A proposed rule was published in the Federal Register on October 11, 2002, at 67 FR 63313. The rule proposed to implement section 343 of the Illegal Immigration Reform and Immigrant Responsibility Act (IIRIRA) of 1996, Public Law 104-208, 110 Stat. 3009, 636-37 (1996), now codified at section 212(a)(5)(C) of the Immigration and Nationality Act (Act), 8 U.S.C. 1182(a)(5)(C), and section 4(a) of the Nursing Relief for Disadvantaged Areas Act of 1999 (NRDAA), Public Law 106-95, codified at section 212(r) of the Act, 8 U.S.C. 1182(r).

Section 343 of IIRIRA created a new ground of inadmissibility. It provides that, subject to section 212(r) of the Act, an alien who seeks to enter the United States for the purpose of performing labor as a health care worker, other than a physician, is inadmissible unless the alien presents a certificate from the Commission on Graduates of Foreign Nursing Schools (CGFNS), or an equivalent independent credentialing organization approved by the Attorney General in consultation with the Secretary of the Department of Health and Human Services (HHS), verifying that:

(1) The alien's education, training, license, and experience meet all applicable statutory and regulatory requirements for admission into the United States under the classification specified in the application; are comparable with that required for an American health care worker of the same type; are authentic; and, in the case of a license, unencumbered;

(2) The alien has the level of competence in oral and written English considered by the Secretary of HHS, in consultation with the Secretary of Education, to be appropriate for health care work of the kind in which the alien will be engaged, as shown by an appropriate score on one or more nationally recognized, commercially available, standardized assessments of the applicant's ability to speak and write English; and

(3) If a majority of States licensing the profession in which the alien intends to work recognize a test predicting an applicant's success on the profession's licensing or certification examination, the alien has passed such a test, or has passed such an examination.

Section 212(r) of the Act created an alternative certification process for aliens who seek to enter the United States for the purpose of performing labor as a nurse. In lieu of a certification under the standards of section 212(a)(5)(C) of the Act, an alien nurse can present to the consular officer (or in the case of an adjustment of status, the Attorney General) a certified statement from CGFNS (or an equivalent independent credentialing organization approved for the certification of nurses) that:

(1) The alien has a valid and unrestricted license as a nurse in a state where the alien intends to be employed and that such state verifies that the foreign licenses of alien nurses are authentic and unencumbered;

(2) The alien has passed the National Council Licensure Examination (NCLEX); and

(3) The alien is a graduate of a nursing program that meets the following requirements:

(i) The language of instruction was English; and

(ii) The nursing program was located in a country which:

(A) Was designated by CGFNS no later than 30 days after the enactment of the NRDAA, based on CGFNS' assessment that designation of such country is justified by the quality of nursing education in that country, and the English language proficiency of those who complete such programs in that country; or

(B) Was designated on the basis of such an assessment by unanimous agreement of CGFNS and any equivalent credentialing organizations which the Attorney General has approved for the certification of nurses; and

(iii) The nursing program:

(A) Was in operation on or before November 12, 1999; or

(B) Has been approved by unanimous agreement of CGFNS and any equivalent credentialing organizations which the Attorney General has approved for the certification of nurses.

CGFNS designated the following countries for purposes of this alternate certification: Australia, Canada, Ireland, New Zealand, South Africa, the United Kingdom, and the United States.

Section 212(a)(5)(C) of the Act became effective upon enactment on September 30, 1996. Shortly thereafter, the DHS met with HHS, the Department of Labor (DOL), the Department of Education (DoED), the Department of Commerce (DOC), the Office of the United States Trade Representative (USTR), and the Department of State (DOS) to reach consensus on the best approach for implementation of the new provision. The DHS also met with interested private organizations including CGFNS, the American Occupational Therapists Association, the National Board for Certification in Occupational Therapy (NBCOT), the Federated State Board of Physical Therapy, and the American Physical Therapy Association.

Section 343 of IIRIRA and NRDAA, was implemented via three interim rules published in the Federal Register as follows:

(1) Interim Procedures for Certain Health Care Workers, 63 FR 55007 (October 14, 1998) (codified at 8 CFR 212.15 and 245.14) (the first Interim Rule);

(2) Additional Authorization to Issue Certificates for Foreign Health Care Workers, 64 FR 23174 (April 30, 1999) (amending 8 CFR 212.15) (the second Interim Rule); and

(3) Additional Authorization to Issue Certificates for Foreign Health Care Workers; Speech Language Pathologists and Audiologists, Medical Technologists and Technicians, and Physician Assistants, 66 FR 3440 (January 16, 2001) (amending 8 CFR 212.15) (the third Interim Rule).

The supplementary information pertaining to the October 11, 2002, proposed rule describes these earlier rules in more detail.

The organizations that have already been granted authority to issue certifications under these interim rules, other than CGFNS, shall be required to seek authority to issue certifications under the provisions of this final rule. However, those organizations will retain interim authority to continue issuing certificates and certified statements provided that they submit a request for continued authorization on Form I-905, Application for Authorization to Issue Health Care Worker Certificates, on or before January 27, 2004. and during the period that the Form I-905 is pending adjudication with the DHS. The DHS will not require CGFNS to apply for authorization to issue certificates or certified statements for those seven health care occupations named in the legislative history to IIRIRA. However, CGFNS will be required to submit information regarding its certification processes via filing of Form I-905 without fee with the Director, Nebraska Service Center, on or before January 27, 2004. The DHS will review CGFNS' Form I-905 for content of the certificates for the seven health care occupations, and content of certified statements for nurses, and to ensure compliance with the universal standards set forth in this rule. Like other credentialing organizations, CGFNS will also be subject to ongoing review by the DHS, and termination of credentialing status for noncompliance with this rule. Further, the DHS will terminate the authority of any organization currently authorized to issue certificates or certified statements if the organization does not submit an application or provide information on Form I-905 on or before January 27, 2004.

The DHS in consultation with HHS initially identified, on the basis of the legislative history, seven categories of health care workers subject to the provisions of section 212(a)(5)(C) of the Act. See H.R. CONF. REP. NO. 104-828 at 227 (1996). The seven categories are nurses, physical therapists, occupational therapists, speech-language pathologists, medical technologists (also known as clinical laboratory scientists), medical technicians (also known as clinical laboratory technicians) and physician assistants. See 63 FR at 55008.

In the first Interim Rule, CGFNS and the NBCOT were authorized to issue certificates to immigrant nurses and occupational therapists respectively, established the appropriate English language competency levels for foreign nurses and occupational therapists, and specified exemptions from English language proficiency testing.

The first Interim Rule applied only to immigrants. The DHS and DOS exercised their discretion under section 212(d)(3) of the Act, 8 U.S.C. 1182(d)(3), to waive the foreign health care worker certification requirement for nonimmigrant health care workers until promulgation of final implementing regulations. The DHS and DOS exercised their waiver discretion after carefully considering the complexity of the implementation issues, including how the health care certificate requirements affect United States obligations under international agreements and the need for health care facilities across the country to remain fully staffed and provide a high quality of service to the public. The waiver of inadmissibility applied to nonimmigrant health care workers already in possession of nonimmigrant visas and visa exempt aliens, including Canadians applying for classification under section 214(e) of the Act, 8 U.S.C. 1184(e) Trade NAFTA (TN) classification.

In the second Interim Rule, CGFNS was temporarily authorized to issue certificates to immigrant occupational therapists and physical therapists, it also temporarily authorized the Foreign Credentialing Commission on Physical Therapy (FCCPT) to issue certificates to immigrant physical therapists, and established the appropriate English language competency levels for physical therapists. The DHS, in consultation with HHS, found that both CGFNS and FCCPT met the “established track record” criterion, and concluded that there was a sustained level of demand for occupational therapists and physical therapists.

In the third Interim Rule, CGFNS was temporarily authorized to issue certificates to immigrant speech-language pathologists and audiologists, medical technologists (also known as clinical laboratory scientists), physician assistants, and medical technicians (also known as clinical laboratory technicians), listed the passing scores for the English language tests for those health care occupations, and amended the regulations concerning which organizations may administer the English language tests. The DHS also modified the criteria it had used in the first and second Interim Rules to temporarily authorize organizations to issue certificates to immigrant health care workers. CGFNS was found to have an established track record in issuing certificates for the additional occupations.

A related interim rule was published in response to the passage of the NRDAA, Petitioning Requirements for the H-1C Nonimmigrant Classification under Public Law 106-95, 66 FR 31107 (June 11, 2001) (amending 8 CFR 214.2(h)). Among other things, the NRDAA created an alternative certification process for foreign nurses only, as provided in section 212(r) of the Act. In the H-1C rule, the DHS announced that it would continue to waive the certification requirements for nonimmigrant nurses, pending the promulgation of new regulations implementing both certification processes.

In the October 11, 2002, rule, the DHS proposed to implement a comprehensive process for the certification of foreign health care workers under sections 212(a)(5)(C) and (r) of the Act. It addresses foreign health care workers coming to the United States on a temporary basis (nonimmigrant aliens) as well as on a permanent basis (immigrants).

This rule proposed to amend 8 CFR 212.15 by:

(1) Specifying which organizations are authorized to issue certificates (8 CFR 212.15(e));

(2) Describing the required content of the certificate itself (8 CFR 212.15(f));

(3) Specifying the English language requirements for certification (8 CFR 212.15(g));

(4) Implementing the alternative certification process for foreign nurses and the required content of the certified statement (8 CFR 212.15(h));

(5) Establishing a streamlined certification process for certain nurses, occupational therapists, physical therapists, and speech language pathologists and audiologists (8 CFR 212.15(i));

(6) Describing the procedure to qualify as a certifying organization (8 CFR 212.15(j));

(7) Listing the standards that an organization must meet in order to obtain and retain authorization to issue foreign health care worker certifications (8 CFR 212.15(k)); and

(8) Providing for periodic review of the performance of certifying organizations (8 CFR 212.15(l)) and the termination of their authority (8 CFR 212.15(m)).

The rule also proposed to amend 8 CFR 103.1 by specifying at new paragraphs (f)(3)(iii)(QQ) and (RR) that the Associate Commissioner for Examinations exercises appellate jurisdiction over applications for authorization to issue foreign health care worker certifications, and the termination of authorization to issue foreign health care worker certifications.

The rule proposed to amend 8 CFR 103.7(b)(1) by adding a fee for filing Form I-905, Application for Authorization to Issue Certification for Health Care Workers. This form was previously approved for use in order to ensure that organizations formally seeking authorization to issue health care worker certificates or certified statements will be able to submit complete and uniform applications. However, because the authorization process was never implemented through a final regulation, the Form I-905 has not yet been distributed for public use.

The rule also proposed to amend 8 CFR 214.1(h) by adding a requirement that an alien who seeks to enter the United States for the purpose of performing labor in a health care occupation must present a foreign health care worker certification to the DHS in accordance with 8 CFR 212.15(d).

The rule further proposed to amend 8 CFR 248.3 by adding paragraph (i) to mandate that a nonimmigrant seeking a change of status to perform labor in a health care occupation must submit a foreign health care worker certification.

Thirty-three comments were received from a variety of individuals and organizations including health care workers, attorneys, professional organizations, U.S. Government organizations, foreign government officials, and organizations granted authority to issue certifications to health care workers. The comments addressed many aspects of the proposed rule. For the sake of clarity, this section will summarize the justification for the regulatory amendments contained in the proposed rule and then discuss the comments that relate to the specific amendment.

It must be noted that the proposed rule generated a number of comments that were not related to the issue of certifications for health care workers. For example, two commenters discussed the general issue of the DHS' role in the importation of nurses to the United States while another commented on the issue of Social Security cards and licenses for nurses. One commenter discussed an alleged contradiction in the statutory language. These comments will not be discussed because they are not germane to the proposed rule.

Ten commenters made general observations on the impact of the rule on health care in the United States. Nine of the commenters provided that the rule will have an adverse affect on health care in the United States because it will make it harder for facilities to recruit, hire, and retain foreign health care workers. The commenters stated that the implementation of the regulation will result in increased backlogs and create difficulties for aliens attempting to enter the United States. The other commenter stated that CGFNS will have a difficult time processing the number of requests it will receive for certifications. One commenter stated that the regulation takes away the authority of hospital administrators to make decisions with respect to health care issues. Finally, one commenter stated that the regulation was not flexible and would create operational difficulties for health care facilities.

The statutory provisions relating to the certification process are complex. In drafting the previous interim rules, the proposed rule, and this final rule, every attempt has been made to minimize the adverse affects that they would have on health care facilities and health care workers and, at the same, ensure that they reflect the intent of Congress.

The DHS took the position in the proposed rule that the requirements of section 212(a)(5)(C) of the Act apply to both immigrants and nonimmigrants who seek to enter the United States for the purpose of performing labor as a health care worker. Physicians are explicitly exempted from the certification requirement by the statute and, therefore, are not covered by this rule.

Further, the DHS held that with respect to immigrants, the certification requirement applies to both aliens overseas who are seeking an immigrant visa, and aliens in the United States who are applying for adjustment of status to that of a permanent resident. The DHS interprets the statutory language, “any alien who seeks to enter the United States for the purpose of performing labor as a health care worker * * *” with respect to immigrants, to limit the scope of this provision to aliens with an approved employment-based (EB) preference petition under section 203(b) of the Act, 8 U.S.C. 1153(b), to perform labor in a covered health care occupation. Therefore, an alien is not subject to section 212(a)(5)(C) of the Act if he or she is seeking an immigrant visa or adjustment of status on any other basis pursuant to a family-sponsored petition under section 203(a) of the Act, 8 U.S.C. 1153(a), an EB preference petition for a non-health care occupation; under section 209 of the Act, 8 U.S.C. 1159 (adjustment of status of refugees); under section 210 of the Act, 8 U.S.C. 1160 (special agricultural workers), or pursuant to section 240A of the Act, 8 U.S.C. 1229b (cancellation of removal); under section 249 of the Act, 8 U.S.C. 1259 (record of admission for permanent residence); or under any other statutory provision relating to admission as an immigrant.

With respect to nonimmigrant aliens, the proposed rule applied the certification requirement to all aliens who have obtained nonimmigrant status for the purpose of performing labor as a health care worker, including, but not limited to, those aliens described in sections 101(a)(15)(H), (J), and (O) of the Act, 8 U.S.C. 1101(a)(15), and aliens entering pursuant to section 214(e) of the Act, 8 U.S.C. 1184(e), as TN professionals.

The DHS also proposed that a nonimmigrant entering the United States to receive training in an occupation listed at 8 CFR 212.15(c) will not be required to obtain a health care certification. This includes, but is not limited to, F-1 nonimmigrants receiving practical training and J-1 nonimmigrants coming to the United States to undertake a training program in a medical field. Nonimmigrant aliens entering the United States to receive training in a health care occupation fall outside the ambit of section 212(a)(5)(C) of the Act because they are not independently performing the full range of duties of their occupation and, therefore, are not entering for the purpose of performing labor as a health care worker. Their primary purpose in the U.S. is not to perform health care but is rather to receive training.

Finally, the DHS concluded in the proposed rule that the alien health care certification requirement should not be applied to the spouse and dependent children of an immigrant or nonimmigrant. Dependent aliens enter the United States for the primary purpose of accompanying the principal alien, not to perform labor as a health care worker, or in any other field. A dependent alien derives his or her nonimmigrant status from his or her familial relationship with the principal alien and is not required to work in a particular occupational field or for a specific employer to maintain his or her status. Accordingly, regardless of whether or not a dependent alien may intend to work in a health care occupation listed at 8 CFR 212.15(c), he or she would not be subject to the health care worker certification requirement.

Eighteen comments were received in response to this portion of the proposed rule. Four commenters stated that all nonimmigrant aliens should be covered by section 212(a)(5)(C) of the Act. Six commenters suggested that section 212(a)(5)(C) of the Act should not apply to TN nonimmigrants because it conflicts with the terms of the North American Free Trade Agreement (NAFTA).

The DHS carefully considered these comments. However, as noted in the proposed rulemaking, based on our consideration of the relevant statutory provisions, legislative history, judicial precedent, and our prior rulemakings, the DHS has concluded that the health care certification requirement is intended to apply to all nonimmigrant health care workers. The legislative history of IIRIRA confirms that, in this instance, the DHS may not rely on the commenters' assertions regarding an alleged conflict with NAFTA to reach a different result. See H.R. CONF. REP. NO. 104-828 at 226-27 (1996).

Four commenters also stated that the certification requirement should be applied to the spouse and dependent children of an immigrant or nonimmigrant alien. One commenter stated that nonimmigrant aliens coming to the United States to obtain training, such as F-1 and J-1 nonimmigrants, should not be required to obtain a certificate while two commenters suggested that they should. Likewise, two commenters suggested that an H-3 alien should also be exempt from the provision because an H-3 alien is also coming to the United States to obtain training. Finally, one commenter suggested that the DHS specifically list the nonimmigrant aliens exempted from the certification requirements in the final regulation.

The DHS will not require dependent aliens to obtain a certificate even if they will eventually be employed in a covered health care occupation. Sections 212(a)(5)(C) and 212(r) of the Act relate to grounds of inadmissibility. Since dependent aliens enter the United States for the primary purpose of accompanying the principal alien, they are not coming to the United States to perform labor as a health care worker, or in any other field, and they will not be required to obtain a certification.

Further, the DHS will not list the specific aliens exempted from the requirement to obtain health care certificates. The language contained in the proposed rule at 8 CFR 212.15(a)(1) provides that the provision applies only to those aliens coming to the United States for the primary purpose of performing labor in a health care occupation. This language clearly does not apply to a nonimmigrant alien coming to the United States for training, including an H-3 nonimmigrant alien. Further, the listing of specific nonimmigrant classifications in the regulation may be erroneously interpreted by some to limit the exemption to those nonimmigrants specifically listed in the regulation.

The proposed rule provided that possession of a state license does not exempt a foreign health care worker from compliance with the certification requirement.

As stated in the proposed rule, this conclusion was reached after considering the language of the statute, and after consultation with HHS. Nothing in the text of section 212(a)(5)(C) of the Act relieves alien health care workers of this requirement, on the ground that they were trained in the United States or are already licensed here. Moreover, the certification requires that any state license the alien may already have is unencumbered. Indeed, had Congress intended to exempt such aliens from the certification requirement, it would not have explicitly provided that the certification must document the fact of an alien=s successful passage of any test or examination that is accepted as evidence of an applicant's likely success on a state licensing examination, if a majority of States recognize such a pre-licensing test or examination. In addition, in NRDAA, Congress explicitly addressed whether a foreign nurse, in possession of a full and unrestricted license issued by the state of intended employment, should be subject to the certification requirement. The NRDAA created a less onerous, alternative method of certification for foreign nurses who have unrestricted state licenses and meet certain other conditions, as provided in section 212(r) of the Act. The fact that Congress has chosen not to provide a less rigorous alternative certification option to state-licensed foreign health care workers other than nurses supports the inference that Congress intended state-licensed foreign health care workers to comply with the certification process.

In addition to the statutory scheme, there are policy considerations that mitigate in favor of applying the certification requirement to state-licensed foreign health care workers. The state screening process alone would not demonstrate that the other two prongs of the certification requirement, English language competency, and comparable training and unencumbered licensing, had been met. First, the state screening process does not always measure English proficiency. Second, HHS had advised that the state screening process may not always discover encumbrances and restrictions on a license.

The statute and legislative history are silent with respect to whether foreign health care workers, who received their training in the United States, are subject to the certification process. While such aliens would satisfy the comparable training certification requirements, their licensure would not be verified, as required by the statute. Given the lack of evidence of congressional intent that such aliens be exempt from the reach of section 212(a)(5)(C) of the Act, the DHS has concluded that foreign health care workers who received their training in the United States must comply with the certification requirement. The DHS will not modify the proposals contained in the proposed rule to wholly exempt foreign health care workers who received their training in the United States or who hold a license to practice in the United States.

One commenter suggested that the verification requirement for nurses at proposed 8 CFR 212.15(h)(2)(i) be amended to include the parenthetical phrase A(including reliance on evidence provided by the alien)” after the word Averified.” Under the suggested language, credentialing organizations would not be permitted to second-guess a state's licensure verification. The DHS will not adopt this proposal. The statutory language at section 212(r) of the Act authorizes CGFNS or any other authorized credentialing organization to verify that the alien has a valid and unrestricted license in a state where the alien intends to be employed, and that such state verifies that the foreign licenses of alien nurses are authentic and unencumbered. The DHS does not have the authority under the statute to determine whether or not a state verifies that the foreign licenses of alien nurses are authentic and unencumbered, nor does the DHS have the authority to prevent CGFNS or any other authorized credentialing organization from making such a finding before issuing certification.

The proposed rule invited comments regarding the feasibility of having a more streamlined certification process for those who train in the United States or who are already licensed here, and regarding specific proposals on how to adopt such a policy.

The DHS received four comments in response to the request for suggestions relating to a streamlined certification process. Three commenters stated that the DHS should develop a streamlined approach without providing any suggested process while one commenter, CGFNS, provided a detailed description of a proposed process.

The CGFNS proposed that an alien nurse who graduated from an entry-level program accredited by the National League for Nursing Accreditation Commission (NLNAC) or the Commission on Collegiate Nursing Education (CCNE) would be exempt from the educational comparability review and English language proficiency testing. The CGFNS also proposed that aliens educated in the United States in any other named discipline and who have graduated from a program accredited by the discipline would be evaluated under this same process.

Pursuant to section 343 of IIRIRA, HHS, in consultation with the Secretary of Education, is required to establish a level of competence in oral and written English which is appropriate for the health care work of the kind in which the alien will be engaged, as shown by an appropriate score on one or more nationally recognized, commercially available, standardized assessments of the applicant's ability to speak and write.

The statute vests the Secretary of HHS with the “sole discretion” to determine the standardized tests and appropriate minimum scores required by section 343 of IIRIRA. Because the organizations identified as the accrediting bodies for nursing go through a rigorous review prior to being recognized by the DoED, HHS has agreed that the proposal to accept graduation from an NLNAC or CCNE accredited program in lieu of a review of educational comparability and English proficiency has merit. Accordingly, the proposal will be adopted in the final rule. It will shorten the certification process required for health care workers educated in the United States. It will also allow CGFNS and any approved organization to comply with the statutory requirements and, at the same time, ease the burden on certain health care workers. This proposal has been implemented in this final rule at 8 CFR 215.15(i).

In addition, HHS has agreed to accept graduation from the following programs in lieu of a review of educational comparability and English proficiency:

(1) For occupational therapists, graduation from a program accredited by the Accreditation Council for Occupational Therapy Education (ACOTE) of the American Occupational Therapy Association (AOTA);

(2) For physical therapists, graduation from a program accredited by the Commission on Accreditation in Physical Therapy Education (CAPTE) of the American Physical Therapy Association (APTA); and

(3) For speech language pathologists and audiologists, graduation from a program accredited by the Council on Academic Accreditation in Audiology and Speech Language Pathology (CAA) of the American Speech-Language-Hearing Association (ASHA).

However, the proposal that aliens educated in the United States in any other named discipline and who have graduated from a program accredited by the discipline would be evaluated under this same process will not be adopted as general provision, because specific accrediting bodies for other professions were not suggested. The HHS will continue to review further proposals for each profession on a case-by-case basis.

In the proposed rule, based on congressional history, seven categories of health care workers subject to the health care certification requirements were identified. See H.R. CONF. REP. NO. 104-828 at 227 (1996). The seven categories are nurses, physical therapists, occupational therapists, speech-language pathologists, medical technologists (also known as clinical laboratory scientists), medical technicians (also known as clinical laboratory technicians) and physician assistants. See the first Interim Rule. The conference report also provided that the DHS could designate additional health care occupations subject to certification by regulation. Since the DHS had limited agency expertise with health care occupations and issues, it consulted extensively with HHS, the agency generally responsible for overseeing health care occupations and other related health care issues in the United States, with respect to the question of whether aliens in additional health care occupations should be required to comply with 8 U.S.C. 1182(a)(5)(C).

The proposed rule identified two factors relevant to the consideration of which health care occupations fall under the ambit of section 212(a)(5)(C) of the Act. The first factor is whether the health care occupation generally requires a license in a majority of the states. This factor reflects the states' historical and practical experience in distinguishing between those health care occupations requiring extensive regulation and those occupations that do not. At the advice of HHS, DHS has included the District of Columbia. While not a state, Washington, DC, has its own licensing authorities and should be included when determining whether a majority of states recognize a licensure or certification predictor exam.

The second factor is whether the health care worker has a direct effect on patient care, or, in other words, whether a health care worker in that occupation could reasonably pose a risk to patient health.

In response to this proposal, CGFNS suggested that a third factor should be considered in determining whether an occupation should be included in the certification process. The CGFNS suggested that an additional factor that should be considered is whether a significant number of foreign nationals enter the United States workforce for the purpose of performing labor in a particular health care occupation. The CGFNS noted that it would not be prudent to spend the time and resources required to establish a certification process for a particular occupation in which very few foreign workers are seeking employment.

The DHS has considered using the factor suggested by CGFNS. It would be difficult to accurately measure the number of “foreign” workers in a given occupation at a particular point in time, and the labor market for any occupation is subject to fluctuations. As the DHS is not currently adding any other occupations to the list of seven occupations requiring certification or certified statements, the DHS will not adopt the suggestion to evaluate inclusion of an occupation based on the number of foreign nationals seeking to enter the United States workforce in that occupation.

Under the proposed rule, health care workers such as, but not limited to, medical teachers, medical researchers, managers of health care facilities, and medical consultants to the insurance industry would not be required to comply with the certification requirement. In contrast, health care workers, such as supervisory physical therapists, who may not typically be involved in hands-on patient care but do have a direct effect on patient care, would be subject to the certification requirements. In the proposed rule, the DHS acknowledged that the job descriptions of certain occupations that could be added to the list may differ in other countries from the United States definition of the occupation. The differences may create confusion about which occupation is subject to certification. The DHS suggested that a possible solution would be to define each health care occupation subject to certification in this final rule. The DHS again invited comments regarding the need to define a health care occupation that is subject to certification.

In response to this provision, the DHS received nine comments. Three commenters suggested that the list of occupations be expanded to include additional occupations including Radiation Therapists and Radiological Technologists. Two commenters suggested that the current list of occupations be retained. Three commenters suggested that the DHS should define a health care occupation as any occupation that requires a license to provide direct and indirect patient care. Another commenter suggested that a health care occupation is any occupation that involves patient care. Finally, one commenter suggested that job descriptions should be used to define a health care occupation.

After reviewing the comments, the DHS will not include a specific definition of each health care occupation subject to certification in the regulation at this time. The definitions offered by the commenters were not sufficiently specific and could cover a range of occupations not contemplated by the legislative history. Further, the suggestions have not addressed concerns that the job descriptions of occupations may differ between the United States and other countries. The DHS will continue the past practice of examining the duties of the position offered to the foreign worker to determine if the position falls into one of the listed health care occupations. The practice of continuing to review the duties of the prospective position on a case by case basis will allow for a thorough evaluation of each application and a determination based on the merits of the case rather than the petitioner's or applicant's ability to make the duties of the position conform to a narrow definition.

The statutory language at section 212(a)(5)(C) of the Act requires certain aliens seeking to enter the United States for the purpose of performing labor as a health care worker to present a certificate from CGFNS or an equivalent credentialing organization to the consular officer or, in the case of an adjustment of status, the Attorney General. In the proposed rule, the DHS also provided that the certification must be used for initial admission into the United States or for a change of status within 5 years of the date that it was issued.

Two comments were received in response to this proposal. One commenter suggested that the organization that issues the certification send it directly to either the DHS or, if the alien is outside the United States, to the consular post. Since the adoption of this suggestion would be contrary to statute, the requirement that the certificate be presented to a consular officer at the time of visa issuance and to the DHS at the time of admission or adjustment of status will continue in this final rule.

The other commenter suggested that the certification should be valid indefinitely. While the proposed regulation did not establish a validity date for the certification, it did require that it be submitted to the appropriate entity within 5 years of its issuance. The purpose of this proposal is to ensure that when the certification is submitted, the holder still has the appropriate language and technical skills to perform the duties of the occupation in the United States. Foreign licenses may be encumbered and therefore invalid after a prolonged period of time. Additionally, it is quite possible that over the course of time that the alien may lose certain skills necessary to safely perform the duties of the occupation in the United States. The 5-year submission period provides a basis to ensure that the holder of the certificate continues to meet the regulatory requirements for issuance of the certificate. The proposed rule also provided that if an alien seeking entry to the United States to perform labor in a particular health care occupation has already presented the certification and been admitted as a nonimmigrant, an immigrant, or has adjusted to permanent resident status, he or she will not be required to present the certificate again when he or she makes future applications for admission to the United States to perform labor in that particular health care occupation. The presentation of a Form I-94 issued to the alien at the initial admission to the United States, or a fee receipt showing that the alien was processed for admission under NAFTA would be used, if required, as evidence that the alien has previously presented a foreign health care worker certificate for a particular health care occupation. Similarly, such an alien would not have been required to again present the foreign health care worker certificate to the DHS, with an application for extension of status to perform labor in that particular health care occupation.

The DHS received no comments on this proposal. However, after considering the impact of this provision, the DHS has determined that it will only accept a valid health care worker certificate or certified statement as evidence that the alien is admissible. Currently, an alien is generally required to surrender the departure stub of Form I-94 upon departure from the United States. Controlling the departure of aliens is consistent with the DHS's efforts to fulfill a congressional mandate to implement a comprehensive entry-exit program by 2005. As a result, many aliens will not be able to present a departure stub from a previously issued Form I-94 as evidence of their continuing admissibility under section 212(a)(5)(C) of the Act. In addition, it is noted that information on a Form I-94 does not always include the occupation for an alien nonimmigrant. For this reason, even in exceptional instances where the alien is permitted to retain the departure stub of the Form I-94 when departing the United States, the DHS would not necessarily be able to use the departure stub of the Form I-94 to verify that a particular alien was previously admitted as a health care worker. Accordingly, the DHS has determined that it is in the best interest of affected aliens to require that they present valid health care worker certificates or certified statements each time they seek admission into the United States. Lawful permanent residents will not be required to present this evidence.

This rule adds a new 8 CFR 248.3(i) to outline the procedure for submitting the certificate to the DHS when an application is made to change nonimmigrant status within the United States.

The proposed rule also provided that, on the effective date of the final rule, nonimmigrants who have already entered the United States under a waiver of inadmissibility under section 212(d)(3) of the Act and are working as health care workers will be required to present a certificate to the DHS only if, at any point in the future, they file an application for an extension of stay, or apply for admission to the United States, whichever event occurs first.

The DHS received 13 comments in response to this provision. All 13 commenters suggested that the DHS delay the implementation of this provision for a period of time in order to ensure that the foreign health care workers already in the United States would not be adversely affected. The commenters noted that some health care workers may be required to travel outside of the United States and would not be able to obtain a certification prior to their departure. Other commenters noted that some health care workers who require an extension of their temporary stay would not be able to obtain a certification in a timely fashion and would be forced to terminate their employment at the health care facility.

The DHS believes that these comments are well-founded. The DHS is concerned about the possibility that health care facilities and the United States public will be adversely affected by an immediate implementation date. In addition, DOS also has recommended that the DHS continue to exercise its waiver authority under section 212(d)(3) of the Act for foreign health care workers for at least one year subsequent to the publication of this rule.

If this rule were effective upon publication, potentially every nonimmigrant working in one of the covered health care occupations and seeking admission into the United States would be immediately inadmissible and ineligible to work in the United States under their current nonimmigrant classifications. This would result in a serious disruption to the United States health care system, and is contrary to the intent of the rule. While the DHS does not have precise figures for the number of nonimmigrant health care workers within the United States, health care workers in general comprise a significant portion of the United States workforce. According to the 2001 National Occupational Employment and Wage Estimates from the Bureau of Labor Statistics, there are approximately 9,241,840 health care workers in the United States. Of these, approximately 2,217,990 are registered nurses; 683,790 are licensed practical nurses and licensed vocational nurses; 126,450 are physical therapists; 77,080 are occupational therapists; 94,150 are speech language pathologists and audiologists; 292,320 are medical technologists and technicians; and 56,200 are physician assistants.

Further, were this rule to be effective upon publication, there is no evidence that organizations authorized to issue health care certifications will be able to issue certifications to this potentially large group of workers within a reasonable amount of time. Not only are potentially affected health care workers required to apply for and obtain the actual certifications, but most workers would also be required to pass certain standardized English language tests as a minimum requirement to obtain certification. As discussed in this rule, one of the currently authorized English language testing organizations advised HHS and the DHS that it will no longer provide testing services to foreign health care workers because it cannot meet the demands placed upon it by foreign health care workers seeking health care certificates, and can no longer provide fair access or guarantee testing security.

In addition, health care workers abroad may be required to travel to remote locations in order to take certain tests and will require sufficient time to schedule testing and make any necessary travel arrangements. Although the tests may be offered several times a year, not all required tests are offered in one location. For example, the TSE is not always offered at the same location as the TOEFL, so a health care worker may have to go through several testing cycles in order to obtain a combination of test scores needed for certification. Finally, it should be noted that this rule is implementing the requirement that all approved credentialing organizations obtain evidence of candidate education and licensure directly from the issuing authorities. Thus, once a candidate has passed the requisite tests and submitted an application for certification, there will be additional delays while the authorized credentialing organization obtains and reviews documents such as educational transcripts and licensure materials.

After consideration of these factors, the DHS believes that it must continue the provision for temporary admission under section 212(d)(3) of the Act for a period of 1 year in order to allow for any potential delays in issuance of health care worker certification and to ensure that the United States public is not adversely affected when nonimmigrant health care workers currently employed in the United States are required to obtain certification. Therefore, the DHS has added language at 8 CFR 215.15(n) that continues in force the First Interim Rule's standing provision for temporary admission under section 212(d)(3) of the Act. An alien qualifies for this special provision only if the alien was admitted on or before July 26, 2004. Moreover, any petition or application to extend the alien's period of authorized stay or change the alien's status will be denied unless the alien obtains the required certification no later than 1 year after the date of the alien's temporary admission.

Process for an Organization to Obtain Authorization to Issue Health Care Certificates

The statute provides that a foreign health care worker must present a certificate from CGFNS or an equivalent credentialing organization or, in the case of certain foreign nurses, a certified statement from CGFNS or an equivalent credentialing organization. In the legislative history to IIRIRA, the conferees identified seven health care occupations (which are currently reflected in 8 CFR 212.15(c)). It is reasonable to infer from the statutory designation of CGFNS as a credentialing organization that Congress considered CGFNS to possess the resources and expertise to issue certificates in at least those seven designated health care occupations. Accordingly, the DHS will not require CGFNS to apply for credentialing status with respect to those seven health care occupations. However, CGFNS will be required to submit information regarding its certification processes via filing of Form I-905 Application for Authorization to Issue Certification for Health Care Workers, without fee with the Director, Nebraska Service Center, in order to enable the DHS to review the content of its certificates for the seven health care occupations, and content of its certified statements for nurses, and ensure compliance with the universal standards set forth in this rule. Like other credentialing organizations, CGFNS will also be subject to ongoing review by the DHS, and termination of credentialing status for noncompliance with this rule.

It is less clear, however, that Congress considered whether CGFNS possessed the expertise to issue certificates for health care occupations other than the seven identified in the legislative history. Therefore, although CGFNS' statutory designation creates a strong presumption of expertise with respect to all health care occupations such that the DHS will not charge a fee for review of the Form I-905 in relation to those occupations, the DHS will require CGFNS to file an application on Form I-905 with fee under the procedures outlined at 8 CFR 212.15(j), for credentialing status with respect to any health care occupation other than the seven identified in the legislative history.

Organizations other than CGFNS may be approved to issue certificates or certified statements by submission of Form I-905 to the Director, Nebraska Service Center, with fee. The fee for Form I-905 will be $230.

For purposes of administrative ease and efficiency, the DHS will centralize all requests for designation as a credentialing organization at the Nebraska Service Center, regardless of the geographical location of the requesting organization. Centralization of these requests will enable personnel at the Nebraska Service Center to establish and maintain the appropriate contacts with HHS and DoED to assist in the adjudication of applications for credentialing status. The DHS will accord significant weight to the opinion of HHS in the adjudication of applications for credentialing status because of that agency's expertise with credentialing requirements for health care occupations and health care issues. It should be noted, however, that the DHS may deny a request for authorization on grounds unrelated to credentialing requirements for health care occupations or health care issues, despite a favorable HHS opinion. For example, the DHS may find that because an organization has been convicted, or the directors or officers of an authorized credentialing organization have individually been convicted of the violation of state or federal laws, it would not be appropriate to authorize an organization to issue certificates or certified statements.

Two comments were received with respect to the DHS's treatment of CGFNS under the proposed rule. One commenter stated that CGFNS should not be permitted to issue certificates to medical laboratory technologists because of the large number of credentialing organizations for this occupation in the United States. The other commenter stated that the treatment of CGFNS in the proposed rule is appropriate.

The DHS will not limit the scope of CGFNS' authority to issue certificates to medical laboratory technologists. The fact that other entities have established different licensing and credentialing processes in the United States does not mean that CGFNS is unable or less qualified to issue certificates to foreign health care workers employed in the same occupation. CGFNS has been issuing certificates and certified statements to health care workers in the field of nursing, a field that has a large number of credentialing entities and with varied standards.

The proposed rule noted that Form I-905 will require the organization seeking credentialing status to:

(1) Provide a point of contact and a written, detailed description of the organization and how the organization meets the standards described in 8 CFR 212.15(k);

(2) List the health care occupations for which the organization is seeking approval to issue certificates, and describe the organization's expertise in each health care occupation for which approval to issue certificates is sought;

(3) Describe how it will process applications and issue certificates on a timely basis; and

(4) Describe the procedure it has designed in order for the DHS to verify the validity of a certificate.

The DHS will provide the organization with a written decision on its application. An organization granted authorization to issue certificates must agree to provide the DHS with all requested documentation and to allow the DHS access to its records relating to the certification process. If the application is denied, the DHS will explain the reason(s) for the denial. Applications that are denied by the DHS may be appealed to the Administrative Appeals Office pursuant to 8 CFR 103.3.

In the proposed rule, the DHS sought comments on the best method of notifying the public when new organizations are approved to issue certifications and certified statements. One method of notifying the public was through the publication of an interim rule in the Federal Register .

In the alternative, the DHS considered designating, by a separate and comprehensive public notice in the Federal Register , the list of organizations approved to issue certification. The DHS would also maintain this list on its Web site at http://www.immigration.gov). This method would allow the DHS to update the list of authorized organizations more quickly than through publication of interim rules.

The DHS did not receive any comments on this particular issue. However, after additional consideration, the DHS has determined that it will provide notice to the public that an organization has been approved to issue certificates and certified statements through the publication of a comprehensive notice in the Federal Register . As a result, this final rule provides at 8 CFR 215.15(e)(4) that the DHS will notify the public of new approved organizations authorized to issue certificates by publishing a public notice in the Federal Register . This rule also adds the same provision with respect to organizations authorized to issue certified statements at 8 CFR 215.15(h)(1). The DHS would maintain the list of organizations authorized to issue certificates or certified statements, or whose authorization has been terminated, on its Web site at http://www.immigration.gov.

The proposed rule recognized that more than one organization could be approved to issue certifications for the same health care occupation. An alien may obtain a certificate from any organization authorized to issue certificates for that occupation.

One commenter suggested that recognizing more than one credentialing organization could create difficulties because the two organizations may establish different procedures for issuing certifications. The DHS is aware that organizations may have slightly different requirements for issuing certifications. However, the DHS is convinced that the standards established for approval guarantee that organizations will follow similar, although not identical, procedures for issuance of certifications.

This rule also adopts the language of the proposed rule and provides that the DHS's approval will be for a 5-year period of time subject to the review process described in 8 CFR 215.15(l).

Two commenters suggested that the organizations granted approval under the previously published interim rules be permitted to issue certificates for a given period of time until they could be approved under the standards listed in the final rule. The proposed rule provided that the authorization granted to organizations under the interim rules would continue pending final adjudication of its credentialing status under the provisions contained in the proposed rule.

The proposed rule set a filing fee of $230 for Form I-905. When establishing fees, the DHS must comply with guidance provided in the Office of Management and Budget (OMB) Circular A-25. This guidance directs federal agencies to charge the Afull cost” of providing benefits when calculating fees that provide a special benefit to recipients. Section 6(d) of OMB Circular A-25 defined Afull cost” as including Aall direct and indirect costs to any part of the Federal Government of providing a good, resource, or service.” The DHS determined that $230 was the appropriate fee for Form I-905 after comparing the processing of the form to the process involved with Form I-17, Petition for Approval of School for Attendance by Nonimmigrant Student, which has a processing fee of $230. The DHS noted in the proposed rule that it will use $230 for the fee for the Form I-905 until the next biennial fee review, as required by the Chief Financial Officers Act of 1990, Public Law 101-576, 104 Stat. 2838.

In response to the new form, the DHS received two comments. One commenter suggested that the fee should be higher. The DHS will not increase the fee because the rationale used in the proposed rule to establish the fee is appropriate. The DHS may revise the fee after the next biennial fee review. The other commenter stated that the questions on the Form I-905 should be tailored to a specific occupation. Upon review, the DHS will not make any changes to Form I-905. The answers to the questions contained on the form will provide the DHS with the information necessary to determine an organization's eligibility to issue certifications.

The proposed rule lists the standards an organization must substantially meet in order to be authorized to issue certificates at 8 CFR 212.15(k). An organization seeking approval to issue certificates or certified statements should submit evidence addressing each of the standards. These standards were developed by HHS in order to ensure that an organization meets the requirements contemplated by Congress. In drafting these standards, HHS drew upon the legislative history to IIRIRA, and drew extensively from the standards of the National Commission for Certifying Agencies, a nationally recognized body that accredits certifying organizations. There are four guiding principles to the standards:

(1) The DHS should not approve a credentialing organization, unless the organization is independent and free of material conflicts of interest regarding whether an alien receives a visa;

(2) The organization should demonstrate an ability to evaluate both the foreign credentials appropriate for the profession, and the results of examinations for proficiency in the English language appropriate for the health care field in which the alien will be engaged;

(3) The organization should also maintain comprehensive and current information on foreign educational institutions, ministries of health, and foreign health care licensing jurisdictions; and

(4) If the health care field is one for which a majority of the States require a predictor examination (currently, this is done only for nursing), the organization should demonstrate an ability to conduct the examination outside the United States.

Since the statute and the report language is intended to ensure that aliens entering the United States for purposes of performing labor as a health care worker are of the same quality as United States trained workers, HHS has determined that this can be assured by requiring that organizations issuing certificates be held to a select group of standards. The DHS is concerned that in the absence of strict standards, unqualified organizations may obtain authorization from the DHS to issue certificates, which could ultimately have adverse consequences for health care in the United States. Since the provisions of section 212(r) of the Act appear to share with section 212(a)(5)(C) of the Act the goal of ensuring a high quality of health care service in the United States, the DHS will use the same standards to adjudicate applications from credentialing organizations under either provision.

The proposed rule solicited comments from the public and from interested organizations regarding the proposed standards, specifically, whether an organization seeking authorization to issue certificates may meet most, but not all of the standards. The DHS sought comment on the question of whether a prospective credentialing organization's inability to meet all of the proposed standards should preclude the DHS from authorizing the organization to issue certificates. The DHS also sought public comment on the question of whether the proposed standards should be considered as guidelines or as strict criteria that would preclude an organization from qualifying. Finally, the DHS invited public comment on the question of how a prospective credentialing organization can meet the requirement that it demonstrate that it is independent and free of material conflicts of interest regarding whether an alien receives a visa.

In response to this proposal, the DHS received 18 comments. Four commenters stated that organizations should be required to meet all the proposed standards and that the standards should be viewed as strict criteria, not merely guidelines. Two commenters stated that the organizations must be independent and free from prejudice. One commenter suggested that the DHS remove or modify the standard that requires organizations to compare the passing rate of foreign health care workers on licensure examinations with those of United States health care workers. Another commenter suggested that tracking the performance of certificate holders would not be practical.

One commenter suggested that recognized experts should be on an organization's board while another commenter suggested that members of the health care profession should be included. One commenter suggested that the standards were so complicated that they might discourage entities from applying for approval while one commenter stated that the requirements were not specific. Three commenters stated that the credential review process developed by the approved organizations must follow established guidelines. One commenter stated that organizations should be required to solicit information from applicants seeking a certification. Finally, one commenter suggested that each organization should require that health care workers complete the same course work for each occupation.

Two commenters made suggestions relative to the composition of the organization's board, including a suggestion from one commenter that the proposed language at 8 CFR 212.15(k)(l)(vi) be amended to clarify that a not-for-profit corporation that has a self-perpetuating board of directors may still demonstrate that it is independent and free of material conflicts of interest regarding whether an alien receives a visa. Many not-for-profit organizations have self-perpetuating boards of directors but may nevertheless be considered independent and free of material conflicts of interest under the statute. This provision was not intended to exclude not-for-profit corporations from receiving authorization to issue health care worker certifications, and the DHS recognizes that a not-for-profit organization with a self-perpetuating board of directors may yet establish that it has met the statutory requirement. Accordingly, the DHS will adopt this suggestion and has added language at 8 CFR 212.15(k)(l)(vi) to provide that not-for-profit corporations which have difficulty meeting the requirement relating to self-perpetuating boards of directors may nevertheless establish that the organization is independent and free of material conflicts of interest regarding whether an alien receives a visa.

One commenter suggested that any credentialing organization that seeks authorization to issue health care worker certificates should be required to request evidence of an alien's degree and transcript from the issuing educational and licensing authorities, rather than accept those documents from the applicants. The DHS, in consultation with HHS, has determined that this suggestion will provide additional protection against fraudulent submissions from applicants, and will ensure the authenticity of documentation relating to an applicant's education and licensure. Accordingly, the DHS will adopt this comment and has added language at 8 CFR 212.15(k)(3)(vi).

In general, the standards as written in the proposed rule have been one of the more contentious issues in the entire health care worker certification process; however, they were developed with HHS based in part on those standards held by other currently authorized entities. The standards are voluminous and, in some situations, can be satisfied in a number of different ways. As such, the DHS has determined that these standards are best viewed as guidelines and not strict criteria. Further, since the approval of an organization by the DHS is a matter of discretion, the final rule reflects that an organization seeking approval is required to meet the majority, but not all, of the listed standards. The burden to establish eligibility, however, rests with the organization seeking approval. An organization seeking approval to issue a health care certificate should make every attempt to submit evidence addressing each of the criteria listed. It should be noted that any organization, including a state agency, for example, could be found eligible for authorization to issue certification so long as it meets the majority of the listed standards.

It is the opinion of the DHS that the standards contained in this rule are specific enough to ensure that approved organizations will develop credentialing processes that are reasonably consistent given the differences in the types of health care occupations that will be reviewed. The DHS is aware that approved organizations will be required to develop different credentialing processes because of the differences in the educational and training requirements for the affected occupations. As a result, the DHS will not dictate specific credentialing processes to the approved organizations.

Aside from modifications relating to not-for-profit corporations and the requirement that a credentialing organization obtain educational and licensing documents directly from the issuing authorities, the DHS will not modify the proposed regulation with respect to the composition of its governing board or the portion of the organization responsible for overseeing certification. The standards as currently written provide sufficient flexibility to ensure that organizations will operate in a fair and objective fashion.

The DHS will not amend the standards describing an organization's responsibility to track the performance of foreign workers holding credentials. These provisions are valuable tools for determining the effectiveness of the credentialing process and are essential to the success of the credentialing program.

In the proposed rule, the DHS provided that it intended to develop a regulatory process to monitor credentialing organizations, including CGFNS, to ensure that a credentialing organization continues to follow the standards described in the proposed rule. The DHS proposed to review and reauthorize the credentialing organizations every 5 years. The rule also proposed that the DHS notify the credentialing organization in writing of the results of the review and reauthorization. If the DHS developed adverse information with respect to the performance of the organization, the DHS could institute termination proceedings. The DHS solicited comments from the public regarding the frequency of review, e.g. , review as part of the 5-year reauthorization, or an annual or bi-annual review, the nature of the review, and whether reviews, if conducted separately from reauthorization, should be targeted versus random, would be of great assistance in the development of a review process.

The DHS also proposed to assess whether an authorized credentialing organization had issued certificates or certified statements in a timely manner so as to minimize any delays that may affect an alien's ability to proceed with his or her application for an immigration benefit, and to assess whether the fee charged for a certificate or certified statement unduly impairs an alien's ability to seek an immigration benefit. The DHS sought comments on what might constitute a reasonable period of time within which a credentialing organization would be required to issue certificates or certified statements, and regarding what methodology the DHS should use in assessing whether a fee constitutes an obstacle to obtaining an immigration benefit.

In response to this proposal the DHS received eight comments. One commenter stated that the 5-year review period was appropriate while two commenters suggested that the DHS conduct bi-annual reviews of approved organizations. Two commenters suggested that the DHS conduct random surveys during the 5-year period. Finally, CGFNS stated that it should be exempt from the 5-year review process because it is specifically listed in the statute as an organization authorized to issue certifications.

The DHS does not feel that it is appropriate to modify the proposed review process at this time by conducting additional scheduled reviews or by exempting any organizations. The DHS will adopt the suggestion to review an organization at any time during the 5-year period by reserving the right to conduct reviews of the approval of any request for authorization to issue certificates. The DHS retains the right to conduct a review at any time within the 5-year period of authorization. This authority under § 212.15(k)(8)(iii) provides that the DHS can request information of the organization and its program for use in investigating allegations of non-compliance with standards and for general purposes of determining continued approval as an independent credentialing organization. The DHS intends to use this authority to conduct periodic reviews. The DHS notes the concerns expressed by the commenters that organizations should be monitored on a bi-annual basis to ensure compliance with the approval standards but finds that a 5-year review period appears appropriate at this time. It should be noted that the DHS also has the ability to initiate termination proceedings any time after approval has been granted. The DHS can initiate termination proceedings at any time during the 5-year period based on information received from other sources, e.g. , adverse information provided by state licensing boards or uncovered during the course of an ordinary review of approval of an entity's authorization.

The DHS will not exempt CGFNS from the 5-year review process. While CGFNS is named in section 212(a)(5)(C) of the Act, it is named as one of the entities from which an alien may receive a valid certificate in order to gain admission. This language relates to the alien and his or her admissibility, not to CGFNS' authority to issue certificates, which is still subject to approval by the Bureau of Citizenship and Immigration Services. Just as this language does not preclude approval of other certifying organizations, it is the position of the Bureau of Citizenship and Immigration Services that it does not guarantee approval in the case of CGFNS either. Finally, Congress named CGFNS as an example in the statute because it was aware that this entity existed and was active in this field, but did not mean to confer any authority on CGFNS. Thus, CGFNS is not exempt from governmental oversight. The approval and review process is a guarantee that CGFNS will continue to meet the standards required for all certifying organizations.

The DHS also received two comments relating to the fees that an organization charges for the certification. One commenter stated that the CGFNS fee was too high while the other commenter proposed a rolling fee based on an alien's monthly income in his or her country.

The DHS will not modify the proposed rule to address the fee issue. The statute does not give the DHS the authority to set fees for organizations approved to issue certifications or certified statements. The DHS is confident that organizations authorized to issue certifications and statements will charge a reasonable fee that covers the cost of their respective processes.

Only one comment was received regarding what might constitute a reasonable period of time within which a credentialing organization would be required to issue certificates. The commenter suggested that 60 days would be an appropriate time period.

The DHS has decided to accommodate this concern. As the comment notes, this rule provides at 8 CFR 212.15(k)(4)(x) that certificates must be provided to applicants in a timely manner. The BCIS shares the commenter's concern that the certification requirement may unduly delay the recruitment of foreign health care workers and adversely affect health care in the United States. The BCIS notes that in such a case, it retains authority to commence termination proceedings against a certifying organization if the situation warrants. The BCIS may also provide other remedies, such as a waiver under section 212(d)(3) of the Act of the certification requirement in individual cases upon request. Such a waiver will only facilitate a determination of admissibility in the context of an application for admission, change of status, and/or extension of stay, however, and the alien must continue the process of obtaining the certificate as described in 8 CFR 212.15(n)(2)(i). The BCIS intends to monitor this situation and welcomes input from the public on the performance of certifying organizations.

Finally, it should be noted that the proposed criteria for awarding and governing certificate holders had the unintended effect of requiring an alien to submit evidence of passage of the profession's licensing or certification examination when in fact the statute permits an alien to demonstrate that he or she has passed the profession's licensing or certification examination or a test predicting the success on such an examination, if a majority of states licensing the profession recognize such a predictor test. After consultation with HHS, the DHS has amended language at 8 CFR 212.15(k)(7)(i) to clarify that health care workers have the option to demonstrate passage of an acceptable predictor test for purposes of obtaining health care worker certification.

The proposed rule provided that, upon notification that an authorized credentialing organization has been convicted, or the directors or officers of an authorized credentialing organization have individually been convicted, of a violation of state or federal laws, so that the fitness of the organization to continue to issue certificates is called into question, the DHS shall automatically terminate authorization to issue certificates via notice to the credentialing organization.

Upon receipt or discovery of information that the credentialing organization is no longer complying with the standards contained in 8 CFR 212.15(k), or upon receipt or discovery of information that termination of the organization's approval is otherwise warranted, the DHS will issue a Notice of Intent to Terminate Authorization to Issue Certificates to Foreign Health Care Workers to the credentialing organization. The credentialing organization will be given 30 days from the date of the Notice of Intent to Terminate Authorization to Issue Certificates to Foreign Health Care Workers to rebut or cure the allegations made in the DHS' notice.

DHS will submit any information received in response to the Notice to HHS upon receipt. Thirty days after the date of the Notice of Intent to Terminate, the DHS will request an opinion from HHS regarding whether the organization's authorization should be terminated and forward any additional evidence. The DHS shall accord HHS' opinion great weight in determining whether the authorization should be terminated. After consideration of the organization's response, if any, to the Notice of Intent to Terminate, and of HHS' opinion, the DHS will provide the organization with a written decision.

The DHS's decision terminating an organization's authorization may be appealed to the AAO pursuant to 8 CFR 103.3. Termination of credentialing status will occur on the date of the decision and remain in effect until and unless the terminated organization reapplies, with fee, for credentialing status and is approved, or its appeal of the termination decision is sustained by the AAO. There is no waiting period for an organization to re-apply for credentialing status.

The DHS received six comments in response to the DHS's proposal on the termination of an organization's authorization to issue certifications. One commenter stated that the two grounds for termination of an organization's approval were sufficient and that no further grounds should be added to the regulation. One commenter suggested that an organization's authorization should be terminated only if the organization has failed to comply with a material term of its authorization. A technical violation should not be grounds for termination. One commenter suggested that HHS should have 30 days to respond to the DHS's Notice of Intent to Terminate. One commenter suggested that the term “or other adverse information” contained in the proposed rule at 8 CFR 215.15(m)(2) is too vague. Finally, CGFNS stated that it should be permitted to issue certifications while the appeal of the termination decision is pending at the AAO.

The DHS will not modify the language contained in the proposed rule relating to the termination process. While certain portions of the regulatory language may be vague, the regulatory language is sufficiently clear to provide the required protection to the public. Further, the term “or other adverse information” provides the DHS with a vehicle to institute termination proceedings based on situations that arise that cannot be predicted at this time. Further, the DHS will not require HHS to respond to the DHS's termination notice within any specific time period because some issues are far too complex to be decided in arbitrarily established timeframes. Finally, although CGFNS has been specifically identified in the statute as an organization authorized to issue certifications, there is nothing in the statutory language that requires the DHS to establish a separate process to determine whether their authorization to issue certifications should be terminated for any of the reasons described in this rule.

This rule also clarifies that the immediate termination provisions of 8 CFR 212(n)(1) may be triggered upon receipt of any information calling into question the entity's fitness to issue certificates. For example, national security concerns, or issues relating to fraud, may not lead to prosecution but certainly relate to the fitness of the organization to issue certificates. This clarification has been made necessary by events and issues identified during the course of the DHS' administration of this program since the proposed rule. The lack of a criminal prosecution or conviction in cases involving national security does not reduce the need to act appropriately to protect the public in such cases.

The proposed rule provided that a credentialing organization must develop policies and procedures for the revocation of certificates at any time if it finds that the certificate holder was not eligible to receive the certificate at the time it was issued. These policies and procedures include notification to the DHS, via the Nebraska Service Center, that a certificate has been revoked. The DHS may then take any appropriate action against the individual alien, including revocation of the petition, and initiation of removal proceedings under section 240 of the Act.

Three commenters responded to this provision. One commenter suggested that an alien's certification should be revoked if the alien does not obtain a license to practice within 1 year of the issuance of the certification. Another commenter suggested that the certification should be revoked if the alien's ability to practice in the occupation is restricted.

The DHS will not adopt the first suggestion. Certifications must be used within 5 years of their issuance. The DHS can envision a number of situations where the alien may be unable to obtain licensure within 1 year of issuance of the certification. In fact, in the case of EB petitions, there is no regulatory or statutory requirement that the alien ever obtain a license. Further, sections 212(a)(5)(C) and 212(r) of the Act are merely grounds of inadmissibility to the United States and therefore address an alien's ability to enter the United States and immediately begin the intended employment. They were not designed to regulate the practice of health care or the continuing qualifications of health care workers within the United States.

However, the DHS is concerned about events that may occur subsequent to an alien's certification and the effect those events may have upon an alien's admissibility to and status in the United States. This final rule therefore adopts the second commenter's suggestion and provides that an organization issuing certificates must include in its revocation process a mechanism to revoke a certificate when it learns that a holder is no longer eligible to hold a certificate.

The third commenter suggested that an alien that is issued a certification should be required to report employment information to the credentialing organization which will then be reported to the DHS. This comment will not be adopted because the role of credentialing organizations is to review a health care worker's qualifications, including education, training, license, and experience. The role of credentialing organizations does not include making a determination that an employment offer is valid and that the alien is continuing to work for the employer.

The proposed rule at 8 CFR 212.15(f) described the content of the certificate. The proposed rule at 8 CFR 212.15(h) described the content of the certified statement. The proposed rule provided that the certification should contain the following information:

(1) The name, designated point of contact to verify the validity of the certificate, address, and telephone number of the certifying organization;

(2) The date the certificate was issued;

(3) The health care occupation for which the certificate was issued; and

(4) The alien's name, and date and place of birth.

The proposed rule also provided that the certificate or certified statement does not constitute professional authorization to practice in that health care occupation.

The DHS received one comment regarding the information that should be included on the certification. The commenter suggested that each certification should contain the regulatory language indicating that the certification did not grant the holder authority to work in a health care occupation.

The DHS will not adopt this suggestion because it is unnecessary. A health care worker certificate or certified statement is evidence of an alien's admissibility under section 212(a) of the Act and not an employment authorization document. Acceptable employment authorization documents are enumerated under 8 CFR 274a. An alien who has made an application for a certification will be aware of the difference between the immigration requirements for entry in order to work in a covered health care occupation and the various state licensure requirements required to practice his or her occupation in the United States. In addition, the DHS has limited the information required on the certification to generally address the identity of the certificate holder and his or her admissibility under section 212(a)(5)(C) or 212(r) of the Act, rather than the certificate holder's authority to practice in the health care occupation.

Another commenter stated that an organization should not issue a certification until such time as the alien obtains a United States license to practice in his or her occupation. This comment will not be adopted because some aliens, e.g. , EB immigrants and certain nonimmigrants subject to this rule, such as aliens with extraordinary ability (O-1) and exchange visitors (J-1), are not required to satisfy state licensure requirements for classification.

One commenter noted that the proposed rule did not contain a description of what an approved organization was required to verify before it issued a certification. The commenter noted that the DHS had previously required approved organizations to examine the alien's education, training, and license prior to issuing a certification. This information was unintentionally omitted from the proposed rule. The DHS will amend 8 CFR 215.15(f) to include this information.

As stated in the proposed rule, HHS, in consultation with DoED, is required to establish a level of competence in oral and written English appropriate for the health care field in which the alien will be engaged, as shown by an appropriate score on one or more nationally recognized, commercially available, standardized assessments of the applicant's ability to speak and write. The statute vests the Secretary of HHS with the “sole discretion” to determine the standardized tests and appropriate minimum scores. In developing the English language test scores, HHS consulted with DoED and appropriate health care professional organizations. HHS also examined a study sponsored in part by NBCOT entitled “Standards for Examinations Assessing English as a Second Language.” The scores reflect the current industry requirements for particular health care occupations.

One commenter suggested that the DHS adopt separate scores and a specific test for the occupation of physician assistant. This comment will not be adopted in this rule because HHS has not designated a separate test and score for the occupation.

One commenter noted that the DHS had failed to specify which modules of the International English Language Testing System (IELTS) would be required for the covered occupations. This information was unintentionally omitted from the proposed rule. The DHS will amend 8 CFR 215.15(g)(4) to clarify when an Academic and/or General Module will be required for a covered health care occupation.

The HHS had initially identified four testing services which conduct a nationally recognized, commercially available, standardized assessment as contemplated in the statute. The four testing services were the Educational Testing Service (ETS), the Michigan English Language Assessment Battery (MELAB), the Test of English in International Communication (TOEIC) Service International, and the IELTS. The proposed regulation at 8 CFR 212.15(g) lists the tests and appropriate scores as determined by HHS for each occupation.

The DHS received 29 comments in response to the English language testing proposals. Eight commenters agreed that the IELTS and TOEIC tests should be included in the final rule. Six commenters expressed dissatisfaction with the test of spoken English (TSE) given by ETS, asserting that it was too difficult to pass and that it prevented health care facilities from recruiting qualified workers. One commenter even suggested that the test intentionally discriminated against certain nationalities.

The English test offered by ETS has been used by colleges, universities, and accrediting organizations for years to test English language skills. Both HHS and the DoED have reviewed this test prior to its inclusion in the previously published interim rules and the proposed rule. The DHS is not persuaded that the test is not a valid test of English language skills and, as a result, the option of TSE will remain in this final rule.

The DHS also proposed that, as an alternative to listing the tests and appropriate scores by Interim Rule, the DHS would designate, by a separate and comprehensive public notice in the Federal Register , the list of tests and appropriate scores. The DHS would maintain this list on its Web site. This method would allow the DHS to update the list of tests and scores more quickly than through publication of interim rules. The DHS will continue to coordinate with the HHS and the DoED to make the designation of tests and appropriate scores needed to satisfy the English proficiency requirement.

The DHS received four comments on this proposal. Three commenters suggested that the DHS adopt the alternative method of advising the public of the approved English tests by a notice in the Federal Register while one commenter suggested that the use of an interim rule would be more appropriate.

After consideration of the comments, the DHS will adopt the alternative method discussed in the proposed rule. In view of the extensive governmental review before a test is approved, it is not likely that the comments received in response to an interim rule would be beneficial. As a result, this final rule at 8 CFR 215.15(g)(4)(iv) provides that the DHS will notify the public of new approved English testing services by publishing a notice in the Federal Register . The DHS will also maintain the list of approved English tests and the appropriate scores on its Web site at http://www.immigration.gov.

One commenter noted that the current availability of English tests did not meet the demand creating significant delays for health care workers. To solve this problem, other testing services are encouraged to submit information concerning their testing services to the DHS, for HHS and DoED review, and credentialing organizations are encouraged to develop a test specifically designed to measure English language skills and to seek HHS approval of the test. As noted in the proposed rule, HHS has advised the DHS that graduates of health profession programs in Australia, Canada (except Quebec), Ireland, New Zealand, the United Kingdom, and the United States are deemed to have met the English language requirements. HHS has determined that aliens who have graduated from these programs have the requisite competency in oral and written English. The level of English that the graduates of these health profession programs would need in order to graduate is deemed equivalent to the level that would be demonstrated by achieving the minimum passing score on the tests previously described. Nurses who are eligible to present an alternate certified statement under section 212(r) of the Act by definition have satisfied the English language requirements.

Six commenters suggested that additional countries be added to the list of countries that should be exempt from the English language requirements. The list of countries has been furnished to HHS for their review for possible inclusion in the list of exempt countries.

One commenter suggested that the English language test be separate and apart from the credentialing portion of the certification process. This suggestion cannot be adopted because it is contrary to the statute.

Finally, after publication of the proposed rule, the DHS was notified that the MELAB no longer wishes to be designated as an approved English test for the purpose of issuing health care certifications. Therefore, MELAB has been removed from the list of approved English tests and is not included in this final rule. As a result, individuals who seek to meet the English language requirements will be required to do one of the following:

(1) Take the three tests offered by ETS;

(2) Take the TOEIC offered by TOEIC Service International, in addition to the test of spoken English and the test of written English offered by ETS; or

(3) Take the IELTS examination.

Two commenters noted that the proposed rule did not contain a requirement that an organization was to verify that an alien either passed a predictor examination or the state licensing examination for his or her occupation. One of the commenters noted that the DHS had previously listed this requirement in the previously published interim rules.

The DHS has unintentionally failed to provide a description of what an organization is required to verify before it can issue a certification under section 212(a)(5)(C) of the Act. This information is now listed at 8 CFR 215.15(f).

Three commenters stated that nurses should not be required to take the predictor examination if they have passed the NCLEX-RN state licensing examination. The statute at sections 212(a)(5)(C) and 212(r) of the Act requires that a certifying entity verify that an alien has passed either the profession's licensing or certification examination, or a predictor test if a majority of states licensing the profession in which the alien intends to work recognize such a predictor test. The DHS has added language at 8 CFR 212.15(f)(1)(iv) to clarify that a nurse who is obtaining a certificate under section 212(a)(5)(C) of the Act must demonstrate that they have passed the profession's licensing examination (NCLEX-RN) or the predictor test.

One commenter stated that some nurses are not eligible to obtain a certified statement as described in section 212(r) of the Act. Section 212(r) of the Act was created as an alternative to the certification process of section 212(a)(5)(C) of the Act. It was specifically designed to accommodate a limited number of nurses who met certain criteria and not all nonimmigrant nurses.

Finally, CGFNS stated that the language in the proposed rule appeared to preclude them from obtaining authorization to issue certifications to audiologists. The DHS has corrected this oversight by amending the language at 8 CFR 215.15(j)(2) to include audiologists among the covered occupations.

I have reviewed this regulation, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), and, by approving it, I have determined that this rule will not have a significant economic impact on a substantial number of small entities. It is projected that there will be, at most, 21 small businesses that apply to the Department of Homeland Security to issue certificates for health care workers. Although these small entities are required to pay a fee when submitting their applications, these small entities may recoup this expense if they charge aliens who must obtain a foreign health care worker certificate.

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any 1 year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule 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 economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

This rule is considered by the Department of Homeland Security to be a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review. Accordingly, this regulation has been submitted to OMB for review. The Department of Homeland Security has assessed both the costs and the benefits of this rule as required by Executive Order 12866, section 1(b)(6), and has made a reasoned determination that the benefits of this rule justify its costs. Briefly, that assessment is as follows:

The Department of Homeland Security has determined that any entity seeking authorization to issue health care worker certifications must apply for authorization on Form I-905. The Department of Homeland Security determined that $230 was the appropriate fee for Form I-905 after comparing the processing of the form to the process involved with Form I-17, Petition for Approval of School for Attendance by Nonimmigrant Student, which has a processing fee of $230. The Department of Homeland Security has estimated that there will be approximately 10 applicants who will each have a time burden of approximately 4 hours, and who will be required to pay a total of $2,300. Once the Form I-905 is approved, an authorized entity will be authorized to issue health care worker certification for a period of 5 years, and will be able to recoup the costs of the Form I-905 by charging a fee for each certificate that it issues.

Each credentialing organization may set its own fee to recover the costs of issuing of a health care worker certificate, although the price may vary between organizations. The CGFNS is the organization that is currently authorized to issue certifications to the largest number of applicants because it is authorized to issue certifications to all seven occupations. The Department of Homeland Security has estimated that the total time burden associated with each certification is approximately 220 minutes. The current price for a CGFNS certificate or certified statement is approximately $325, which is charged to an individual alien. In some cases, a petitioning employer may choose to pay on behalf of the alien. Finally, the Department of Homeland Security has determined that the benefit to the United States public of the statute requiring the issuance of certificates will be to ensure that all health care workers covered by the regulations, including all nonimmigrants, have met the same minimum requirements with regard to an evaluation of their credentials, licensing, training and English language ability before commencing employment in their respective occupations. Even in cases where all states require a foreign health care worker to be licensed to practice within the United States, as in the case of nurses, the underlying requirements for licensure differ from state to state. This rule will ensure that uniformly qualified foreign health care professionals enter the United States workforce and that foreign health care workers and the Department of Homeland Security are in compliance with the statutory requirements of section 212(a)(5)(C) of the Act.

The rule will 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. Therefore, in accordance with section 6 of Executive Order 13132, it is 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.

The information collection requirement contained in this rule (Form I-905) (OMB Control Number 1115-0238) has been approved for use by OMB under the Paperwork Reduction Act. The information required on the health care certificate or certified statement (OMB Control Number 1115-0226) has been revised to reflect that a certificate must demonstrate that an alien has met the requirements of section 212(a)(5)(C) of the Act. This revision was submitted to OMB for review in accordance with the Paperwork Reduction Act.

The FAA published FR Document 03-15526 in the Federal Register on June 19, 2003, (68 FR 36743) to modify Class E airspace at Window Rock, AZ. The paragraph pertaining to the legal description of the 1,200’ Class E airspace was described incorrectly. The following information corrects the airspace legal description for Window Rock, AZ.

Need for Correction

The temporary rule establishing no-entry zones at White Bank North Patch and White Bank South Patch, off of Key Largo in the Florida Keys National Marine Sanctuary (68 FR 39005; July 1, 2003), contained errors in the coordinates for White Bank South Patch. The correct coordinates are:

White Bank South Patch—

(1) 25 degrees 02.414 seconds N 80 degrees 22.425 seconds W;

(2) 25 degrees 02.446 seconds N 80 degrees 22.267 seconds W;

(3) 25 degrees 02.314 seconds N 80 degrees 22.278 seconds W;

(4) 25 degrees 02.336 seconds N 80 degrees 22.408 seconds W.

Under 5 U.S.C. 553(b)(B), the Assistant Administrator of the National Ocean Service, NOAA, for good cause, finds that providing prior notice and public procedure thereon with respect to this correction is impracticable and contrary to the public interest. Recent evidence has come to light of an outbreak of infectious coral disease in areas of White Bank Dry Rocks near Key Largo. It is possible that humans entering the waters of the affected areas could inadvertently carry infectious agents to healthy coral reef areas. Infected corals are also most subject to stress from human activities. This action is intended to limit the innocent spread of infectious agents to healthy coral and to reduce stress to corals within the infected areas. As such, further damage to the infected corals as well as to healthy corals outside of the close areas would occur if the prohibition implemented by this rule is delayed to provide prior notice and opportunity for public comment.

Likewise, under 5 U.S.C. 553(d)(3), the Assistant Administrator of the National Ocean Service, NOAA, finds good cause to waive the 30-day delay in effective date for this correction. First, if the correction is delayed for 30 days, significant damage to the living coral resources could result. Further, 30 days are not necessary to give notification to visitors who might use the area in the future to move to other nearby sites. The U.S. Coast Guard will give immediate notification to vessels to stay out of the no-entry zones. Notification will be made by the U.S. Coast Guard via notice to mariners, Sanctuary radio announcements, press releases, press conferences, and with assistance by the U.S. Coast Guard and Sanctuary staff on the water within the area. This correction is effective upon filing at the Office of the Federal Register .

The Trade Act of 2002 (Pub. L. 107-210) (Trade Act) includes the “Andean Trade Promotion and Drug Eradication Act” (ATPDEA), which contains provision on enhanced trade benefits for eligible Andean countries. The ATPDEA renews and amends the Andean Trade Preference Act (ATPA) (19 U.S.C. 3201 et seq. ) Section 3103(d) of the ATPDEA requires the President to promulgate regulations regarding the review of eligibility of articles and countries for the benefits of the ATPA, consistent with section 203(e) of the ATPA, as amended by the ATPDEA, not later than 180 days after the date of enactment of the Trade Act of 2002. The Trade Act was enacted on August 6, 2002. In Executive Order 13277 of November 19, 2002, the President assigned this function to the U.S. Trade Representative (USTR).

Section 203(e) of the ATPA, as amended, gives the President the authority to withdraw or suspend the designation of any ATPA or ATPDEA beneficiary country, or withdraw, suspend, or limit the application of preferential treatment under the ATPA, as amended by the ATPDEA, to any article of any such country, if the President determines that, as a result of changed circumstances, the country is not meeting the eligibility criteria of the ATPA and ATPDEA. Section 203(e) also establishes certain procedural guidelines for taking any of the actions described above.

An interim rule, on a final and emergency basis, was published in the Federal Register (68 FR 5542) for public comment on February 4, 2003. Consistent with section 3103(d)(2) of the ATPDEA, the interim rule was similar to the regulations governing the annual review used to modify the U.S. Generalized System of Preferences (GSP), which is authorized by title V of the Trade Act of 1974 (19 U.S.C. 2461 et seq. ), as amended. The interim rule established an annual review that allows for public input, and includes procedures for requesting the withdrawal, suspension, or limitation of preferential duty treatment under the ATPA, as amended, and for reviewing such requests and implementing granted requests. USTR received two submissions with several comments on the interim rule. The following summarizes the comments and USTR's response to them. USTR has also made technical changes to the final regulations that do not affect the substance of the provision.

1. Public Comment: The regulations must provide for an article eligibility review as well as a country eligibility review.

USTR Response: The interim rule, consistent with section 203(e) of the ATPA, as amended, and section 3103(d) of the ATPDEA, addressed the issue of article eligibility in the context of country eligibility. The commenter suggests that the ATPDEA also requires the regulations to allow for petitions to add articles pursuant to section 204(b)(1) of the ATPA, as amended, which gives the President authority to proclaim certain articles as eligible for duty-free treatment under the ATPA if he determines that an article is not “import-sensitive in the context of imports from ATPDEA beneficiary countries.”

In response, USTRA notes first that section 3103(d)(1) requires the President to promulgate regulations regarding the review of eligibility of articles and countries under the ATPA, consistent with section 203(e). As noted above, the President assigned this function to the USTR per Executive Order. Section 203(e) gives the President the authority to withdraw or suspend the designation of any ATPA or ATPDEA beneficiary country, or withdraw, suspend, or limit the application of preferential treatment under the ATPA, as amended by the ATPDEA, to any article of any such country, if the President determines that, as a result of changed circumstances, the country is not meeting the eligibility criteria of the ATPA and ATPDEA. Section 203(e) also establishes certain procedural guidelines for taking any of the actions described above. Second, section 3103(d)(2) requires the regulations to “include procedures for requesting withdrawal, suspension, or limitations of preferential duty treatment” under the ATPA.

Section 3103(d)(1) calls for the President (the USTR, by delegation) to promulgate regulations regarding the review of eligibility of articles and countries under the ATPA, “consistent with section 203(e).” Section 203(e) refers solely to the withdrawal, suspension, or limitation of preferential duty treatment, and makes no reference to procedures for adding articles to the list of those eligible for preferential treatment. Moreover, section 3103(d)(2), which addresses the content of the regulations that must be promulgated, refers exclusively to procedures for requesting “withdrawal, suspension, or limitations” of preferential duty treatment under the ATPA, making no mention of procedures for adding articles. Thus. USTR does not agree that regulations implementing section 3103(d) must include procedures for adding articles pursuant to section 204(b)(1).

2. Public Comment: The regulations must be revised to expressly include the possibility of restoring benefits for an article for which benefits have been withdrawn, suspended, or limited.

USTR Response: Neither the GSP regulations, section 203(e) of the ATPA, as amended, nor section 3103(d) of the ATPDEA addresses the possibility of restoring benefits for an article for which benefits have been withdrawn, suspended, or limited. Consequently, USTR does not consider that it is required to include in the regulations procedures for restoring benefits. However, the ATPA provides authority for the President to restore benefits that were withdrawn, suspended, or limited pursuant to section 203(e) if he determines that the country in question has resumed compliance with the eligibility criteria of the ATPA, as amended by the ATPDEA.

3. Public Comment: The procedures set out in the regulations should more closely adhere to those in the GSP regulations, in particular by limiting the right to file petitions to “interested parties,” by establishing a petition process for adding products to the list of eligible articles, and by creating procedures for submitting economic data in support of such petitions.

USTR Response: This commenter makes three recommendations. First, the commenter suggests that the ATPA regulations, like the GSP regulations at 15 CFR 2007.0, should limit the right to file a petition to “interested parties.” However, only the GSP provision that addresses petitions related to product eligibility under the GSP program, 15 CFR 2007.0(a), limits the right to petition to “interested parties.” By contrast, the section of the GSP regulations that addresses country eligibility, 15 CFR 20007.0(b), affords the right to petition to “any person.” Section 3103(d)(1) of the ATPDEA calls for regulations consistent with section 203(e) of the ATPA, which addresses both country and product eligibility. However, section 203(e) provides that any action to remove benefits for products must be based on a determination that a country no longer meets the eligibility criteria for ATPA benefits. It would be inappropriate to limit petitions addressing the broad range of issues related to a country's eligibility for benefits under the ATPA solely to “interested parties,” as that term is defined in 15 CFR 2007.0(d). Rather, “any person” should be eligible to raise concerns about whether a country is continuing to meet the relevant eligibility criteria. Therefore, consistent with the broader approach to country eligibility petitions in the GSP regulations, the final ATPA regulations will permit “any person” to submit a petition seeking either the suspension or withdrawal of country eligibility or duty-free treatment. (The interim final rule inadvertently referred to “any person” as “any party” in several places. That error has been corrected in the final regulations.)

Second, the commenter suggests that the ATPA regulations should be similar to the GSP regulations in that they should contain procedures for adding products in accordance with section 204(b)(1) of the ATPA, as amended. This recommendation is addressed in response to the first public comment above.

Lastly, the commenter suggests that, if USTR amends the regulations to authorize petitions that seek to add products in accordance with section 204(b)(1) of the ATPA, as amended, USTR should spell out the information to be provided in support of such petitions. Because USTR has decided not to amend the interim rule in the manner suggested, it is not necessary to address this recommendation.

4. Public Comment: Columbia should meet its commitment to cease applying a price band adjustment to imports of dry pet food.

USTR Response: This comment was previously submitted in response to USTR notice, published in the Federal Register on August 15, 2002 (67 FR 53379), requesting public comment on the designation of eligible countries as ATPDEA beneficiary countries. The interagency Andean subcommittee of the Trade Policy Staff Committee (TPSC) has already considered and acted on this comment.

Under the Regulatory Flexibility Act, a Regulatory Flexibility Analysis is not required under sections 603 or 604 because USTR is not publishing a Notice of Proposed Rulemaking. This final rule is significant under Executive Order 12866 of September 30, 1993, and has been review by the Office of Management and Budget.

Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA 30601, filed ANADA 200-266 for the oral use of BUTEQUINE (phenylbutazone) Paste in horses for relief of inflammatory conditions associated with the musculoskeletal system. Bioniche Animal Health's BUTEQUINE Paste is approved as a generic copy of Schering-Plough Animal Health's PHENYLZONE (phenylbutazone) Paste, approved under NADA 116-087. The ANADA is approved as of February 21, 2003, and the regulations are amended in 21 CFR 520.1720c to reflect the approval and current format. The basis of approval is discussed in the freedom of information summary.

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 Dockets Management Branch (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.

FDA has determined under 21 CFR 25.33(a)(1) 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.

On July 17, 2003, the Coast Guard published a final rule (68 FR 42289) establishing a safety zone, in 33 CFR 165.1316, to provide for the safety of vessels in the vicinity of the Astoria Regatta fireworks display. The safety zone will include all waters of the Columbia River at Astoria, Oregon enclosed by the following points: North from the Oregon shoreline at 123°49′36″ West to 46°11′51″ North thence east to 123°48′53″ West thence south to the Oregon shoreline and finally westerly along the Oregon shoreline to the point of origin. Entry into this zone is prohibited unless authorized by the Captain of the Port or his designee. The Captain of the Port Portland will enforce this safety zone on August 9, 2003 from 9:30 p.m. until 10:30 p.m. (PDT). The Captain of the Port may be assisted by other Federal, state, or local agencies in enforcing this security zone.

The Coast Guard is implementing the permanent safety zones in 33 CFR 165.907 (a)(22) and (23) (66 FR 27868, May 21, 2001), for fireworks displays in the Captain of the Port Detroit Zone during August 2003. The following safety zones are in effect for fireworks displays occurring in the month of August 2003:

(1) Maritime Day Fireworks, Marine City, MI. This safety zone will be enforced on August 9, 2003, from 8 p.m. until 11:59 p.m.

(2) Venetian Festival Boat Parade & Fireworks, St. Clair Shores, MI. This safety zone will be enforced on August 9, 2003, from 7 p.m. until 11:59 p.m.

In order to ensure the safety of spectators and transiting vessels, these safety zones will be enforced for the duration of the events. In cases where shipping is affected, commercial vessels may request permission from the Captain of the Port Detroit to transit the safety zone. Approval will be made on a case-by case basis. Requests must be made in advance and approved by the Captain of the Port Detroit before transits will be authorized. The Captain of the Port Detroit may be contacted via U.S. Coast Guard Group Detroit on Channel 16, VHF-FM.

Under existing law and regulations, a veteran desiring medical care from VA must enroll in VA's health care system, except for veterans whose service-connected disabilities are 50% or greater, or any veteran seeking treatment for a service-connected condition. When a veteran first enrolls in the VA system, and requests an appointment for care, VA schedules an appointment for a visit with a primary care physician. During that first appointment, a VA health care provider examines the veteran and determines what care the veteran needs. That primary care physician generally learns from the veteran what medication the veteran is taking, if any, assesses the need for medication, and writes prescriptions for any needed medication. Those prescriptions written by the VA physician are then filled by a VA pharmacy.

In recent years, VA has faced an extraordinary increase in demand for health care services. The increased demand has been caused, at least in part, by veterans enrolling in the VA health care system to obtain pharmacy benefits at no cost or at a reasonable cost. With dramatically increased enrollment, VA has been unable to provide all enrolled veterans with services in a timely manner. In many places that means veterans may wait a considerable length of time to receive an initial primary care visit. Many of those veterans have prescriptions, written by non-VA physicians, that VA primary care physicians may confirm and renew when the veterans are able to have initial primary care visits. In an effort to ease the financial burden on enrolled veterans currently waiting lengthy periods of time for their initial primary care visits, VA will provide these veterans with medications prior to their initial primary care visits at VA if these veterans present valid prescriptions from their non-VA physicians. VA will fill prescriptions written by non-VA physicians only for the period of time such veterans are awaiting a scheduled appointment with a VA health care provider. VA anticipates asking the veterans whether they want to have the next available appointment, or whether they want to postpone the initial appointment. VA will schedule the veterans' initial appointments within the period covered by the prescriptions written by their non-VA physicians. VA anticipates that some veterans will choose to postpone the initial appointment, shortening waiting lists and making appointment dates available to other veterans.

VA anticipates that in the near future, it will be able to provide all enrolled veterans with primary care in a timely manner. That would effectively eliminate the need for providing medications under this rule. However, it is important that VA have such regulations in place until such time as waiting periods can be reduced.

VA is undertaking this rulemaking pursuant to its authority under 38 U.S.C. 1710(a) to furnish needed medical services. As clarified in paragraph (a) of this rule, VA does not generally fill prescriptions for veterans that are written by non-VA physicians. Instead, VA usually provides only medications prescribed by VA physicians or VA contractors retained for that purpose. This is consistent with the primary purpose of the Veterans Health Administration, which is to provide integrated comprehensive health care for veterans, not simply act as a conduit for furnishing prescription medications.

In light of the backlog of veterans seeking VA care, however, the Secretary has determined that the filling of some prescriptions written by non-VA physicians is needed during the period of time such veterans are awaiting a scheduled appointment with a VA health care provider. As a result, paragraph (b) of this rule states that beginning September 22, 2003, VA may furnish medications for veterans enrolled in VA's health care system prior to July 25, 2003, if the veterans have requested an initial appointment for primary care in a VA health care facility before July 25, 2003, and the next available appointment date is scheduled more than 30 days after the veteran requests the appointment. VA chose the 30-day limitation because it is generally considered reasonable in the community at large to expect that one could obtain a first time primary care visit with a physician within 30 days. VA chose to limit the provision of medications in question to only those veterans enrolled prior to July 25, 2003, in order to specifically address the problems of currently enrolled veterans facing lengthy waits for initial primary care appointments in a cost-effective manner. ( See 38 U.S.C. 1706(a) requiring VA to “design, establish and manage health care programs in such a manner as to promote cost-effective delivery of health care services”). Moreover, without these limitations, the very issuance of the new rule could invite an influx of new enrollments and requests for appointments, exacerbating the wait-time problem the rule is intended to address. This rule also should benefit those who enroll after the effective date or attempt to make appointments after that date. By allowing those presently enrolled and waiting more than 30 days to reschedule appointments at dates closer to expiration of presently held non-VA prescriptions, additional near term appointments should become available for those who are not entitled to this limited benefit. Thus, the out-of-pocket costs for prescriptions filled while waiting for VA appointments should also be reduced for those not specifically included in this rule because their waiting time should be reduced.

Paragraph (c) of this rule states that VA may furnish an amount of medication that will appropriately meet the treatment needs of veterans until the date of the veterans' initial appointment for primary care in a VA facility. If veterans choose to postpone their initial appointment date until they have used all of the medication prescribed by the non-VA provider, VA will furnish the amount prescribed, including refills. VA will furnish such medications consistent with long-standing pharmacy practices. The decision on the precise quantity of medication that would be needed is generally considered to be a medical determination and would be left to appropriate VA clinicians including pharmacists.

Paragraph (d) of this rule states that if VA reschedules an initial appointment for primary care in a VA health care facility for veterans eligible under this rule, or if veterans reschedule their appointments for good reasons, as determined by the local VA medical facility, VA may furnish the eligible veterans with a quantity of medication that is sufficient to meet the treatment needs of the veterans until the date of the veterans' rescheduled appointments for primary care in a VA health care facility. If VA reschedules veterans' initial primary care visits, it is reasonable that VA would provide additional medication to meet the veterans' needs until the date of their rescheduled appointments. VA also understands that there are occasions when, for good cause, veterans might be forced to cancel appointments. For example, if the veteran had to reschedule an appointment because of inclement weather, or because of the illness or death of a family member, VA would not disqualify the veteran from continuing to receive the benefits of this remedial program. However, VA would not furnish medications to veterans who simply cancel or reschedule and extend their appointments without good reasons.

Paragraph (e) of this rule states that VA may furnish medications beginning on September 22, 2003, only if veterans provide VA with written current prescriptions for their medications signed by duly licensed physicians within the previous 90 days. To ensure the health and safety of veterans, VA will only fill prescriptions when veterans present VA with written prescriptions signed by licensed physicians. VA will not accept prescriptions called in by veterans' non-VA pharmacies or non-VA health care providers. VA lacks the resources to accept and manage those calls.

Paragraph (f) of this rule states that VA may furnish only medication under paragraph (b) that (1) must be dispensed by prescription, (2) is not an over-the-counter medication, (3) is not listed as a controlled substance under schedule I through V of the Comprehensive Drug Abuse Prevention and Control Act, 21 U.S.C. 812, (4) is included on VA's National Formulary, unless VA determines a non-Formulary medication is medically necessary, and (5) is not an acute medication, intravenous medication, nor one required to be administered only by a medical professional. By providing only medications that must be dispensed by prescription, VA is not furnishing over-the-counter drugs. Veterans can easily purchase over-the-counter medications without regard to whether they are able to schedule visits with a physician. For patient health and safety reasons, VA will not furnish controlled substances without a VA physician first seeing the patient and ordering the medication. VA will furnish veterans with medications prescribed by non-VA physicians only if the medication is on VA's National Formulary, or approved in advance through a special approval process. If a veteran provides VA with a prescription for medications that are not on VA's formulary, VA will contact the physician who wrote the prescription to determine whether a medication on VA's formulary is appropriate, and if not, the medical reasons why it is not appropriate. If VA determines that a medication is medically necessary, but is not on VA's formulary, VA will provide that medication. Finally, acute medications, intravenous medications, and medications required to be administered only by a medical professional will not be furnished because under this rule prescriptions will be filled only by mail.

Paragraph (g) of this rule provides that the existing copayment requirements applicable to VA furnishing medication will apply to medications furnished under this rule. Statutes ( e.g. , 38 U.S.C. 1722A) require application of the copayment requirements.

Paragraph (h) of this rule provides that VA will furnish medications under this rule only by having the medication mailed to the veteran, typically by one of VA's Consolidated Mail Out-patient Pharmacies, or with VA contract pharmacies. Therefore, this benefit is not useful for veterans who require acute medications, intravenous medications, or medications to be administered only by a medical professional. VA pharmacies will not directly furnish medications or reimburse veterans for medications that they obtain from non-VA pharmacies.

Paragraph (i) of this rule restates, with no substantive change, longstanding regulatory provisions regarding prescriptions found in § 17.96.

Pursuant to 5 U.S.C. 553, we have found for this rule that notice and public procedure are impracticable, unnecessary, and contrary to the public interest, and that we have good cause to dispense with notice and comment on this rule and to dispense with a 30-day delay of its effective date. This is an effort to ease the financial burden on enrolled veterans currently waiting lengthy periods of time for their initial primary care visits. Delaying implementation of this benefit would only exacerbate the problems veterans are experiencing while waiting for VA treatment.

The Unfunded Mandates Reform Act requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before developing any rule that may result in an expenditure by State, local, or tribal governments, in the aggregate, or by the private sector of $100 million or more in any given year. This proposed amendment would have no such effect on State, local, or tribal governments, or the private sector.

OMB assigns a control number for each collection of information it approves. Except for emergency approvals under 44 U.S.C. 3507(j), VA 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 interim final rule at § 17.96(e) contains collections of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521). Accordingly, under section 3507(d) of the Act, VA has submitted a copy of this rulemaking action to OMB for its review of the collections of information. We have requested OMB to approve the collection of information on an emergency basis by August 25, 2003. If OMB does not approve the collections of information as requested, we will immediately remove § 17.96(e) or take such other action as is directed by OMB.

We are also seeking an approval of the information collection on a non-emergency basis. Accordingly, we are also requesting comments on the collection of information provisions contained in § 17.96(e) on a non-emergency basis. Comments must be submitted by September 23, 2003.

OMB assigns a control number for each collection of information it approves. VA 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.

Comments on the collections of information should be submitted to the Office of Management and Budget, Attention: Desk Officer for the Department of Veterans Affairs, Office of Information and Regulatory Affairs, Washington, DC 20503, or faxed to 202 395-6974, with copies mailed or hand-delivered to: Director, Regulations Management (00REG1), Department of Veterans Affairs, 810 Vermont Ave., NW., Room 1068, Washington, DC 20420. Comments should indicate that they are submitted in response to “RIN 2900-AL68.”

Title: Medication Prescribed by non-VA Physicians.

Summary of collection of information: The interim final rule at § 17.96(e) contains application provisions for written prescriptions and information requirements. The interim rule at § 17.96(e) contains requirements for provision of medication to veterans when the medication is prescribed by non-VA physicians.

Application Provisions for Written Prescriptions and Information Requirements.

Description of the need for information and proposed use of information: This information is needed to determine eligibility for provision of medication to veterans when the medication is prescribed by non-VA physicians.

Description of likely respondents: veterans and treating physicians.

Estimated number of respondents per year: 181,723.

Estimated frequency of responses per year: 1.

Estimated total annual reporting and recordkeeping burden: 33,316 hours.

Estimated annual burden per collection: 11 minutes.

The Department considers comments by the public on collections of information in—

• Evaluating whether the collections of information are necessary for the proper performance of the functions of the Department, including whether the information will have practical utility;

• Evaluating the accuracy of the Department's estimate of the burden of the collections of information, including the validity of the methodology and assumptions used;

• Enhancing the quality, usefulness, and clarity of the information to be collected; and

• Minimizing the burden of the collections of information on those who are to respond, including responses through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

OMB is required to make a decision concerning the collections of information contained in this rule between 30 and 60 days after publication of this document in the Federal Register . Therefore, a comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication. This does not affect the deadline for the public to comment on the interim final rule.

The Office of Management and Budget has reviewed this document under Executive Order 12866.

The Secretary hereby certifies that this regulatory amendment would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This amendment would not directly affect any small entities. Only individuals could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this amendment is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

The Catalog of Federal Domestic Assistance numbers for the programs affected by this document are 64.005, 64.007, 64.008, 64.009, 64.010, 64.011, 64.012, 64.013, 64.014, 64.015, 64.016, 64.018, 64.019, 64.022, and 64.025.

EPA is publishing this rule without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comment. No adverse comment is expected due to the fact that the U.S. Senate gave its advice and consent to ratification of the Montreal Amendment on October 9, 2002, and this rule simply adopts one of the provisions contained in that Amendment. However, in the “Proposed Rules” section of today's Federal Register , we are publishing a separate document that will serve as the proposal to implement the methyl bromide trade bans if adverse comments are filed. This rule will be effective on October 23, 2003 without further notice unless we receive adverse comment by August 25, 2003 (or, if a public hearing is requested, by September 18, 2003). If EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any persons interested in commenting must do so at this time.

Entities potentially regulated by this action are those associated with the import and export of methyl bromide. Potentially regulated categories and entities include:

The above table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. To determine whether your facility, company, business, or organization is regulated by this action, you should carefully examine the regulations promulgated at 40 CFR part 82, subpart A. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

1. Docket. EPA has established an official public docket for this action under the Office of Air and Radiation Docket & Information Center, Air Docket ID No. A-92-13, Section XIII. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at EPA West, 1301 Constitution Ave. NW., Room B108, Mail Code 6102T, Washington, DC 20460, Phone: (202)-566-1742, Fax: (202)-566-1741. The materials may be inspected from 8:30 a.m. until 4:30 p.m. Monday through Friday, excluding legal holidays. A reasonable fee may be charged for copying docket materials.

2. Electronic Access. You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the appropriate docket identification number.

Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

You may submit comments electronically, by mail or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of comment period will be marked late. EPA is not required to consider these late comments. If you plan to submit comments, please also notify Kate Choban, U.S. Environmental Protection Agency, Global Programs Division (6205J), 1200 Pennsylvania Ave. NW., Washington, DC 20460, (202) 564-3524.

1. Electronically. If you submit an electronic comment as prescribed below, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments.

2. By Mail. Send two copies of your comments to: Air and Radiation Docket (6102), Air Docket No. A-92-13, Section XIII, U.S. Environmental Protection Agency, Mailcode 6205J, 1200 Pennsylvania Ave. NW., Washington, DC 20460.

3. By Hand Delivery or Courier. Deliver your comments to: 501 3rd Street NW., Washington, DC, 20001, Attention Docket ID No. A-92-13, Section XIII. Such deliveries are only accepted during the Docket's normal hours of operation as identified under ADDRESSES.

4. By Facsimile. Fax your comments to: (202) 566-1741, Attention Docket ID No. A-92-13, Section XIII.

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. Send or deliver information identified as CBI only to the mail or courier addresses listed in Units C.2 or C.3, as appropriate, to the attention of Air Docket ID No. A-92-13, Section XIII. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR Part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified in the FOR FURTHER INFORMATION CONTACT section.

The Clean Air Act Amendments of 1990 direct the Environmental Protection Agency (EPA) to issue regulations to implement the provisions of the Protocol within the United States through a system of controls on production and consumption of ozone-depleting substances. The current regulatory requirements of the Stratospheric Ozone Protection Program are codified at subpart A to Part 82 of Volume 40 of the Code of Federal Regulations (40 CFR part 82, subpart A). As the control measures of the Protocol have been amended or adjusted, and in consideration of other factors, subpart A has also been amended. For example, the amendments to the Protocol made at the Fourth Meeting of the Parties in Copenhagen in 1992 included an accelerated phaseout of ODS production and consumption. EPA published a final regulation in December of 1993, implementing the United States' accelerated phaseout obligation under the Copenhagen amendments (58 FR 65018).

The requirements contained in the final rules published in the Federal Register on December 20, 1994 and May 10, 1995 establish an Allowance Program. The Allowance Program and its history are described in the notice of proposed rulemaking published in the Federal Register on November 10, 1994 (59 FR 56276). The control and the phaseout of the production and consumption of class I ozone-depleting substances as required under the Protocol and the CAA are accomplished through the Allowance Program.

In developing the Allowance Program, we collected information on the amounts of ozone-depleting substances produced, imported, exported, transformed and destroyed within the U.S. for specific baseline years for specific chemicals. This information was used to establish the U.S. production and consumption ceilings for these chemicals. The data were also used to assign company-specific production and import rights to companies that were in most cases producing or importing during the specific year of data collection. These production or import rights are called “allowances.” Due to the complete phaseout of many of the ozone-depleting chemicals, the quantities of allowances granted to companies for those chemicals were gradually reduced and eventually eliminated. Production allowances and consumption allowances continue to exist for only one specific class I controlled ozone-depleting substance—methyl bromide. All other production or consumption of class I controlled substances is prohibited under the Protocol and the CAA, but for a few narrow exemptions.

In the context of the regulatory program, the use of the term consumption may be misleading. Consumption does not mean the “use” of a controlled substance, but rather is defined as the formula: production + imports − exports, of controlled substances (Article 1 of the Protocol and Section 601 of the CAA). Class I controlled substances that were produced or imported through the expenditure of allowances prior to their phaseout date can continue to be used by industry and the public after that specific chemical's phaseout under these regulations, unless otherwise precluded under separate regulations.

The specific names and chemical formulas for the class I controlled ozone-depleting substances are in appendix A and appendix F in subpart A of 40 CFR part 82. The specific names and chemical formulas for the class II controlled ozone-depleting substances are in appendix B and appendix F in subpart A.

Methyl bromide is an odorless and colorless gas used in the U.S. and throughout the world as a fumigant. Methyl bromide, which is toxic to living things, is used in many different situations to control a variety of pests, such as insects, weeds, pathogens, and nematodes. Additional characteristics and details about the uses of methyl bromide, as well as information on the basis for listing methyl bromide as a class I substance, can be found in the proposed rule published in the Federal Register on March 18, 1993 (58 FR 15014) and the final rule published in the Federal Register on December 10, 1993 (58 FR 65018). Updated information on methyl bromide can be found at the following sites of the World Wide Web: http://www.epa.gov/ozone/mbr/ and http://www.teap.org or by contacting the Stratospheric Ozone Protection Hotline at 1-800-296-1996.

The Parties to the Protocol established a freeze in the level of methyl bromide production and consumption for industrialized countries at the 1992 Meeting in Copenhagen. The Parties agreed that each industrialized country's level of methyl bromide production and consumption in 1991 should be the baseline for establishing the freeze. EPA published a final rule in the Federal Register on December 10, 1993, listing methyl bromide as a class I, Group VI controlled substance, freezing U.S. production and consumption at this 1991 level, and, in § 82.7 of the rule, setting forth the percentage of baseline allowances for methyl bromide granted to companies in each control period (each calendar year) until the year 2001 (58 FR 65018). Consistent with the CAA requirements for newly listed class I ozone-depleting substances, this rule established a 2001 phaseout for methyl bromide. In the rule published in the Federal Register on December 30, 1993 (58 FR 69235), we established baseline methyl bromide production and consumption allowances for specific companies in § 82.5 and § 82.6.

At their 1997 meeting, the Parties agreed to establish the phaseout schedule for methyl bromide in industrialized countries. The U.S. Congress followed by amending the CAA (in Oct. 1998) to direct EPA to promulgate regulations reflecting the Protocol phaseout date of 2005, with interim phasedown steps in 1999, 2001, and 2003. EPA promulgated a regulation that was published in the Federal Register on June 1, 1999 (64 FR 29240), instituting the initial interim reduction of 25 percent in the production and import  1 of methyl bromide for the 1999 and 2000 control periods. In a subsequent rule, published in the Federal Register on November 28, 2000 (65 FR 70795), EPA implemented reductions in the production and consumption of methyl bromide for 2001 and beyond, as follows: beginning January 1, 2001, a 50 percent reduction in baseline levels; beginning January 1, 2003, a 70 percent reduction in baseline levels; and, beginning January 1, 2005, the complete phaseout of methyl bromide.

With today's action EPA is proposing to prohibit the import and export of methyl bromide (class I, Group VI controlled substance) from or to a foreign state that is not a Party to the 1992 Copenhagen Amendments to the Protocol. EPA is banning trade in methyl bromide with non-Parties to the Copenhagen Amendments to the Protocol in order to ensure the United States meets its obligations under the Protocol and associated amendments. Article 4, paragraph 1 qua of the Protocol bans the import of methyl bromide (Annex E substances) from any country not a Party to the Protocol amendments creating control obligations for methyl bromide (Copenhagen Amendments). Later refinements made to the methyl bromide phaseout schedule were in the form of adjustments, not amendments, and any Party that has ratified the Copenhagen Amendments is subject to those adjustments. Article 4, paragraph 2 qua of the Protocol bans exports of methyl bromide to any Party that has not ratified the Copenhagen Amendments to the Protocol. These bans were added as part of the 1997 Montreal Amendments to the Protocol. Section 614 of the CAA states, “This title as added by the Clean Air Act Amendments of 1990 shall be construed, interpreted, and applied as a supplement to the terms and conditions of the Montreal Protocol, as provided in Article 2, paragraph 11 thereof, and shall not be construed, interpreted, or applied to abrogate the responsibilities or obligations of the United States to implement fully the provisions of the Montreal Protocol. In the case of conflict between any provision of this title and any provision of the Montreal Protocol, the more stringent provision shall govern. Nothing in this title shall be construed, interpreted, or applied to affect the authority or responsibility of the Administrator to implement Article 4 of the Montreal Protocol with other appropriate agencies.” Pursuant to section 614, today's action fulfills the U.S. obligation to implement the methyl bromide trade ban provisions of the Montreal Protocol.

Current regulations (60 FR 24970; 40 CFR 82.4(l)(2)) prohibit the import and export of certain class I controlled substances from or to foreign states not Parties to the Montreal Protocol or specific amendment packages to the Protocol ( e.g. , the London Amendments). These bans on imports from and exports to non-Parties to amendment packages reflect an agreed strategy by the Parties to the Montreal Protocol to encourage ratification of each successive amendment package to the Protocol and to ensure that controlled ozone-depleting substances are not provided to countries that have not agreed to control measures.

A list of Parties that have ratified the Montreal Protocol and that have ratified successive amendments to the Protocol is published with today's action in appendix C. For the purposes of today's methyl bromide trade ban, companies should refer to appendix C to subpart A of part 82 to identify nations that have not yet ratified the Copenhagen Amendments. Today's action prohibits imports of methyl bromide from, or exports of methyl bromide to, these nations that have not ratified the Copenhagen Amendments. EPA will publish notices on a periodic basis to update this list (appendix C) to reflect when Parties ratify the Montreal Protocol and its amendments. For additional information on countries that have ratified the Protocol and its amendments, you may want to visit the website of the United Nations Environmental Program (UNEP) Ozone Secretariat at http://www.unep.org/ozone/ and look for the “Status of Ratification”.

Article 4, paragraph 8 of the Protocol recognizes that countries may actually be complying with relevant control measures without having officially ratified the Protocol or its relevant Amendments and permits the Parties to meet and determine that imports from and exports to these countries are permitted. Therefore, EPA is reserving Annex 2 of appendix C for any country determined by the Parties to be complying with the relevant control measures.

EPA is publishing this rule without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comment. No adverse comment is expected due to the fact that the U.S. Senate gave its advice and consent to ratification of the Montreal Amendment on October 9, 2002, and this rule simply adopts one of the provisions contained in that Amendment. The regulated producers, importers and exporters attended both meetings of the Parties to the Montreal Protocol the year that the trade ban provisions were agreed through an amendment. EPA did not hear from the producers, importers and exporters when this provision was up for consideration by the Parties. Therefore, we do not anticipate any adverse comments on this action. Establishing such a trade ban is now standard practice under the Protocol for controlled ozone-depleting substances. However, in the “Proposed Rules” section of today's Federal Register , we are publishing a separate document that will serve as the proposal to implement the methyl bromide trade bans if adverse comments are filed. This rule will be effective on October 23, 2003 without further notice unless we receive adverse comment by August 25, 2003 (or, if a public hearing is requested, by September 18, 2003). If EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any persons interested in commenting must do so at this time.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether this regulatory action is “significant” and therefore subject to OMB review and the requirements of the Executive Order. The Order defines a “significant” regulatory action as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

It has been determined by EPA and OMB that this rule is not a “significant regulatory action” within the meaning of the Executive Order.

The Office of Management and Budget (OMB) previously approved the information collection requirements that can be used to implement today's direct final rule. The previously approved ICR is assigned OMB control number 2060-0170 (EPA ICR No. 1432.21).

There is no additional paperwork burden as a result of this rule. Current record keeping will allow EPA to implement the provisions of today's action.

The information collection previously approved will be used to implement the trade ban in paragraph 1 qua under Article 4 of the Montreal Protocol for methyl bromide. The information collection under this rule is authorized under sections 603(b) and 603(d) of the Clean Air Act Amendments of 1990 (CAA). This information collection is conducted to meet U.S. obligations under Article 7, Reporting Requirements, of the Montreal Protocol on Substances that Deplete the Ozone Layer (Protocol); and to carry out the requirements of Title VI of the CAA, including sections 603 and 614.

The reporting requirements included in this rule are intended to:

(1) Satisfy U.S. obligations under the international treaty, The Montreal Protocol on Substances that Deplete the Ozone Layer (Protocol), to report data under Article 7;

(2) Fulfill statutory obligations under Section 603(b) of Title VI of the Clean Air Act Amendments of 1990 (CAA) for reporting and monitoring;

(3) Provide information to report to Congress on the production, use and consumption of class I controlled substances as statutorily required in section 603(d) of title VI of the CAA.

EPA informs respondents that they may assert claims of business confidentiality for any of the information they submit. Information claimed confidential will be treated in accordance with the procedures for handling information claimed as confidential under 40 CFR part 2, subpart B, and will be disclosed only to the extent, and by means of the procedures, set forth in that subpart. If no claim of confidentiality is asserted when the information is received by EPA, it may be made available to the public without further notice to the respondents (40 CFR 2.203).

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 are listed in 40 CFR part 9 and 48 CFR chapter 15.

EPA has determined that it is not necessary to prepare a regulatory flexibility analysis in connection with this final rule. EPA has also determined that this rule will not have a significant economic impact on a substantial number of small entities. For purposes of assessing the impact of today's rule on small entities, small entities are defined as: (1) A small business that is identified by the North American Industry Classification System (NAICS) Code in the Table below; (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.

Based on an analysis of the U.S. exports of methyl bromide to specific countries, EPA has determined that only 3 countries of the 50 to whom U.S. producers of methyl bromide have exported over the past three years would be impacted because they have not yet ratified the Copenhagen Amendments to the Protocol. Specifically, the rule would ban the export of 41 metric tonnes to Cyprus, Cote d'Ivoire, and the United Arab Emriates compared to an average export from the entire U.S. of 5,236 metric tonnes. These countries represent less than 1% of all U.S. exports of methyl bromide for the years 2000, 2001, and 2002. So, economic impacts for U.S. producers of methyl bromide would be extremely minimal. The rule will not constrain U.S. farmers' ability to obtain methyl bromide from importers because the major methyl bromide exporting countries have already ratified the Copenhagen Amendments.

After considering the economic impacts of today's final rule on small entities, EPA has concluded that this action will not have a significant economic impact on a substantial number of small entities. This final rule will not impose any requirements on small entities. None of the entities affected by this rule are considered small as defined by the NAICS Code listed above.

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 by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. If a written statement is required under section 202, 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, unless the Agency explains why this alternative is not selected or the selection of this alternative is inconsistent with law.

Section 203 of the UMRA requires the Agency to establish a plan for obtaining input from and informing, educating, and advising any small governments that may be significantly or uniquely affected by the rule. Section 204 of the UMRA requires the Agency to develop a process to allow elected state, local, and tribal government officials to provide input in the development of any proposal containing a significant Federal intergovernmental mandate.

EPA has determined that this rule does not contain a Federal mandate that may result in expenditures of $100 million or more by State, local and tribal governments, in the aggregate, or by the private sector, in any one year. The provisions in today's rule fulfill the obligations of the United States under the international treaty, The Montreal Protocol on Substances that Deplete the Ozone Layer, as well as those requirements set forth by Congress in section 614 of the Clean Air Act. Viewed as a whole, all of today's amendments do not create a Federal mandate resulting in costs of $100 million or more in any one year for State, local and tribal governments, in the aggregate, or for the private sector. Thus, today's rule is not subject to the requirements of sections 202 and 205 of the UMRA. EPA has also determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments; therefore, EPA is not required to develop a plan with regard to small governments under section 203. Finally, because this proposal does not contain a significant intergovernmental mandate, the Agency is not required to develop a process to obtain input from elected state, local, and tribal officials under section 204.

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.”

Under Section 6 of Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law, unless the Agency consults with State and local officials early in the process of developing the regulation.

This rule does not have federalism implications. It will 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. Today's rule is expected to primarily affect importers and exporters of methyl bromide. EPA is not aware of any current uses of methyl bromide by public sector entities. Thus, the requirements of section 6 of the Executive Order do 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. Today's final rule does not significantly or uniquely affect the communities of Indian tribal governments. It does not impose any enforceable duties on communities of Indian tribal governments. Thus, Executive Order 13175 does not apply to this rule.

Executive Order 13045: “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 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 E.O. 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the Order has the potential to influence the regulation. This is not such a rule, and therefore E.O. 13045 does not apply. This rule is not subject to E.O. 13045 because it implements specific trade measures adopted under the Montreal Protocol and required by section 614 of the CAA.

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 a significant regulatory action under Executive Order 12866.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, Section 12(d) (15 U.S.C. 272 note) 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 rulemaking does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

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 rule is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective October 23, 2003.

EPA published a Direct Final Rule on June 2, 2003, granting the delisting petition submitted by Bekaert Steel, Inc. (Bekaert) for an F006 waste water treatment sludge from electroplating operations, where Bekaert manufactured copper plated steel cord for the automobile tire industry. The rule would have become effective on August 1, 2003, without further notice, unless EPA received adverse comment by July 17, 2003. The direct final rule 45-day public comment period explained that if we received adverse comments, we would withdraw the relevant direct final action.

We received adverse comment and are therefore withdrawing the direct final rule approving Bekaert's delisting petition. Commentors argued that EPA could not issue a delisting petition based on another identical facility's data, and that the regulations specifically require the delisting to be based on site specific information. Therefore, for the petition to be complete Bekaert should submit at a minimum, three additional data points from the Dyersburg, Tennessee facility to support the initial delisting petition. The three additional data points must be collected in compliance with 40 CFR 260.22, and be sufficient to demonstrate the temporal and spatial variability of the petitioned waste. EPA shall review the data submitted and shall publish a proposed rule to provide public notice on EPA's proposed decision and collect comments on the proposed decision.

Inspection of Public Comments: Comments received timely will be available for public inspection as they are recorded and processed, generally beginning approximately 4 weeks after the publication of the document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone (410) 786-7197.

Under section 1862(b)(2)(A) of the Social Security Act (the Act), Medicare payments may not be made for any item or service for which payment has been made or can reasonably be expected to be made “promptly” (as determined in accordance with our regulations) under a liability insurance policy. The regulations at § 411.54(c)(2) and a portion of § 489.20(g) require providers and suppliers (including physicians) to bill Medicare for Medicare covered services. These regulations also prohibit those providers and suppliers from billing a liability insurer or asserting or maintaining a lien against the beneficiary's insurance settlement, regardless of when the liability insurer is billed or when the lien is asserted. After the regulations at § 411.54(c)(2) and § 489.20(g) were published, but before the effective date, the American Hospital Association (AHA), filed a lawsuit on behalf of its member hospitals to prevent us from implementing these sections. ( See American Hospital Association (AHA) v. Sullivan , 1990 WL 274639 (D.D.C. May 24, 1990).) During the litigation, the parties stipulated to allow providers to bill liability insurers or assert or maintain a lien against a beneficiary's insurance settlement.

The court ultimately held that this statutory provision (that prohibits Medicare from making payment where liability insurance that is expected to pay promptly exists) permits a provider to seek payment from insurance or assert or maintain a lien against the beneficiary's insurance settlement during the “promptly” period. Therefore, we were unable to implement § 411.54(c)(2) and the portion of § 489.20(g) that states, “except when the primary payer is a liability insurer and except as provided in paragraph (j) of this section.” The court took no action affecting existing special rules for Oregon. The court also did not address billing a liability insurer or asserting or maintaining a lien after the expiration of the “promptly” period. The AHA decision has not been appealed. Therefore, to the extent that § 411.54(c)(2) and a portion of § 489.20(g) are inconsistent with the court's decision, they are unenforceable.

In light of the AHA decision, we are continuing the policy which we stipulated during the AHA case with respect to all providers and suppliers (including physicians); that is, we are allowing them to bill liability insurers or assert or maintain liens on a beneficiary's liability insurance settlement rather than billing Medicare. The Commerce Clearing House, Inc. (CCH) published two policy memoranda that addressed the issue of billing a liability insurer or asserting or maintaining a lien against a beneficiary's liability insurance settlement, referring to the holding in the AHA case. (Medicare & Medicaid Guide (CCH) 45, 187 at 53, 508-53, 512 (1997). The first policy memorandum entitled, “Provider and Supplier Billing When Medicare is Secondary Payer to Liability Insurance—Information”, is dated August 21, 1995. The second policy memorandum entitled “ Charges to Beneficiaries and Handling Improper Collections By Providers and Suppliers When Medicare is Secondary Payer to Liability Insurance—Action”, is dated March 12, 1996. These memoranda can be obtained by calling the contact person listed in this final rule with comment period or by accessing the CMS Web site: http://www.cms.hhs.gov.

To date, we have not enforced § 411.54 (c)(2) or the portion of § 489.20(g) that is inconsistent with the court's decision. Because § 411.54(c)(2) was written without regard to the pre- and post “promptly” period, we are removing this section in its entirety, even though the AHA decision found it unenforceable only during the “promptly” period. This final rule with comment period does not establish lien rights that are not available to providers and suppliers (including physicians) under State law. The final rule with comment period does not alter the prohibition against double billing; that is, it does not allow a provider or supplier (including a physician) to bill Medicare and simultaneously bill the liability insurer or assert or maintain a lien against the beneficiary's liability insurance settlement.

The final rule with comment period removes § 411.54(c)(2) and revises paragraphs (c) and (d) of our regulations. It also removes the words “except when the primary payer is a liability insurer and except as provided in paragraph (j) of this section” from § 489.20(g).

Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment when a collection of information requirement is submitted to the OMB for review and approval. In order to fairly evaluate whether OMB should approve an information collection, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

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

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

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

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

Therefore, we are soliciting public comment on each of these issues for the information collection requirements discussed below.

Section 411.54(c) states that a hospital must, upon request, furnish to the beneficiary or his or her representative an itemized bill of the hospital's charges.

This requirement, which is subject to the PRA, is not being revised in this regulation. The burden associated with this requirement is currently captured under OMB control number 0938-0565, which is approved through November of 2005.

We have submitted a copy of this final rule with comment period to OMB for its review of the information collection requirements described above. These requirements are not effective until they have been approved by OMB.

If you comment on these information collection and recordkeeping requirements, please mail copies directly to the following: Centers for Medicare and Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development and Issuances, Attn.: Dawn Willinghan (Attn: CMS-1475-F), Room C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850.

Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Attn: Brenda Aguilar, CMS Desk Officer.

We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule. The notice of proposed rulemaking includes a reference to the legal authority, under which the rule is proposed, and the terms and substances of the proposed rule or a description of the subjects and issues involved. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued. The AHA decision holds that the Medicare Secondary Payer provisions permit a provider to seek payment from that insurance or assert or maintain a lien against the beneficiary's insurance settlement during the “promptly” period. To the extent that § 411.54(c)(2) and a portion of § 489.20(g) are inconsistent with the court's decision, they are unenforceable. Good cause exists to waive notice and comment because the agency's action to remove § 411.54(c)(2) and revise § 489.20(g) is compelled by the AHA decision.

Therefore, we find good cause to waive the notice of proposed rulemaking and to issue this final rule with comment period.

We have examined the impacts of this final rule with comment period as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We have determined that the effect of this final rule on the economy and the Medicare program is negligible. Therefore, this final rule is not a major rule as defined in Title 5, United States Code, section 804(2) and is not an economically significant rule under Executive Order 12866.

Because these regulations have been unenforceable since the AHA decision, the impact of this regulation is limited to the expected elimination of potential lawsuits that may be brought against hospitals by beneficiaries seeking to require hospitals to bill Medicare for the cost of their treatment. Since 1990 we have been aware of only several cases where beneficiaries have brought litigation against hospitals seeking State court orders requiring the hospitals to bill Medicare. The beneficiaries have based their cases on the published regulations. While we do not believe that many such suits have or will be filed, individual hospitals can spend substantial monies defending these types of lawsuits. Beneficiaries who bring these suits, only to lose based on the State court's reading of CMS' policy, also may be responsible for some attorneys' costs and may be responsible for fees for the hospital's attorneys in some cases. To the extent that this regulation clarifies CMS policy by eliminating unenforceable regulations, we believe that the number of lawsuits filed may decline.

The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to $29 million in any 1 year. Individuals and States are not considered to be small entities. Because this regulation merely deletes these unenforceable provisions from our regulations, we have determined and we certify that this final rule will not have a significant economic impact on a substantial number of small entities. Therefore, we are not preparing an analysis for the RFA.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule or notice having the effect of a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. We have determined that this final rule will not have a significant effect on the operations of a substantial number of small rural hospitals. Therefore, we are not preparing an analysis for section 1102(b) of the Act.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule or notice having the effect of a rule that may result in expenditures in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. This final rule has no consequential effect on State, local, or tribal governments or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule or notice having the effect of a rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This final rule will not have a substantial effect on State or local governments.

In accordance with the provisions of Executive Order 12866, this final rule was reviewed by the Office of Management and Budget.

This is a summary of the Commission's Fourth Memorandum Opinion and Order, ET Docket No. 98-206, FCC 03-97, adopted April 22, 2003, and released April 29, 2003. The full text of this Commission decision is available on the Commission's Internet site at http://www.fcc.gov. It is available for inspection and copying during normal business hours in the FCC Reference Information Center, Room CY-A257, 445 12th Street, SW., Washington, DC 20554. The complete text of this document also may be purchased from the Commission's copy contractor, Qualex International, 445 12th Street, SW., Room, CY-B402, Washington, DC 20554. Alternative formats are available to persons with disabilities by contacting Brian Millin at (202) 418-7426 or TTY (202) 418-7365. File comments with the Office of the Secretary, a copy of any comments on the information collection contained herein should be submitted to Les Smith, Federal Communications Commission, Room 1-A804, 445 12th Street, SW., Washington, DC 20554 or via the Internet to Leslie.Smith@fcc.gov, and to Kim A. Johnson, OMB Desk Officer, Room 10236 NEOB, 725 17th Street, NW., Washington, DC 20503 or via the Internet to Kim A.Johnson@omb.eop.gov.

1. DBS Issues. In this Fourth Memorandum Opinion and Order (Fourth MO&O), the Commission affirms that the four regional EPFD limits and the 14 dBm EIRP limit adopted for MVDDS operation constitute objective standards that will prevent harmful interference to DBS as defined by § 2.1 of the Commission's rules and will provide certainty that, along with other reasonable procedures that were adopted, can be discerned and relied upon by DBS operators. The Commission declines to adopt higher EIRP and EPFD limits for rural areas because the adopted standards are sufficiently conservative to protect DBS in general application while preserving the flexibility for each MVDDS provider to make its own business decisions about what type of transmission system best suits its needs.

2. The Commission affirms that the rules and procedures adopted in the Second R&O, (ET Docket No. 98-206), 67 FR 43031, June 26, 2002 comply with the legislative history and provisions of the Rural Local Broadcast Signal Act (RLBSA) and the Satellite Home Viewer Protection Act (SHVIA)   1 that prohibit harmful interference to DBS. The Commission finds that, under the powers granted by the Communications Act, it was proper to define interference standards in terms of EPFD and EIRP limits on MVDDS that it concluded would prevent harmful interference to DBS. The Commission further finds that the adoption of these standards complies with the Administrative Procedure Act (APA) because they were developed through the usual notice and comment rule making process.

3. The Commission affirms that the rules and procedures adopted in the Second R&O do not violate other Commission rules or international radio regulations, and are consistent with the regulatory history of DBS and FS allocations in the 12 GHz band because MVDDS, unlike previous FS operations, is designed to coexist with DBS and because the adopted rules and procedures will prevent harmful interference to DBS.

4. The Commission affirms the self-mitigation responsibilities adopted in the Second R&O for new DBS receivers and finds that they are consistent with the primary status of DBS because, due to their modest, effective and infrequently required nature, they strike an appropriate public interest balance that will result in more efficient spectrum utilization and will facilitate compliance with the non-harmful interference provisions of the statutes while allowing initiation of a new service.

5. The Commission finds that adequate notice was given for the computer model used to derive the EPFD limits on MVDDS, and that the various inputs for this model—including using a 10% increase in DBS unavailability as a starting point rather than as a hard limit, the “double averaging” of EPFDs, and the decision not to include “wing satellites”—are reasonable and supported by the evidence of record particularly in light of the deficiencies or impracticalities involved in other models that were considered.

6. The Commission affirms that the “safety valve” rule, as written, is sufficiently specific and is a useful tool to ensure that MVDDS operations fully protect DBS. Consistent with past practice, the Commission notes that in many cases it has provided opportunities for licensees to petition for adjustments to rules (outside the waiver process) without specifying in exacting detail how such a filing should be made.

7. The Commission affirms its decision to require that MVDDS conduct a site survey as specified in § 101.1440(b) of the Commission's rules and finds that, in conjunction with other adopted procedures, it has provided sufficient detail and specificity—similar in nature to the broad good-faith-based guidelines that have proven to be both workable and beneficial in other proceedings—that the Commission concludes will protect DBS customers in this proceeding.

8. The Commission affirms the 45-day DBS response time specified in § 101.1440(d)(2) of the Commission's rules, because it provides a reasonable balance between the needs of DBS licensees to ensure protection of their customers before MVDDS begins operation while affording MVDDS licensees the ability to initiate service on a reasonably expeditious basis. Further, the Commission concludes that DBS customers are protected once MVDDS begins operation because the MVDDS provider must correct interference or cease operation if it causes harmful interference to or exceeds the permitted EPFD limits to a DBS customer of record.

9. The Commission amends § 101.1440(e) of the rules to clarify the responsibility of DBS licensees in regard to future DBS receive antenna installations. The Commission recognizes that § 101.1440(e) of the rules adopted in the Second R&O appears to require a DBS licensee to oversee all future DBS receive antenna installations, which they currently may not do. It was not intent of the Commission to alter these arrangements. Rather, the Commission only expects a DBS licensee to provide information that they deem necessary so that other entities installing DBS receive antennas may take into account the presence of MVDDS operations. Typically, this information could be conveyed with installation guidelines for DBS equipment.

10. The Commission amends § 101.1440(d)(2) of the rules to allow DBS providers to identify—instead of all DBS customers of record—only those new DBS customers of record that they believe would receive harmful interference from the proposed MVDDS transmitter during the 30-day period specified in the rule. The Commission takes this action to address petitioners' concern regarding the possible uses to which other parties could put such information.

11. The Commission declines to adopt a methodology for measuring EPFD values in the field because any measurement techniques that might be described would artificially limit the flexibility of the licensees to perform these measurements, and could seemingly prohibit the use of a technique that is satisfactory for this purpose.

12. Concerning dispute resolution procedures, the Commission clarifies that an MVDDS transmitter can be turned on after expiration of the 90-day period specified in § 101.1440 of the rules. The Commission believes that the adopted EPFD contour methodology will reduce disputes to a minimum, and this time frame will ensure that licensees participate in conflict resolution in good faith.

13. The Commission affirms its decision to dismiss the pending applications of Broadwave Network, LLC (Northpoint), PDC Broadband Corporation (Pegasus), and Satellite Receivers, Ltd. (SRL) because the original Ku-band Cut-Off Notice did not provide adequate notice for all entities interested in filing applications for licenses to provide terrestrial services in the 12 GHz band. The Commission further finds that its decision to dismiss the pending applications is consistent with the LOCAL TV Act because there is no evidence that Congress explicitly ordered the Commission to limit terrestrial applications in this band to those already on file and validated by independent testing.

14. The Commission finds that the rules and procedures adopted in the Second R&O do not violate the Administrative Procedure Act ( APA ) because the decisions were fully explained and rationally based upon all the information in the record and, therefore, are not arbitrary, capricious or contrary to law.

15. The Commission finds that the adoption of the Second R&O did not violate the provisions of the Government in the Sunshine Act (Sunshine Act) because the item was not adopted at an open meeting as defined by the Act and that, therefore, the Sunshine Act is not applicable.

16. The Commission dismisses, as repetitious, the petitions for reconsideration to the extent that they challenge the underlying decision in the First Report and Order, 66 FR 10601, February 16, 2001, and Further Notice of Proposed Rulemaking, 66 FR 7607, January 24, 2001, in this proceeding to authorize MVDDS in the 12 GHz band, and to the extent they challenge the determination made in the memorandum opinion and order portion of the Second R&O that MVDDS is authorized on a primary, rather than secondary, non-harmful interference basis as to DBS.

17. The Commission denies as not ripe, because it relies upon purely speculative conjecture, a petition for reconsideration that asserts that DBS providers might at some time in the future suffer a “regulatory taking” as the result of being required to increase satellite power to overcome MVDDS interference.

18. NGSO FSS Issues. The Commission affirms the −135 dBW/m 2 /4kHz PFD limit at 3 km, and the 10 km separation rules for MVDDS because they provide reasonable interference protection to NGSO FSS and strike a reasonable balance between affording the first in service provider with easier and better use of the band while not unduly precluding deployment by the later-in provider. The Commission affirms its finding that an alternate NGSO FSS protection scheme proposed by one petitioner is unduly complex and provides no benefit over the adopted limits.

19. The Commission amends § 25.139(a) to reflect that the information NGSO FSS licensees are required to provide MVDDS should be construed narrowly and that only information necessary to achieve the required 10 km separation under § 25.139(b) needs to be provided.

20. The Commission clarifies the NGSO FSS low-angle PFD limit of § 25.208(o) for MVDDS protection. The limit will be treated in a manner consistent with the rules for NGSO FSS and BSS sharing where validation ( i.e. , “hard limit”) and operational ( i.e. , can be exceeded so long as they are not exceeded into an operational receiver) EPFD limits were adopted. The low-angle PFD limit adopted by the Commission in the Second R&O for MVDDS protection is therefore intended to be an operational limit which means that it does not need to be met in all cases so long as it is not exceeded into an operational MVDDS receiver. To clarify this intent, the Commission modifies § 25.146 to add paragraph (g) to specify that the required technical showing shall demonstrate the NGSO FSS system is capable of meeting the limits specified in § 25.208(o). The Commission also amends § 25.208(o) to require that the specified power flux density shall not be exceeded into an operational MVDDS receiver.

21. The Commission clarifies the MVDDS emission mask by amending the footnote immediately after the definition of “B” in § 101.111(a)(2)(i) to add the proviso that the emission mask only applies at the 12.2-12.7 GHz band edges and does not restrict MVDDS channelization bandwidths within the band.

22. Paperwork Reduction Act Analysis: This Fourth Memorandum Opinion and Order contains a new or modified information collections. This Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and the Office of Management and Budget to comment on the information collections contained in the Fourth Memorandum Opinion and Order, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. Public and agency comments are due September 23, 2003.

23. The Regulatory Flexibility Act of 1980, as amended (RFA), 2 requires that a regulatory flexibility analysis be prepared for notice-and-comment rule making proceedings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.”  3 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.”  4 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. 5 A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). 6

24. Under the amended rules adopted in the Fourth Memorandum Opinion and Order, DBS licensees are required to provide the MVDDS licensee with a list of only those new DBS customer locations that have been installed in the 30-day period following the MVDDS notification and that the DBS licensee believes may receive harmful interference or where the prescribed equivalent power flux density (EPFD) limits may be exceeded. This requirement is less burdensome than the rule adopted in the Second R&O   7 that required disclosure of all DBS customer locations under similar circumstances. Furthermore, under the amended rules, DBS licensees are required to provide merely the information deemed necessary by DBS licensees to enable others to take into account the presence of MVDDS transmitters. This requirement is less burdensome than the rule adopted in the Second R&O that imposed direct responsibility on DBS licensees for proper siting of future DBS receivers to take into account the presence of MVDDS.

25. Licensees of NGSO FSS systems are required to submit, ninety days prior to the initiation of service to the public, a technical showing that demonstrates that they are capable of meeting low-angle radiation limits specified in § 25.208(o) of the Commission's rules for the 12.2-12.7 GHz band. Finally, licensees of NGSO FSS systems are required under the amended rules to ensure that the PFD limit is not exceeded into an operational MVDDS receiver. Taken together, these requirements are less burdensome than those adopted in the Second R&O because they merely require a showing that the NGSO FSS system is capable of meeting (instead of demonstrating the system has factually met) the specified technical limits, and because the PFD limit need only be met into operational , rather than all , MVDDS receivers.

26. These changes are deregulatory because they lessen compliance requirements. Therefore, we certify that the requirements of the Fourth Memorandum Opinion and Order will not have a significant economic impact on a substantial number of small entities.

27. The Commission will send a copy of the Fourth Memorandum Opinion and Order, including a copy of this Final Regulatory Flexibility Certification, in a report to Congress pursuant to the Congressional Review Act. 8 In addition, the Fourth Memorandum Opinion and Order and this final certification will be sent to the Chief Counsel for Advocacy of the SBA. 9

28. Pursuant to sections 4(i), 302, 303(e) 303(f), 303(g), 303(r) and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 302, 303(e), 303(f), 303(g) and 405, the petitions for reconsideration filed by Pegasus Broadband Corporation, MDS America, Inc., EchoStar Satellite Corporation and DIRECTV, Inc., SkyBridge L.L.C., SES Americom, Inc., and Satellite Broadcasting and Communications Association Are denied.

29. Parts 25 and 101 of the Commission's rules are amended as specified in the rule changes, effective August 25, 2003, except § 25.146 which contains information collection requirements which have not been approved by the Office of Management and Budget (“OMB”). The Commission will publish a document in the Federal Register announcing the effective date. This action is taken pursuant to sections 4(i), 303(c), 303(f), 303(g) 303(r) and 309(j) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303(c), 303(f), 303(g), 303(r) and 309(j).

30. It is further ordered that the proceeding in ET Docket No. 98-206 is terminated.

Background and Purpose

Five DOT agencies and the USCG collect drug and alcohol program data from their regulated employers on an annual basis. Employers compile this data on MIS forms and each form is DOT-agency specific. In fact, twenty-one MIS data collection forms will be replaced within the DOT agencies by the new single-format form. The Department believes that data collection and entry will be greatly simplified for transportation employers and the Department if a single form is utilized throughout the transportation industries and the DOT agencies.

All drug and alcohol testing conducted under DOT authority uses a standard form for drug testing—Federal Drug Testing Custody and Control Form—and a standard form for alcohol testing—DOT Alcohol Testing Form. In essence, use of standard testing forms serves to limit MIS reporting to a finite number of data elements. Therefore, a core set of data elements will make up the new MIS form which all transportation employers will complete, as appropriate, for their companies and the DOT agencies regulating them.

This MIS form will simplify and streamline data recording for transportation employers and will require employers to enter less data. In addition, because the form contains fewer data elements and is on a one-page format, it can be more easily entered and processed via electronically-based systems. As an added benefit, there is a single set of MIS instructions for all transportation employers, regardless of DOT agency.

However, not every DOT agency expects information for all potential data elements ( e.g. , RSPA does not conduct random alcohol testing), and some data elements may be collected through some means other than MIS ( e.g. , USCG receives alcohol data immediately following each post-accident testing event). The form's instructions highlight some of those peculiar testing differences, and companies not required to conduct or report certain types of tests will simply leave those sections blank or may enter zeros. For instance, because USCG wants no alcohol testing data on the MIS form, USCG-regulated employers will leave blank (or enter zeros in) Section IV of the form. In addition, when no testing was done or no results were received for particular data elements, employers may leave those items blank or insert zeros.

The Department issued a notice of proposed rulemaking (NPRM) on September 30, 2002 (67 FR 61306), asking for comments and suggestions for changes to the MIS form and process. In response to the NPRM, we received a modest amount of comments from a dozen or so individuals, groups, and associations. The final rule responds to all those comments. The final rule also makes significant modifications to the previous DOT agency MIS forms.

In the NPRM we said, “On June 6, 2002, President Bush announced his proposal to create a Cabinet-level homeland security department. Inside this new department, the President proposes to put several agencies, including the USCG. The President urged Congress to pass legislation to create the new Department of Homeland Security. This process may take some time. As a result, if you have USCG ties and MIS interests, please submit your comments to this NPRM. We will consider congressional and presidential action regarding the USCG and homeland security in the final rule.”

The Department of Homeland Security (DHS) has been established and the USCG's being part of that cabinet agency is reality. However, the USCG intends to keep 49 CFR part 40 as an incorporated part of its regulated industry testing rules—46 CFR part 16. Consequently, the USCG intends to follow part 40 regulations applicable ( e.g. , part 40 alcohol rules do not apply) to the marine industry until such time as resources permit them to create their own rules, should that become necessary in the future. The USCG intends to rely upon 49 CFR part 40 for testing procedures, guidance, and interpretations. They also intend to remain a part of the MIS form, its process, and its related regulation section in part 40. Therefore, USCG-regulated employers will continue to report on this MIS form until further notice.

ODAPC desires to support the USCG efforts to facilitate a seamless transition from DOT to DHS. In this light, we will support the USCG's use of 49 CFR part 40 in their regulated industry testing program. [We view USCG's use of part 40 as being similar to DOT's required incorporation of Department of Health and Human Services (HHS) laboratory regulations and guidance into part 40.] In this light, the MIS regulation, form, and instructions will continue to reference the USCG as a DOT agency even though it became part of DHS on March 1, 2003.

The Department has decided that use of the new MIS form will be required for employer MIS submissions in CY 2004 documenting CY 2003 data. Therefore, employers must immediately adopt provisions in the rule which will permit them to start, as appropriate, collection of the required data and which establish how companies are to determine the number of employees upon which 2003 random testing is based.

Comment: The vast majority of commenters supported the Department's decision to streamline and simplify the various MIS forms currently in use into one form that will be used across all DOT agencies. Most expressed the belief that doing so will enhance accuracy of data being reported and the efficiency of those employers and service agents who will be tasked with providing the reports. A few commenters suggested that the new form will also be more easily processed through electronic means (when those are up and running) than would the variety of past MIS iterations.

Two commenters believed the new form did not effectively address the needs of data collection. One of these commenters expressed the belief that much more information needed to be collected and needed to be collected on a more frequent than once per year basis. The other commenter indicated that use of one specific DOT agency's MIS forms should not be changed because those forms best fit, the commenter asserts, the needs of a particular industry which the commenter represents (and because companies do not wish to change established reporting programs which are geared to provide the information required on current forms).

DOT Response: We agree with the preponderance of commenters who supported use of a single form across all modes of transportation. We agree with the majority of commenters who supported use of a trimmed-down version of the form. We agree with commenters who believed the new form readily lends itself to electronic transfer of items and data. In this light, it is important to note that the new form represents an all important first step in the Department's desire to have this form on-line and to permit electronic transmission of data. The fact that one form will be used throughout the transportation industry makes the difficult task of designing the system much simpler (to say nothing of our being able to obtain accurate data in consistent fields across all DOT agencies).

The Department, after reaching a self-imposed deadline date for the publication of the NPRM, did not intend for the new form to be used to collect 2002 MIS information. To do so would have meant a change in the way companies that had already collected 2002 data would have had to download that information. In addition, many companies had not been collecting vital data regarding refusals to test. Therefore, use of the new form will be required in CY 2004 for collecting data representing CY 2003 testing.

During 2003, the Federal Transit Administration (FTA) has agreed to field-test an electronic data collection system using data elements of the new form. The FTA will select transit systems for reporting MIS data as part of this field-test. FTA's Volpe Center resources will coordinate the data collection. Through field-testing we can expose the Volpe-developed system software to a wide range of equipment and real-world usage. This field test will be accomplished with an eye toward full implementation across all DOT agencies as soon as possible. We believe the revised MIS form and its data format represent the best way to accomplish the Department's ultimate goal of having full automation for MIS submissions. Early demonstrations of FTA's system have shown the design to be very user-friendly and uncomplicated for the input required data.

Comment: Several commenters expressed the concern that employers could believe the data requirements no longer reflected on MIS forms are being de-emphasized by the DOT agencies. Most of these commenters wished us to reiterate the importance of training information that will no longer be asked for on the MIS form.

DOT Response: As we stated in the NPRM, the items for which we are no longer asking are items that DOT agencies can obtain in a variety of other ways and in other venues and formats. It is worth reiterating that the vast majority of items removed from the MIS form remain important. Employers would be remiss, to say nothing about being in violation of part 40 and DOT agency regulations, if they chose not to obtain, maintain, and furnish information required by regulations. Employers and service agents will be in clear violation of regulations and subject to sanctions if the DOT agency requirements ( e.g. , for supervisory training, for recordkeeping) are now ignored simply because the data generated by those requirements are no longer being recorded on the MIS form.

Comment: The bulk of commenters supported how the Department proposed to count the number of covered employees ( i.e. , employees subject to testing because they perform DOT safety-sensitive duties) using the averaging formula. Some commenters, while supporting the averaging formula method, expressed concern for companies that make random selections on a daily or weekly basis (as opposed to those selecting monthly or quarterly). Only one commenter expressed the desire to use a number determined at the start of the year believing it simpler than factoring-in employee census fluctuations. This commenter believed that doing so would be better than having an employer determine the average number of employees at year's end—which was not an idea proposed by the Department in the NPRM. In addition, this commenter indicated that employers represented by the commenter did not know how many safety-sensitive employees they actually employ throughout the year.

DOT Response: The Department believes the calculation of the employee average will be the best way for employers to determine the number of covered employees eligible for DOT testing throughout the year. This process will more readily enable employers to take into account employment of seasonal workers; periods of downsizing; and business start-ups and other increases in employee numbers. To fix the number of covered employees at the start of a year does not take those important factors into consideration. For some employers, establishing the number at the start of the year may lead to their conducting much more random testing than required, and for others, far too little random testing.

Companies that do not know how many employees they employ and release from employment; do not know how many eligible employees are in each random selection pool; and do not know if eligible employees are placed into and taken out of random selection pools have problems irrespective of how the MIS form is completed.

In any case, the Department believes the best way for the random testing pools to be kept current and for the random testing rate to reflect the number of employees actually performing safety sensitive duties is the proposed averaging formula, and we have adopted it in this regulation. It is imperative that companies not wait until the end of the year to make this calculation. Companies must place all covered employees into the pool, know how many are in the pool, and select and test the appropriate percentages.

While we believe that companies conducting their random testing draws on a daily or weekly basis have computer systems sophisticated enough to factor the average on a daily or weekly basis, the Department will not require those companies to do so. However, those companies conducting random draws more frequently than monthly ( e.g. , daily, weekly, bi-weekly) will not be required to do the averaging more than once each month. And, for example, companies selecting monthly, must calculate monthly; and companies selecting quarterly, must calculate quarterly.

Comment: One commenter believed the requirement to capture “refusal to test” data would be too complex for employers. This commenter also stated that counting the number of cancelled tests would also add a burden to employers, although the commenter wished to have cancelled tests counted toward satisfaction of the random testing rate. In short, this commenter did not favor changes to the old single-industry-specific forms.

DOT Response: The Department believes that the testing panorama has changed considerably since the inception of the DOT testing program. Other program forms, such as the Breath Alcohol Testing Form and the Federal Drug Testing Custody and Control Form, have changed to reflect program changes. We believe it is important that the MIS form transform accordingly. At one time the Department did not envision that specific reasons for refusals would become important enough to track. However, a troubling industry has risen whose primary goal is to “beat the drug test.” Adulterated and substituted test results have increased considerably: when we speak of refusals, no longer are we simply talking about employees failing to appear for tests. Times change and this refusal delineation is now important for the Department, the DOT agencies, and employers to have.

As proposed in the NPRM, we have determined that refusals to test should count as a test result—one that goes toward satisfaction of a company's random testing rate. However, we do not believe that cancelled tests should count toward satisfaction of the rate. We continue to support part 40's contention that a cancelled test does not count toward compliance with DOT's testing requirements.

Again, we believe a single MIS format is the most appropriate approach. We believe that the many items we no longer desire to capture on the form more than offset the few new collection requirements for refusals and cancellations.

Comment: Two commenters believed the collection of data on separate sheets for each employee category would present too much work for those charged with completing the form. One commenter supported the one-page concept while recognizing that some companies may have to enter data on additional sheets.

DOT Response: The Department gave a lot of thought to this issue, but did not see a valid way around separate pages for different employee categories, at least in the short term. Again, it is important to note that the Department views the use of this standard format, one-page MIS form to be a logical first step in providing an automated system for future MIS data entry. A “must” for the automated system will be the ability of the employer to view entry options only for eligible categories of employees. For instance, an employer entering MIS data online for the FTA will see only employee categories corresponding to the FTA rules. For an employer entering MIS data for the FAA, only those FAA employee categories will appear.

Interestingly, even if an employer has multiple employee categories, the amount of information collected equates to far less than if the employer used the old forms. There is no more actual work involved in entering the employee testing data even if using separate sheets. In fact, our test runs of the form ( e.g. , to obtain industry estimates on the amount of time to fully complete the form) with companies having multiple employee categories were met with positive feedback. From those estimates, we concluded that completion of the form—even with multiple sheets—will take between 45 minutes and 1.5 hours. For the old MIS forms, estimates showed that the “EZ” forms took between 30 minutes and 1 hour to complete; and the long forms took 2.5 hours each (alcohol and drug) to complete. Again, we hold that the time savings is substantial using the new form rather than the multitude of old forms.

Comment: Two commenters asked us to clarify MIS requirements for companies reporting MIS data to more than one DOT agency—companies that, for instance, may have full-time drivers and full-time pipeline workers. In addition, they asked us to resolve confusion over how to record testing data for employees who perform duties that are regulated by more than one DOT agency—for example, a company's employees drive trucks sometimes and perform safety-sensitive railroad duties at other times.

DOT response: In its first paragraph, the NPRM's MIS instruction form provided guidance for companies regulated by more than one DOT agency. It said, “If you are preparing reports for more than one DOT Operating Administration (OA), then you must submit OA-specific forms.” We have maintained that text requirement intact. Therefore, if a company has drivers and pipeline workers covered under FMCSA and RSPA regulations respectively, and the company is asked by FMCSA and by RSPA to submit MIS data, the company should send an MIS report on its drivers to the FMCSA and an MIS report on its pipeline workers to RSPA.

The second scenario the commenters brought up, how to record MIS data for employees who perform cross-modal safety sensitive duties where an employee performs duties regulated by two or more DOT agencies ( e.g. , the employee is a truck driver and a pipeline maintenance worker), is more complex. For a number of years, DOT agency rules have stipulated that a covered employee, subject to testing under more than one DOT agency rule for the same employer, would be subject to random testing at the percentage rate established for the calendar year by the DOT agency regulating more than 50 percent of the employee's safety-sensitive duties.

Further complicating the issue becomes the fact that some DOT agencies ( i.e. , RSPA and USCG) do not authorize random alcohol testing for employees. So while an employee who drives a truck and performs pipeline maintenance for a company may carry out more than 50% of his or her duties under RSPA rules and be in a RSPA random pool for drug testing, that employee must still be in an FMCSA pool for random alcohol testing. Or, the company can choose to place all these employees in the same random drug testing pool if they test at or above the highest random rates established by the DOT agency under whose jurisdiction they fall.

The Department is settling the issue by stating that for purposes of the MIS form, employees covered under more than one DOT agency rule need only be reported on the MIS form for the DOT agency under which they are randomly tested.

For example, an employee conducting 51% of her safety-sensitive work under FMCSA rules will be randomly tested under those rules rather than under the rules of another DOT agency under which she performs the other 49% of her DOT safety sensitive duties. For MIS purposes, therefore, she will be counted and her tests reported only under the MIS submission to the FMCSA. If 49% of her duties are under FTA, for instance, she will not appear on the FTA MIS submission even though she would continue to be eligible for testing under the FTA rule for post accident and reasonable suspicion, and perhaps for return-to-duty and follow-up testing. Employers may have to explain her testing data to FMCSA and FTA agency representatives during an inspection or audit.

The ODAPC and the DOT agencies have revised the MIS reporting requirements to standardize the collection of data for the agencies. The proposed rulemaking will impose a few new requirements for data collection; specifically, data related to information associated with the revised (65 FR 122, June 23, 2000) Federal Drug Testing Custody and Control Form. However, the overall amount of required data is less than that required currently. The Department has also placed the MIS form and instructions for completing it into part 40. The forms and instructions will be removed from all DOT agency regulations.

As stated earlier, many data elements are no longer part of the MIS form. DOT agencies have decided that some information items required on previous MIS forms are available in other formats or are items obtainable during inspections, reviews and audits. The following represents a listing for each DOT agency of most of the data elements we are eliminating from reporting on the MIS form:

5. Employee initial drug training data.

6. Supervisor initial drug training data.

7. Supervisor recurrent drug training data.

8. Number of persons denied a position for an alcohol test 0.04 or greater.

9. Number of employees returned to duty after engaging in alcohol misuse.

10. Actions taken for alcohol regulation violations.

11. Number of employees having both a positive drug test and an alcohol test of 0.04 or greater when both tests were administered at the same time.

12. Number of other violations of the alcohol regulation.

13. Actions taken for refusals to take an alcohol test.

14. Supervisor alcohol training data.

1. Number of persons denied a position for alcohol results 0.04 or greater.

2. Number of accidents (noted as fatal and non-fatal) with alcohol results 0.04 or greater.

3. Number of fatalities from accidents resulting in alcohol results 0.04 or greater.

4. Number of employees returned to duty following an alcohol violation.

5. Number of employees having both a positive drug test and an alcohol test of 0.04 or greater when both tests were administered at the same time.

6. Actions taken for other alcohol rule violations.

7. Supervisor alcohol training data.

8. Number of persons denied a position for positive drug test results.

9. Number of accidents (noted as fatal and non-fatal) with positive drug test results.

10. Number of fatalities from accidents resulting in positive drug tests results.

11. Number of persons returned to duty following a positive drug test or refusal result.

12. Employee drug education data.

13. Supervisor drug training data.

14. Funding source information.

1. Number of applicants/transfers denied employment/transfer for a positive drug test.

2. Number of employees returned to duty after having failed or refused a drug test.

3. Detailed breakouts of for-cause drug and alcohol testing.

4. Non-qualifying accident drug testing data.

5. Supervisor drug training data.

6. Number of applicants/transfers denied employment/transfer for alcohol results 0.04 or greater.

7. Number of employees returned to duty after engaging in alcohol misuse.

8. Supervisor alcohol training data.

1. Number of persons denied a position for a positive drug test.

2. Number of employees returned to duty following a drug violation.

3. Employee drug and alcohol training data.

4. Supervisor drug and alcohol training data.

5. Post-accident alcohol testing data.

6. Reasonable cause alcohol testing data.

1. Number of employees returned to duty after engaging in alcohol misuse.

2. Actions taken for alcohol test results equal to or greater than 0.04.

3. Number of other alcohol rule violations and actions taken for them.

4. Actions taken for alcohol test refusals.

5. Supervisor initial alcohol training data.

6. Number of persons denied a position following a positive drug test.

7. Number of employees returned to duty following a positive or refusal drug test.

8. Actions taken for positive drug tests.

9. Actions taken for drug test refusals.

10. Supervisor initial drug training data.

The Department will also count collections differently than under the old MIS regimen. Under the old MIS counting method a drug collection was considered to be a testing event that resulted in a negative, positive, or cancellation. Refusals to test—no matter the reason for the refusal—were not considered appropriate for inclusion. Despite the instruction to include no refusals, we know that many companies included those that were the result of adulterated or substituted results that were verified by the MRO as refusals. Still other companies counted these types of refusals as well as refusal events for which no urine was sent to laboratories for testing ( e.g. , employee failed to show-up at the collection site; employee left the collection site before urine had been collected).

Similarly, in determining if companies were conducting random testing at the appropriate established annual rates, some DOT agencies did not count refusals; some counted all refusals; and still others counted only refusals reported by the MRO (as a result of adulteration or substitution) toward satisfaction of the random testing rate requirement. Furthermore, in calculating the annual random rates for testing, all DOT agency rules said the following will be factored for the positive rate: number of random positives plus number of random refusals divided by the number of random tests plus the number of random refusals. This means that some cancelled random tests and random refusals were already in the random test numbers before the number of random refusals had been added to the total.

To clear up these discrepancies, the Department will count the number of specimens collected as the number of testing events resulting in negative, positive, and refusal to test results no matter the reason for the refusal. We have added all refusals to the number of tests because DOT agencies factor refusals into determining whether or not employers have met annual random testing rate requirements. We will not add cancelled test results to the mix because part 40.207(b) says, “. . . a cancelled test does not count toward compliance with DOT requirements ( e.g. , being applied toward the number of tests needed to meet the employer's minimum random testing rate).”

Invalid test results are always cancelled and will not be included. However, those invalid results requiring a subsequent directly observed collection will simply be considered another collection that will have a final result. In addition, blind testing will not be counted as a testing event. Counting in this manner will enable many of the columns and rows of the MIS form to total up.

In addition, annual random testing rates will be determined using more accurate counts because no cancelled test will be mistakenly included and no refusals will be factored twice in the total. DOT agency inspectors, reviewers, and auditors will count all refusals ( e.g. , be they from an adulterated specimen result or from “shy bladder” evaluation with no medical condition) as satisfying a company's meeting its random testing rate.

For cancellations requiring the employee to take a second test, the test that is cancelled will not count. However, the result of the subsequent recollection will count, provided that it too is not cancelled. These situations include: invalid test cancellations requiring the employee to go in for an observed collection; split specimen cancellations requiring the employee to go in for an observed collection; and cancellations requiring the employee to go in for another collection because a negative result is needed (for pre-employment; return to duty; and follow-up testing).

In addition, if more than one set of specimens is sent to the lab during one testing event, they will count together as one collection: These include: negative-dilute specimens when the employee goes in for a second collection per employee policy [the result of the second test is the result of record]; and observed collections requiring both the original collection and the observed collection be sent to the laboratory ( e.g. , specimen out of temperature range) [the result requiring the most stringent consequence will ultimately be the result of record].

The Department is also clarifying and making uniform among DOT agencies how employers determine the total number of employees against which the annual random rate applies. Some DOT agencies have told employers to count the number of covered employees working at the start of the calendar year; some DOT agencies have directed employers to count the total number of covered employees that worked for the company within the year; and still others have advised employers to count the average number of employees on a monthly or quarterly basis.

This rule directs employers to add the total number of covered employees eligible for random testing in each random testing selection period for the year and divide that total by the number of random testing periods. For instance, a company conducting random testing quarterly will add the total of safety-sensitive employees they had in the random pool when each selection was made; then divide this number by 4 to obtain the yearly average number of covered employees. [As an example, if Company A had 1500 employees in the first quarter random pool, 2250 in the second quarter, 2750 in the third quarter; and 1500 in the fourth quarter; 1500 + 2250 + 2750 + 1500 = 8000; 8000 / 4 = 2000; the total number of employees subject to testing for the year would be reported as “2000”. (Note: This number, “2000”, would also be the number on which an employer would base the random testing rate.)]

As stated earlier, no company will be required to factor the average number of employees more often than once per month: No more than 12 times per year.

Companies (and their contractors, as applicable) will continue to submit the MIS reports in accordance with requirements ( e.g. , dates for submission; selection of companies required to submit, etc.) that will continue to be in each DOT agency regulation. Likewise, DOT agency regulations will continue to address the manner ( e.g. , mail; CD; electronic transmission) and locations for submitting the forms. Responding to a commenter, we have added a reference to this in rule text.

It is important to note that MIS alcohol testing data reflects all these proposals made for MIS drug testing data. Refusals will count as testing events; cancelled tests will not; and random pool averages will determine the number of employees against which the annual testing rate applies.

The Department is currently working toward an electronic MIS form capable of Internet submission. Each form would be DOT agency specific and would not have extraneous items showing (for example, the USCG-specific form would not include an alcohol testing section; the RSPA-specific form would not show an alcohol random testing category). Additionally, the system would bring to the attention of the person completing the form any items that did not accurately compute mathematically. Finally, employee categories listed would only be those for the specific DOT agency.

The Department recognizes that Consortia/Third Party Administrators (C/TPAs) are responsible for administering a large number of transportation industry drug and alcohol testing programs. For this reason, the MIS form will contain a space for the employer to note the name of the C/TPA the company uses, if any. Finally, we have made some of the minor, but useful changes recommended by several commenters and DOT agency representatives. These include typographical, counting, and example errors; and the option to use zeros instead of leaving testing data items blank.

Finally, the Department wants reasonable suspicion and reasonable cause testing to be counted together on the MIS form with no differentiation between the two. The issue of how to count these two types of tests has been complicated by the fact that neither the CCF nor the BATF distinguish between the two even though the DOT agencies do. For instance, FMCSA and FTA authorize reasonable suspicion drug testing; FAA, RSPA, and USCG authorize reasonable cause drug testing; and FRA authorizes both. FMCSA, FAA, FTA, and RSPA authorize reasonable suspicion alcohol testing; and FRA authorizes both reasonable suspicion and reasonable cause alcohol testing. Sufficient documentation should exist with employers for DOT agency representatives to tell the difference between the two during inspections and audits.

This rule is not a significant rule for purposes of Executive Order 12866 or the DOT's regulatory policies and procedures. Nor is the rule an economically significant regulation. It is a reworking of existing requirements; it imposes no new mandates; and it will not create any new costs. In fact, the rule will serve to reduce requirements and costs. The Department realizes that some companies maintain their current MIS data items on basic computer spreadsheets. However, we are requiring only a minimal number of additions to the format while removing a larger number of items.

This final rule does not have sufficient Federalism impact to warrant a Federalism assessment under Executive Order 13132. With respect to the Regulatory Flexibility Act, the certifies that, if adopted, this rule would not have a significant economic impact on a substantial number of small entities, so a Regulatory Flexibility analysis has not been prepared. Even though this rule might affect a large number of small entities, we do not expect the new MIS requirements to have a significant economic impact on anyone.

The rule also contains information collection requirements. As required by the Paperwork Reduction Act of 1995, (the PRA, 44 U.S.C. 3507(d)), the Department is submitting these requirements to the Office of Information and Regulatory Affairs of the Office of Management and Budget (OMB) for review, as required under the PRA. For informational purposes, the Department will place its entire PRA package for the MIS form on the Internet when that submission is approved.

As noted elsewhere in this preamble, the proposal would amend part 40 to include a new format and a new set of instructions for the MIS form. This single form would be used across DOT agencies rather than the multiple forms with multiple instructions currently in use. The form's data elements would be reduced significantly as well.

Completing an MIS report requires a company to collect and compile drug and alcohol testing data generated throughout the year by that company's drug and alcohol testing program and placing some of that data onto the form. Certainly, the more complex a company's testing program set-up, the more complex assembling needed data becomes. Companies having decentralized program locations may have to draw information from a variety of localized programs. Companies with a number of subsidiaries may have large amounts of data to compile and authenticate. In addition, companies failing to regularly update and bring together their testing data may find themselves in positions of having to do so in a hurried manner at the end of the year. Also, companies lacking computerization of data capabilities may have to rely on manual methods.

Because MIS reporting has been part of the DOT testing equation for several years, many companies have become experienced in and have applied sound business sense to putting the report together. Many companies update their drug and alcohol program data on a regular, throughout-the-year basis rather than doing so at the last minute. Most companies require their localized programs, subsidiaries, and contractors to regularly provide program updates rather than authenticate data at the end of the year. Many companies utilize computer databases rather than “pen-and-ink” data entries. Still other companies prefer to have data entry provided as part of their C/TPA's contracted services.

Whatever the case, the Department does not require any particular management approach to compiling program data: We simply require that the data be accurate; that it be in a system that has controlled access; that it be readily auditable; and that specific data be included in MIS reports when they are required or requested by DOT agencies. The Department would prefer that companies update their drug and alcohol program data throughout the year; require their divisions, subsidiaries, and contractors to report their data regularly to them; and computerize their data-entry methodologies. However, we do not mandate these actions even though we think they are all preferable to end-of-the-year company scrambles to complete MIS forms.

The Department believes that requiring less data entry on MIS forms and having only one form throughout the transportation industries will make data gathering and compilation simpler. For instance, no longer will employers need to provide employee and supervisor training data, violation consequence data, and non-Part 40 violation data (among other entries). Furthermore, the single-format MIS form replaces the “EZ” drug form, the “EZ” alcohol form, the long drug form, and the long alcohol form, the formats of which were different for each DOT agency. Therefore, employers subject to more than one DOT agency rule will not have to navigate their ways through multiple MIS formats.

These represent important steps in reducing the amount of time needed to compile data for MIS purposes—no matter how a company chooses to manage their drug and alcohol testing data. The Department believes the simplicity of the form will result in another significant time saving action for employers.

DOT agency MIS PRA submissions for the old MIS forms reveal that nearly 6,800 companies submit 13,541 MIS forms annually to DOT; and the time it takes to fill out the forms is 18,406 hours. Estimates for the new MIS form indicate that these companies will send 7,186 MIS reports to DOT and the time to complete them will be 10,779 hours. Therefore, we foresee over 7,500 hours saved per year in filling out the new MIS form as opposed to completing the old multiple MIS forms. [Based upon industry and DOT agency estimates, we have concluded that the new MIS report will take between 45 minutes and 1.5 hours to complete. We have chosen, for this paragraph and for our OMB PRA submission, to use the highest industry and DOT agency estimate —1.5 hours. We estimate that slightly over 300 companies report to more than one DOT agency.]

According to OMB's regulations implementing the PRA (5 CFR 1320.8(b)(2)(vi)), an agency may not conduct or sponsor, and a person need not respond to a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information will be published in the Federal Register after OMB approves it.

A number of other Executive Orders can affect rulemakings. These include Executive Orders 13084 (Consultation and Coordination with Indian Tribal Governments), 12988 (Civil Justice Reform), 12875 (Enhancing the Intergovernmental Partnership), 12630 (Governmental Actions and Interference with Constitutionally Protected Property Rights), 12898 (Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations), 13045 (Protection of Children from Environmental Health Risks and Safety Risks), and 12889 (Implementation of North American Free Trade Agreement). We have considered these Executive Orders in the context of this rule, and we believe that the rule does not directly affect matters that the Executive Orders cover.

We have prepared this rulemaking in accordance with the Presidential Directive on Plain Language.

By letter dated August 12, 1997, the American Automobile Manufacturers Association (AAMA) (which has since evolved into the Alliance of Automobile Manufacturers) petitioned us to amend Federal Motor Vehicle Safety Standard (FMVSS) No. 205, “Glazing Materials” (49 CFR 571.205), to incorporate the most recent update of the American National Standards Institute (ANSI) standard: American National Standard for Safety Glazing Materials for Glazing Motor Vehicles and Motor Vehicle Equipment Operating on Land Highways—ANSI/SAE Z26.1-1996 (“ANSI/SAE Z26.1-1996”). AAMA stated in its petition that incorporating ANSI/SAE Z26.1-1996 would improve safety, achieve international harmonization, streamline and clarify FMVSS No. 205, and eliminate wire glass as an approved safety glazing option. On January 2, 1998, we granted the AAMA's petition.

FMVSS No. 205 specifies performance requirements for the types of glazing that may be installed in motor vehicles. It also specifies the vehicle locations in which the various types of glazing may be installed. The standard incorporates by reference ANSI Standard Z26.1, “Safety Code for Safety Glazing Materials for Glazing Motor Vehicles Operating on Land Highways,” as amended through 1980 (“ANS Z26.1”). 1 The requirements in ANS Z26.1 are specified in terms of performance tests that the various types or “items” of glazing must pass. There are 21 “items” of glazing for which requirements are currently specified in FMVSS No. 205.

The Society of Automotive Engineers (SAE) Glazing Materials Standards Committee, acting under the sponsorship of ANSI, has revised the ANSI standard periodically. However, since the FMVSS cannot be changed except through rulemaking, revisions to the ANSI standard do not become part of FMVSS No. 205 unless we expressly identify and incorporate them through a rulemaking. SAE previously petitioned us to upgrade ANS Z26.1 with 1983 and 1990 revisions. However, we denied those petitions.

In addition to incorporating some of the revisions of the ANSI standard, we have occasionally updated FMVSS No. 205 directly by adding provisions similar or identical to those in various revisions of the ANSI standard.

On August 4, 1999, NHTSA published a NPRM (64 FR 42330) proposing to amend FMVSS No. 205 by incorporating by reference ANSI/SAE Z26.1-1996. In this notice, NHTSA discussed the benefits of incorporating ANSI/SAE Z26.1-1996, and proposed revisions to FMVSS No. 205.

NHTSA tentatively concluded that incorporating ANSI/SAE Z26.1-1996 would be beneficial for (1) improved safety, (2) harmonization with foreign glazing standards, and (3) streamlining and clarification.

ANSI Z26.1 requires a fracture test (Test No. 7) of a 305 mm (12 in.) square, flat sample of glazing. In contrast, ANSI/SAE Z26.1-1996 requires the use of a full-size production piece of vehicle window glass. Paragraph 5.7.2 of ANSI/SAE Z26.1-1996 states that the specimens of glazing selected for testing “'shall be of the most difficult part or pattern designation within the model number.” NHTSA stated that it interpreted this to mean the portion of glazing which we consider most likely to fail the test.

ANSI/SAE Z26.1-1996 also improves safety by eliminating wire glass as an approved glazing material. Wire glass is flat-rolled glass reinforced with wire mesh. Wire glass is known to shatter more readily at lower impact speeds and is more lacerative than laminated glass. Wire glass was used in past automotive applications. However, this practice has been discontinued and, to our knowledge, no company currently produces wire glass for vehicle use.

Incorporating ANSI/SAE Z26.1-1996 will improve harmonization between US, Canadian, and European glazing standards in the following ways:

• The test fixture for the impact, fracture and penetration resistance tests (Tests 6, 7, 8, 9, 10, 11, 12, 13, 14 and 26) is identical to the support frame required in Economic Commission for Europe (ECE) Regulation R43.

• The equipment used for the abrasion test (Tests 17 and 18) is similar to that used under ECE R43.

• The Weathering Test (Test 16) is similar to International Organization for Standardization (“ISO”) Standard 3917, which requires a xenon light source, instead of the carbon arc light source currently specified in FMVSS No. 205.

• The solvents specified in the chemical resistance test (Test 20) have been revised to conform to the requirements of the American Society for Testing and Materials (ASTM) and Occupant Safety and Health Administration (OSHA). These are the same solvents specified in ECE R43. This will also result in consistency with the NTTAA (National Technology Transfer Advancement Act), which requires use of voluntary consensus standards unless such use is infeasible or otherwise inconsistent with law.

• Canadian Motor Vehicle Safety Standard No. 205, “Glazing Materials,” already incorporates ANSI/SAE Z26.1-1996. Therefore, we would achieve closer harmonization of our Standard No. 205 and Canadian Standard No. 205.

The proposed incorporation by reference of ANSI/SAE Z26.1-1996 would permit the deletion of most of the existing text of FMVSS No. 205. The amendments of the past 20 years have resulted in a patchwork of requirements that must be read in conjunction with the ANSI Z26.1 in order to gain a comprehensive understanding of the overall requirements of FMVSS No. 205. Adoption of the proposal would simplify FMVSS No. 205, consistent with our regulatory reform efforts.

NHTSA discussed some proposed revisions to FMVSS No. 205, as described below.

First, NHTSA discussed the general nature of the textual changes to ANSI Z26.1. We stated that our substitution of the 1996 version for the 1980 version of the ANSI standard would not make many substantive changes to our standard since our current standard already contains many provisions of the 1996 version. They were directly added to our standard in various rulemaking proceedings between 1977 and 1996 to supplement the 1977 version of the ANSI standard. 2 Therefore, the practical effect of our incorporation by reference of the 1996 ANSI standard is that it would enable us to eliminate the provisions added to our standard between 1977 and 1996.

Second, NHTSA proposed to modify the application section of FMVSS No. 205 so that the standard explicitly applied to vehicles.

Third, NHTSA proposed that “the most difficult part or pattern” for the Fracture Test means that all portions of the glazing surface must be able to pass the test requirements. 3 We explained that we believe “the most difficult part or pattern” was intended to mean the part of the glazing that provides for “worst case” testing, not the type of difficulty contemplated or how we select the most difficult part or pattern in our compliance testing. Therefore, all portions of the glazing surface must be able to pass the test requirements. NHTSA proposed that this interpretation would be made explicit in the regulatory text of FMVSS No. 205.

Fourth, NHTSA tentatively concluded that a xenon arc light source produces a spectral power distribution closer to that of sunlight than the carbon arc lamp currently utilized in the weathering test procedures of ANSI Z26.1 and requested comment on this issue. 4 We said that carbon arc technology, which was developed in 1919 for textile and printing industries, is no longer the best light source for simulating sunlight because the spectral power distribution of carbon arc is unlike that of natural sunlight. 5 Further, we noted that most of the testing industry is currently using xenon-arc lamp test devices to simulate weathering.

Fifth, NHTSA proposed to modify FMVSS No. 205 to incorporate the June 1995 version of the Society of Automotive Engineers, Inc. (SAE), Recommended Practice J100, “Class ‘A’ Vehicle Glazing Shade Bands” (SAE J100) and requested comments on the appropriateness of that shade band standard or any alternative shade band standard that should be considered. NHTSA said that a visibility requirement needs to be set to establish boundaries for shade bands on glazed surfaces since we need to be able, for the purposes of compliance testing, to differentiate between those areas of a window that are intended to meet the 70 percent transmittance requirements and those areas that are not so intended. 6 Currently, neither FMVSS No. 205 nor the updated ANSI/SAE Z26.1-1996 set boundaries for the area of glazing that does not have to meet the 70 percent light transmittance requirement. SAE J100 sets limits for the shade band on the windshield, rear window and fixed side windows based upon the eyellipse of the 95th percentile male driver's eye positions in a vehicle. 7

Sixth, NHTSA proposed modifying S5(b)(8) of FMVSS No. 500, “Low-speed vehicles” (49 CFR 571.500), to eliminate the incorporation by reference of ANSI Z26.1 and any reference to the permitted types of glazing. 8 Instead, S5(b)(8) would simply state that low speed vehicles must have windshield glazing that meets the requirements of FMVSS No. 205.

NHTSA also proposed to revise the applicability paragraph of FMVSS No. 205 to add low speed vehicles to the list of vehicles to which the standard applies. This would assure that manufacturers of glazing materials in low speed vehicles certify compliance with FMVSS No. 205. In addition, we proposed adding a paragraph to the requirements specifying the use of AS-1 or AS-4 glazing in the windshields of low speed vehicles. This section is necessary because the descriptions of the locations of glazing specified by the ANSI standard would not otherwise allow AS-5 glazing.

Also, NHTSA proposed to correct a technical error in FMVSS No. 500. We replaced AS-5 glazing with AS-4 glazing as a permitted glazing type in low speed vehicles. AS-4 is equivalent glazing to AS-5 but contains a light transmittance requirement so that it can be used in windshields, since the windshield is a location considered requisite for driving visibility.

Finally, NHTSA requested comments on the need to verify DOT numbers based on the concern of SAE's Glazing Materials Standards Committee regarding the accuracy of our Glazing Manufacturer list. 9 SAE has contended that only 25 percent of the manufacturers listed with DOT numbers are currently active; some of the manufacturers have gone out of business without notifying us, and many other manufacturers have moved or merged.

NHTSA received eight comments on the August 1999 NPRM. Three glazing manufacturers, three vehicle manufacturers, one glazing manufacturers association, and one automotive standards organization submitted the eight comments. The comments are summarized below.

Several manufacturers stated that NHTSA had misinterpreted the meaning of “most difficult part or pattern” and that the fracture test could be interpreted to have many fracture points, instead of a single point 25 mm (1 in.) in-bound along the center of the longest edge.

Sekurit Saint-Gobain (Sekurit), a glazing manufacturer, suggested that NHTSA adopt ISO 3537. ISO 3537 has several fracture points [(point 1, 30 mm (1.2 in.) from the edge in one corner; point 2, 30 mm (1.2 in.) from the nearest edge; point 3 at the geometric center, and for curved materials, point 4 on the longest median at a point of maximum curvature)] and allows for fracture of the windshield.

SAE encouraged NHTSA to revise S5.1.2 to read as follows: “NHTSA may conduct the Fracture Test as specified in ANSI/SAE Z26.1-1996 Section 5.7 on any piece of glazing material that is required to comply with Section 5.7.”

Ford Motor Company (Ford) and SAE both commented that a xenon arc light source more closely simulates sunlight than does a carbon arc and that the xenon arc is a much-improved light source for the weathering tests. Ford also said that a xenon arc lamp would meet the requirement of ECE R43 stating that any source of radiation which produces the same effect as a mercury vapor lamp may be used for the test procedure.

DaimlerChrysler (DC) and SAE supported the adoption of SAE J100 to identify areas of glazing not requisite for driving visibility. DC also urged the agency to clarify the definition of shade band to mean any obscuration band on a glazing because of the variations in band application to laminated safety glass (dye or pigment added to interlayer material prior to application) and tempered safety glass (pattern of lines and dots printed onto the glass surface).

Toyota Motor Corporation (Toyota) and the Flat Glass Manufacturers Association of Japan (FGMAJ), however, suggested incorporating “area B,” specified in ECE R43 92/22EC to establish boundaries for the shade band instead of incorporating SAE J100 because it would harmonize FMVSS No. 205 with the requirements adopted in Europe and Japan and because application of the “area B” requirement of ECE R43 is current practice for Toyota. More specifically, Toyota stated that FMVSS No. 205 should “prescribe that the area of the windshield other than the ‘area B’ may be tinted” and FGMAJ stated that the “[d]etermination of the top boundary of windshield for driving visibility should be the upper edge of Zone B, which is drawn in accordance with V1 prescribed in ECE R43.”

Additionally, on the issue of whether shade band requirements should be applied to side and rear windows, FGMAJ stated, “[t]his non-requirement provision for driving visibility should be limited to the windshield, which would harmonize with the international standard.”

Pilkington Libbey Owens Ford (LOF), and Glassig Inc. (Glassig), both glazing manufacturers, commented that DOT numbers should be kept current and suggested notification to the agency or re-certification every five years so that separate active and non-active manufacturer lists can be prepared. SAE suggested that NHTSA avoid reassigning DOT numbers and also supported the use of separate active and non-active manufacturer lists. Sekurit said that the confusion that results from the reassigning of DOT numbers could be avoided if glass manufacturers were required to apply their trade names to their products. FGMAJ suggested that a manufacturer who simply cuts sections of glazing for use in a motor vehicle application obtain a separate DOT code number from that of the prime glazing manufacturer who produces the glazing. Additionally, FGMAJ suggested that the definition of “prime glazing manufacturer” should specify the inclusion of aftermarket manufacturers.

DC and SAE encouraged NHTSA not to delete paragraph S5.1.1.6 of FMVSS No. 205, which states that glazing intended for use in multipurpose passenger vehicles (MPVs) is treated identically to glazing used in trucks. ANSI/SAE Z26.1-1996 expressly prohibits the use of deep tinted windows adjacent to the driver in trucks but is silent with regard to tinting in MPVs.

The SAE recommended that NHTSA eliminate paragraph S5.2 of FMVSS No. 205 because it incorporates by reference the edge treatment requirements (SAE Recommended Practice J673, “Automotive Safety Glasses”) that are already incorporated by reference in ANSI/SAE Z26.1-1996. 10

Toyota suggested that FMVSS No. 205 specify that the cleaning instruction label currently required for Items 12, 13, 16A and 16B not be required for these items of glazing because these items of glazing are not required to meet the 70% light transmittance requirement (Test 2 of the ANSI standard). The NPRM proposed deleting S5.1.2.2 and S5.1.2.10, which contains cleaning instruction label requirements from FMVSS No. 205. Since ANSI/SAE Z26.1-1996 contains the cleaning instruction label requirements for the aforementioned Items, FMVSS No. 205 would incorporate them by reference.

Sekurit expressed the view that additional tests, not included in ANSI/SAE Z26.1-1996, could have been added to FMVSS No. 205. These tests include a head-impact test for windshields (ISO 3537), a requirement for testing of optical properties of a windshield according to ISO 3538, and a mechanical strength test using a 227 g (0.5 lb.) ball at high and low temperatures. According to Sekurit, ISO 3538 takes windscreen design, rake angle, and field of vision into account while ANSI/SAE Z26.1-1996 tests optical properties by an obsolete method that does not take into account the current design of windshields. Additionally, Sekurit argued that a mechanical strength test using a 227 g (0.5 lb.) ball would more closely proximate real-life conditions than the strength test in ANSI.

In response to the comments, the agency is modifying the approach it proposed in the NPRM. The major deviations from the proposal are summarized below.

• The fracture test of ANSI/SAE Z26.1-1996 is clarified to indicate that any piece of glazing subject to the fracture test may be tested, and that the test procedure is a single fracture origin or break point 25 mm (1 in.) inboard at the edge of the midpoint of the longest edge of the specimen as specified in ANSI/SAE Z26.1-1996.

• Shade band areas are required to conform with the SAE J100 recommended practice. However, a substitution of the ECE R43 procedure “up angle” of 7 degrees, instead of the SAE procedure “up angle” of 5 degrees, will be used to determine the upper limit of the area for driving visibility.

Currently, Fracture Test No. 7 specifies dropping a 227 g (0.5 lb) ball onto 305 mm × 305 mm (12 in. × 12 in.) laboratory samples of glazing. The drop height starts at ten feet and increases until the samples break. To pass the test, the largest fractured particle must weigh 4.3 g (0.15 oz.) or less.

The proposed fracture test in S5.7.2 specified six production parts representing each construction type model number. Fracture Test No. 7 stated, “[T]he number of specimens selected from each model number of glazing shall be six (6) and shall all be of the most difficult part or pattern (emphasis added) designation within the model number.” The fracture origin or break point is 25 mm (1 in.) inboard of the edge at the midpoint of the longest edge of the specimen. If the specimen has two long edges of equal length, the edge nearer the manufacturer's trademark is chosen. To obtain fracture, a spring loaded center punch or a hammer of about 75 g (2.65 oz.), each with a point having a radius of curvature of 0.2 mm ± 0.05 mm (0.0008 in. ± 0.002 in.), is used. To pass the test, the largest fractured particle must weigh 4.3g (0.15 oz.) or less.

In the NPRM, NHTSA stated “we believe that the phrase “most difficult part or pattern” was intended to mean the part of the glazing that provides for ‘worst-case’ testing.” After consideration of the comments, NHTSA now agrees that this interpretation of the phrase was not the intent of the authors of ANSI/SAE Z26.1-1996. In the context of ANSI/SAE Z26.1-1996, as clarified by SAE in its comment to the NPRM, the “most difficult part or pattern” refers to the most difficult application or component with respect to the fracture performance for a given glazing model number. In other words, ANSI/SAE Z26.1 calls for fracture testing on the “worst-case” use, rather than on the worst case target area. It does not refer to the fracture location on a given piece of glazing, nor does it refer to the part of the glazing that provides for “worst-case” testing.

For the purposes of FMVSS No. 205, the phrase “the most difficult part or pattern” means the worst-case component with respect to fracture performance, not the worst-case test location on that component. The worst-case component could be picked from the grouping of such articles that are described by a common manufacturer's model number. For instance, using the example cited by SAE in its comments to the NPRM, 11 if a manufacturer produces side and rear windows with the same model number and the rear window performs worse in the fracture performance test, then the rear window must pass the fracture performance test. The difficulty referred to is in regard to meeting the particle weight requirement of the fracture test.

Sekurit suggested requiring multiple fracture points and other manufacturers have objected to conducting fracture testing on production parts with a single fracture origin or breakpoint 25 mm (1 in.) inboard at the edge of the midpoint of the longest edge of the specimen. They stated that the fracture test could be interpreted to have many fracture points. These manufacturers, however, have not demonstrated a safety need to deviate from the testing specified in ANSI/SAE Z26.1-1996. For this reason, NHSTA believes that the test procedures need not be revised at this time. However, as suggested by Sekurit, NHTSA will continue to explore the desirability of extending the test procedures to multiple break points in the future, through participation in the UN/ECE Working Party 29's Working Party on General Safety Provisions (GRSG).

In retaining the “most difficult part or pattern” requirement, NHTSA agrees with the SAE and has decided to clarify that any piece of glazing subject to the fracture test may be tested, and that the test procedure will be a single fracture origin or break point 25 mm (1 in.) inboard at the edge of the midpoint of the longest edge of the specimen as specified in ANSI/SAE Z26.1-1996.

As noted above, Ford and SAE concurred with the agency's tentative conclusion that a xenon arc produces a spectral power distribution closer to that of sunlight than carbon arc lamps and that it is an improved light source for the weathering tests. As in the NPRM, we also note that most of the testing industry is currently using xenon arc lamp test devices to simulate weathering. For these reasons, the agency has decided to adopt the use of the xenon arc lamp test device for the weathering tests as specified in ANSI/SAE Z26.1-1996.

In response to comments by DaimlerChrysler, Toyota, and FGMAJ, NHTSA commissioned a study at General Test Laboratories (GTL) of current industry practices (SAE J100 and ECE R43) concerning shade band areas. 12

As a preliminary matter, NHTSA collected data for a series of five windshields from current production vehicles to evaluate the lower boundary of actual windshield shade bands in comparison to the SAE J100 recommendations. The vehicle manufacturers supplied full size templates for each windshield. On these templates, NHTSA engineers measured the difference between the AS-1 line and the boundary of the shade band zone defined in Section 4.1 of SAE J100 for forward glazing (J100 line). The boundary value for the upper limit of level of visibility in SAE J100 is defined as the intersection of the windshield's centerline with an inclined plane tangent to the upper edge of the 95th eyellipse. The AS-1 line marked on the upper edge of the windshield equipped with a shade band shows the current shade band practice by the manufacturer. 13 NHTSA's limited survey of vehicles found that the manufacturer-provided shade bands did not extend as far downward as permitted by SAE J100, and the distance between the lower boundary of the shade bands and the boundary limit recommended in SAE J100 ranged from 45 mm (1.8 in.) for the Chevrolet Camaro to about 191 mm (7.5 in.) for the Pontiac Grand Am (Table 1). Based on these measurements, all vehicles tested exceeded the recommendations set forth in SAE J100.

Next, NHTSA determined the extent to which the ECE R43 requirement (ECE R43 line) was exceeded. It then compared the extent to which the ECE R43 line was exceeded with the extent to which the J100 line was exceeded. These comparisons are shown in Table 1.

As demonstrated in Table 1, not all tested vehicles comply with ECE R43, and differing results occur for the SAE J100 procedure and the ECE R43 procedure. The SAE procedure uses an “up angle” of 5 degrees to determine the lower limit of the shade band area and the ECE R43 procedure uses an “up angle” of 7 degrees to determine the upper limit of the area for driving visibility. Other minor factors distinguish the SAE method from the ECE method, but these differences are due only to the method by which the point of origin for the 5 degree and 7 degree lines is established. 14

As stated in the NPRM, NHTSA believes that establishing a lower boundary for windshield shade bands is a necessary component of the amended glazing standard. Further, no negative comments were received on the proposal to institute a requirement for the lower boundary for a shade band on a windshield.

The net safety benefit from the slight differences in allowable shade band design between SAE J100 and ECE R43 is negligible. While the SAE procedure offers slightly greater glare protection, the ECE R43 procedure allows a greater daylight opening for visibility at luminous transmittance values of 70% or greater. NHTSA believes that the approaches set forth in both ECE R43 and SAE J100 represent reasonable approaches to determining the limits of a windshield shade band.

However, each procedure is dependent upon the location of a seating design point defined by the vehicle manufacturer. The ECE method relies upon the location of the European “R-point” whereas the SAE method relies upon the SAE seating reference point (SgRP). Due to the existence of only slight technical differences between the two methods and the use of SgRP in other FMVSS, NHTSA has decided to adopt the SAE J100 recommended practice. This adoption includes, however, a substitution of the ECE R43 procedure “up angle” of 7 degrees, instead of the SAE procedure “up angle” of 5 degrees, to determine the upper limit of the area for driving visibility.

Using the 7 degree “up angle” method for determining the location of the AS-1 line increases the total windshield visibility. Additionally, manufacturers that presently manufacture their shade bands in accordance with SAE J100 can continue using the same testing conditions and procedures defined in SAE J100, except for the “up angle.” However, due to the substantial similarity between the provisions of SAE J100 and ECE R43, except for the degree of the “up angle,” the agency anticipates the shade band boundary line under the new rule would more closely approximate the ECE R43 line due to the 7 degree “up angle” for most vehicles. Therefore, we believe manufacturers would be able to market vehicles with the same AS-1 line in both Europe and the United States.

Agency testing indicates that most manufacturers do not use all of the potential available windshield shade band area available under ECE R43 for shade band coverage. However, as demonstrated above in Table 1, not all tested vehicles complied with ECE R43 (one out of four did not comply). Therefore, a small percentage of current production vehicles may not comply with the new shade band requirement. However, as with the 2000 Chevrolet Camaro, the anticipated extent of failure for this small percentage of vehicles is slight. The agency believes that modifying the shade band location by 25 mm (1 inch) or less on most vehicles represents a reasonable undertaking that should not be costly for manufacturers and that can be accomplished within a short lead time. Based on the results of the agency's testing, manufacturers should have no difficulty adjusting shade bands to meet the new requirement.

With regard to shade band requirements for glazing areas other than the upper edge of the windshield, SAE J100 does not address driver visibility for the bottom edge of the windshield or for the side of the windshield. SAE J100 does include shade band requirements for fixed side and rear windows. While SAE J100 includes this requirement for side and rear windows, the majority of side and rear windows are tempered glass. Shade bands can only be applied to laminated glazing (by tinting the inner layer). Laminated glazing is required only for windshield applications. Therefore, shade bands rarely exist on fixed side and rear windows. Further, ECE R43 does not contain shade band requirements for side or rear windows. Because of the limited number of fixed side and rear windows containing shade bands and because of harmonization concerns, as commented by FGMAJ, the agency has decided to apply the provisions of SAE J100 exclusively to windshield applications. However, the light transmittance requirements for side and rear windows contained in FMVSS No. 205 and ANSI/SAE Z26.1-1996 will continue to apply to side and rear windows.

Comments concerning the certification and verification of DOT numbers suggest that NHTSA's DOT registry process should require additional certification and verification activities such as the re-certification of numbers every 5 years and the maintenance of active and non-active manufacturer lists. Commenters did not, however, provide evidence that the additional certification and verification activities would yield safety benefits. Further, the agency believes that additional certification and verification activities would require additional resources and manpower which would, in turn, adversely impact the agency's use of its resources to upgrade its safety standards. Due to the absence of apparent safety benefits and because additional registry and certification activities would detract resources from its safety mission, the agency is not amending the current DOT registry process at this time.

As stated above, FGMAJ suggested that a manufacturer who cuts glazing should be required to obtain a separate DOT code number from the one used by the prime glazing manufacturer who produces the glazing. NHTSA is unaware of any safety benefits associated with this suggestion. Additionally, this suggested action would create an additional resource burden for the agency. 15 Therefore, NHTSA is not adopting the suggested requirement. NHTSA, however, is aware of the need for clarification regarding certification responsibilities and is adopting the language proposed in the NPRM for S6 of FMVSS No. 205. This revised section provides a more straightforward and clearer statement of the certification and marking responsibilities of a manufacturer who fabricates, laminates, or tempers glazing material and distinguishes those responsibilities from those of a manufacturer who cuts a section of glazing material for subsequent use in a motor vehicle application. This text also makes clear that the requirement to affix a manufacturer's code mark to the glazing applies only to the prime glazing manufacturer  16 and not to a manufacturer or distributor who simply cuts a piece of glazing.

The proposed regulatory text in the NPRM included a definition of “prime glazing manufacturer” as “a manufacturer that fabricates, laminates, or tempers glazing materials.” FGMAJ commented that this definition should also include a reference to aftermarket manufacturers. The agency considers it unnecessary to add a reference to aftermarket manufacturers in the definition of “prime glazing manufacturer.” FMVSS No. 205 applies to all glazing for use in motor vehicles, whether it is supplied as original equipment in a vehicle or as an aftermarket product. Besides this suggestion by FGMAJ, the agency received no other comments concerning the definition of “prime glazing manufacturer.” Therefore, the agency has decided to adopt the definition of “prime glazing manufacturer” as proposed in the NPRM.

Today's rule retains S5.1.1.6 in the regulatory text of FMVSS 205. Paragraph S5.1.1.6 ensures that MPVs must meet the same glazing requirements as those required for trucks. NHTSA agrees with DC and SAE that the requirements for glazing to be used in trucks should be applied to glazing for use in MPVs. This approach of applying identical requirements to both trucks and MPVs is consistent with the treatment of trucks and MPVs in past interpretations (57 FR 2496; 63 FR 37820).

NHTSA agrees with SAE that the requirements of S5.2 of FMVSS No. 205 are redundant with the edge treatment provisions of Section 6 of ANSI/SAE Z26.1-1996, which requires that exposed edges in vehicles other than school buses shall be treated in accordance with SAE J673 (April 1993 version) and that exposed edges in school buses shall be banded. Section 6 of ANSI/SAE Z26.1-1996 is identical to the current requirements for edge treatment in FMVSS No. 205, except that FMVSS No. 205 incorporates by reference an outdated (1967) version of SAE J673. Due to the redundancy between FMVSS No. 205 and ANSI/SAE Z26.1-1996 concerning the requirements for edge treatment and because ANSI/SAE Z26.1-1996 contains a more recent version of SAE J673, the agency will delete S5.2 from FMVSS No. 205 and revise the regulatory text accordingly.

Toyota has requested that FMVSS No. 205 state that the cleaning instruction label requirement in ANSI/SAE Z26.1-1996 is not applicable to Items 12, 13, 16A and 16 B. With the deletion of S5.1.2.2 and S5.1.2.10, the cleaning instruction requirements for these items would be found in ANSI/SAE Z26.1-1996.

Toyota is correct that Items 12, 13, 16A and 16B are not required to meet the light transmittance test in ANSI/SAE Z26.1-1996. However, ANSI/SAE Z26.1-1996 does include tests, e.g. , the weathering test, which ensure that they maintain a luminous transmittance that closely approximates the transmittance found in their original manufactured state. This indicates to NHTSA that, while Items 12, 13, 16A and 16B need not meet the 70% light transmittance test, it is important for these items of glazing to maintain a luminous transmittance which is achieved, in part, by proper maintenance and cleaning indicated on the cleaning instruction label on the glazing. Additionally, ANSI/SAE Z26.1-1996 provides manufacturers with the option of placing cleaning instructions in the vehicle's owner's manual rather than on a label affixed to the glazing for Items 16A and 16B. The agency believes that the option of placing the cleaning instructions in the owner's manual rather than on a cleaning instruction label on the glazing partially alleviates Toyota's concern.

As discussed above, Sekurit suggested that the agency incorporate additional tests for head impact into windscreens, optical properties, and mechanical strength into FMVSS No. 205. Currently, the agency, through participation in GRSG meetings on the proposed Global Glazing Regulation, is evaluating the tests recommended by Sekurit. If NHTSA tentatively concludes that these tests would have a safety benefit, the agency may propose adoption of one or more of these tests in a future rulemaking.

The agency proposed a leadtime of 45 days. AP Technoglass, a glazing manufacturer, commented that the new requirements, including shade band, glass fracture test, and weathering test requirements, may affect glazing currently under production that does not conform to the new requirements. For instance, manufacturers may need to purchase new equipment to perform the weathering test with a xenon arc lamp. NHTSA agrees that these new requirements may take longer than 45 days to incorporate. In NHTSA's judgment, these changes can be accomplished within 180 days. Consequently, the changes to FMVSS No. 205 will become effective, and compliance will be required, 180 days following the publication of the final rule. However, manufacturers may voluntarily comply with this rule earlier.

In accordance with Executive Order 12866, we have rewritten or reorganized portions of the regulatory text for clarity and conformance to Plain Language practices. These include portions of the regulatory text that are not being substantively changed by this rule. For example, we have replaced passive verbs with active verbs, replaced “shall” with “must,” and made explicitly clear who has the responsibility for acting.

Rewriting is especially apparent in the certification and marking requirements of section 6. We eliminated the marking requirement of former S6.1 because it is already incorporated in section 7 of ANSI/SAE Z26.1-1996. We moved the definition of prime glazing manufacturer in S6.1 into the S4 definitions section. To eliminate redundancy, former S6.2 and S6.3 have been combined in S6.1, and former S6.4 and S6.5 have been combined in S6.3. We do not intend by this rule to make any substantive changes in S6.

This rulemaking action was not reviewed under Executive Order 12866. The rulemaking action is not significant under Department of Transportation regulatory policies and procedures. The effect of the rulemaking action is to clarify existing requirements. It will not impose any additional burden upon any person. Impacts of the final rule are, therefore, so minimal that preparation of a full regulatory evaluation is not warranted.

We have considered the impacts of this rulemaking action in relation to the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). I certify that this rulemaking action will not have a significant economic impact upon a substantial number of small entities.

The following is our statement providing the factual basis for the certification (5 U.S.C. 605(b)). The final rule affects manufacturers of motor vehicles and motor vehicle glazing. According to the size standards of the Small Business Association (at 13 CFR part 121.601), manufacturers of glazing are considered manufacturers of “Motor Vehicle Parts and Accessories” (SIC Code 3714). The size standard for SIC Code 3714 is 750 employees or fewer. The size standard for manufacturers of “Motor Vehicles and Passenger Car Bodies” (SIC Code 3711) is 1,000 employees or fewer. This Final Rule will not have any significant economic impact on a small business in these industries because it makes no significant substantive change to requirements currently specified in FMVSS No. 205. Small organizations and governmental jurisdictions that purchase glazing will not be significantly affected because this rulemaking will not cause price increases. Accordingly, we have not prepared a Regulatory Flexibility Analysis.

Executive Order 13132 requires us 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.” Under Executive Order 13132, we may not issue a regulation with Federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or unless we consult with State and local governments, or unless we consult with State and local officials early in the process of developing the proposed regulation. We also may not issue a regulation with Federalism implications and that preempts State law unless we consult with State and local officials early in the process of developing the proposed regulation.

This final rule will not have any 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. Thus, the requirements of Section 6 of the Executive Order do not apply to this rule.

This rule does not have any retroactive effect. According to 49 U.S.C. 30103, whenever a Federal motor vehicle safety standard is in effect, a state may not adopt or maintain a safety standard applicable to the same aspect of performance which is not identical to the Federal standard. 49 U.S.C. 30161 sets forth a procedure for judicial review of final rules establishing, amending, or revoking Federal motor vehicle safety standards. That section does not require submission of a petition for reconsideration or other administrative proceedings before parties may file suit in court.

Under the National Technology and Transfer and Advancement Act of 1995 (NTTAA) (Public Law 104-113), “all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments.” Certain technical standards developed by the American National Standards Institute (ANSI) and Society of Automotive Engineers (SAE) have been considered and incorporated by reference in the formulation of these requirements.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501, et. seq. ), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct, sponsor, or require through regulations. NHTSA has reviewed this proposal and determined that it does not contain collection of information requirements.

This rule does not impose a Federal mandate resulting in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. (2 U.S.C. 1531 et seq. ).

Motor vehicle crashes killed more than 42,000 individuals and injured 2.9 million others in six million crashes in 2001. In addition to the terrible personal toll, these crashes make a huge economic impact on our society with an estimated annual cost of $230.6 billion, or an average of $820 for every person living in the United States. One of the most important ways in which NHTSA carries out its safety mandate is to issue and enforce Federal Motor Vehicle Safety Standards (FMVSS). Through these rules, NHTSA strives to reduce the number of crashes and to minimize the consequences of those crashes that do occur. NHTSA's rulemaking activities, via the Rulemaking Program with support from the offices of Applied Research, Enforcement, Planning, Evaluation and Budget, Advanced Research and Analysis, and Chief Counsel, identify safety problem areas, develop countermeasures, and collect and analyze information to develop new FMVSS and amendments to existing FMVSS.

As we continue into the new century, NHTSA will strive to influence the automotive industry to incorporate the rapidly accelerating pace of advances in vehicle and safety technology into new vehicles while ensuring that the use of the new technologies enhances vehicle safety. The plan outlines the highlights of NHTSA's vehicle safety rulemaking plans through 2006. Agency priorities emanate from many sources, including: the size of the safety problem and likelihood of solutions, Executive initiatives, Congressional interest and mandates, petitions to the agency for rulemaking and other expressions of public interest, interest in harmonizing safety standards with those of other nations, and changes needed as a result of new vehicle technologies. The starting point for rulemaking priorities is the quest for the greatest potential protection of lives and prevention of injury.

The plan is organized along several broad categories: Crash Prevention includes crash avoidance data, driver distraction, vehicle visibility, crash warnings, and vehicle control and handling. Occupant Protection includes protection in frontal, side, rollover, and rear crashes. Other sections cover Incompatibility Between Passenger Cars and Light Trucks, Heavy Truck Safety, and Protecting Special Populations, including safety for children, people with disabilities, and older people.

The plan includes several potential rulemaking projects that require additional research to determine whether rulemaking action is needed, but are priorities based on their potential for significantly sizeable death and injury prevention benefits. The plan also contains an appendix that discusses some other regulatory activities that the agency considers important, although not rising to the same level of immediate high priority as the activities included in the main body of the plan. Another appendix discusses upcoming milestones in consumer information activities that the agency plans to pursue in the next few years, including the New Car Assessment Program (NCAP).

This document announces the availability of the document to the public. Received comments on the draft plan were evaluated and incorporated, as appropriate, into planned agency activities. Comments that could not be accommodated in the current plan will be considered in the context of future updates.

The plan will be posted on NHTSA's Web site on July 21, 2003. The agency intends to periodically update the plan.

You may also see the plan on the Internet by taking the following steps:

1. Go to the Docket Management System (DMS) Web page of the Department of Transportation ( http://dms.dot.gov ).

2. On that page, click on “search.”

3. On the next page ( http://dms.dot.gov/search/ ) type in the five-digit Docket number shown at the beginning of this document (NHTSA-2003-15505). Click on “search.”

4. On the next page, which contains Docket summary information for the Docket you selected, click on the desired document. You may also download the document.

The final rule implementing measures contained in Framework 38 to the FMP was published in the Federal Register on July 9, 2003 (68 FR 40810), and became effective on the date of publication. The North Latitude coordinate for Point GRF5 (44° 58.5′) in the table, GOM Grate Raised Footrope Trawl Whiting Fishery Exemption Area, contained in § 648.80(a)(16), is incorrect. The correct North Latitude coordinate for Point GRF5 is 43° 58.8′.

When the Council voted to include the ocean area adjacent to the original experimental fishery area because of its similarity to the area in which the experimental fishery took place, it incorrectly listed the GRF5 decimal point reference as 44.98 N. Latitude in the EA. This point reference should have been 43.98 N. Latitude, which converts to the geographic coordinates equivalent of 43 58.8'. While substitution of the correct geographic coordinates for Point GRF5 does not change the seaward boundaries of the fishing area, it removes the erroneous landward extension of the fishing area north from the shoreline.

Therefore, because the final rule published on July 9, 2003, which was the subject of FR Doc. 03-17106, contained an incorrect coordinate in the table contained in § 648.80(a)(16), on page 40810, in the third column, in the table contained in § 648.80(a)(16), second column under “N. Lat.”, the last coordinate, “44° 58.5′” is removed, and in its place “43° 58.8′” is added.

This document corrects the table under § 648.80(a)(16) as follows: