# National Registry of Certified Medical Examiners > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2012-9034 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** April 20, 2012 - **Citation:** 77 FR 24104 ## Text DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Parts 350, 383, 390, and 391 [Docket No. FMCSA-2008-0363] RIN 2126-AA97 National Registry of Certified Medical Examiners AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Final rule. SUMMARY: FMCSA establishes a National Registry of Certified Medical Examiners (National Registry) with requirements that all medical examiners who conduct physical examinations for interstate commercial motor vehicle (CMV) drivers meet the following criteria: Complete certain training concerning FMCSA's physical qualification standards, pass a test to verify an understanding of those standards, and maintain and demonstrate competence through periodic training and testing. Following establishment of the National Registry and a transition period, FMCSA will require that motor carriers and drivers use only those medical examiners on the Agency's National Registry and will only accept as valid medical examiner's certificates issued by medical examiners listed on the National Registry. FMCSA is developing the National Registry program to improve highway safety and driver health by requiring that medical examiners be trained and certified so they can determine effectively whether a CMV driver's medical fitness for duty meets FMCSA's standards. DATES: Effective on May 21, 2012. Compliance required beginning on May 21, 2014. FOR FURTHER INFORMATION CONTACT: Elaine Papp, Office of Carrier, Driver and Vehicle Safety Standards (MC-PSP), Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. Telephone (202) 366-4001. Email: FMCSAMedical@dot.gov. ADDRESSES: Availability of Rulemaking Documents: For access to docket FMCSA-2008-0363 to read background documents and comments received, go to http://www.regulations.gov at any time, or to U.S. Department of Transportation, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m. e.t., Monday through Friday, except Federal holidays. Privacy Act: Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement, published in the Federal Register on April 11, 2000 (65 FR 19476), or you may visit http://DocketInfo.dot.gov. SUPPLEMENTARY INFORMATION: This document is organized as follows: I. Table of Acronyms and Abbreviations II. Legal Basis for the Rulemaking III. Background IV. Discussion of Comments Received on the Proposed Rule V. Section-by-Section Explanation of Changes from the NPRM VI. Regulatory Analyses and Notices Table of Acronyms and Abbreviations Acronym or abbreviation Term AANP American Academy of Nurse Practitioners AAOHN American Association of Occupational Health Nurses AAPA American Academy of Physician Assistants ABA American Bus Association ACOEM American College of Occupational and Environmental Medicine ADA American Diabetes Association Advocates Advocates for Highway and Auto Safety AME Aviation Medical Examiner APN Advanced Practice Nurse ATA American Trucking Associations, Inc. BISC Bus Industry Safety Council CAA Clean Air Act CDL Commercial Driver's License CDLIS Commercial Driver's License Information System CME Continuing Medical Education CMV Commercial Motor Vehicle DC Doctor of Chiropractic DEP Diabetes Expert Panel DO Doctor of Osteopathy DOT U.S. Department of Transportation EA Environmental Assessment FHWA Federal Highway Administration FMCSA Federal Motor Carrier Safety Administration FMCSRs Federal Motor Carrier Safety Regulations HIPAA Health Insurance Portability and Accountability Act ISAREC Indiana Statewide Association of Rural Electric Cooperatives LTCCS Large Truck Crash Causation Study LFC Licencia Federal de Conductor MCMIS Motor Carrier Management Information System MCSAP Motor Carrier Safety Assistance Program MD Doctor of Medicine ME Medical Examiner MEP Medical Expert Panel Med. Cert./CDL Medical Certification Requirements as Part of the CDL MOU Memorandum of Understanding MRB (FMCSA's) Medical Review Board MRO Medical Review Officer NADME National Academy of DOT Medical Examiners NAFTA North American Free Trade Agreement NCCA National Commission of Certifying Agencies NPRM Notice of Proposed Rulemaking National Registry National Registry of Certified Medical Examiners NSTA National School Transportation Association NTSB National Transportation Safety Board OOIDA Owner-Operator Independent Drivers Association PA Physician Assistant PHI Protected Health Information PIA Privacy Impact Assessment PII Personally Identifiable Information PRA Paperwork Reduction Act RDS Role Delineation Study RIA Regulatory Impact Analysis SAFETEA-LU Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users SBA Small Business Administration SDLAs State Driver Licensing Agencies Wynne Wynne Transport Services, Inc. I. Summary of the Final Rule This rule establishes a training, testing, and registration program to certify medical professionals as qualified to conduct medical certification examinations of commercial drivers. Current regulations require all interstate commercial drivers (with certain limited exceptions) to be medically examined by a licensed health care provider to determine whether these drivers meet the FMCSA physical qualification requirements. All drivers must carry a medical examiner's certificate as proof that they have passed this physical qualification examination. The MEs who conduct said physical examinations must retain copies of the Medical Examination Reports of all drivers they examine and certify. The Medical Examination Report lists the specific results of the various medical tests used to determine whether a driver meets the physical qualification standards set forth in subpart E of part 391 of the FMCSRs. Before the adoption of this rule, there was no required training program for the medical professionals who conduct driver physical examinations, although the FMCSRs required MEs to be knowledgeable about the regulations (49 CFR 391.43(c)(1)). The former rules required that any medical professional licensed by his or her State to conduct physical examinations could conduct driver medical certification exams. No specific knowledge of the Agency's physical qualification standards was required or verified by testing. As a result, some of the medical professionals who conduct these examinations may be unfamiliar with FMCSA physical qualification standards and how to apply them. These professionals may also be unaware of the mental and physical rigors that accompany the occupation of CMV driver, and how various medical conditions (and the therapies used to treat them) can affect the ability of drivers to safely operate CMVs. This rule establishes the National Registry to ensure that all MEs who conduct driver medical certifications have been trained in FMCSA physical qualifications standards and guidelines. In order to be listed on the National Registry, MEs are required to attend an accredited training program and pass a certification test to assess their knowledge of the Agency's physical qualifications standards and guidelines and how to apply them to drivers. Upon passing this certification test, and meeting the other administrative requirements associated with the Program, MEs will be listed on the National Registry. Once this rule is fully implemented, only medical certificates issued to drivers by MEs on the National Registry will be considered valid by the Agency as proof of medical certification. II. Legal Basis for the Rulemaking The primary legal basis for the National Registry of Certified Medical Examiners program comes from 49 U.S.C. 31149, enacted by section 4116(a) of Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users, Public Law 109-59, 119 Stat. 1726 (Aug. 10, 2005) (SAFETEA-LU). Subsection (d) of section 31149 provides that: The Secretary, acting through the Federal Motor Carrier Safety Administration— • Shall establish and maintain a current national registry of medical examiners who are qualified to perform examinations and issue medical certificates; • Shall remove from the registry the name of any medical examiner that fails to meet or maintain the qualifications established by the Secretary for being listed in the registry or otherwise does not meet the requirements of this section or regulation issued under this section; • Shall accept as valid only medical certificates issued by persons on the national registry of medical examiners; and • May make participation of medical examiners in the national registry voluntary if such a change will enhance the safety of operators of commercial motor vehicles. In addition to implementing the provisions in subsection (d), which specifically directs the establishment of a national registry of qualified medical examiners, FMCSA implements through this rulemaking certain other provisions from section 31149 related to a national registry. First, subsection (c) requires FMCSA, with the advice of the Agency's Medical Review Board and Chief Medical Examiner (established by subsections (a) and (b), respectively), to develop, as appropriate, specific courses and materials for training required for medical examiners to be listed on a national registry. Medical examiners will be required to undergo initial and periodic training and testing in order to be listed on the national registry (section 31149(c)(1)(A)(ii) and (c)(1)(D)). Second, FMCSA also implements requirements for medical examiners to transmit electronically, on a monthly basis, certain information about completed Medical Examination Reports of CMV drivers (section 31149(c)(1)(E)). Third, the rule requires medical examiners to provide copies of Medical Examination Reports and medical examiner's certificates to FMCSA within 48 hours of a request from enforcement personnel. This level of responsiveness is required to enable FMCSA to investigate patterns of errors or improper certification by medical examiners, in accordance with 49 U.S.C. 31149(c)(2). Finally, the rule establishes the procedures and grounds for removal of medical examiners from the National Registry, as authorized by section 31149(c)(2) and (d)(2). SAFETEA-LU also revised the statutory minimum standards for the regulation of CMV safety to ensure that medical examinations of CMV drivers are “performed by medical examiners who have received training in physical and medical examination standards and, after the national registry maintained by the Department of Transportation * * * is established, are listed on such registry” (49 U.S.C. 31136(a)(3), as amended by section 4116(b) of SAFETEA-LU). The statute requires FMCSA, in developing its regulations, to consider both the effect of driver health on the safety of CMV operations and the effect of such operations on driver health (49 U.S.C. 31136(a)). In addition to the general rulemaking authority in 49 U.S.C. 31136(a), the Secretary of Transportation is specifically authorized by section 31149(e) to “issue such regulations as may be necessary to carry out this section.” Authority to establish and implement the National Registry program has been delegated to the Administrator of FMCSA (49 CFR 1.73(g)). III. Background On December 1, 2008, FMCSA published a notice of proposed rulemaking (NPRM) to establish the National Registry (73 FR 73129). The public comment period for the NPRM closed on January 30, 2009. The FMCSA also proposed to require that all medical examiners who conduct physical examinations for interstate CMV drivers complete certain training concerning FMCSA physical qualification standards, pass a test to verify an understanding of those standards, and maintain and demonstrate competence through periodic training and testing. Following establishment of the National Registry and a transition period, only medical examiner's certificates issued by medical examiners listed on the National Registry would be accepted as valid. IV. Discussion of Comments Received on the Proposed Rule A. Overview of Comments In response to the December 2008 NPRM, FMCSA received approximately 80 comments. Most of the commenters were individuals, many of whom identified themselves as health care professionals. Among other commenters were the following: nine health care provider professional associations, among them the American College of Occupational and Environmental Medicine (ACOEM) and the American Chiropractic Association; the American Diabetes Association; five trucking and other trade associations, including the American Trucking Associations, Inc. (ATA), Owner-Operator Independent Drivers Association (OOIDA), and jointly from American Bus Association (ABA) and Bus Industry Safety Council (BISC); six motor carriers; six other private businesses, including driver training and testing organizations; nine State agencies (from Arizona, California, Delaware, Florida, Illinois, Indiana, Iowa, Missouri, and Virginia); Advocates for Highway and Auto Safety (Advocates); and the National Transportation Safety Board (NTSB). Comments were also received from FMCSA's Medical Review Board (MRB), an advisory group of physicians appointed by FMCSA to make evidence-based recommendations for the development of physical qualification standards for drivers, driver examination requirements, and materials for training Medical Examiners (MEs). The MRB is convened by FMCSA to provide information, advice, and recommendations to the Secretary of Transportation and the FMCSA Administrator on the development and implementation of science-based physical qualification standards applicable to interstate CMV drivers. The MRB does not hold regulatory development responsibilities, manage programs, or make decisions affecting such programs. Fourteen commenters expressed support for the proposed rule. However, nearly all of those supporting the proposed rule added recommendations or voiced concern about various parts of the proposed requirements, including increased costs and training requirements for MEs, the implementation period, and the lack of a developed training curriculum. Seven commenters explicitly opposed the proposed rule. Other commenters expressed serious concerns over specific requirements that they believed would cause the proposed rule to fail, including increased costs, lack of access to MEs, and driver privacy rights if State Driver Licensing Agencies (SDLAs) are permitted to obtain the commercial driver's Medical Examination Reports. The following sections provide details regarding specific issues raised by the commenters. B. Scope of National Registry Program 1. Eligibility To Be a Medical Examiner Who should be eligible? Under 49 CFR 390.103, FMCSA proposed a requirement, based on the existing regulation at 49 CFR 390.5, that medical examiners must be licensed, certified, or registered in accordance with applicable State laws and regulations to perform physical examinations. The list of major health care professionals who may apply for ME certification included: Advanced Practice Nurses (APNs), Doctors of Chiropractic (DCs), Doctors of Medicine (MDs), Doctors of Osteopathy (DOs), Physician Assistants (PAs), or other health care professionals authorized by their States to perform physical examinations. Commenters asserted that only physicians (MDs and DOs), or only physicians, APNs, and PAs, or only health care providers who are permitted by their States to prescribe medications, should be eligible to be certified and be on the National Registry. Others argued that other health care professionals who are licensed by their States to perform physical examinations are qualified to perform the driver examinations and should be eligible. Several commenters thought that the proposed requirements would lead to a decrease in the quality of MEs. Arizona stated that with fewer doctors serving as MEs due to the time needed for training and testing, there would be an increase in the number of allied health and non-physician medical professionals completing examinations. On the other hand, Schneider National suggested that the National Registry requirements will deter only those medical professionals who today may be performing commercial driver medical examinations with little or no knowledge of the driver physical requirements of FMCSA. FMCSA Response: The final rule makes no change in the regulatory text. In a 1992 rule, the Federal Highway Administration (FHWA) (which was responsible for administering Federal motor carrier safety requirements until 1999) amended the FMCSRs to expand the definition of “medical examiner” to allow other health care professionals such as PAs, APNs, and DCs, in addition to MDs and DOs authorized previously, to perform examinations of CMV drivers (57 FR 33276; July 28, 1992). All medical examiners were required to be licensed, registered, or certified by their States to perform physical examinations, and to be proficient in the use of, and to use, medical protocols necessary to perform the examination in accordance with the FMCSRs. The 1992 rule acknowledged that should an ME discover a medical condition outside his or her scope of practice, best practice would be to refer the driver to an MD, DO, or specialist. The FHWA indicated this was consistent with what other medical practitioners do in “this age of specialization.” States determine who is legally qualified to perform physical examinations within their jurisdictions by setting scope of practice requirements, and FMCSA will continue to rely on State determinations. Qualification by Other Criteria. FMCSA proposed that medical examiner candidates be required to complete training that meets the core curriculum specifications established by FMCSA for medical examiner training and pass an FMCSA-provided certification test. Both the core curriculum specifications and the FMCSA-provided certification test will be based on FMCSA regulations and guidelines. Several commenters proposed the substitution of other types of training for the training requirements proposed in the NPRM. Two MDs, and the States of Arizona and Delaware, suggested that Federal Aviation Administration (FAA) aviation medical examiners (AMEs) could be certified, without further training or testing as FMCSA MEs. One physician recommended that we accept MD and DO board certification. The American Association of Occupational Health Nurses (AAOHN) suggested similarly that we should reduce required training for APNs and physicians who are experienced and professionally trained in occupational health. National Registry Training Systems, an independent entity not affiliated with FMCSA, and a clinician suggested that we should certify health care professionals who participated as subject matter experts in the development of the National Registry program training and testing components. Similarly, a MD suggested that we permit health care professionals to by-pass training if they have a working knowledge of the DOT requirements and guidance. FMCSA Response: The FMCSA acknowledges the specialized knowledge and expertise that some health care professionals bring to the driver qualification process. Physicians can and do serve as both MEs for CMV drivers and designated AMEs for pilots. However, the National Registry program has been developed with strategic differences from the FAA AME designee program, as detailed in the regulatory evaluation for this rulemaking, to be suitable for the oversight of large numbers of MEs performing examinations for large numbers of drivers, using medical standards and guidelines developed specifically for CMV drivers. The final rule will require all ME candidates to undergo the initial training and the certification testing that objectively measures candidate qualification and ensures that all MEs have the same level of working knowledge of the FMCSA regulations and guidelines. Due to the specialized nature of CMV driving, FMCSA retains the requirement that MEs must take training and pass its certification test to give driver exams. Only the specified training will provide pertinent knowledge of the FMCSA regulations and guidelines. Limitations on Performance of Driver Examinations. FMCSA did not propose any change in the regulations and guidelines for performance of the driver qualification physicals. The MRB's members submitted comments that reiterated the Board's recommendation that only physicians should perform examinations on drivers who have more severe or multiple medical conditions. ADA commented specifically on drivers with diabetes. Claiming that not all MEs would have the requisite clinical knowledge to complete the examination, ADA urged FMCSA to include physicians who treat individuals with diabetes, including endocrinologists, in the process of certifying drivers with diabetes. The commenter said that a physician or endocrinologist should examine drivers with that condition before such drivers are rejected. ADA also referenced the recommendations of FMCSA's Medical Expert Panel (MEP) on Diabetes, Expert Panel Commentary and Recommendations, Diabetes and Commercial Motor Vehicle Driver Safety, September 8, 2006, available at http://www.fmcsa.dot.gov/rules-regulations/topics/mep/mep-reports.htm and recommended that no denial of certification could be made for any reason related to diabetes without the review and approval of an endocrinologist. OOIDA, the American Academy of Nurse Practitioners (AANP), and the American Academy of Physician Assistants (AAPA) claimed that we should reject the recommendation to only allow physicians as MEs for drivers who have multiple active medical problems, claiming that this requirement would require most drivers to be examined by MEs who are physicians and would contribute to a shortage of qualified MEs. Both OOIDA and AAPA stated that this requirement would negatively affect a significant portion of the CMV driver population. OOIDA said that a large percentage of drivers would have to travel greater distances for medical exams. AAPA noted the results of a survey of 1,167 drivers across the United States, which found 32 percent of drivers with hypertension and 14 percent with diabetes. AAPA said that the proposed requirement could mean a driver who discovers an additional condition during an exam with an ME, who is not a physician, would have to stop that examination and reschedule with a physician. AANP and AAPA argued that practitioners in their respective professions are well-qualified to perform examinations on drivers with multiple active medical problems. AANP noted that its members have been performing driver examinations since 1992 without incident. AAPA similarly claimed that PAs have regularly been performing examinations on this class of drivers for 17 years and have specifically received authorization to do so in the FMCSRs. This commenter also noted that State laws and regulations do not preclude PAs from treating patients with diabetes or multiple medical conditions. AAPA stated that SAFETEA-LU and the Agency charge the MRB with making science and evidence-based recommendations, but the commenter claimed that no evidence, studies, or data were presented in support of restricting PAs from performing examinations on drivers with multiple active medical problems. AAPA argued that it would be unfair to eliminate PAs from performing these types of examinations since the commenter and many individual PAs aided FMCSA's development of the National Registry program by participating as subject matter experts in the development of several components of the program. Finally, because of the potential for a conflict of interest in completing an objective examination, comments from the MRB and Schneider National recommended against allowing primary care or personal health care professionals to perform the examinations. The MRB advised FMCSA to allow for an exception to this prohibition if no other medical provider was located within a 200-mile radius from the driver's residence or location of employment. In its comments, OOIDA recommended that the final rule expressly prohibit motor carriers from restricting the driver's rights to be examined by the ME of his or her choice, noting that once the final rule is implemented, all MEs listed on the National Registry will be equally qualified to perform a driver examination. Therefore, there should be no ME quality concern on the part of the motor carrier. FMCSA Response: We do not believe we should impose an additional burden on drivers by requiring them to be examined by MEs who do not provide primary care to them. FMCSA anticipates that requirements for medical examiners to be trained and tested in FMCSA standards and guidelines will result in more consistency in certification decisions among MEs. FMCSA anticipates that MEs will be deterred from making driver qualification decisions that violate FMCSA standards by the provisions in the rule that would allow FMCSA to remove an ME from the National Registry. In addition, we believe that employers should continue to have the option to require their drivers to be examined by a ME selected and/or compensated by the employer, because they have an obligation to require drivers to comply with the regulations that apply to the driver (49 U.S.C. 31135(a) and 49 CFR 390.11). This option is permitted by 49 CFR 390.3(d), which states that nothing in the FMCSRs “shall be construed to prohibit an employer from requiring and enforcing more stringent requirements relating to safety of operation and employee safety and health.” Comments that recommended restricting some MEs from performing examinations for certain drivers or to include specialists in the driver certification decision relate to medical standards and guidelines for determining the physical qualifications of drivers and are therefore beyond the scope of this rulemaking. Moreover, the MRB does not have authority to undertake regulatory development responsibilities, manage programs, or make decisions affecting such programs. 2. Employer and Carrier Responsibilities FMCSA proposed that all driver examinations would be performed by a medical examiner on the National Registry three years after the final rule implementation date, and all examinations for drivers who worked for an employer who employed 50 or more drivers would be required to be performed by a medical examiner on the National Registry two years after the final rule implementation date. FMCSA also proposed that medical examiners on the National Registry would be required to provide copies of the Medical Examination Reports and medical examiner's certificates to FMCSA or to authorized Federal, State and local enforcement agency personnel within 48 hours of the request. Daecher Consulting Group and Comcar Industries expressed concern that motor carriers would be responsible for determining whether a driver's physical qualification information was accurate. Asserting that the proposed rule was an attempt to make carriers responsible for ensuring that physical examination data are correct, Comcar Industries said that a carrier could not provide such assurances because it is not present for the physical examination and has no access to medical information from any previous employer. Dart Transit Company suggested that the ME should be required to notify the motor carrier if a driver fails the medical examination. ATA recommended that motor carriers should have access to an electronic database to obtain their drivers' Medical Examination Reports. OOIDA opposed disclosure of sensitive medical information to motor carriers because misconceptions or prejudices about the driver's medical condition could lead to termination of an employee from a job, even though the condition would not prevent the driver from doing his or her job in a safe and professional manner. Daecher Consulting Group stated that there was no method proposed in the NPRM for notifying a carrier that it employs a driver certified by an examiner who was removed from the National Registry. The commenter said that unless a notification system is devised and implemented (which would require registering Commercial Driver's License (CDL)-licensed drivers in a database, matching them with current carriers employing them, and having a method to track any change in carriers), significant liability may rest with carriers that use a driver certified by a once-certified ME who has since been involuntarily removed from the National Registry. FMCSA Response: Although the rule provides for FMCSA and State and local law enforcement personnel to obtain copies of driver examination records, the purpose of this requirement is to monitor ME performance, not driver qualification. FMCSA is not requiring employers to monitor ME performance. In order to clarify this matter in light of these comments, FMCSA is making one change in employer responsibility under this rule. FMCSA is adding a requirement that the employer verify that the driver was issued a medical certificate by an ME on the National Registry and place a note to that effect in the driver qualification file required by 49 CFR 391.51. This will also be consistent and enhance compliance with 49 U.S.C. 31149(d)(3). Beyond that, FMCSA recognizes that employers are not required by the current FMCSA regulations to obtain copies of Medical Examination Reports for their drivers, and does not hold employers responsible for knowing what medical conditions may be recorded therein. FMCSA has the discretion to void any medical certificate issued to a driver by a medical examiner who has been removed from the National Registry (49 U.S.C. 31149(c)(2)). The NPRM did not need to propose and does not include any provisions to implement that authority, which can be exercised by FMCSA on a case-by-case basis when the facts and circumstances indicate that it would be appropriate. Notification of employers of failed examinations is desirable, and in the future, FMCSA may use driver physical examination results data to notify employers. However, FMCSA modifies the final rule to require employers, upon hiring or upon expiration of a medical examiner's certificate on or after 24 months after the effective date of this final rule to verify the driver presenting a medical certificate was examined by a ME on the National Registry. The rule does not require employers to recheck the National Registry Web site to determine if the medical examiner has been involuntarily removed subsequent to conducting an examination and completing the certificate. 3. State Responsibilities FMCSA proposed revising medical examiner's certificate to include the National Registry number issued by FMCSA to identify the ME. California and Virginia expressed uncertainty about the State's role in determining whether the medical examination was completed by an ME on the National Registry and expressed concern about the cost of re-programming the Commercial Driver's License Information System (CDLIS) to query the ME database, when processing driver medical certifications. Indiana asked whether MEs would be expected to include the National Registry number on any old medical examiner's certificate forms or would States have to look up the number. Indiana questioned how involuntary removal of an ME from the National Registry will affect that ME's previously issued certificates. Similarly, Indiana also requested that we clarify how we will notify SDLAs that an ME has been removed from the National Registry. FMCSA Response: States will not be required to cross-check National Registry numbers with the National Registry database when processing driver medical certifications. Indiana's concern about entering National Registry numbers on old certificates is moot, because the final rule will not allow the use of any old forms. This final rule does not require changes to State driver's license databases or CDLIS beyond those required by the already-published final rule in Medical Certification Requirements as Part of the CDL (73 FR 73096, December 1, 2008) (Med. Cert./CDL). However, FMCSA anticipates initiating a future rulemaking to expand medical certification information exchange with the States. Certificates previously issued by a medical examiner who has been involuntarily removed are not automatically voided. FMCSA has the discretion to void any medical certificate issued to a driver by an ME who is removed from the National Registry (49 U.S.C. 31149(c)(2)). The NPRM did not need to propose and does not include any provisions to implement that authority, which can be exercised by FMCSA on a case-by-case basis when the facts and circumstances indicate that it would be appropriate. State Investigation of Driver Certification. Advocates criticized the lack of any systematic procedure in the proposed rule that requires State law enforcement agencies to compare each Medical Examination Report with the related medical examiner certificate. The commenter noted that in the preamble to the proposal we do not explain why and how State enforcement agencies would have reason to investigate specific Medical Examination Reports and medical certificates. On the other hand, OOIDA argued that Federal preemption would prohibit State and local agencies from requesting an ME to give a driver's Medical Examination Report to them as we proposed. The commenter said that once we prescribe safety standards requiring MEs on the National Registry to examine and issue certificates to show a CMV driver's physical condition is adequate for safe vehicle operations, those regulations would have a preemptive effect under section 31136. OOIDA cited Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995), and Gade v. National Solid Wastes Management Ass'n, 505 U.S. 88, 98 (1992), in support of implied preemption “when a `state law is in actual conflict with federal law * * * or where state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress'.” OOIDA argued that allowing State and local authorities to access a driver's personal medical information might dissuade drivers from openly discussing their health issues with an ME. OOIDA said unqualified State government personnel might apply their own standards to driver medical information and inconsistently judge them medically unfit for reasons that are erroneous or unjustifiably exceed the Federal medical standards being applied. OOIDA concluded that, at a minimum, we should require States to limit any Medical Examination Report (commonly called the “long-form”) request to circumstances where the State has clearly articulated legitimate reasons for believing that the medical certificate was falsified or otherwise improperly issued. FMCSA Response: OOIDA's comment does not recognize that State and local enforcement personnel have a role in enforcing the FMCSRs. The final rule retains the requirement for MEs to give State and local enforcement personnel access to Medical Examination Reports and ME certificates within 48 hours of a request for purposes of monitoring ME performance. States that receive Motor Carrier Safety Assistance Program (MCSAP) grant funds are required as a condition of receiving the grants to adopt regulations that are compatible with these final regulations (49 U.S.C. 31102(a) and 49 CFR 350.201(a)). States receiving MCSAP grants, therefore, will generally have to adopt regulations compatible with requirements that all drivers be examined by an ME on a registry of trained and certified MEs applicable to both interstate and intrastate transportation as soon as practicable, but not later than 3 years from effective date of this rule (49 CFR 350.331(d)). 1 State government personnel operating under MCSAP will have the same authority and responsibility to request that an ME produce a driver's Medical Examination Report that FMCSA personnel will have in accordance with this final rule. The States receiving MCSAP grants will be expected to adopt and implement compatible provisions and apply them consistently. There will be no inconsistency between State and Federal law that would require either express or implied preemption. 1 As explained later, States that have in effect variances for physical qualification requirements for drivers operating CMVs in intrastate commerce will have the option of not establishing a separate registry of medical examiners trained and qualified to apply those standards. FMCSA believes that the establishment of the National Registry, with its training and testing requirements will improve the performance of the MEs. Verification of the certification and listing of the MEs on the National Registry will be enhanced. In addition, the availability of the examiner's records to enforcement personnel, when necessary to conduct an investigation into the validity of the medical certificate, is sufficient to deter improper medical certification of CMV drivers. 4. Intrastate-Only CMV Drivers FMCSA proposed that MEs would include information on the monthly reports of driver examinations whether each driver operated only in intrastate commerce. OccuMedix and Missouri raised the issue that MEs would not be able to distinguish between interstate drivers and intrastate-only drivers required by their States to obtain a medical certification from an ME on the National Registry. The commenters suggested that the final rule should require all drivers—interstate and intrastate—to obtain medical examinations from examiners listed on the National Registry. Missouri said we should consider that many States require CMV drivers operating in intrastate commerce to follow the FMCSRs and that there would be confusion if we require MEs to examine only CDL drivers operating in interstate commerce. Missouri argued that we can promote public safety further if all nonexempt CDL drivers are required to obtain medical examinations from examiners listed on the National Registry, even when the drivers operate CMVs exclusively in intrastate commerce. FMCSA Response: States will continue to set requirements for intrastate drivers. States that receive MCSAP grant funds are required, as a condition of receiving the grants, to adopt regulations compatible with these final regulations (49 U.S.C. 31102(a) and 49 CFR 350.201(a)); however, the Agency is including in this final rule a revision to 49 CFR 350.341 to make it clear that States that have in effect variances for physical qualification requirements for drivers operating CMVs in intrastate commerce will have the option of not establishing a separate registry of medical examiners trained and qualified to apply those intrastate standards, although they have the discretion to do so if they wish. A State with variances in effect under 350.341(h)(1) and (2) that chooses to set up a separate registry of examiners qualified to apply those variances to intrastate drivers will not be allowed to use MCSAP funds for that purpose. Such use of MCSAP grant funds would not be consistent with the overall purpose of establishing a uniform standard for all CMV drivers nationwide. Intrastate-only CMV drivers in States that do not have such variances can utilize MEs on the National Registry because they will be trained and qualified in applying physical qualification standards that are identical for both interstate and intrastate drivers. All MCSAP States, either with or without variances, thus will have the option to establish their own registries, but FMCSA is not requiring them to do so as a condition of receiving MCSAP funds. The rule does not restrict MEs who are certified to perform physical examinations for interstate drivers from performing physical examinations for intrastate only drivers. MEs should ask drivers whether they intend to operate in intrastate commerce only. FMCSA Form MCSA-5850, CMV Driver Medical Examination Results Form, requires MEs to identify “Intrastate Only” drivers on the CMV Driver Examination Results so that FMCSA can distinguish data about intrastate-only driver examinations. 5. Canadian and Mexican Drivers The NPRM noted that existing reciprocity agreements with Canada and Mexico will govern Canada-domiciled and Mexico-domiciled drivers, respectively, operating in the United States (73 FR 73131, n.3). As a result, Canadian and Mexican drivers do not need to be examined by an ME on the National Registry before operating a CMV in the United States. OOIDA said this language constituted an exemption from Federal regulations, and that we had no authority to grant such an exemption. FMCSA Response: OOIDA's contention that 49 U.S.C. 31149 does not allow FMCSA to “exempt” Canadian and Mexican drivers operating in the United States from being examined by an ME is incorrect because two separate executive agreements 2 with Canada and Mexico remain in effect. A brief history of these two agreements is provided for clarification. 2 Executive agreements have the same legal effect as treaties. Prior to the amendments made by section 4116(b) of SAFETEA-LU, the provisions of 49 U.S.C. 31136(a)(3) stated: The Secretary of Transportation shall prescribe regulations on commercial motor vehicle safety. The regulations shall prescribe minimum safety standards for commercial motor vehicles. At a minimum, the regulations shall ensure that— • The physical condition of operators of commercial motor vehicles is adequate to enable them to operate the vehicles safely. * * * For this purpose, a “commercial motor vehicle” is defined in 49 U.S.C. 31132(1). FMCSA regulations generally required all operators of CMVs in the United States to be examined by an ME (as defined in 49 CFR 390.5) and to obtain from the examiner a certificate that the operator is physically qualified. 49 CFR 391.11(b)(4) and 49 CFR part 391, subpart E. These requirements will continue to apply after establishment of the National Registry Program. In 1991, the Secretary and his counterpart in Mexico entered into an agreement on the matter of driver license reciprocity. The agreement is contained in a memorandum of understanding (MOU) that was reproduced as Appendix A to a final rule issued in 1992 by FMCSA's predecessor agency, the FHWA. Commercial Driver's License Reciprocity with Mexico, 57 FR 31454 (July 16, 1992), affirmed, Int'l Brotherhood of Teamsters v. Peña 17 F.3rd 1478 (DC Cir. 1994). The primary purpose of the MOU was to establish reciprocal recognition of the CDL issued by the States to U.S. operators and the Licencia Federal de Conductor (LF) issued by the government of the United Mexican States (i.e., by the national government of Mexico, not by the individual Mexican states). In light of the agreement, the FHWA determined that an LF meets the standards contained in 49 CFR part 383 for a CDL. 49 CFR 383.23(b)(1) and note 1. The FHWA's final rule preamble also states, at 57 FR 31455: It should be noted that Mexican drivers must be medically examined every 2 years to receive and retain the Licencia Federal de Conductor; no separate medical card [certificate] is required as in the United States for drivers in interstate commerce. As the Licencia Federal de Conductor cannot be issued to or kept by any driver who does not pass stringent physical exams, the Licencia Federal de Conductor itself is evidence that the driver has met medical standards as required by the United States. Therefore, Mexican drivers with a Licencia Federal de Conductor do not need to possess a medical card while driving a CMV in the United States. Implicit in the determination that Mexican drivers with an LF do not need to possess a separate medical certificate is an underlying determination that the medical examination necessary to obtain the LF meets the standards for an examination by an ME in accordance with FMCSA regulations, and would therefore meet the requirements of 49 U.S.C. 31136(a)(3). The MOU does not specifically address medical qualifications for Mexican drivers operating a CMV in the United States that does not require a CDL. In order to enter the United States at the border crossing points (all of which are accessed only by federal highways in Mexico) a Mexican driver must have a Licencia Federal. FMCSA enforcement policy accepts a Licencia Federal as proof of physical qualification for a driver to operate a CMV that does not require a CDL in the United States. In 1998, a similar agreement was reached with Canada under the auspices of the Land Transportation Standards Subcommittee established by the North American Free Trade Agreement (NAFTA). This agreement supplements a 1988 agreement with Canada accepting the CDLs issued by Canadian provinces in accordance with the Canadian National Safety Code as valid for operation of a CMV in the United States. 49 CFR 383.23(b), note 1. The 1998 agreement, which became effective on March 30, 1999, provides, with some exceptions, that Canadian drivers holding such a CDL issued in Canada are physically qualified to operate a CMV in the United States and are not required to possess a medical certificate issued by a ME. In Canada, drivers are required to have CDLs in order to operate a CMV that would not require a CDL to operate in the United States. Under the 1998 agreement, a Canadian CDL issued in conformity with the National Safety Code is accepted by FMCSA as proof of a driver's physical qualification to operate a CMV in the United States. The substance of these two agreements is also reflected in a note in 49 CFR 391.41(a)(1), as recently amended. Medical Certification Requirements as Part of the CDL, 73 FR 73096, 73127 (December 1, 2008). In 2005, 49 U.S.C. 31136(a)(3) was amended by SAFETEA-LU section 4116(b), which added the following at the end: [T]he periodic physical examinations required of such operators are performed by medical examiners who have received training in physical and medical examination standards and, after the national registry maintained by the Department of Transportation under section 31149(d) is established, are listed on such registry. As explained above, section 4116(a) of SAFETEA-LU added a new 49 U.S.C. 31149, which among other things, includes a provision that FMCSA “shall accept as valid only medical certificates issued by persons on the national registry of medical examiners.” Section 31149(d)(3). OOIDA contends that this statute supersedes the two agreements with Canada and Mexico and that drivers from these two countries operating CMVs will have to be examined and certified by MEs on the National Registry. According to the cases that are cited in OOIDA's comments subsequently enacted statutes may abrogate an executive agreement or treaty. The case law states, however, that “neither a treaty nor an executive agreement will be considered abrogated or modified by a later statute unless such purpose on the part of Congress has been clearly expressed.” Roeder v. Islamic Republic of Iran, 333 F.3d 228, 237 (D.C. Cir. 2003), cert. denied, 542 U.S. 915 (2004) (internal quotations and citations omitted). There is no such clear expression of purpose in the relevant statutes. Neither the amended statutes nor their legislative histories contain any provision addressing these two executive agreements. The reciprocity agreements with Canada and Mexico, and the implementing provisions in the note in 49 CFR 391.41(a)(1), will continue to be in effect after issuance of this final rule. Accordingly, Canadian and Mexican drivers operating CMVs in the United States who hold the proper licenses will not be required to obtain a medical certificate from an ME on the National Registry. In any case, FMCSA has reviewed the Canadian and Mexican physical qualification processes. Driver medical examinations in Canada are performed only by MDs. National standards direct the medical examiners when to obtain the opinion of a medical specialist. In addition, in most jurisdictions, doctors, including family doctors, have a legal obligation to report any medical condition that may affect driving functions. The medical examinations in Mexico are conducted by Federal government doctors or Federal government-approved doctors. In addition, the medical certification for an LF is part of Mexico's licensing process for commercial drivers. This means the license is not issued or renewed unless there is proof the driver has satisfied the Mexican physical qualifications standards. FMCSA has compared each of its physical qualifications standards with the corresponding requirements in Mexico and continues to believe acceptance of the Mexico government's medical certificate is appropriate. C. Components of the National Registry Program 1. Training of Medical Examiners Length of Training. In the NPRM, FMCSA projected it would take one day to cover the FMCSA core curriculum specifications. Two commenters claimed that the length of training was inadequate and we should consider increasing it. A chiropractor stated that training should last perhaps two long days followed with reading and study materials. NRCME Training Systems claimed that it would be very difficult in a lecture-based setting, with all of the class questions and discussions generated in a presentation of this nature, to complete quality training in one day. The commenter concluded that, at minimum for a 17-module National Registry training program to thoroughly provide quality training for examiner candidates, five to six, six-hour days of didactic lecture in an attended seminar format would be required. FMCSA Response: The rule does not prescribe how long training must be. The core curriculum specifications are limited to FMCSA regulations and guidelines, and the mental and physical demands of CMV driving. One advantage of the Public-Private Partnership, is that training can be expanded to meet the needs of health care professionals from diverse educational and professional backgrounds. Training Intervals. The NPRM proposed that the ME would be required to complete periodic retraining at least every three years and repeat the complete initial training program once every 12 years in lieu of periodic training. Some commenters asserted that repeating the initial training was not necessary, or suggested other frequencies for training. AAPA and ACOEM recommended that FMCSA eliminate the proposed requirement to retake the initial training course every 12 years. AAPA stated that the requirement offers no benefit to MEs who are already required to participate in periodic training and recertification examinations. ACOEM supported requiring MEs to obtain 12 hours of advanced training every three years instead. Iowa recommended requiring MEs to attend a one-day course in person after the sixth year to renew certification. FMCSA Response: FMCSA agrees with the commenters that the proposed requirement for MEs to repeat the initial training is not necessary for those MEs who do not allow their certifications to lapse and has modified the final rule to require only periodic training at five-year intervals for recertification. MEs will be required to pass the test for recertification every 10 years. Training Program Accreditation. FMCSA proposed that medical examiner candidates be required to complete a training program accredited by a nationally-recognized medical profession accrediting organization. NRCME Training Systems endorsed having post-graduate institutions review and approve National Registry training for MEs, reasoning that these institutions are already certified by a national accrediting agency and that FMCSA would retain control over the training programs through third-party post-graduate programs. FMCSA Response: Only training programs that have been accredited by a nationally recognized medical profession accrediting organization to provide continuing education units will be eligible to provide the required training to MEs. As long as the training program is accredited, and is based on FMCSA's core curriculum specifications and guidelines, the Agency does not seek to restrict the number or location of programs that provide ME training. Post-graduate divisions of colleges and universities would be eligible to provide training to MEs, as would other accredited training organizations such as professional association continuing medical education (CME) programs and provider network training organizations. Core Curriculum Specifications. Several commenters expressed concern that we did not provide the content of the core curriculum in the proposed rule and questioned how it would be established and implemented. One physician commenter was concerned that since the core curriculum specifications have not been developed or approved, it will likely be several years before there are a significant number of trained MEs to accommodate the proposed requirements. A certified Medical Review Officer (MRO) urged us to incorporate good scientific rationale into the development of the curriculum and commented that all sections of the driver examination need to be addressed. ABA and BISC requested that we engage the private bus industry in developing ME curricula that are related to bus operations and driver wellness. ADA requested that the FMCSA-appointed Diabetes Expert Panel (DEP) be consulted with regard to curriculum elements pertaining to diabetes and suggested that these core curriculum elements be submitted to the DEP for final approval. The commenter also suggested that the DEP's 2006 suggested training module be incorporated in the curriculum. FMCSA Response: The core curriculum specifications are being issued as guidance for organizations delivering training for MEs who apply for listing on the National Registry when it is implemented. FMCSA published a notice of availability of draft guidance and request for comments on the core curriculum specifications in the Federal Register on May 17, 2011 (76 FR 28403). Additionally, FMCSA has posted these specifications on the National Registry Web site ( http://nrcme.fmcsa.dot.gov ) and in the docket for this rulemaking. The guidance for the core curriculum specifications is Appendix A to this Federal Register document. The guidance for the core curriculum specifications are based on current FMCSA regulations on physical qualifications published in 49 CFR part 391, as well as guidance that is published in 49 CFR 391.43. The guidance for the core curriculum specifications are also based on the task list developed in the Role Delineation Study (RDS) completed in April 2007, as described in the NPRM. The RDS is a rigorous methodology regularly employed in the certification and medical fields when developing a valid, reliable, and fair certification test. An executive summary of the RDS Final Report and the full text of the Final Report are available through the National Registry Web site 3 and the docket for this rulemaking. 3 http://nrcme.fmcsa.dot.gov/training.aspx, retrieved July 13, 2011. The Agency does not envision separate medical criteria for bus drivers at this time. Any changes in the basic requirements for training specified in 49 CFR 390.105(b) will be subject to notice and comment proceedings. On the other hand, future changes in the guidance for the core curriculum specifications do not require a notice and comment rulemaking proceeding because they will reflect only regulations and guidelines for performing the driver physical examination. FMCSA has provided and continues to provide for stakeholder input into revising the standards and guidelines through MRB meetings, and public notice of MRB meetings, including specific instructions on where to send comments. FMCSA will revise the guidance for the core curriculum specifications only after we have established new or revised existing, regulations and guidelines. The training provider could expand its course content to tailor training to the needs of its target audience but the course content must cover the FMCSA core curriculum specifications. FMCSA considered the recommendations of the DEP for ME training in the development of the guidance for the core curriculum specifications. At this time, FMCSA is not adopting the ADA's request to implement the recommendation of the DEP on drivers with diabetes. In general, such MEPs are convened on an ad hoc basis to act in an advisory capacity to FMCSA in its work of reviewing and revising physical qualification standards and guidelines. In any event, FMCSA will consider recommendations from the MEP on standards and specifications for drivers with diabetes in future proceedings. Comments on the Notice of Availability of the Core Curriculum Specifications. FMCSA published a notice of availability and request for comments on the draft guidance for the core curriculum specifications in the Federal Register on May 17, 2011 (76 FR 28403). Additionally, FMCSA has posted this guidance on the National Registry Web site ( http://nrcme.fmcsa.dot.gov ) and in the docket for this rulemaking. FMCSA received five comments from interested parties during the public comment period. The Agency considered the public comments on the draft guidance and now publishes the guidance as Appendix A to this Federal Register document. In response to the notice of availability, ATA suggested that FMCSA needs to educate MEs about the mental and physical demands of driving a CMV. Several commenters suggested that the curriculum convey to MEs an understanding of the distinction between guidance and recommendations submitted by various FMCSA advisory committees and boards. NRCME Training Systems thought that FMCSA expected training programs to give continuing education credits. There was also a comment requesting notice and comment rulemaking for future changes in the core curriculum. There were several comments addressing other aspects of the rulemaking other than the core curriculum specifications, which are beyond the scope of the notice of availability. FMCSA Response: In response to ATA's comment, MEs are, and will still be, required to be knowledgeable of the specific physical and mental demands associated with operating a CMV. 49 CFR 391.43(c)(1). Section 2 of the core curriculum specifications addresses the job of CMV driving, including physical and emotional demands. Section 7 includes consideration of driver ability to perform physical tasks associated with operating a CMV. The guidance for the core curriculum specifications expands the description of the topics to be covered in training, and do not provide the details that should be included in the actual training. FMCSA commercial driver medical certification regulations, advisory criteria, MRB and MEP functions, and other resources on the Web site are outside the scope of this notice. Nonetheless, FMCSA continuously reviews and updates information on its Web sites for content and clarity, and will make sure the difference between regulations, guidance, and advisory recommendations are made clear. FMCSA wants to clarify that it is not requiring that the training given to MEs qualify for continuing education credits, although the training organizations must be accredited to give continuing education credits. The Agency is making no changes to the draft guidance for the core curriculum specifications, and issues them as an appendix A to this Federal Register document. Only future changes in medical certification standards will be subject to notice and comment rulemaking. FMCSA will then update the guidance for the core curriculum specifications as appropriate. Because the core curriculum specifications are guidance, consideration and issuance of updated specifications does not require notice and comment in a rulemaking proceeding. 2. Testing of Medical Examiners Certification Testing Intervals. Some commenters suggested different intervals for such testing. FMCSA proposed a requirement that MEs pass the ME certification test every 6 years in order to remain listed on the National Registry. FMCSA Response: FMCSA modifies the requirement for MEs already on the registry to pass the certification test again before 10 years instead of before 6 years to demonstrate knowledge of changes and retention of previous knowledge and application. This period was chosen as there are varying lengths of times utilized by medical and healthcare boards to issue board certifications. FMCSA chose 10 years because it is not as burdensome on the medical examiner, but, in FMCSA's judgment, it is a short-enough period to verify MEs are knowledgeable about any changes to our physical qualifications standards and guidance. MEs will also be kept knowledgeable by completing refresher training every 5 years, and receiving updates from FMCSA by email and Web site postings. 3. Accreditation of National Registry Program FMCSA asked for comment on its consideration of obtaining accreditation of the components of the National Registry Program that test and certify MEs for listing on the National Registry, in order to demonstrate the robustness of its Program. This accreditation was not the same as the accreditation that was proposed to be required for training. Several commenters commented regarding the process of obtaining National Commission of Certifying Agencies (NCCA) accreditation of the certification component of the National Registry Program. ATA expressed concern that the accreditation process might cause delay or increase program costs. Calling accreditation time-consuming, burdensome, and costly, ATA said it would oppose accreditation of the ME certification program if the process delayed implementation of the National Registry. Instead, ATA recommended that we either certify the program through a periodic program evaluation and audits conducted by a designated oversight authority, or certify the program using a third-party certifying body. FMCSA Response: The Agency agrees that accreditation of the National Registry certification component could be expensive and delay implementation of the program. As stated in the NPRM, FMCSA proposed accrediting the testing and certification components of the National Registry Program using the accreditation standards of the NCCA, and is considering the costs and benefits of applying for accreditation for these components (which are administered by the Agency). A new certification program (one that has not previously received accreditation by the NCCA), may apply for accreditation either after 1 year of administration of the certification test or when at least 500 candidates have been assessed with that test instrument, whichever comes first. FMCSA will conduct program evaluations which are subject to internal and external audits, as well as Congressional oversight. 4. Public Participation in Development of Components Advocates said FMCSA failed to provide the key features of the preferred Public-Private Partnership approach for evaluation through notice and comment. Advocates contended that the Agency should publish a supplementary notice of proposed rulemaking (SNPRM) with details of the major features to allow for public review and comment. The features Advocates believes are not covered are the core curriculum provided for training companies to use, the criteria to qualify private organizations to conduct training and testing, and the reason for choosing the NCCA as the accreditation organization for the program. Advocates asserts further that another feature of the proposal that “must be exposed to public comment” is the specific content of the test that would be administered to MEs. FMCSA Response: FMCSA has determined that it is unnecessary to accept Advocate's view that an SNPRM is either required or appropriate. However, the Agency has taken steps to make certain components of the National Registry program available for public comment before their implementation. FMCSA has determined that the guidance for the core curriculum specifications and other similar documents implementing the National Registry program, such as information for testing providers, does not have to be a subject to a notice and comment rulemaking. The guidance for the core curriculum specifications will meet the minimum requirements of 49 CFR 390.105(b), but will not establish a “binding norm” for MEs for compliance with that provision. American Hospital Ass'n v. Bowen, 834 F.2d 1037, 1046 (D.C. Cir., 1987). Organizations that will provide the training must have the flexibility to develop a particular training curriculum suitable for the type of medical professionals who intend to be listed on the National Registry. This is especially important because, as explained above in Section IV.B.1, FMCSA's regulations will continue to allow several different types of medical professionals, with a wide range of different backgrounds, knowledge, and skills, to act as MEs. This approach is entirely consistent with the authority granted to FMCSA to “develop, as appropriate, specific courses and materials for medical examiners” 49 U.S.C. 31149(c)(1)(D) (emphasis added). In view of the nature of the training that needs to be provided to applicants for certification and listing on the National Registry, and the broad discretionary authority delegated to the Agency to implement the training component, FMCSA has determined that it is appropriate to issue guidance providing the core curriculum specifications for development of training by the various training providers. Moreover, there are criteria for determining which organizations would be deemed acceptable for conducting the training. The requirements of 49 CFR 390.105 that the Agency proposed in the NPRM set out the criteria that candidates for certification and listing on the National Registry must use in selecting an organization to provide their training. Those criteria were thus available for public comment. FMCSA has responded to those comments (including substantive comments by Advocates) in Section IV.C.1 above. Finally, MEs seeking to be listed on the National Registry will need to successfully complete a test administered in accordance with 49 CFR 390.103 and 390.107. Like the core curriculum specifications, the specific content of the test will be based on current FMCSA regulations and guidelines on the Medical Examination Report applicable at the time the test is administered. As those underlying regulations and guidelines are updated, both the core curriculum specifications and the certification test will be modified accordingly. The Agency has added a requirement to the final rule (49 CFR 390.107(d)) to make it clear that any testing organization administering the test must use only the test obtained from FMCSA. This requirement was stated in the preamble to the NPRM (73 FR at 73133). 5. Records and Recordkeeping Retention of Driver Examination Records. The NPRM proposed implementation of the SAFETEA-LU requirement that MEs electronically transmit to the FMCSA Chief Medical Examiner on a monthly basis the name of the CMV driver and a numerical identifier for any completed Medical Examination Report required under 49 CFR 391.43 (49 U.S.C. 31149(c)(1)(E)). Additionally, the proposed rule would require MEs to retain for 3 years the Medical Examination Report for each examination performed and the medical examiner's certificate, if the ME certified the driver as physically qualified. It would also require MEs to provide copies of specified Medical Examination Reports and medical examiner's certificates to FMCSA or to authorized Federal, State, and local enforcement agency personnel, within 48 hours of the request, in order to allow for investigation of errors and improper certification of CMV drivers (49 U.S.C. 31149(c)(2)). ACOEM, AAOHN, and an occupational medicine consulting firm, OccuMedix, Inc., claimed that MEs should be required to retain driver examination records for longer than 3 years to allow MEs to check their own records or the records of other MEs so that medical conditions would not be overlooked. The commenters noted that some drivers may use different MEs from year to year or may enter or leave the driver pool, so records should be maintained for 6 or 7 years and reviewed if questions arise. FMCSA Response: FMCSA proposed a minimum time of 3 years for retention of driver examination records because a driver is certified for a period of 2 years or less, and an additional year will allow FMCSA time to request driver examination records from MEs to assess ME performance by determining whether the ME completed the medical examination report accurately and did not certify a driver in error. Also, MEs are still subject to any State laws requiring medical records to be retained for longer than 3 years. Therefore, FMCSA will retain the requirement for MEs to keep the Medical Examination Report and the medical examiner's certificate for 3 years and retains the words “at least” from the Med. Cert./CDL rule to clarify that this is a minimum. Privacy of Information. Transportation Safety Services, a consulting firm, stated that Federal government databases established to monitor medical information cannot be adequately protected from unauthorized access. AAOHN, however, suggested that a standardized electronic database with appropriate safeguards is imperative for the confidentiality of personal health information and compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations. Dart Transit Company encouraged us to address the question of possible conflicts with HIPAA that would be encountered in the industry's attempt to comply with the rule. FMCSA Response: Pursuant to 49 CFR 391.43(g), as revised by this final rule, each month MEs will be required to transmit on Form MCS-5850 the results of every physical examination performed on a CMV driver and the information from each medical examination certificate issued to a CMV driver. This form indicates whether or not the driver examined was issued a medical certificate. This information is necessary to satisfy the requirements of 49 U.S.C. 31149(c)(1)(E). The form does not contain any personal health information about the driver. It does include information identifying each driver examined such as driver's name and driver's license information. If the Agency should find it appropriate in conducting any review of the performance of MEs on the National Registry, as provided by 49 U.S.C. 31149(c)(1)(C) and (F), to obtain copies of the Medical Examination Reports and any supporting medical records for CMV drivers examined, it will follow the applicable policies and procedures to ensure the security and privacy of the personal health information about the drivers contained therein. FMCSA will also follow similar procedures in conducting any investigation into whether or not a CMV driver is or should be physically qualified to operate a CMV. Therefore, we are requiring submission of medical records through a secure Web application for which each certified ME will have a password-protected account. FMCSA will implement policies and procedures to reasonably limit the uses and disclosures of Protected Health Information (PHI). The Privacy Impact Assessment (PIA) supporting the final rule gives a full and complete explanation of FMCSA practices for protecting Personally Identifiable Information (PII) in general and specifically in relation to this rule. The PIA is available for review in the docket. On the other hand, HIPAA privacy regulations do not apply to the transmission of PHI to FMCSA because the Agency does not provide services on behalf of the ME, and therefore does not qualify as a business associate. The definition of a business associate requires more than receipt of PHI. As stated in 45 CFR 160.103, to qualify as a business associate the entity or person must perform a function or activity involving the use or disclosure of individually identifiable health information on behalf of such covered entity or of an organized health care arrangement. FMCSA is not providing services on behalf of a covered entity or in association with an organized health care arrangement. In this case, FMCSA is not performing services for the ME, but for the public by ensuring the safe performance of commercial vehicle drivers. FMCSA will monitor the performance of MEs in order to ensure they effectively determine whether CMV drivers are safe to drive in interstate commerce. FMCSA disagrees that there are possible conflicts with HIPAA that would be encountered by employers (or the MEs for that matter) in complying with the final rule. The Agency did not propose and is not making any changes in the existing regulations governing the physical qualifications of drivers and the responsibilities of employers to ensure compliance with those requirements, with the exception of the requirement for employers to verify that the ME is listed on the National Registry. The employer may validate the National Registry Number from the medical examiner's certificate or State driver record, without the need to access any of the driver's personal health information. Public Web site. We indicated in the preamble to the proposed rule that information about the National Registry Program would be available through a public Web site, so that drivers and employers could find the names and addresses of nearby MEs listed on the National Registry. Several commenters described other information pertaining to the ME that should be provided as well. A chiropractor and Dart Transit Company suggested that the Web site should also include information about parking, hours, and directions. Schneider National, Inc. mentioned that the ME's State license number, National Registry Number, and certification expiration date should be posted. Schneider National, ACOEM, and OccuMedix expressed that the Web site and email notifications to MEs could be used for informational purposes. Wynne Transport Service, Inc. (Wynne), California, and AAOHN noted that the National Registry itself must be updated frequently so drivers and motor carriers always have access to the most current ME information. Wynne asked whether the ME's unique identifier will be recognizable as valid. OOIDA noted that although we envision a resource center with a toll-free telephone number, it is not clear what information will be available by telephone and whether the Resource Center would be staffed by knowledgeable people who can answer a variety of physical examination-related questions. California urged us to ensure that the toll-free telephone number is staffed during regular business hours in the Pacific Time Zone. OOIDA also argued that reliance on the Internet posed an obstacle because long-haul drivers often spend extended periods of time away from home and not all own laptop computers that could be used to identify conveniently located MEs over the Internet. FMCSA Response: FMCSA is considering these ideas in the design and implementation of the National Registry Web site. FMCSA anticipates the National Registry will include the unique National Registry Number and the certification date for each ME. Information for MEs who have been removed from the National Registry will be shown with the date of removal. We anticipate using the public Web site and email notifications to MEs for informational updates. Callers to the Resource Center will be able to receive assistance in locating an ME on the National Registry and will be given access to knowledgeable personnel who can answer questions about the commercial driver physical examination. Access to Driver Examination Records. ATA, Road Ready, Inc., and Florida argued for a Web-based electronic data entry and document-storage system for Medical Examination Reports. Road Ready, a company that electronically collects and stores drivers' DOT medical examination information for motor carriers, argued that developing and maintaining such a system would enhance our ability to effectively manage and audit driver files and obtain required medical information. Florida said an FMCSA repository of Medical Examination Reports would eliminate the need to require and enforce monthly entry of separate data. AAOHN, Dart Transit Company, ATA, and an individual MD suggested that the ME should have access to previous driver physical examination records in order to more easily detect disqualifying illnesses not reported by the driver. FMCSA Response: The Agency acknowledges the potential benefits of a comprehensive, searchable Web-based database of Medical Examination Reports. This type of system could incorporate automated checks that would prevent the erroneous certification of drivers who do not meet certification standards and would facilitate the collection of driver examination records for monitoring ME performance. However, this rule will not require MEs to enter all data into a prescribed on-line Medical Examination Report form, because of the administrative burden this would place on MEs. Medical Examiner's Certificates. The NPRM proposed a change in the medical examiner's certificate form to require the ME to record his or her unique National Registry Number. The proposed rule would have allowed the ME to use existing medical examiner's certificate forms (without a box for the National Registry Number) for up to 4 years. Iowa opposed the use of obsolete forms. FMCSA Response: FMCSA agrees there is no need to delay implementation of the updated medical examiner's certificate and has made changes to the final rule to require MEs to use the medical examiner's certificate with the National Registry Number for all examinations on or after a date 24 months after the effective date of this final rule. FMCSA has posted the current medical examiner's certificate on its public Web site since 2003, so MEs have not had to order supplies of paper copies. Therefore the two-year implementation date will not impose hardship or waste with regard to availability of the current certificate. D. Costs and Benefits of the National Registry Program 1. Benefits FMCSA requested comments on the costs and benefits of the proposed rule. The Indiana Statewide Association of Rural Electric Cooperatives (ISAREC) questioned the need for and the benefit of the National Registry, arguing that it might not be a good, targeted use of Agency resources. A private citizen questioned whether any study shows MEs make highways safer. Southern Company, a public utility company, opposed establishment of a National Registry and suggested instead that physicians should be given easy access to on-line directions and guidance to use any time. In contrast, a chiropractor reported that in the past year, he had disqualified drivers who previously had been improperly qualified to drive by other MEs or required exemptions for blindness in one eye, insulin use, psychological conditions, limb/appendage loss, implanted defibrillators, seizure disorders, and cardiovascular disorders. California noted a 2005 study that found that 10 percent of Medical Examination Reports (long forms) submitted and marked as qualified were actually from unqualified drivers, which, to the commenter, indicates that MEs misinterpreted the Agency standards. The American Chiropractic Association and a comment signed by 147 chiropractors stated that the National Registry will both improve highway safety and reduce the number of erroneous driver disqualifications. They agreed that the ME certification program will raise the quality and conformity of the CMV driver physical examination. California and Iowa expressed similar opinions in stating that the training protocol will ensure that MEs are knowledgeable and capable of performing these examinations. FMCSA Response: FMCSA is required by statute to establish the National Registry. As described in the regulatory evaluation, the Large Truck Crash Causation Study (LTCCS) data show that approximately 2.2 percent of crashes involve a crash where the truck driver was assigned the critical reason for the crash and the main contributing factor was the health or physical condition of the truck driver. 4 The LTCCS is the most comprehensive examination of truck-crash causation conducted in the United States. It is clear that driver health is a factor contributing to a significant number of crashes. Clearly, there are benefits from a program that would improve the screening of drivers, keep medically unqualified drivers off the road, and that would, therefore, in FMCSA's estimation, prevent 1,219 crashes per year. 4 Internal analysis of the LTCCS conducted by Agency data analysts. A description of the LTCCS, it's methodology, and the data is available at http://ai.fmcsa.dot.gov/ltccs/default.asp . It will not be possible to evaluate the effectiveness of training programs for MEs to be listed in the National Registry until after the training programs have been initiated. It is impossible to predict the degree to which the training program will improve ME screening of drivers. However, comments received from MEs who currently conduct driver physical evaluations, and evidence from the field from MEs and enforcement personnel indicate that many drivers who do not meet the Agency's physical qualification standards are being erroneously medically certified. The Agency expects the National Registry Program to reduce the number of errors committed by MEs. It will depend upon the effectiveness of training and the knowledge that MEs gain about Agency standards and guidelines. CME programs have received extensive evaluations and have been shown to improve medical practitioner knowledge and skills, as well as patient outcomes. 5 A comprehensive review of the effectiveness of CME programs sponsored by the U.S. Department of Health and Human Services demonstrated that these programs are effective in increasing participant knowledge, skills, and clinical practices, among other improvements. 6 The National Registry Program is more rigorous than many CME programs because it includes a post-training knowledge assessment. Given that other CME programs have been shown to be effective, it is reasonable to expect, therefore, that the National Registry Program would attain some level of effectiveness. 5 Bordage G, Carlin B, Mazmanian PE. “Continuing medical education effect on physician knowledge: Effectiveness of continuing medical education: American College of Chest Physicians Evidence-Based Educational Guidelines.” Chest. 2009 and Neff JA, Weiner RV, Gaskill SP, Smith JA, Weiner M, Brown HP, Prihoda TJ, Newton E. “Preliminary Evaluation of Continuing Medical Education-Based Versus Clinic-Based Sexually Transmitted Disease Education Interventions for Primary Care Practitioners” Teaching and Learning in Medicine. 10(2) 74-82. 1998. 6 Marinopoulos, S, Dorman T, Ratanawongsa N, Wilson LM, Ashar BH, Magaziner JL, Miller RG, Thomas PA, Prokopowicz GP, Qayyum R, Bass EB. Effectiveness of Continuing Medical Education. Evidence Report/Technology Assessment Number 149, Agency for Healthcare Research and Quality—U.S. Department of Health and Human Services, 2007. Available online at: http://www.ahrq.gov/downloads/pub/evidence/pdf/cme/cme.pdf . 2. Costs We proposed developing the core curriculum specifications and administrative requirements for ME training— referred to as the Public-Private Partnership Model. We asked for comment on alternative training delivery methods and the ability of accredited training programs to adapt their continuing education programs to ensure quality and consistency of training. We received many comments about the cost of ME training, testing, and certification. In 49 CFR 390.105, we require that all ME applicants complete training conducted by a private-sector training provider (administered by a nationally accredited medical professional organization that provides continuing education units). In 49 CFR 390.103(a)(3), we require that after completing mandatory training, an ME applicant must pass our ME certification test. In 49 CFR 390.111, we list requirements for continued listing on the National Registry, including periodic retraining every 5 years and recertification every 10 years. We anticipate that FMCSA will provide Web-based, periodic retraining at no cost to MEs. We estimate the annual costs of training and testing—including lost time to MEs—as varying between $14 million and $59 million (undiscounted) during the initial training phase. Costs to Medical Examiners. Commenters presented various arguments concerning whether we had properly assessed the cost of the rule and which stakeholders would pay the cost of ME training and certification. Comcar Industries said we had “significantly understated” the cost impact of this rule on the trucking industry. A private citizen questioned whether we had properly evaluated what costs will increase after the National Registry is established. ISAREC, OOIDA, Virginia, and Wynne said that MEs would pass on cost increases to drivers or motor carriers and other employers of drivers. A chiropractor, ATA, the National School Transportation Association (NSTA), OOIDA, and Wynne agreed that to recover their training investments, MEs in remote areas would impose higher physical examination fees over a smaller base of drivers. NSTA recommended that to prevent disparate examination fees across the country, FMCSA should limit the amount by which MEs can increase their physical examination fees to recover the cost of having to comply with the National Registry rule. FMCSA Response: There will likely be a minimal increase in the cost charged by MEs to reflect the cost of becoming certified. In the regulatory evaluation, we estimated that becoming certified would cost approximately $550 per examiner in out of pocket costs—$440 for training and $110 to take the certification test. Fees for driver examinations vary, but generally fall in the range of $70-$100, assuming no specialized tests are required. As noted by one commenter, MEs in lower volume areas may already charge higher fees—up to $170 per examination. At $170 per examination, an ME would only have to conduct 3-4 examinations in order to recoup the out-of-pocket costs of certification. At the lower-end price of $70 per examination, an ME would need to conduct a minimum of approximately 8 driver examinations to recoup the out-of-pocket costs of certification. In addition, many occupational health consortia and other organizations offer training on the CMV driver physical, and other ME training, free of charge, to physicians and other providers in their networks. It is unclear how many MEs would have access to these free courses, but at least some would bear little or no out-of-pocket costs for obtaining the required training. The opportunity cost of time for an ME to attend certification training and testing was estimated at $83 per hour, and the time commitment for certification was estimated at 11.5 hours, for a total cost of approximately $954. If an ME took on these costs, approximately 148 examinations at most would be needed to pay back the investment of time required to become certified. The NPRM proposed requiring MEs to repeat initial training every 12 years. This final rule eliminates this requirement for repeating the initial training but substitutes refresher training every 5 years, thereby reducing the cost to MEs for maintaining certification. At a maximum, an ME would need to conduct approximately 26 examinations to compensate for the total cost of certification including both out-of-pocket costs and indirect costs of the time involved. The financial payoff for being able to continue conducting these examinations seems sufficient to induce most MEs who currently conduct 10 or more driver certifications per year to become certified. Based on the revenue generated by the examination, this volume would be sufficient to pay back both the value of time spent by an ME in training and out-of-pocket expenses in a little over 2 years. The initial training required by this certification program is a fixed cost—a one-time expense. This is not a marginal cost that is incurred with each examination. In competitive markets, the cost of a service approaches its marginal cost, as fixed costs are averaged over multiple units of production. Given that there are MEs who evaluate hundreds of CMV drivers per year, the amount that initial certification costs would contribute to the per-unit cost of providing examinations would approach zero. We expect these higher volume MEs to set the market price for driver examinations. Those MEs who conduct fewer examinations would have pressure to match the prevailing price, or most drivers would go to an ME who charges a lower fee. We therefore expect a minimal increase in the fees charged for these examinations. In addition, we expect that the MEs who choose to obtain training and be listed on the National Registry will see an increase in the volume of commercial driver examinations, because there may be fewer professionals eligible to conduct the driver examinations. Greater volume should help control cost increases because the cost of training will be spread across a greater number of examinations. As a result, a smaller price per examination increase would be necessary for MEs to recover their costs. If training costs are incorporated into higher medical examination fees, this would not result in an increase in the total cost of the program, although it would result in a pass-through of these costs to the industry. If MEs pass some or all of the costs of the training on to the industry, the costs passed on would be borne by drivers and carriers rather than MEs, but whether these costs are passed on or absorbed by MEs would not change the total cost of the program. Therefore, the Agency feels it has fully accounted for the potential effects of the rule, although we cannot predict with a great deal of certainty how much of the associated costs would be absorbed by MEs rather than passed on to the industry. Finally, the Agency disagrees that we should put a ceiling on the fees MEs are allowed to charge for physical examinations. Commenters are concerned both that there will be a shortage of MEs and that fees will increase. However, the ability to charge a higher fee for driver examinations increases the incentive that MEs have to obtain certification. Capping the fee too low would exacerbate any shortage in MEs, because it would reduce the financial incentive to become certified. In the interest of ensuring the broadest geographic coverage possible for the National Registry, we do not agree that capping driver examination fees would be advisable. It must be kept in mind that once this program reaches full implementation, all MEs who choose not to participate in this certification program will lose all revenue associated with conducting driver physical examinations. MEs face the choice of becoming certified to retain the current revenue stream they receive from driver examinations, or not becoming certified and losing this revenue to other professionals who are certified. The Agency believes that, for most MEs, preserving this revenue stream will outweigh any costs associated with becoming certified. Scarcity of Medical Examiners. FMCSA requested comments on whether the proposed requirements may deter otherwise qualified MEs from performing these types of examinations and on ways to ensure that MEs are accessible to drivers in rural areas and areas where the demand for driver certification may be low. The Agency also asked for comments on additional costs drivers may incur to locate and travel to an ME for periodic examinations. AAPA, AAOHN, Advocates, California, Virginia, and two individuals said that the cost of training and testing would diminish the number of physicians and others willing to become MEs. However, a physician with the Delaware Department of Health suggested that most physicians would find the costs of training and travel, certification, and recertification acceptable. OOIDA also expressed concern that the burdensome and costly administrative obligations for listed MEs will discourage health care professionals from providing driver physical examinations. Administrative burdens would include the need for a computer system that can interface with the Agency and personnel available to provide the Medical Examination Reports when requested. California requested that MEs be given sufficient notice prior to an onsite inspection and sufficient time to comply with a request for information. Several commenters discussed the scarcity of MEs in rural areas and the resulting costs to CMV drivers. ATA, Arizona, Comcar Industries, ISAREC, National Academy of DOT Medical Examiners (NADME), OOIDA, Southern Company, Virginia, and Wynne said that a scarcity of MEs would burden truck drivers with having to travel long distances for physical examinations. ATA commented further that such travel likely would result in a loss of wages for the driver and loss of revenue to the motor carrier. Commenters also argued that scarcity would result in difficulties in scheduling physical examinations. Commenters said many drivers will experience longer wait times and no walk-in opportunities for physical examinations. According to NSTA, difficulties in scheduling physical examinations could impede school bus service because newly hired drivers may be unable to receive physical examinations before the start of school. Several commenters suggested actions we might take to avoid a scarcity of MEs. These suggestions included offering financial incentives to secure a local ME, permitting physical examinations by CMV drivers' family doctors, though not certified, having motor carriers take responsibility for finding physicians in their areas who are willing to become MEs, and extending the rule's implementation date if there are not sufficient numbers of MEs. FMCSA Response: There are 3,140 counties or county-equivalent administrative units in the United States, according to the U.S. Census Bureau. Assuming the Agency reaches its goal of certifying 40,000 MEs, there would certainly be a sufficient number of certified MEs to provide broad geographic coverage. Even half that number of certified MEs would be sufficient to provide comprehensive national coverage. It is unlikely that MEs would be evenly distributed throughout the Nation, but coverage should be sufficient to ensure reasonably convenient access in all but the most remote areas of the Nation. Lack of access to a certified ME would be likely to affect only a small number of drivers, especially considering that many of these drivers from rural areas would be delivering loads on a regular basis to larger towns and cities and, thus, have access to the broader ME populations in such areas. Given the mobile nature of the CMV driver occupation and the number of MEs we anticipate to join the National Registry, we do not believe that access to certified MEs will be an issue once the Registry is fully populated. In addition, we anticipate that the searchable National Registry may make it easier for drivers to find health care professionals who are qualified to conduct the driver physical certification examination. It is possible that in some areas where MEs are in short supply, such as rural areas, driver examination costs might increase, but the increase is not a certainty and is not likely to be large. Also, travel costs to drivers might increase due to drivers traveling further to find MEs. Mode of Training and Testing. We proposed developing the core curriculum specifications and administrative requirements for ME training, which we would provide to private-sector training organizations for developing course content. We mentioned that training delivery could vary among providers and include self-paced, on-line training; the traditional classroom model; or a blended format. We also envisioned private-sector organizations administering a proctored and secure certification test, with the ME applicant traveling to the test center. We asked for comment on alternative training and testing delivery methods and how FMCSA could offer training directly to MEs in a cost-effective manner. ATA, Comcar Industries, ISAREC, MRB, NADME, NRCME Training Systems, OOIDA, and Schneider National endorsed on-line training as efficient and cost-effective. Schneider National also endorsed other cost-efficient technologies like video-conferencing, along with traditional classroom training. A chiropractor said that live Web conferencing had the benefit of reducing costs and allowing conversation between a trainer and course attendees. Delaware noted that some physicians favored an initial on-line Web-based product designed to educate new examiners, followed by on-site lectures and then initial testing, leading to qualification. However, OccuMedix stated that in-person, classroom training was optimal for initial certification since discussing case studies and in-person interacting with other ME candidates and faculty would be extremely beneficial. Several of the commenters, including ATA, supported on-line testing. ATA said that on-line testing should be the preferred method of administration of the test to reduce costs. One commenter, a chiropractor, said that FMCSA should offer the test on its Web site. FMCSA Response: The Agency agrees with comments that on-line training would reduce the cost associated with training. This rule does not preclude on-line training as a viable training, or the other suggested training formats, delivery methods. Allowing flexibility in alternative training delivery methods is one of the primary benefits of the Public-Private Partnership Model. While some organizations may charge for this training, others (larger hospital systems, occupational health consortiums, professional associations, etc.) may offer training that is free of charge to group members. The Agency is aware of several ME training programs that are offered free to members of particular organizations. It is therefore likely that under the Public-Private Partnership Model a percentage of MEs would be able to obtain on-line training with no out-of-pocket costs or travel costs. At present, the Agency cannot estimate with any degree of certainty the number of MEs who might take advantage of on-line training, so we leave the travel costs estimates at the NPRM stage unchanged for the Public-Private Partnership Model. It is expected, however, that on-line training will reduce travel costs associated with this model. The Agency agrees with commenters that allowing on-line testing will increase accessibility and decrease costs. This rule allows for secure online testing to be offered by testing organizations as an alternative or additional option to in-person testing. It requires online testing to be subject to specific security and privacy requirements due to the nature of the test and the need for authentication and security of the test. The Agency expects that, just as with on-line training, allowing for the increased flexibility provided by secure on-line testing in the final rule will reduce costs for MEs without adversely impacting the ability of the Agency to verify the qualifications of the MEs on the National Registry or compromising safety. Estimates of Frequency of Driver Examinations. The NPRM estimated the number of MEs who would need to be certified by estimating that 3 million driver examinations are performed on interstate CMV drivers per year. All CMV drivers must be certified at least every 2 years, and some drivers are certified more frequently. We specifically requested comments on how frequently drivers are examined more often than every 2 years. A chiropractor said that in 2008, his practice issued 41 percent of CMV medical certificates for less than 2 years. Schneider National said that of the approximately 650 medical examinations it performed each month, it issued about 50 percent of the medical certifications for less than 2 years. Comcar Industries reported that 39 percent of its drivers receive medical certificates for less than 2 years. NSTA said FMCSA underestimated the number of drivers by not including intrastate drivers, because all States but two adopt the FMCSRs for intrastate drivers. NSTA also said that most States require school bus drivers to have a physical examination annually. FMCSA Response: The Agency agrees that, given the estimates of the number of drivers who require certification more than once every two years, it is likely that more than 3 million drivers would be certified in a given year. However, we do not believe that this increase in the estimated number of drivers needing medical examinations per year is great enough to require more registered MEs than the 40,000 we used as the baseline for calculating the costs of the program. The increase in medical certifications does not, therefore, impact our estimate of the direct costs of the rule, which are based on the cost of training, certifying, and registering a given number of MEs. This rule does not change the regulations and guidelines that MEs use to determine how long drivers are certified. In regard to counting intrastate-only driver examinations, FMCSA acknowledges the potential impact of certifying intrastate drivers and exempted school bus drivers on the number of driver examinations MEs on the National Registry will perform. However, for the purposes of estimating the costs of the program, as required by 49 U.S.C. 31136(c)(2)(A) and Executive Order 12866 (see Section VI below), we considered the direct impact of the rule, which is limited to interstate drivers. E. Implementation of National Registry Program 1. Phased-In Implementation The NPRM proposed phasing in the requirement for using MEs listed on the National Registry, with phase one requiring compliance for motor carriers with more than 50 drivers (so-called large carriers), and phase two requiring compliance for drivers not covered in phase one. Phase one would have begun 2 years after the rule's effective date; phase two would have begun 3 years after that date. The majority of commenters to this section opposed the implementation schedule, while some offered alternatives to the proposed approach. ATA claimed that it is unfair to require drivers of large motor carriers to bear the costs of compliance for one year longer than drivers of smaller motor carriers. A joint comment from ABA and BISC voiced concern that the phased-in implementation schedule could result in only a limited number of MEs obtaining certification, which would make it difficult for drivers to locate an ME. The commenter recommended a single two-year implementation period, which it believed would provide adequate time for MEs to obtain certification. Comcar Industries added that the proposed implementation schedule demonstrates a lack of understanding of the transportation industry and is not realistic or reasonable. The commenter stated that we did not provide any valid reasons for proposing the approach and are unjustified in forcing the motor carriers to be responsible for implementation by requiring them to search for an ME when one may not be available in certain areas. Both ATA and Comcar Industries urged us to ensure that the National Registry is sufficiently populated throughout the country before implementing the proposed requirements. NSTA said that the proposed phase-in schedule would cause hardships for rural school bus operations, because many school bus companies are not located in areas where there is easy access to MEs. NSTA suggested that we phase in the National Registry Program by either population density or by facility size from which buses are dispatched rather than by company size. OOIDA claimed that the schedule was developed on flawed Agency assumptions. First, it stated that drivers employed by large carriers, just as their smaller independent counterparts, have the same likelihood of living in rural areas where MEs will not be concentrated. The commenter then suggested that there will always be a shortage of MEs in rural areas or other areas where the demand for examinations is low. Dart Transit Company opposed the implementation schedule, suggesting that to actually improve highway safety, all motor carriers should be required to comply at the same time. California also recommended that the proposed requirements should be applicable to all participants on the effective date of the final rule. It noted that a driver could avoid compliance by claiming employment by a “small” carrier; a claim that the State SDLAs would be unable to verify. Schneider National and a chiropractor suggested a “geographical” or “regional” approach to implementation. Schneider National claimed that ensuring there are a sufficient number of MEs in a particular region will reduce the traveling burden on a driver to obtain his or her examination. However, the chiropractor noted a potential drawback to implementing this geographic or regional approach, suggesting that MEs and drivers may not receive adequate notice that they are in a regional area where they must follow the new requirements. Finally, Delaware suggested that FMCSA create a matrix that would allow a State to determine by date when they must only accept medical certificates issued by certified examiners. FMCSA Response: The Agency concurs with comments that the phase-in schedule would pose some issues, such as limiting the number of MEs in the first year. Additionally, FMCSA does not believe this would reflect the reality of the industry's distribution of drivers. In response, the Agency has eliminated the phase-in schedule from the final rule. The final rule will require that all drivers requiring certification under 49 CFR part 391, subpart E must be certified by an ME on the National Registry beginning 2 years after the effective date of this rule, regardless of the size of the employing carrier. The cost estimates based on the original phase-in period have been adjusted to account for this change in the accompanying regulatory evaluation. 2. Reviews of Performance of Medical Examiners The NPRM proposed implementation of the SAFETEA-LU requirement that MEs electronically transmit to the FMCSA Chief Medical Examiner on a monthly basis the name of the CMV driver and a numerical identifier for any completed Medical Examination Report required under 49 CFR 391.43 (49 U.S.C. 31149(c)(1)(E)). OccuMedix, Dart Transit Company, and Advocates supported implementing a quality assurance program with a detailed removal process for non-compliant MEs. Advocates asserted we must ensure MEs fulfill the requirement to provide information about completed medical examinations on a regular basis. The commenter described our proposed oversight as vestigial and hit-or-miss, expressing concern that we did not detail the approach to ensure that MEs actually are properly administering the physical examination. Transportation Safety Services recommended that we address the problem area of many physician errors resulting from the physician's support staff incorrectly completing the paperwork. California requested that we provide a mechanism and authorize SDLAs to immediately report to FMCSA any health care professionals not on the National Registry who are performing driver examinations, and any MEs engaged in fraudulent or illegal activity. Finally, a certified MRO recommended that we incorporate the Federal Transit Administration's approach for “Best Practices” awards for MEs that set model examples. FMCSA Response: FMCSA intends to ensure that MEs comply with the requirement in this rule to electronically submit a completed MCSA-5850, CMV Driver Medical Examination Results, form monthly to FMCSA. The details of FMCSA's compliance and monitoring program will relate to FMCSA's future implementation of the provision of SAFETEA-LU (49 U.S.C. 31149(c)(2)), and therefore will not be part of this rulemaking. FMCSA acknowledges that expanding the National Registry to include training and certification of auxiliary staff, whether health care professionals or administrative personnel, might be beneficial. However, in order to minimize the cost burden to the public, the Agency will not include these requirements in the final rule. MEs are reminded that they are responsible for reviewing and correcting any errors in the driver examination documentation. States, other stakeholders, or the public may direct complaints about the performance of MEs as follows: If health care professionals not listed in the National Registry are known to be performing required driver examinations on or after 24 months from the effective date, or if MEs are believed to be engaged in fraudulent or illegal activity, FMCSA should be notified by: (1) Writing the Office of Carrier, Driver and Vehicle Safety Standards, FMCSA, 1200 New Jersey Avenue SE., Washington, DC 20590; (2) sending an email to contactnrcme@dot.gov; or (3) calling an FMCSA-designated toll-free telephone number listed on the National Registry Web site. Finally, FMCSA does not anticipate creating a “best practice award” for MEs as part of the initial implementation of the National Registry Program. FMCSA may revisit this issue after the program has been fully implemented. F. Issues Outside of the Scope of the Rulemaking A number of respondents submitted comments on topics that were either outside the scope of what was proposed in the NPRM or were based on a misunderstanding of what the Agency proposed in this rulemaking. Many of these issues concern how FMCSA could prevent driver fraud in the medical certification process, track commercial driver examinations, require SDLAs to review Medical Examination Reports as part of the CDL, or establish specific medical examination requirements. FMCSA Response: FMCSA acknowledges the policy concerns of the commenters. However, as stated in the NPRM, the legal and policy direction of this rulemaking is limited to requiring drivers to be examined by MEs that have been trained and certified to effectively determine whether they meet FMCSA physical qualification standards under 49 CFR part 391. FMCSA continues to believe this rulemaking represents a major step in improving oversight capabilities by establishing the National Registry, ensuring that MEs are trained and qualified to perform driver examinations, removing MEs who do not meet program requirements from the National Registry, and requiring carriers and drivers to use only MEs on the National Registry. The driver certification issues addressed by this rule complement the driver licensing issues that were addressed by the rule titled “Medical Certification Requirements as Part of the CDL” (December 1, 2008, 73 FR 73096), which established a system for interstate CDL drivers to provide medical certification status information to the SDLAs by providing the ME's certificates. It also required the SDLA to post that medical certification status information into the CDLIS driver record for licensing, enforcement, and employment decisions. The 2008 rule represented a significant first step in improving the oversight capabilities of medical certification status information for non-excepted, interstate CDL drivers. Neither this final rule nor the 2008 rule are intended to address fraud perpetrated by drivers regarding their medical certification or to update SDLAs on disqualified drivers. While we acknowledge that these are important issues, these comments are outside the scope of this rule. However, as previously stated, FMCSA anticipates initiating a future rulemaking to expand medical certification information exchange with the States. A third step toward improving oversight of the driver qualification process is the review and revision, as necessary, of the driver physical qualification standards. The Agency, with the advice of its Medical Review Board and its newly appointed Chief Medical Examiner, has begun the process, which will take several years to complete. Changes to the standards and guidelines for driver qualification are beyond the scope of this rulemaking. G. Comments on the Modified Information Collection FMCSA published a request for public comments concerning a modification of the proposed information collection request under consideration on March 16, 2011 (76 FR 14366). FMCSA proposed a new information collection burden related to a requirement for employers of CMV drivers to verify the National Registry Number of the ME for each driver required to be examined by an ME on the National Registry, and to place a note relating to verification in the driver qualification file. Comment on the information collection burden. One commenter, OOIDA, noted that the information collection burden would affect a large number of motor carriers and add to the already existing burden of recordkeeping obligations for both small motor carriers and owner-operators. FMCSA Response: The Agency's regulations already require small carriers and owner-operators to comply with all of the regulations applicable to both carriers and drivers (see 49 CFR 390.11). The additional information collection burden from this verification requirement on an individual employer is minimal, amounting to a few minutes per driver. The Agency adopts the requirement for employers to verify the ME's National Registry Number for each of its drivers, as proposed. Comments beyond the scope of the information collection notice. Multiple commenters, including several State organizations, stated that requiring employers to verify the National Registry Number would be redundant and unnecessary, because they believed the SDLAs would or should verify the qualifications of the MEs as part of the process for posting medical status information on CDLIS. FMCSA is not requiring SDLAs to verify the National Registry Number. CDLIS only contains this information for CDL holders, and, as employers will be required to verify the ME numbers for both CDL holders and non-CDL holders, this would not be sufficient. Several commenters, including AHAS, ATA, and OOIDA, noted that the Agency's proposal would not substantially deter driver fraud, and suggested alternate ways of addressing fraud. Several of these suggestions would, if adopted, increase the burden of this rulemaking on the employer or require additional public notice and comment rulemaking. FMCSA Response: This rulemaking is one of several incremental steps towards a comprehensive medical certification oversight process that includes the ME, driver, and motor carrier. FMCSA believes that employer verification of an ME National Registry Number is one of several steps toward improving the driver medical certification process. Eliminating opportunities for fraud from the process is one of the goals for the medical certification oversight process. Though the Agency is unable to implement these various suggestions for fraud reduction in this final rule, they have been noted, and may be considered in a future rulemaking. V. Section-by-Section Explanation of Changes From the NPRM Part 350 Commercial Motor Carrier Safety Assistance Program Section 350.341. FMCSA is revising this section so that States that receive MCSAP grants and that have in effect variances for physical qualification requirements for drivers operating CMVs in intrastate commerce will have the option of not establishing a separate registry of medical examiners trained and qualified to apply those standards. Without this option, in order to comply with the general requirement of compatibility established by 49 U.S.C. 31102 and 49 CFR 350.201(a), such States would have the burden of establishing and administering a separate registry for such examiners applying different standards to intrastate-only CMV drivers. FMCSA does not believe it is necessary to place that burden on the States that may have such variances in effect. A State with variances in effect under 350.341(h)(1) and (2) that chooses to set up a separate registry of examiners qualified to apply those variances to intrastate drivers will not be allowed to use MCSAP funds for that purpose. Such use of MCSAP grant funds would not be consistent with the overall purpose of establishing a uniform standard for all CMV drivers nationwide. Part 383 Medical Recordkeeping Section 383.73(o)(1)(iii)(E). FMCSA revises the list of items that the State must post to the CDLIS driver record by deleting the phrase “(if the National Registry of Medical Examiners, mandated by 49 U.S.C. 31149(d), requires one)” after “Medical examiner's National Registry identification number,” because the National Registry Program implementation will indeed require such a number for certified MEs. Part 390 Definitions Section 390.5. The NPRM contained a phase-in schedule for implementation. In the final rule, however, the proposed phase-in has been eliminated and the revised definition applies beginning 2 years after the effective date of the final rule. Thereafter, every medical examination under subpart E of part 391 must be conducted by an ME listed on the National Registry. FMCSA revises the proposed definition of medical examiner to reflect that there is no phase-in schedule. Subpart D of Part 390—National Registry of Certified Medical Examiners Section 390.103. FMCSA adds an introductory phrase to paragraph (b) to clarify that it applies to a person who has ME certification. FMCSA adopts paragraph (a)(1) as proposed. We require the applicant for medical certification to have a legally permitted scope of practice (i.e., license, certification, or registration) that allows him or her to perform independently the requirements of § 391.43. FMCSA eliminates the reference to Appendix A from paragraph (a)(3) because Appendix A was not adopted in the final rule. As originally proposed in the NPRM, Appendix A specified contact information and required statements ME candidates would have to submit to testing organizations before the testing organizations would permit them to take the ME test. In paragraph (a)(3), FMCSA also prohibits an applicant who does not pass the certification test from retaking the test within 30 days, and requires an applicant to take the certification test no more than three years after completing the training. Section 390.105. FMCSA deletes the provision on compliance with section 508 of the Rehabilitation Act for two reasons. First, this section only applies to Federal departments and agencies that provide electronic and information technology to their employees, or who use such technology to provide information and services to members of the public. Second, it is unnecessary in light of the provisions of section 504 of the Rehabilitation Act and Department regulations in 49 CFR part 28. Section 390.107. FMCSA makes changes to proposed § 390.107 Medical examiner certification testing. The Agency adds a new paragraph (b) (and changes the designation of the subsequent paragraphs as appropriate), to require additional security and privacy procedures for those testing organizations who intend to administer the test on-line as an alternative or additional option to in-person testing. FMCSA also eliminates the reference to Appendix A of this part. The NPRM had proposed an Appendix A, but FMCSA did not adopt it in th [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2012-9034. Public record. Not legal advice.