81 FR 18935 - Request for Public Comments on NHTSA Enforcement Guidance Bulletin 2016-02: Safety-Related Defects and Emerging Automotive Technologies
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration Federal Register Volume 81, Issue 63 (April 1, 2016)
National Highway Traffic Safety Administration
Federal Register Volume 81, Issue 63 (April 1, 2016)
| Page Range | 18935-18939 | |
| FR Document | 2016-07353 |
[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)] [Notices] [Pages 18935-18939] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-07353] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration [Docket No. NHTSA-2016-0040] Request for Public Comments on NHTSA Enforcement Guidance Bulletin 2016-02: Safety-Related Defects and Emerging Automotive Technologies AGENCY: National Highway Traffic Safety Administration (NHTSA), Department of Transportation. ACTION: Request for public comments. ----------------------------------------------------------------------- SUMMARY: Automotive technology is at a moment of rapid change and may evolve farther in the next decade than in the previous 45-plus year history of the Agency. As the world moves toward autonomous vehicles and innovative mobility solutions, NHTSA is interested in facilitating the rapid advance of technologies that will promote safety. NHTSA is commanded by Congress to protect the safety of the driving public against unreasonable risks of harm that may occur because of the design, construction, or performance of a motor vehicle or motor vehicle equipment, and mitigate risks of harm, including risks that may be emerging or contingent. As NHTSA always has done when evaluating new technologies and solutions, we will be guided by our statutory mission, the laws we are obligated to enforce, and the benefits of the emerging technologies appearing on America's roadways. NHTSA has broad enforcement authority, under existing statutes and regulations, to address existing and emerging automotive technologies. This proposed Enforcement Guidance Bulletin sets forth NHTSA's current views on emerging automotive technologies--including its view that when vulnerabilities of such technology or equipment pose an unreasonable risk to safety, those vulnerabilities constitute a safety-related defect--and suggests guiding principles and best practices for motor vehicle and equipment manufacturers in this context. This notice solicits comments from the public, motor vehicle and equipment manufacturers, and other interested [[Page 18936]] parties concerning the proposed guidance for motor vehicle and equipment manufacturers in developing and implementing new and emerging automotive technologies, safety compliance programs, and other business practices in connection with such technologies. DATES: Comments must be received on or before May 2, 2016. ADDRESSES: You may submit comments by any of the following methods:Internet: Go to http://www.regulations.gov and follow the online instructions for submitting comments. Mail: Docket Management Facility, M-30, U.S. Department of Transportation, 1200 New Jersey Avenue SE., West Building, Room W12- 140, Washington, DC 20590. Hand Delivery or Courier: U.S. Department of Transportation, 1200 New Jersey Avenue SE., West Building, Room W12- 140, Washington, DC 20590 between 9 a.m. and 5 p.m. Eastern Time, Monday through Friday, except Federal holidays. Facsimile: (202) 493-2251. Regardless of how you submit your comments, please mention the docket number of this document. You may also call the Docket at (202) 366-9322. Instructions: All comments received must include the Agency name and docket ID. Please submit your comments by only one means. Regardless of the method used for submitting comments, all submissions will be posted without change to http://www.regulations.gov, including any personal information provided. Thus, submitting such information makes it public. You may wish to read the Privacy Act notice, which can be viewed by clicking on the ``Privacy and Security Notice'' link in the footer of http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Justine Casselle, Office of the Chief Counsel, National Highway Traffic Safety Administration, or Elizabeth Mykytiuk, Office of the Chief Counsel, National Highway Traffic Safety Administration, at (202) 366-2992. SUPPLEMENTARY INFORMATION: I. Executive Summary II. Legal and Policy Background A. NHTSA's Enforcement Authority Under the Safety Act B. Determining the Existence of a Defect C. Determining an Unreasonable Risk to Safety III. Guidance and Recommended Best Practices: Safety-Related Defects, Unreasonable Risk, and Emerging Technologies I. Executive Summary Recent and continuing advances in automotive technology have great potential to generate significant safety benefits. Today's motor vehicles are increasingly equipped with electronics, sensors, and computing power that enable the deployment of safety technologies and functions, such as forward-collision warning, automatic-emergency braking, and lane keeping assist, which dramatically enhance safety. New technologies may not only prevent drivers from crashing, but may even do some or all of the driving for them. The safety implications of such emerging technologies are vast. Importantly, as these technologies become more widespread, manufacturers must ensure their safe development and implementation. To facilitate automotive safety innovation, to aid in the successful development and deployment of emerging automotive technologies, and to protect the public from potential flaws or threats associated with emerging automotive technologies, NHTSA is publishing, for guidance and informational purposes, this Enforcement Guidance Bulletin setting forth the Agency's current view of its enforcement authority and principles guiding its exercise of that authority. This includes guiding principles and best practices for use by motor vehicle and equipment manufacturers. NHTSA is not establishing a binding set of rules, nor is the Agency suggesting that one particular set of practices applies in all situations. The Agency recognizes that best practices vary depending on circumstances, and manufacturers remain free to choose the solution that best fits their needs and the demands of automotive safety. However, to address safety concerns associated with emerging technologies in a comprehensive way, and to advise regulated entities of the Agency's present views of certain enforcement subjects and issues, NHTSA submits this proposed Enforcement Guidance Bulletin for public comment. Based on the Agency's review and analysis of that input, it will develop and issue a final ``Enforcement Guidance Bulletin'' on this topic. II. Legal and Policy Background A. NHTSA's Enforcement Authority Under the Safety Act The National Traffic and Motor Vehicle Safety Act, as amended (``Safety Act''), 49 U.S.C. 30101 et seq., provides the basis and framework for NHTSA's enforcement authority over motor vehicle and motor vehicle equipment defects and noncompliances with federal motor vehicle safety standards (FMVSS). This authority includes investigations, administrative proceedings, civil penalties, and civil enforcement actions. While automation and other advanced technologies may modify motor vehicle and equipment design, NHTSA's statutory enforcement authority is general and flexible, which allows it to keep pace with innovation. The Agency has the authority to respond to a safety problem posed by new technologies in the same manner it has responded to safety problems posed by more established automotive technology and equipment, such as carburetors, the powertrain, vehicle control systems, and forward collision warning systems--by determining the existence of a defect that poses an unreasonable risk to motor vehicle safety and ordering the manufacturer to conduct a recall. See 49 U.S.C. 30118(b). This enforcement authority applies notwithstanding the presence or absence of an FMVSS for any particular type of advanced technology. See, e.g., United States v. Chrysler Corp., 158 F.3d 1350, 1351 (D.C. Cir. 1998) (NHTSA ``may seek the recall of a motor vehicle either when a vehicle has `a defect related to motor vehicle safety' or when a vehicle `does not comply with an applicable motor vehicle safety standard.' '').\1\ --------------------------------------------------------------------------- \1\ A manufacturer's obligation to recall motor vehicles and motor vehicle equipment determined to have a safety-related defect is separate and distinct from its obligation to recall motor vehicles and motor vehicle equipment that fail to comply with an applicable FMVSS. See 49 U.S.C. 30120. --------------------------------------------------------------------------- Under the Safety Act, NHTSA has authority over motor vehicles, equipment included in or on a motor vehicle at the time of delivery to the first purchaser (i.e., original equipment), and motor vehicle replacement equipment. See 49 U.S.C. 30102(a)-(b). Motor vehicle equipment is broadly defined to include ``any system, part, or component of a motor vehicle as originally manufactured'' and ``any similar part or component manufactured or sold for replacement or improvement of a system, part, or component.'' 49 U.S.C. 30102(a)(7)(A)-(B). The Safety Act also gives NHTSA jurisdiction over after-market improvements, accessories, or additions to motor vehicles. See 49 U.S.C. 30102(a)(7)(B). All devices ``manufactured, sold, delivered, or offered to be sold for use on public streets, roads, and highways with the apparent purpose of safeguarding users of motor vehicles against risk of accident, injury, or death'' are similarly subject to NHTSA's enforcement authority. 49 U.S.C. 30102(a)(7)(C). [[Page 18937]] With respect to new and emerging technologies, NHTSA considers automated vehicle technologies, systems, and equipment to be motor vehicle equipment, whether they are offered to the public as part of a new motor vehicle (as original equipment) or as an after-market replacement(s) of or improvement(s) to original equipment. NHTSA also considers software (including, but not necessarily limited to, the programs, instructions, code, and data used to operate computers and related devices), and after-market software updates, to be motor vehicle equipment within the meaning of the Safety Act. Software that enables devices not located in or on the motor vehicle to connect to the motor vehicle or its systems could, in some circumstances, also be considered motor vehicle equipment. Accordingly, a manufacturer of new and emerging vehicle technologies and equipment, whether it is the supplier of the equipment or the manufacturer of a motor vehicle on which the equipment is installed, has an obligation to notify NHTSA of any and all safety-related defects. See 49 CFR part 573. Any manufacturer or supplier that fails to do so may be subject to civil penalties. See 49 U.S.C. 30165(a). NHTSA is charged with reducing deaths, injuries, and economic losses resulting from motor vehicle crashes. See 49 U.S.C. 30101. Part of that mandate includes ensuring that motor vehicles and motor vehicle equipment, including new technologies, perform in ways that ``protect[] the public against unreasonable risk of accidents occurring because of the design, construction, or performance of a motor vehicle, and against unreasonable risk of death or injury in an accident.'' 49 U.S.C. 30102(a)(8). This responsibility also includes the nonoperational safety of a motor vehicle. Id. In pursuit of these safety objectives, and in the absence of adequate action by the manufacturer, NHTSA is authorized to determine that a motor vehicle or motor vehicle equipment is defective and that the defect poses an unreasonable risk to safety. See 49 U.S.C. 30118(b) and (c)(1). B. Determining the Existence of a Defect Under the Safety Act, a ``defect'' includes ``any defect in performance, construction, a component, or material of a motor vehicle or motor vehicle equipment.'' 49 U.S.C. 30102(a)(2). It also includes a defect in design. See United States v. General Motors Corp., 518 F.2d 420, 436 (D.C. Cir. 1975) (``Wheels''). A defect in an item of motor vehicle equipment (including hardware, software and other electronic systems) may be considered a defect of the motor vehicle itself. See 49 U.S.C. 30102(b)(1)(F). Congress intended the Safety Act to represent a ``commonsense'' approach to safety and courts have followed that approach in determining what constitutes a ``defect.'' Wheels, 518 F.2d at 436. Accord Center for Auto Safety, Inc. v. National Highway Traffic Safety Administration, 342 F. Supp. 2d 1, 15 (D.D.C. 2004); Clarke v. TRW, Inc., 921 F. Supp. 927, 934 (N.D.N.Y. 1996). For this reason, a defect determination does not require an engineering explanation or root cause, but instead ``may be based exclusively on the performance record of the component.'' Wheels, 518 F.2d at 432 (``[A] determination of a `defect' does not require any predicate of a finding identifying engineering, metallurgical, or manufacturing failures.''). Thus, a motor vehicle or item of equipment contains a defect if it is subject to a significant number of failures in normal operation, ``including those failures occurring during `specified use' or resulting from predictable abuse, but not including those resulting from normal deterioration due to age and wear.'' \2\ Center for Auto Safety, 342 F.2d at 13-14 (citing Wheels, 518 F.2d at 427). --------------------------------------------------------------------------- \2\ ``The protection afforded by the [Safety] Act was not limited to careful drivers who fastidiously observed speed limits and conscientiously complied with manufacturer's instructions on vehicle maintenance and operation . . . . [the statute provides] an added area of safety to an owner who is lackadaisical, who neglects regular maintenance . . .'' Wheels, 518 F.2d at 434. --------------------------------------------------------------------------- A ``significant number of failures'' is merely a ``non-de minimus'' quantity; it need not be a ``substantial percentage of the total.'' Wheels, 518 F.2d at 438 n.84. Whether there have been a ``significant number of failures'' is a fact-specific inquiry that includes considerations such as: The failure rate of the component in question; the failure rates of comparable components; and the importance of the component to the safe operation of the vehicle. Id. at 427. In addition, where appropriate, the determination of the existence of a defect may depend upon the failure rate in the affected class of vehicles compared to that of other peer vehicles. See United States v. Gen. Motors Corp., 841 F.2d 400, 412 (D.C. Cir.1988) (``X-Cars''). Finally, to constitute a defect, the failures must be attributable to the motor vehicle or equipment itself, rather than the driver or the road conditions. See id. It must be noted, however, that in some circumstances, a crash, injury, or death need not occur in order for a vulnerability or safety risk to be considered a defect. The Agency relies on the performance record of a vehicle or component in making a defect determination where the engineering or root cause is unknown. See Wheels, 518 F.2d at 432. Where, however, the engineering or root cause is known, the Agency need not proceed with analyzing the performance record. See id.; see also United States v. Gen. Motors Corp., 565 F.2d 754, 758 (D.C. Cir. 1977) (``Carburetors'') (finding a defect to be safety-related if it ``results in hazards as potentially dangerous as sudden engine fire, and where there is no dispute that at least some such hazards . . . can definitely be expected to occur in the future.''). For software or other electronic systems, for example, when the engineering or root cause of the vulnerability or risk is known, a defect exists regardless of whether there have been any actual failures. C. Determining an Unreasonable Risk to Safety In order to support a recall, a defect must be related to motor vehicle safety. United States v. General Motors Corp., 561 F.2d 923, 928-29 (D.C. Cir. 1977) (``Pitman Arms''). In the context of the Safety Act, ``motor vehicle safety'' refers to an ``unreasonable risk of accidents'' and an ``unreasonable risk of death or injury in an accident.'' 49 U.S.C. 30102(a)(8). Thus, while the defect analysis has generally entailed a retrospective look at how many failures have occurred (see Wheels, Center for Auto Safety, and Pitman Arms), the safety-relatedness question is forward-looking, and concerns the hazards that may arise in the future. See, e.g., Carburetors, 565 F.2d at 758. In general, for a defect to present an ``unreasonable risk,'' there must be a likelihood that it will cause or be associated with a ``non- negligible'' number of crashes, injuries, or deaths in the future. See, e.g., Carburetors, 565 F.2d at 759. This prediction of future hazards is called a ``risk analysis.'' See, e.g., Pitman Arms, 561 F.2d at 924 (Leventhal, J., dissenting) (``GM presented a `risk analysis' which predicts the likely number of future injuries or deaths to be expected in the remaining service life of the affected models''). A forward- looking risk analysis is compelled by the purpose of the Safety Act, which ``is not to protect individuals from the risks associated with defective vehicles only after serious injuries have already occurred; it is to prevent serious injuries stemming from established defects before they occur.'' Carburetors, 565 F.2d at 759 (emphasis added). [[Page 18938]] If the hazard is sufficiently serious, and at least some harm, however small, is expected to occur in the future, the risk may be deemed unreasonable. Carburetors, 565 F.2d at 759 (``In the context of this case . . . even an `exceedingly small' number of injuries from this admittedly defective and clearly dangerous carburetor appears to us `unreasonably large.' ''). In other words, where a defect presents a ``clearly'' or ``potentially dangerous'' hazard, and where ``at least some such hazards''--even an ``exceedingly small'' number--will occur in the future, that defect is necessarily safety-related. See Carburetors, 565 F.2d 754. This is so regardless of whether any injuries have already occurred, or whether the projected number of failures/injuries in the future is trending down. See id. at 759. Moreover, a defect may be considered ``per se'' safety-related if it causes the failure of a critical component; causes a vehicle fire; causes a loss of vehicle control; or suddenly moves the driver away from steering, accelerator, and brake controls--regardless of how many injuries or accidents are likely to occur in the future. See Carburetors, 565 F.2d 754 (engine fires); Pitman Arms, 561 F.2d 923 (loss of control); United States v. Ford Motor Co., 453 F. Supp. 1240 (D.D.C. 1978) (``Wipers'') (loss of visibility); United States v. Ford Motor Co., 421 F. Supp. 1239, 1243-1244 (D.D.C. 1976) (``Seatbacks'') (loss of control). Similarly, where it is alleged that a defect ``is systematic and is prevalent in a particular class [of motor vehicles or equipment], . . . this is prima facie an unreasonable risk.'' Pitman Arms, 561 F.2d at 929. III. Guidance and Recommended Best Practices: Safety-Related Defects, Unreasonable Risk, and Emerging Technologies Consistent with the foregoing background, NHTSA's enforcement authority concerning safety-related defects in motor vehicles and equipment extends and applies equally to new and emerging automotive technologies. This includes, for example, automation technology and equipment, as well as advanced crash avoidance technologies. Where an autonomous vehicle or other emerging automotive technology causes crashes or injuries, or has a manifested safety-related failure or defect, and a manufacturer fails to act, NHTSA will exercise its enforcement authority to the fullest extent. Similarly, should the Agency determine that an autonomous vehicle or other new automotive technology presents a safety concern, the Agency will evaluate such technology through its investigative authority to determine whether the technology presents an unreasonable risk to safety. To avoid violating Safety Act requirements and standards, manufacturers of emerging technology and the motor vehicles on which such technology is installed are strongly encouraged to take steps to proactively identify and resolve safety concerns before their products are available for use on public roadways. The Agency recognizes that much emerging automotive technology heavily involves electronic systems (such as hardware, software, sensors, global positioning systems (GPS) and vehicle-to-vehicle (V2V) safety communications systems). The Agency acknowledges that the increased use of electronic systems in motor vehicles and equipment may raise new and different safety concerns. However, the complexities of these systems do not diminish manufacturers' duties under the Safety Act--both motor vehicle manufacturers and equipment manufacturers remain responsible for ensuring that their vehicles or equipment are free of safety-related defects or noncompliances, and do not otherwise pose an unreasonable risk to safety. Manufacturers are also reminded that they remain responsible for promptly reporting to NHTSA any safety-related defects or noncompliances, as well as timely notifying owners and dealers of the same. In assessing whether a motor vehicle or piece of motor vehicle equipment poses an unreasonable risk to safety, NHTSA considers the likelihood of the occurrence of a harm (i.e., fire, stalling, or malicious cybersecurity attack), the potential frequency of a harm, the severity of a harm, known engineering or root cause, and other relevant factors. Where a threatened harm is substantial, low potential frequency may not carry as much weight in NHTSA's analysis. Software installed in or on a motor vehicle--which is motor vehicle equipment--presents its own unique safety risks. Because software often interacts with a motor vehicle's critical safety systems (i.e., systems encompassing critical control functions such as braking, steering, or acceleration) the operation of those systems could be substantially altered by after-market software updates. Additionally, software located outside the motor vehicle (i.e., portable devices with vehicle- related software applications) could be used to affect and control a motor vehicle's safety systems. If software has manifested a safety- related performance failure, or otherwise presents an unreasonable risk to safety, then the software failure or safety-risk constitutes a defect compelling a recall. In the case of cybersecurity vulnerabilities, NHTSA will weigh several factors in determining whether a vulnerability poses an unreasonable risk to safety (and thus constitutes a safety-related defect), including: (i) The amount of time elapsed since the vulnerability was discovered (e.g., less than one day, three months, or more than six months); (ii) the level of expertise needed to exploit the vulnerability (e.g., whether a layman can exploit the vulnerability or whether it takes experts to do so); (iii) the accessibility of knowledge of the underlying system (e.g., whether how the system works is public knowledge or whether it is sensitive and restricted); (iv) the necessary window of opportunity to exploit the vulnerability (e.g., an unlimited window or a very narrow window); and, (v) the level of equipment needed to exploit the vulnerability (e.g., standard or highly specialized). NHTSA uses those factors, and others, to help assess the overall probability of a malicious cybersecurity attack. The probability of an attack includes circumstances in which a vulnerability has been identified, but no actual incidents have been documented or confirmed. Confirmed field incidents may increase the weight NHTSA places on the probability of an attack in its assessment. Even before evidence of an attack, it is foreseeable that hackers will try to exploit cybersecurity vulnerabilities. For instance, if a cybersecurity vulnerability in any of a motor vehicle's entry points (e.g., Wi-Fi, infotainment systems, the OBD-II port) allows remote access to a motor vehicle's critical safety systems (i.e., systems encompassing critical control functions such as braking, steering, or acceleration), NHTSA may consider such a vulnerability to be a safety-related defect compelling a recall. Manufacturers should consider adopting a life-cycle approach to safety risks when developing automated vehicles, other innovative automotive technologies, and safety compliance programs and other business practices in connection with such technologies. A life-cycle approach would include ``elements of assessment, design, implementation, and operations as well as an effective testing and certification program.'' National Highway Traffic Safety Administration, A Summary of Cybersecurity Best Practices, (Oct. 2014), http://www.nhtsa.gov/DOT/ [[Page 18939]] NHTSA/NVS/Crash%20Avoidance/Technical%20Publications/2014/ 812075_CybersecurityBestPractices.pdf. Considering hardware, software, and network and cloud security, manufacturers should consider developing a simulator, using case scenarios and threat modeling on all systems, sub-systems, and devices, to test for safety risks, including cybersecurity vulnerabilities, at all steps in the manufacturing process for the entire supply chain, to implement an effective risk mitigation plan. See id. Manufacturers of emerging technologies and the motor vehicles on which such technology is installed have a continuing obligation to proactively identify safety concerns and mitigate the risks of harm. If a manufacturer discovers or is otherwise made aware of any defects, noncompliances, or other unreasonable risks to safety after the vehicle and/or technology has been in safe operation for some time, then it should strongly consider promptly contacting the appropriate NHTSA personnel to determine the necessary next steps. Where a manufacturer fails to adequately address a safety concern, NHTSA, when appropriate, will explicitly address that concern through its enforcement authority. Applicability/Legal Statement: This proposed Enforcement Guidance Bulletin sets forth NHTSA's current views on the topic of emerging automotive technology and suggests guiding principles and best practices to be utilized by motor vehicle and equipment manufacturers in this context. This proposed Bulletin is not a final agency action and is intended as guidance only. This proposed Bulletin does not have the force or effect of law. This Bulletin is not intended, nor can it be relied upon, to create any rights enforceable by any party against NHTSA, the U.S. Department of Transportation, or the United States. These recommended practices do not establish any defense to any violations of the Safety Act, or regulations thereunder, or violation of any statutes or regulations that NHTSA administers. This Bulletin may be revised in writing without notice to reflect changes in the Agency's views and analysis, or to clarify and update text. Authority: 49 U.S.C. 30101-30103, 30116-30121, 30166; delegation of authority at 49 CFR 1.95 and 49 CFR 501.8. Issued in Washington, DC, on March 25, 2016 under authority delegated pursuant to 49 CFR 1.95. Paul A. Hemmersbaugh, Chief Counsel. [FR Doc. 2016-07353 Filed 3-29-16; 4:15 pm] BILLING CODE 4910-59-P
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• Medical Direction; emergency medical services for 26. Do you have any additional
• Education Systems; children? comments regarding the revision of the
• Public Education; 9. How could the revised EMS EMS Agenda?
• Prevention; Agenda address the future of EMS data Issued on: March 22, 2016.
• Public Access; collection and information sharing?
Jeffrey P. Michael,
• Communication Systems; 10. How could the revised EMS
Associate Administrator, Research and
• Clinical Care; Agenda support data-driven and
Program Development.
• Information Systems; evidence-based improvements in EMS
• Evaluation. systems? [FR Doc. 2016–06960 Filed 3–31–16; 8:45 am]
In 2014, NEMSAC recommended that 11. How could the revised EMS BILLING CODE 4910–59–P
NHTSA undertake a major revision of Agenda enhance collaboration among
the EMS Agenda. NHTSA, on behalf of EMS systems, health care providers,
FICEMS, intends to work closely with hospitals, public safety answering DEPARTMENT OF TRANSPORTATION
EMS stakeholders in revising the EMS points, public health, insurers, National Highway Traffic Safety
Agenda. It is anticipated the revised palliative care and others? Administration
EMS Agenda will envision the evolution 12. How will innovative patient care
of EMS systems over the next 30 years. delivery and finance models impact [Docket No. NHTSA–2016–0040]
EMS systems over the next 30 years?
Questions on the Proposed Revision of 13. How could the revised EMS Request for Public Comments on
the EMS Agenda Agenda promote community NHTSA Enforcement Guidance Bulletin
Responses to the following questions preparedness and resilience? 2016–02: Safety-Related Defects and
are requested to help plan the revision 14. How could the revised EMS Emerging Automotive Technologies
of the EMS Agenda. Please provide Agenda contribute to improved AGENCY: National Highway Traffic
references as appropriate. coordination for mass casualty incident Safety Administration (NHTSA),
1. What are the most critical issues preparedness and response? Department of Transportation.
facing EMS systems that should be 15. How could the revised EMS
Agenda enhance the exchange of ACTION: Request for public comments.
addressed in the revision of the EMS
Agenda? Please be as specific as evidence based practices between SUMMARY: Automotive technology is at a
possible. military and civilian medicine? moment of rapid change and may evolve
2. What progress has been made in 16. How could the revised EMS farther in the next decade than in the
implementing the EMS Agenda since its Agenda support the seamless and previous 45-plus year history of the
publication in 1996? unimpeded transfer of military EMS Agency. As the world moves toward
3. How have you used the EMS personnel to roles as civilian EMS autonomous vehicles and innovative
Agenda? Please provide specific providers? mobility solutions, NHTSA is interested
17. How could the revised EMS in facilitating the rapid advance of
examples.
Agenda support interstate credentialing technologies that will promote safety.
4. As an EMS stakeholder, how might
of EMS personnel? NHTSA is commanded by Congress to
the revised EMS Agenda be most useful 18. How could the revised EMS
to you? protect the safety of the driving public
Agenda support improved patient
5. What significant changes have against unreasonable risks of harm that
outcomes in rural and frontier
occurred in EMS systems at the may occur because of the design,
communities?
national, State and local levels since 19. How could the revised EMS construction, or performance of a motor
1996? Agenda contribute to improved EMS vehicle or motor vehicle equipment, and
6. What significant changes will education systems at the local, State, mitigate risks of harm, including risks
impact EMS systems over the next 30 and national levels? that may be emerging or contingent. As
years? 20. How could the revised EMS NHTSA always has done when
7. How might the revised EMS Agenda lead to improved EMS systems evaluating new technologies and
Agenda support the following FICEMS in tribal communities? solutions, we will be guided by our
Strategic Plan goals: 21. How could the revised EMS statutory mission, the laws we are
a. Coordinated, regionalized, and Agenda promote a culture of safety obligated to enforce, and the benefits of
accountable EMS and 9–1–1 systems among EMS personnel, agencies and the emerging technologies appearing on
that provide safe, high-quality care; organizations? America’s roadways.
b. data-driven and evidence-based 22. Are there additional EMS NHTSA has broad enforcement
EMS systems that promote improved attributes that should be included in the authority, under existing statutes and
patient care quality; revised EMS Agenda? If so, please regulations, to address existing and
c. EMS systems fully integrated into provide an explanation for why these emerging automotive technologies. This
State, territorial, local, tribal, regional, additional EMS attributes should be proposed Enforcement Guidance
and Federal preparedness planning, included. Bulletin sets forth NHTSA’s current
response, and recovery; 23. Are there EMS attributes in the views on emerging automotive
d. EMS systems that are sustainable, EMS Agenda that should be eliminated technologies—including its view that
forward looking, and integrated with the from the revised edition? If so, please when vulnerabilities of such technology
evolving health care system; or equipment pose an unreasonable risk
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provide an explanation for why these
e. an EMS culture in which safety EMS attributes should be eliminated. to safety, those vulnerabilities constitute
considerations for patients, providers, 24. What are your suggestions for the a safety-related defect—and suggests
and the community permeate the full process that should be used in revising guiding principles and best practices for
spectrum of activities; and the EMS Agenda? motor vehicle and equipment
f. a well-educated and uniformly 25. What specific agencies/ manufacturers in this context. This
credentialed EMS workforce. organizations/entities are essential to notice solicits comments from the
8. How could the revised EMS involve, in a revision of the EMS public, motor vehicle and equipment
Agenda contribute to enhanced Agenda? manufacturers, and other interested
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With respect to new and emerging may be considered a defect of the motor vulnerability or safety risk to be
technologies, NHTSA considers vehicle itself. See 49 U.S.C. considered a defect. The Agency relies
automated vehicle technologies, 30102(b)(1)(F). on the performance record of a vehicle
systems, and equipment to be motor Congress intended the Safety Act to or component in making a defect
vehicle equipment, whether they are represent a ‘‘commonsense’’ approach to determination where the engineering or
offered to the public as part of a new safety and courts have followed that root cause is unknown. See Wheels, 518
motor vehicle (as original equipment) or approach in determining what F.2d at 432. Where, however, the
as an after-market replacement(s) of or constitutes a ‘‘defect.’’ Wheels, 518 F.2d engineering or root cause is known, the
improvement(s) to original equipment. at 436. Accord Center for Auto Safety, Agency need not proceed with
NHTSA also considers software Inc. v. National Highway Traffic Safety analyzing the performance record. See
(including, but not necessarily limited Administration, 342 F. Supp. 2d 1, 15 id.; see also United States v. Gen.
to, the programs, instructions, code, and (D.D.C. 2004); Clarke v. TRW, Inc., 921 Motors Corp., 565 F.2d 754, 758 (D.C.
data used to operate computers and F. Supp. 927, 934 (N.D.N.Y. 1996). For Cir. 1977) (‘‘Carburetors’’) (finding a
related devices), and after-market this reason, a defect determination does defect to be safety-related if it ‘‘results
software updates, to be motor vehicle not require an engineering explanation in hazards as potentially dangerous as
equipment within the meaning of the or root cause, but instead ‘‘may be based sudden engine fire, and where there is
Safety Act. Software that enables exclusively on the performance record no dispute that at least some such
devices not located in or on the motor of the component.’’ Wheels, 518 F.2d at hazards . . . can definitely be expected
vehicle to connect to the motor vehicle 432 (‘‘[A] determination of a ‘defect’ to occur in the future.’’). For software or
or its systems could, in some does not require any predicate of a other electronic systems, for example,
circumstances, also be considered motor finding identifying engineering, when the engineering or root cause of
vehicle equipment. Accordingly, a metallurgical, or manufacturing the vulnerability or risk is known, a
manufacturer of new and emerging failures.’’). Thus, a motor vehicle or defect exists regardless of whether there
vehicle technologies and equipment, item of equipment contains a defect if have been any actual failures.
whether it is the supplier of the it is subject to a significant number of C. Determining an Unreasonable Risk to
equipment or the manufacturer of a failures in normal operation, ‘‘including Safety
motor vehicle on which the equipment those failures occurring during
is installed, has an obligation to notify ‘specified use’ or resulting from In order to support a recall, a defect
NHTSA of any and all safety-related predictable abuse, but not including must be related to motor vehicle safety.
defects. See 49 CFR part 573. Any those resulting from normal United States v. General Motors Corp.,
manufacturer or supplier that fails to do deterioration due to age and 561 F.2d 923, 928–29 (D.C. Cir. 1977)
so may be subject to civil penalties. See wear.’’ 2 Center for Auto Safety, 342 F.2d (‘‘Pitman Arms’’). In the context of the
49 U.S.C. 30165(a). at 13–14 (citing Wheels, 518 F.2d at Safety Act, ‘‘motor vehicle safety’’ refers
NHTSA is charged with reducing 427). to an ‘‘unreasonable risk of accidents’’
deaths, injuries, and economic losses A ‘‘significant number of failures’’ is and an ‘‘unreasonable risk of death or
resulting from motor vehicle crashes. merely a ‘‘non-de minimus’’ quantity; it injury in an accident.’’ 49 U.S.C.
See 49 U.S.C. 30101. Part of that need not be a ‘‘substantial percentage of 30102(a)(8). Thus, while the defect
mandate includes ensuring that motor the total.’’ Wheels, 518 F.2d at 438 n.84. analysis has generally entailed a
vehicles and motor vehicle equipment, Whether there have been a ‘‘significant retrospective look at how many failures
including new technologies, perform in number of failures’’ is a fact-specific have occurred (see Wheels, Center for
ways that ‘‘protect[] the public against inquiry that includes considerations Auto Safety, and Pitman Arms), the
unreasonable risk of accidents occurring such as: The failure rate of the safety-relatedness question is forward-
because of the design, construction, or component in question; the failure rates looking, and concerns the hazards that
performance of a motor vehicle, and of comparable components; and the may arise in the future. See, e.g.,
against unreasonable risk of death or importance of the component to the safe Carburetors, 565 F.2d at 758.
injury in an accident.’’ 49 U.S.C. operation of the vehicle. Id. at 427. In In general, for a defect to present an
30102(a)(8). This responsibility also addition, where appropriate, the ‘‘unreasonable risk,’’ there must be a
includes the nonoperational safety of a determination of the existence of a likelihood that it will cause or be
motor vehicle. Id. In pursuit of these associated with a ‘‘non-negligible’’
defect may depend upon the failure rate
safety objectives, and in the absence of number of crashes, injuries, or deaths in
in the affected class of vehicles
adequate action by the manufacturer, the future. See, e.g., Carburetors, 565
compared to that of other peer vehicles.
NHTSA is authorized to determine that F.2d at 759. This prediction of future
See United States v. Gen. Motors Corp.,
a motor vehicle or motor vehicle hazards is called a ‘‘risk analysis.’’ See,
841 F.2d 400, 412 (D.C. Cir.1988) (‘‘X-
equipment is defective and that the e.g., Pitman Arms, 561 F.2d at 924
Cars’’). Finally, to constitute a defect,
defect poses an unreasonable risk to (Leventhal, J., dissenting) (‘‘GM
the failures must be attributable to the
safety. See 49 U.S.C. 30118(b) and (c)(1). presented a ‘risk analysis’ which
motor vehicle or equipment itself, rather
predicts the likely number of future
B. Determining the Existence of a Defect than the driver or the road conditions.
injuries or deaths to be expected in the
See id.
Under the Safety Act, a ‘‘defect’’ remaining service life of the affected
It must be noted, however, that in
includes ‘‘any defect in performance, models’’). A forward-looking risk
some circumstances, a crash, injury, or
construction, a component, or material analysis is compelled by the purpose of
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death need not occur in order for a
of a motor vehicle or motor vehicle the Safety Act, which ‘‘is not to protect
equipment.’’ 49 U.S.C. 30102(a)(2). It 2 ‘‘The protection afforded by the [Safety] Act was individuals from the risks associated
also includes a defect in design. See not limited to careful drivers who fastidiously with defective vehicles only after
United States v. General Motors Corp., observed speed limits and conscientiously serious injuries have already occurred;
518 F.2d 420, 436 (D.C. Cir. 1975) complied with manufacturer’s instructions on it is to prevent serious injuries
vehicle maintenance and operation . . . . [the
(‘‘Wheels’’). A defect in an item of motor statute provides] an added area of safety to an
stemming from established defects
vehicle equipment (including hardware, owner who is lackadaisical, who neglects regular before they occur.’’ Carburetors, 565
software and other electronic systems) maintenance . . .’’ Wheels, 518 F.2d at 434. F.2d at 759 (emphasis added).
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![18938 Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices
If the hazard is sufficiently serious, the Agency will evaluate such related performance failure, or
and at least some harm, however small, technology through its investigative otherwise presents an unreasonable risk
is expected to occur in the future, the authority to determine whether the to safety, then the software failure or
risk may be deemed unreasonable. technology presents an unreasonable safety-risk constitutes a defect
Carburetors, 565 F.2d at 759 (‘‘In the risk to safety. compelling a recall.
context of this case . . . even an To avoid violating Safety Act In the case of cybersecurity
‘exceedingly small’ number of injuries requirements and standards, vulnerabilities, NHTSA will weigh
from this admittedly defective and manufacturers of emerging technology several factors in determining whether a
clearly dangerous carburetor appears to and the motor vehicles on which such vulnerability poses an unreasonable risk
us ‘unreasonably large.’ ’’). In other technology is installed are strongly to safety (and thus constitutes a safety-
words, where a defect presents a encouraged to take steps to proactively related defect), including: (i) The
‘‘clearly’’ or ‘‘potentially dangerous’’ identify and resolve safety concerns amount of time elapsed since the
hazard, and where ‘‘at least some such before their products are available for vulnerability was discovered (e.g., less
hazards’’—even an ‘‘exceedingly small’’ use on public roadways. The Agency than one day, three months, or more
number—will occur in the future, that recognizes that much emerging than six months); (ii) the level of
defect is necessarily safety-related. See automotive technology heavily involves expertise needed to exploit the
Carburetors, 565 F.2d 754. This is so electronic systems (such as hardware, vulnerability (e.g., whether a layman
regardless of whether any injuries have software, sensors, global positioning can exploit the vulnerability or whether
already occurred, or whether the systems (GPS) and vehicle-to-vehicle it takes experts to do so); (iii) the
projected number of failures/injuries in (V2V) safety communications systems). accessibility of knowledge of the
the future is trending down. See id. at The Agency acknowledges that the underlying system (e.g., whether how
759. Moreover, a defect may be increased use of electronic systems in the system works is public knowledge
considered ‘‘per se’’ safety-related if it motor vehicles and equipment may raise or whether it is sensitive and restricted);
causes the failure of a critical new and different safety concerns. (iv) the necessary window of
component; causes a vehicle fire; causes However, the complexities of these opportunity to exploit the vulnerability
a loss of vehicle control; or suddenly systems do not diminish manufacturers’ (e.g., an unlimited window or a very
moves the driver away from steering, duties under the Safety Act—both motor narrow window); and, (v) the level of
accelerator, and brake controls— vehicle manufacturers and equipment equipment needed to exploit the
regardless of how many injuries or manufacturers remain responsible for vulnerability (e.g., standard or highly
accidents are likely to occur in the ensuring that their vehicles or specialized).
future. See Carburetors, 565 F.2d 754 equipment are free of safety-related NHTSA uses those factors, and others,
(engine fires); Pitman Arms, 561 F.2d defects or noncompliances, and do not to help assess the overall probability of
923 (loss of control); United States v. otherwise pose an unreasonable risk to a malicious cybersecurity attack. The
Ford Motor Co., 453 F. Supp. 1240 safety. Manufacturers are also reminded probability of an attack includes
(D.D.C. 1978) (‘‘Wipers’’) (loss of that they remain responsible for circumstances in which a vulnerability
visibility); United States v. Ford Motor promptly reporting to NHTSA any has been identified, but no actual
Co., 421 F. Supp. 1239, 1243–1244 safety-related defects or incidents have been documented or
(D.D.C. 1976) (‘‘Seatbacks’’) (loss of noncompliances, as well as timely confirmed. Confirmed field incidents
control). Similarly, where it is alleged notifying owners and dealers of the may increase the weight NHTSA places
that a defect ‘‘is systematic and is same. on the probability of an attack in its
prevalent in a particular class [of motor In assessing whether a motor vehicle assessment. Even before evidence of an
vehicles or equipment], . . . this is or piece of motor vehicle equipment attack, it is foreseeable that hackers will
prima facie an unreasonable risk.’’ poses an unreasonable risk to safety, try to exploit cybersecurity
Pitman Arms, 561 F.2d at 929. NHTSA considers the likelihood of the vulnerabilities. For instance, if a
occurrence of a harm (i.e., fire, stalling, cybersecurity vulnerability in any of a
III. Guidance and Recommended Best or malicious cybersecurity attack), the motor vehicle’s entry points (e.g., Wi-Fi,
Practices: Safety-Related Defects, potential frequency of a harm, the infotainment systems, the OBD–II port)
Unreasonable Risk, and Emerging severity of a harm, known engineering allows remote access to a motor
Technologies or root cause, and other relevant factors. vehicle’s critical safety systems (i.e.,
Consistent with the foregoing Where a threatened harm is substantial, systems encompassing critical control
background, NHTSA’s enforcement low potential frequency may not carry functions such as braking, steering, or
authority concerning safety-related as much weight in NHTSA’s analysis. acceleration), NHTSA may consider
defects in motor vehicles and Software installed in or on a motor such a vulnerability to be a safety-
equipment extends and applies equally vehicle—which is motor vehicle related defect compelling a recall.
to new and emerging automotive equipment—presents its own unique Manufacturers should consider
technologies. This includes, for safety risks. Because software often adopting a life-cycle approach to safety
example, automation technology and interacts with a motor vehicle’s critical risks when developing automated
equipment, as well as advanced crash safety systems (i.e., systems vehicles, other innovative automotive
avoidance technologies. Where an encompassing critical control functions technologies, and safety compliance
autonomous vehicle or other emerging such as braking, steering, or programs and other business practices
automotive technology causes crashes or acceleration) the operation of those in connection with such technologies. A
asabaliauskas on DSK3SPTVN1PROD with NOTICES
injuries, or has a manifested safety- systems could be substantially altered life-cycle approach would include
related failure or defect, and a by after-market software updates. ‘‘elements of assessment, design,
manufacturer fails to act, NHTSA will Additionally, software located outside implementation, and operations as well
exercise its enforcement authority to the the motor vehicle (i.e., portable devices as an effective testing and certification
fullest extent. Similarly, should the with vehicle-related software program.’’ National Highway Traffic
Agency determine that an autonomous applications) could be used to affect and Safety Administration, A Summary of
vehicle or other new automotive control a motor vehicle’s safety systems. Cybersecurity Best Practices, (Oct.
technology presents a safety concern, If software has manifested a safety- 2014), http://www.nhtsa.gov/DOT/
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![Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices 18939
NHTSA/NVS/Crash%20Avoidance/ Issued in Washington, DC, on March 25, calling (202) 649–6700 or, for persons
Technical%20Publications/2014/ 2016 under authority delegated pursuant to who are deaf or hard of hearing, TTY,
812075_CybersecurityBestPractices.pdf. 49 CFR 1.95. (202) 649–5597. Upon arrival, visitors
Considering hardware, software, and Paul A. Hemmersbaugh, will be required to present valid
network and cloud security, Chief Counsel. government-issued photo identification
manufacturers should consider [FR Doc. 2016–07353 Filed 3–29–16; 4:15 pm] and submit to security screening in
developing a simulator, using case BILLING CODE 4910–59–P order to inspect and photocopy
scenarios and threat modeling on all comments.
systems, sub-systems, and devices, to All comments received, including
test for safety risks, including DEPARTMENT OF THE TREASURY attachments and other supporting
cybersecurity vulnerabilities, at all steps materials, are part of the public record
in the manufacturing process for the Office of the Comptroller of the and subject to public disclosure. Do not
Currency include any information in your
entire supply chain, to implement an
comment or supporting materials that
effective risk mitigation plan. See id. Agency Information Collection you consider confidential or
Manufacturers of emerging Activities; Information Collection inappropriate for public disclosure.
technologies and the motor vehicles on Renewal; Submission for OMB Review; Additionally, please send a copy of
which such technology is installed have Securities Exchange Act Disclosure your comments by mail to: OCC Desk
a continuing obligation to proactively Rules and Securities of Federal Officer, 1557–0106, U.S. Office of
identify safety concerns and mitigate the Savings Associations Management and Budget, 725 17th
risks of harm. If a manufacturer AGENCY: Office of the Comptroller of the Street NW., #10235, Washington, DC
discovers or is otherwise made aware of Currency (OCC), Treasury. 20503, or by email to: oira_submission@
any defects, noncompliances, or other ACTION: Notice and request for comment.
omb.eop.gov.
unreasonable risks to safety after the FOR FURTHER INFORMATION CONTACT:
vehicle and/or technology has been in SUMMARY: The OCC, as part of its Shaquita Merritt, Clearance Officer,
safe operation for some time, then it continuing effort to reduce paperwork (202) 649–5490 or, for persons who are
should strongly consider promptly and respondent burden, invites the deaf or hard of hearing, TTY, (202) 649–
contacting the appropriate NHTSA general public and other Federal 5597, Legislative and Regulatory
personnel to determine the necessary agencies to take this opportunity to Activities Division, Office of the
next steps. Where a manufacturer fails comment on a continuing information Comptroller of the Currency, 400 7th
to adequately address a safety concern, collection, as required by the Paperwork Street SW., Washington, DC 20219.
NHTSA, when appropriate, will Reduction Act of 1995 (PRA). SUPPLEMENTARY INFORMATION: The OCC
In accordance with the requirements is proposing to extend OMB approval of
explicitly address that concern through
of the PRA, the OCC may not conduct the following information collection:
its enforcement authority. or sponsor, and respondents are not Title: Securities Exchange Act
Applicability/Legal Statement: This required to respond to, an information Disclosure Rules and Securities of
proposed Enforcement Guidance collection unless it displays a currently Federal Savings Associations.
Bulletin sets forth NHTSA’s current valid Office of Management and Budget OMB Control No.: 1557–0106.
views on the topic of emerging (OMB) control number. Description: This submission covers
automotive technology and suggests The OCC is soliciting comment
an existing regulation and involves no
guiding principles and best practices to concerning the renewal of its
change to the regulation or to the
be utilized by motor vehicle and information collection titled, ‘‘Securities
information collection requirements.
equipment manufacturers in this Exchange Act Disclosure Rules and
The Securities and Exchange
context. This proposed Bulletin is not a Securities of Federal Savings
Commission (SEC) is required by statute
final agency action and is intended as Associations.’’ The OCC also is giving
to collect, in accordance with its
guidance only. This proposed Bulletin notice that it has sent the collection to
regulations, certain information and
does not have the force or effect of law. OMB for review.
documents from any firm that is
This Bulletin is not intended, nor can it DATES: Comments must be received by required to register its stock with the
be relied upon, to create any rights May 2, 2016. SEC.1 Federal law requires the OCC to
enforceable by any party against ADDRESSES: Because paper mail in the apply similar regulations to any national
NHTSA, the U.S. Department of Washington, DC area and at the OCC is bank or Federal savings association
Transportation, or the United States. subject to delay, commenters are similarly required to be registered (those
These recommended practices do not encouraged to submit comments by with a class of equity securities held by
establish any defense to any violations email, if possible. Comments may be 2,000 or more shareholders).2
sent to: Legislative and Regulatory 12 CFR part 11 ensures that a national
of the Safety Act, or regulations
Activities Division, Office of the bank or Federal savings association
thereunder, or violation of any statutes
Comptroller of the Currency, Attention: whose securities are subject to
or regulations that NHTSA administers.
1557–0106, 400 7th Street SW., suite registration provides adequate
This Bulletin may be revised in writing 3E–218, mail stop 9W–11, Washington,
without notice to reflect changes in the information about its operations to
DC 20219. In addition, comments may
asabaliauskas on DSK3SPTVN1PROD with NOTICES
current and potential shareholders,
Agency’s views and analysis, or to be sent by fax to (571) 465–4326 or by depositors, and the public. The OCC
clarify and update text. electronic mail to prainfo@occ.treas.gov. reviews the information to ensure that it
Authority: 49 U.S.C. 30101–30103, 30116– You may personally inspect and complies with Federal law and makes
30121, 30166; delegation of authority at 49 photocopy comments at the OCC, 400 public all information required to be
CFR 1.95 and 49 CFR 501.8. 7th Street SW., Washington, DC 20219. filed under the rule. Investors,
For security reasons, the OCC requires
that visitors make an appointment to 1 15 U.S.C. 78m(a)(1).
inspect comments. You may do so by 2 15 U.S.C. 78l(i).
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Document Created: 2016-04-06 00:08:23
Document Modified: 2016-04-06 00:08:23
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Request for public comments. | |
| Dates | Comments must be received on or before May 2, 2016. | |
| Contact | Justine Casselle, Office of the Chief Counsel, National Highway Traffic Safety Administration, or Elizabeth Mykytiuk, Office of the Chief Counsel, National Highway Traffic Safety Administration, at (202) 366-2992. | |
| FR Citation | 81 FR 18935 |
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