injured sea turtles probably obtained those injuries after being caught in the water column by unmodified gear, because the turtles were captured in the dredge bag. After an interaction in the water column, severe injuries and mortality to sea turtles following capture in a dredge bag without the chain mat configuration likely result from crushing by debris in the dredge bag, dumping of the turtle on the vessel's deck, or crushing them with falling gear. NMFS does not have information on the proportion of takes occurring in the water column. However, preventing the turtles from entering the dredge bag will prevent injuries resulting from such capture.

With the chain mat in place, it is reasonable to assume that the sea turtles on the sea floor would still interact with the gear, but that the nature of the interaction would be different. With the modified gear, the sea turtles may still be hit by the leading edge of the frame and cutting bar and would likely be forced down to the sea floor rather than swept into the dredge bag. Since the turtles are not being swept into the bag, they could be run over by the dredge bag and club stick. At this point, the turtle will have likely already been hit and run over by the cutting bar and the leading edge of the dredge frame, which constitutes a substantial weight.

As described in the response to Comment 3, NMFS worked with industry to evaluate a dredge designed to minimize impacts from interactions with a sea turtle encountered on the bottom (NMFS, 2005; Milliken et al. , 2007). The video from the 2005 study did show that it is possible that sea turtles encountering the dredge on the bottom may become caught on the chains after being hit by the leading bar of the dredge. However, this follows the turtle being struck by the leading edge of the dredge during which it is likely to have sustained serious injuries.

NMFS has made the conservative assumption that a turtle in a bottom interaction sustains serious injuries on the bottom regardless of whether the chain mat is used. Under this conservative assumption, there would not be a benefit from the chain mat for bottom interactions. This assumption, however, may be too conservative in that it is possible that turtles in a bottom interaction may only receive minor injuries. In the unlikely scenario of a turtle receiving only minor injuries following a bottom interaction, the chain mat modification would prevent serious injuries that result from capture in the dredge bag (i.e., injuries from debris in the bag, forced submergence, dropping on deck, or crushing by the dredge). A detailed description the assumptions made and the assessment of the interactions can be found in the EA on this action.

The chain mats have been noted in four reported interactions. During the pilot study to test the chain-mat modified gear, a sea turtle was reported on the chain mat, subsequently swimming away as the gear was hauled to the surface. The NEFSC FSB has documented other interactions where the sea turtle is observed on the dredge gear, swimming away as the gear nears/breaks the surface. NMFS has no indication that this type of interaction would result in serious injury. The sea turtle may be held against the gear by water pressure as the gear moves through the water. Once the pressure is relieved, the animal is able to swim away. In 2007, two sea turtles were observed captured in the dredge bag. As described in the response to Comment 1, the gear modification was improperly configured in each of these cases, resulting in the capture in the dredge bag.

In 2007, a sea turtle was reported as being caught between the chains and the dredge, on the outside of the chain mat. This animal was unable to swim away and was brought aboard the vessel. It is not known exactly where or how the turtle was caught/hung up in the gear nor is it known whether the chain mat contributed to the interaction or the injuries resulting from the interaction. It is also not known whether this interaction occurred on the sea floor or in the water column. NMFS is not aware of any other interactions of this nature and it is possible that this interaction was a unique event on an individual haul. NMFS will continue to work with the observers to gain a better understanding of how sea turtles may be interacting with other parts of the dredge gear (i.e., outside of the dredge bag) and to determine whether this interaction was, in fact, a unique event.

Comment 25: In their comments on the original chain mat regulation, one commenter stated that the EA for the August 2006 rule contends that the chain mat modification would significantly benefit sea turtles and that the characteristics of the geographic area, the presence of loggerhead sea turtles, indicate the need for an Environmental Impact Statement. They also state that the action considered in the EA is highly controversial, highly uncertain, and creates a significant precedent.

Response: The EAs on the chain mat requirements support a finding of no significant impact. There is expected to be a benefit to sea turtles by reducing significant injury and mortality following a take in the water column; however, the degree of benefit is limited given that the installation of a chain mat would only reduce the severity of injuries resulting from a portion of possible takes. No unique characteristics of the geographic area were identified. The presence of loggerhead sea turtles in the mid-Atlantic is not a unique characteristic of the area. The gear modifications are limited in geographic area and time and are implemented in an effort to facilitate the coexistence of fishing activity and sea turtles. These factors restrict the scope of the effects. This action is not highly controversial given that the action is designed to benefit sea turtles, it would have a relatively small impact on the fishing industry, and the industry has petitioned NMFS for a similar action, albeit over a shorter time period each year, slightly different geographic area, and for a fixed number of chains.

While there is not perfect information available on the nature of the interaction between sea scallop dredge gear and sea turtles, NMFS has made reasonable assumptions in evaluating the risks and benefits of this action. The best available scientific information shows that the use of the chain mat will prevent most sea turtles from entering the dredge bag and injuries ensuing from such capture. The action also does not set a significant precedent as gear modifications are a commonly used tool to reduce the severity of interactions between fishing gear and sea turtles.

Comment 26: The proposed action could have profound adverse effects on efforts to protect loggerhead sea turtles and thus on loggerhead turtle populations. Without video monitoring, no one will know how many loggerhead turtles were taken, injured, and killed underwater, an accurate estimate of sea turtle takes would be impossible, and neither individuals nor the agency would be able to assess whether these takes may exceed the incidental take statement. Deploying adequate monitoring for sea turtle takes must be considered and adopted.

Response: NMFS recognizes that interactions between sea scallop dredge gear and sea turtles are likely to occur and that these interactions may not be observed from on deck. As described above, NMFS will continue to use observer information, fishing effort data, and other data, as available, to monitor the fishery and its possible effects on sea turtles. NMFS will use observer data to continue to evaluate the take of sea turtles in other parts of the dredge (e.g., the forward parts of the frame and on top of the gear) as well as to better understand stretch and breakage in the chain mat gear. NMFS has developed a methodology to assess compliance with the ITS.

Prior to the chain mat requirement, observer coverage was used as the principal means to estimate sea turtle bycatch in the scallop fishery and to monitor incidental take levels provided in biological opinions for the scallop fishery. However, the use of chain mats on scallop dredge gear is expected to greatly reduce the likelihood that sea turtles struck by or incidentally swimming into scallop dredge gear would enter the bag and be carried to the surface (70 FR 30660, May 27, 2005; 71 FR 50361, August 25, 2006; 72 FR 63537, November 9, 2007). Injuries to sea turtles that occur as a result of the turtle being struck by the dredge gear underwater will continue to occur but will not be observed unless the turtle is small enough to pass between the chains and enter the dredge bag or is otherwise caught on the dredge frame and carried to the surface. Based on information provided by the NEFSC on fishery dependent and fishery independent approaches to monitoring bycatch (memo from John Boreman to Patricia A. Kurkul, March 6, 2006), NERO concluded that a method does not currently exist for enumerating sea turtle taken by chain-mat equipped scallop dredge gear that meets the NEFSC's definition of a scientifically robust and accurate take estimate and the guiding principles for the preparation of biological opinions provided in the Final ESA Section 7 Handbook developed jointly by the Fish and Wildlife Service and NMFS (memo from Patricia A. Kurkul to The Record, April 5, 2006; NMFS, 2008). In the absence of a method for enumerating most takes to monitor the ITS on the scallop dredge fishery, NMFS has developed a method of monitoring the fishery, as a proxy. Specifically, NMFS will use dredge hours as a surrogate measure of actual takes, and find that the ITS provided in the Biological Opinion has been exceeded when the fishery operates in a manner that, based on the best available information, would reasonably likely result in greater sea turtle interactions with scallop dredge gear than what is estimated to have occurred in 2003 and 2004 (NMFS, 2008). A detailed description of the approaches considered and the methodology chosen to monitor sea turtle takes in the dredge component of the fishery are included in the Biological Opinion and the associated memoranda (NMFS, 2008; memo from John Boreman to Pat Kurkul, March 6, 2006; memo from Patricia A. Kurkul to The Record, April 5, 2006).

As described previously, there have been several projects designed to look at the details of sea turtle-sea scallop dredge interactions (DuPaul et al. , 2004; Smolowitz et al. , 2005; Smolowitz and Weeks, 2006; Milliken et al. , 2007). It is evident from these studies that using video to document the specific nature of sea turtle-sea scallop dredge interactions, in general, and sea turtle-chain mat interactions specifically, is logistically difficult given the low interaction rate. To date, no sea turtles have been documented on video used in the commercial fishery. Additional difficulties identified through these studies include low visibility due to water clarity and available light, improper focus, inappropriate camera angle, and the range of viewing field. Requiring all scallop dredges using the modification to carry observers and monitor underwater interactions with video cameras may provide some additional information on interactions between sea turtles and scallop dredges. However, given the low rate of interaction and the technical challenges of underwater video, it is not clear that this approach would provide sufficient information to understand the nature of these interactions.

In addition, this level of coverage is infeasible at this time given existing resources. The video would need to be reviewed by the observer or NMFS personnel upon completion of the trip. If the observer was to review the video in real-time, they would likely be unable to collect all the information, including discards, biological information on the catch, and gear performance and characteristics, that is currently collected and utilized by NMFS. Given the total dredge hours in the mid-Atlantic, review of the video taken would require additional resources. NERO has investigated the feasibility of using video technology on a subset of vessels to monitor sea turtle-sea scallop dredge interactions and found that, at this time, video monitoring is not feasible. The use of video monitoring is discussed in detail in the most recent Biological Opinion (NMFS 2008).

Despite the challenges associated with using video to document interactions between sea turtles and sea scallop dredges, NMFS does plan to continue to collect video in conjunction with other gear projects. These projects may shed light on how to overcome the difficulties of using video to monitor sea turtle behavior and interactions with gear.

Comment 27: NMFS should put in a cap system that would have 100 percent observer coverage, including underwater video monitoring, and would shut down the fishery when they reached their capped level of turtle takes.

Response: As described in the response to Comment 26, 100 percent observer coverage with video monitoring is not feasible at this time. The anticipated level of take and the monitoring of the ITS are addressed through the section 7 process under the ESA.

Comment 28: Turtle chains are not scientifically validated. The information used to support the chain mat requirements is based on assumptions and guesswork, not scientific research and this information is inadequate. The studies on which the chain-mat modification is based are fatally flawed as they rely only on on-deck observations and so only addressed whether the chain mat could reduce the number of sea turtles caught in the dredge and did not address whether the chains reduced the number of sea turtle takes, injuries, and deaths caused by scallop dredging. It is crucial to study the effects of the chains through underwater video monitoring.

Response: The experimental fishery used two paired dredges, one equipped with a standard dredge and one equipped with a modified dredge. This paired design is an industry standard in gear work and is utilized to minimize unaccountable environmental variation. The study involved over 3000 paired hauls, which resulted in enough statistical power to be able to detect differences in the turtle catches between the modified and the unmodified dredge. There was a statistical difference between turtle catches in the control and modified dredges (at alpha—0.05 level). NMFS recognizes that these studies relied on on-deck observations, and that sea turtles may be struck by the dredge while fishing near the bottom or while being hauled through the water column and not brought onboard. Unfortunately, these types of interactions cannot be quantified at this time because information on these interactions does not exist. However, the best available information does show that the chain mat modification prevents most captures of sea turtles in the dredge bag; thereby preventing injury and mortality that occur from such capture. Nevertheless, NMFS intends to use video in conjunction with other projects in an attempt to learn more about sea turtle-sea scallop dredge interactions (see response to Comment 3).

Comment 29: NMFS must obtain data on sea turtles' oceanic and neritic life history stages by conducting in-water surveys for all sea turtle species in order to accurately determine sea turtle abundance and population structure.

Response: NMFS concurs that data on sea turtles' oceanic and neritic life history stages from in-water surveys is important in determining sea turtle abundance and population structure. The preliminary findings of the TEWG offer recommendations regarding research that include a program to provide annual estimates of turtles in the NE and SE regions which would include a survey program to obtain estimates of total turtle in-water tagging studies and nesting beach tagging studies (memo from Nancy Thompson to James Lecky, December 4, 2007).

The rule has been determined to be not significant under Executive Order 12866.

NMFS prepared an initial regulatory flexibility analysis for the proposed rule, which was described in the classification section of the preamble to the proposed rule. The public comment period ended on December 10, 2007. One comment was received on the economic impacts of the proposed action (comment/response 20 in this final rule). No changes were made as a result of the comment.

NMFS has prepared a final regulatory flexibility analysis (FRFA) that describes the economic impact this final rule would have on small entities. A description of the action, why it is being considered and the legal basis for this action are contained at the beginning of the preamble, in the SUMMARY, and in the FRFA. A summary of the analysis follows:

The fishery affected by this final rule is the Atlantic sea scallop dredge fishery. The action requires all vessels with a Federal Atlantic sea scallop fishery permit, regardless of dredge size or vessel permit category, that enter waters south of 41°9.0′ N. latitude, from the shoreline to the outer boundary of the EEZ to modify their dredge gear with a chain mat. Vessels transiting the area are exempt from this requirement provided that the gear is stowed and there are no scallops on board. According to Vessel Trip Report Data for 2003, 314 vessels fished in this area from May 1 through November 30. The economic analysis assumes that all 314 vessels are independently owned and operated. All 314 sea scallop dredge vessels are considered small entities.

This final rule does not contain any additional reporting, recordkeeping, or other similar compliance requirements.

The FRFA considered three alternatives. The preferred alternative (PA), Alternative 1, and the “no action” alternative. The PA, alternative 1, and the “no action” alternative were analyzed in the regulatory flexibility analysis and summarized in the proposed rule (72 FR 63537, November 9, 2007). NMFS selected the preferred alternative in the final rule (modification of the current regulatory requirements) because this alternative would clarify the regulatory language and add a transiting provision while maintaining the level of protection to sea turtles. The agency minimized impacts to small entities from the requirement to use chain-mat modified gear by limiting the requirements to the May through November time period and limiting the spatial extent to south of 41°9.0′ N latitude. NMFS rejected Alternative 1 (no chain mat requirement) because this alternative would leave sea turtles vulnerable to capture in the sea scallop dredge bag and to injury and mortality that may result from such capture. This alternative would have the least economic impact. NMFS also rejected the no action alternative. Although this alternative would provide the same level of protection to sea turtles as the preferred alterative, this alternative does not clarify the regulatory requirements or provide a transiting provision.

This final rule is consistent with the ESA and other applicable laws.

On December 27, 2006, we published a proposed rule (71 FR 77694) to list the North Pacific right whale ( Eubalaena japonica ) as an endangered species pursuant to the Endangered Species Act (ESA) (16 U.S.C. 1531 et seq. ), and we listed this species as endangered on March 6, 2008 (73 FR 12024). On October 29, 2007, we published a proposed rule (72 FR 61089) to designate critical habitat for the North Pacific right whale. We proposed the same two areas that we had previously designated as critical habitat for the northern right whale in the North Pacific Ocean (71 FR 38277, July 6, 2006). We now designate these same areas as critical habitat for the North Pacific right whale. A description of, and the basis for, the designation follows.

Section 3 of the ESA defines critical habitat as “(i) the specific areas within the geographical area occupied by the species, at the time it is listed . . . on which are found those physical or biological features (I) essential to the conservation of the species and which may require special management considerations or protection; and (II) specific areas outside the geographical area occupied by the species at the time it is listed upon a determination by the Secretary to be essential for the conservation of the species.” Section 3 of the ESA (16 U.S.C. 1532(3)) also defines the terms “conserve,” “conserving,” and “conservation” to mean “to use, and the use of, all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to this chapter are no longer necessary.”

In determining what areas meet the definition of critical habitat, 50 CFR 424.12(b) requires that we “consider those physical or biological features that are essential to the conservation of a given species including space for individual and population growth and for normal behavior; food, water, air, light, minerals, or other nutritional or physiological requirements; cover or shelter; sites for breeding, reproduction, and rearing of offspring; and habitats that are protected from disturbance or are representative of the historical geographical and ecological distribution of a species.” The regulations refine our task by directing us to “focus on the principal biological or physical constituent elements . . . that are essential to the conservation of the species,” and specify that the “known primary constituent elements shall be listed with the critical habitat description.” The regulations identify primary constituent elements (PCEs) as including, but not limited to: “roost sites, nesting grounds, spawning sites, feeding sites, seasonal wetland or dryland, water quality or quantity, host species or plant pollinator, geological formation, vegetation type, tide, and specific soil types.” An area within the geographic area occupied by the species must contain one or more PCEs to be eligible for designation as critical habitat; an area upon which no PCE is found may not be designated in the hope it will acquire one or more PCEs in the future.

Section 4 of the ESA requires that, before designating critical habitat, the Secretary consider economic impacts, impacts on national security, and other relevant impacts of specifying any particular area as critical habitat. The Secretary may exclude any area from critical habitat if the benefits of exclusion outweigh the benefits of inclusion, unless excluding an area from critical habitat will result in the extinction of the species concerned. Once critical habitat is designated, section 7(a)(2) of the ESA requires that each Federal agency, in consultation with and with the assistance of NMFS, ensure that any action authorized, funded, or carried out by such agency is not likely to result in the destruction or adverse modification of critical habitat.

The ESA defines critical habitat (in part) as areas within the geographical area occupied by the species at the time it was listed under the ESA. Prior to the onset of commercial whaling in 1835, right whales were widely distributed across the North Pacific (Scarff, 1986; Clapham et al. , 2004; Shelden et al. , 2005). By 1900 they were scarce throughout their range. Japan and the USSR did not sign a League of Nations agreement in 1935 to protect right whales, so they continued right whaling until 1949, when the newly created International Whaling Commission endorsed the ban. After this, 23 North Pacific right whales were legally killed by Japan and the USSR under Article VIII of the International Convention for the Regulation of Whaling (1946), which permits the taking of whales for scientific research purposes. However, it is now known that the USSR illegally caught many right whales in the North Pacific (Doroshenko, 2000; Brownell et al. , 2001; Ivashchenko, 2007). By 1973, the North Pacific right whale had been severely reduced by commercial whaling. Sighting data from this remnant population are too sparse to identify the range of these animals in 1973. However, no reason exists to suspect that the right whales that remain alive today inhabit a substantially different range than right whales alive during the time of the Soviet catches; indeed, given the longevity of this species, it is likely that some of the individuals who survived that whaling episode remain alive now. Consequently, recent habitat use is unlikely to be different today.

Both the SEBS and the western GOA (shelf and slope waters south of Kodiak) have been the focus of many sightings (as well as the illegal Soviet catches) in recent decades. In general, the majority of North Pacific right whale sightings (historically and in recent times) have occurred from about 40° N to 60° N latitude (lat.). There are historical records from north of 60° N lat., but these are rare and are likely to have been misidentified bowhead whales. North Pacific right whales have on rare occasions been recorded off California and Mexico, as well as off Hawaii. However, as noted by Brownell et al. (2001), there is no evidence that either Hawaii or the west coast of North America from Washington State to Baja California were ever important habitats for right whales. Given the amount of whaling effort as well as the human population density in these regions, it is highly unlikely that substantial concentrations of right whales would have passed unnoticed. Furthermore, no archaeological evidence exists from the U.S. west coast suggesting that right whales were the target of local native hunts. Consequently, the few records from this region are considered to represent vagrants.

For the foregoing reasons, we determine that the geographical area occupied by the North Pacific right whale at the time of ESA listing extends over a broad area of the North Pacific Ocean, between 120° E and 123° W longitude and 40° N and 60° N latitude, as shown in Figure 1.