Comments Invited

We invite you to submit any written relevant data, views, or arguments regarding this proposal. Send your comments to an address listed under ADDRESSES. Include “AD Docket No. 2003-NE-08-AD” in the subject line of your comments. If you want us to acknowledge receipt of your mailed comments, send us a self-addressed, stamped postcard with the docket number written on it; we will date-stamp your postcard and mail it back to you. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. If a person contacts us through a nonwritten communication, and that contact relates to a substantive part of this proposed AD, we will summarize the contact and place the summary in the docket. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments.

We are reviewing the writing style we currently use in regulatory documents. We are interested in your comments on whether the style of this document is clear, and your suggestions to improve the clarity of our communications that affect you. You may get more information about plain language at http://www.plainlanguage.gov.

You may examine the AD Docket (including any comments and service information), by appointment, between 8 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays. See ADDRESSES for the location.

The Civil Aviation Authority (CAA), which is the airworthiness authority for the United Kingdom (U.K.), recently notified the FAA that an unsafe condition may exist on RR RB211 Trent 875-17, Trent 877-17, Trent 884-17, Trent 892-17, Trent 892B-17, and Trent 895-17 turbofan engines. The CAA advises that reports were received of two IP turbine blade release incidents as a result of dust caps separating from the blades. Subsequently, the manufacturer applied improved modeling techniques for analysis, which revealed higher than predicted operating temperatures at the IP turbine disc rim and surrounding area due to inflow of annulus exhaust gases. As a result of this analysis, the manufacturer has assigned new lower life limits of 8,600 cycles-since-new (CSN) for IP turbine disc P/N FK21117, and 3,000 CSN for IP turbine disc P/N FK33083.

These RR RB211 Trent 875-17, Trent 877-17, Trent 884-17, Trent 892-17, Trent 892B-17, and Trent 895-17 turbofan engines, manufactured in the U.K., are type-certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the CAA has kept us informed of the situation described above. We have examined the CAA's findings, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States. Therefore, we are proposing this AD, which would require replacing IP turbine discs, P/Ns FK21117 and FK33083, at or before reaching the new reduced life cycle limits of 8,600 CSN and 3,000 CSN respectively.

On July 10, 2002, we published a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's AD system. This regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. This material previously was included in each individual AD. Since this material is included in 14 CFR part 39, we will not include it in future AD actions.

There are approximately 350 RR RB211 Trent 875-17, Trent 877-17, Trent 884-17, Trent 892-17, Trent 892B-17, and Trent 895-17 turbofan engines of the affected design in the worldwide fleet. We estimate that 114 engines installed on airplanes of U.S. registry would be affected by this proposed AD. We also estimate that the prorated cost of the life reduction per engine would be approximately $246,000. Based on these figures, the total cost of the proposed AD is estimated to be $28,044,000.

We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that the proposed regulation:

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

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

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

We prepared a summary of the costs to comply with this proposal and placed it in the AD Docket. You may get a copy of this summary by sending a request to us at the address listed under ADDRESSES. Include “AD Docket No. 2003-NE-08-AD” in your request.

Accordingly, under the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend 14 CFR part 39 as follows:

You may submit or retrieve comments online through the Document Management System (DMS) at: http://dmses.dot.gov/submit . Acceptable formats include: MS Word (versions 95 to 97), MS Word for Mac (versions 6 to 8), Rich Text File (RTF), American Standard Code for Information Interchange (ASCII)(TXT), Portable Document Format (PDF), and WordPerfect (versions 7 to 8). The DMS is available 24 hours each day, 365 days each year. Electronic submission and retrieval help and guidelines are available under the help section of the Web site. An electronic copy of this document may also be downloaded by using a computer, modem and suitable communications software from the Government Printing Office's Electronic Bulletin Board Service at (202) 512-1661. Internet users may also reach the Office of the Federal Register's Home page at: http://www.archives.gov and the Government Printing Office's Web page at: http://www.access.gpo.gov/nara .

The principal mission of the U.S. Department of Transportation (USDOT) is to provide the American people with a transportation system that is safe, effective, and secure. Transportation is vital to our Nation's economy, national security, and quality of life. We depend on transportation for access to jobs, to enable us to conduct our business, to supply us with services and goods, and to facilitate our leisure and recreational activities. When we take appropriate action to address our mobility needs, we can also improve the safety of our system and enhance our natural and human environment. We also find that there is a decrease in safety and a degradation in environment when we do not address critical mobility issues on our highway system. To help attain the mission of the USDOT, the FHWA has identified strategic goals in the areas of safety, mobility and productivity, environment, National security, and organizational excellence. Under the “mobility and productivity” area, the FHWA has identified “congestion reduction” as one of the vital few strategies. One way to reduce congestion is to improve the performance of our Nation's “work zones.”

The FHWA proposes to amend 23 CFR part 630 subpart J, “Traffic Safety in Highway and Street Work Zones.” Work zones cause safety and mobility impacts on the traveling public, businesses, workers, and transportation agencies, resulting in an overall loss in productivity and growing frustration. These work zone impacts are exacerbated by growing congestion in many locations. The FHWA recognizes the trends of increased road construction, growing traffic, increased crashes, and public frustration with work zones. These trends call for a more broad-based understanding and examination of the safety and mobility impacts of work zones on road users, other affected parties, and workers. Better addressing work zone safety and mobility requires consideration of work zone issues starting early in project development and continuing through project completion.

The current regulation has a broadly stated purpose of providing guidance and establishing procedures to ensure that adequate consideration is given to motorists, pedestrians, and construction workers on all Federal-aid construction projects. However, the content of the current regulation is focused primarily on the development of traffic control plans (TCPs), the operation of work zones on two-lane, two-way roadways, and other provisions that address project responsibility, pay items, training and process review and evaluation. These provisions in the current regulation primarily address the issue of traffic control through the work zone itself. At the time this regulation was written, the TCP was an important concept that was and still is essential for work zone safety. Today's environment includes new challenges due to growing congestion, increasing reconstruction and public frustration with work zones. TCPs for work zones are still essential, but they are no longer a sufficient approach for managing work zone impacts that may extend to an area much bigger than the actual work area. The proposed changes to 23 CFR part 630 subpart J are intended to facilitate consideration of the broader safety and mobility impacts of work zones in a coordinated and comprehensive manner across project development stages. The following is a summary of key proposed changes:

• Title change of 23 CFR part 630 subpart J to “Work Zone Safety and Mobility.”

• State transportation departments (hereinafter referred to as “States”) to develop and adopt work zone safety and mobility policies. These policies will support the systematic consideration of the safety and mobility impacts of work zones during project development; and address the safety and mobility needs of all road users ( i.e. , motorists, pedestrians, bicyclists, and persons with disabilities), workers, and other affected parties ( i.e. , public facilities such as parks, recreational facilities, fire stations, police stations, and hospitals; and private parties such as businesses and residences) on Federal-aid highway projects.

• States to conduct work zone impacts analysis during project development to better understand individual project characteristics and the associated work zone impacts. This will facilitate better decisionmaking on alternative project options and in the development of appropriate work zone impact mitigation measures.

• States to develop Transportation Management Plans (TMPs) for projects as determined by the State's policy and the results of the work zone impacts analysis. A Transportation Management Plan (TMP) documents the mitigation strategies identified during this analysis. The TMP facilitates a more comprehensive approach to manage the safety and mobility impacts of work zones, by including a Transportation Operations Plan (TOP) and a Public Information and Outreach Plan (PIOP) in addition to the current requirement for a Traffic Control Plan (TCP).

• Provisions that allow States to be more creative and performance oriented in their procurement processes by allowing flexibility to choose either method-based or performance-based specifications for their contracts.

Work zones are a necessary part of meeting the need to maintain and upgrade our aging highway infrastructure. As much of the Nation's transportation infrastructure approaches the end of its service life, preservation, rehabilitation, and maintenance become an increasing part of our transportation improvement program. 1 The Transportation Equity Act for the 21st Century (TEA-21), (Pub. L. 105-178, 112 Stat. 107) enacted in June 1998, provides for a 40 percent increase in transportation funding over the total provided in the Intermodal Surface Transportation Efficiency Act of 1991 (ISTEA), (Pub. L. 102-240; 105 Stat. 1914; Dec. 18, 1991). 2 Much of this funding is being spent on performing capital improvements and maintaining existing roads, since comparatively few new roads are being built.

At the same time, traffic volumes continue to grow and create more congestion. As vehicle travel continues to increase significantly faster than miles of roadway, we have a growing congestion problem that is exacerbated by work zones. From 1980 to 1999, the U.S. experienced a 76 percent increase in total vehicle-miles traveled, while total lane miles of public roads increased only by 1 percent. 3 Congestion affects normal vehicular movement including that of cars, trucks, and buses, and is frustrating and costly to both individuals and businesses. Studies indicate that over the years, “extremely” or “severely” congested highway miles more than doubled from 1982 to 1997, while uncongested miles dropped by almost half. The Texas Transportation Institute (TTI) estimated that the cost of congestion was approximately $78 billion in 1999. The combination of heavier traffic volumes passing through a road network with more work zones increases the operational and safety impacts of those work zones on the road network. Recent analysis shows that of this congestion, work zones on freeways cause an estimated 24 percent of nonrecurring delay, resulting in lost capacity of 60 million vehicles per day (VPD) in the summer, and that of 64 million VPD in the winter. 4 According to FHWA estimates, about 12.8 percent of the National Highway System is under construction at any time during the summer roadwork season, leading to 3,110 work zones. 5

Work zones continue to have adverse impacts on traveler and worker safety. Work zone fatalities reached a high of 1,079 in 2001, 6 while over 40,000 people were injured in work zone related crashes in the same year. 7 From 1997 to 2001, over 4,000 people were killed in work zone crashes, with over 220,000 injured; and about 300 workers died in road construction activities during the same time frame, as indicated by the Bureau of Labor Statistics' Census of Fatal Occupational Injuries. 8

Over the years, highway professionals have devised and implemented several strategies and innovative practices for minimizing the disruption caused by work zones, while ensuring successful project delivery. For example, more work is done during night time to minimize the impacts of work zones on the traveling public by avoiding work during the more heavily traveled daytime hours. However, the current and expected level of investment activity in highway infrastructure (a significant portion of which is for maintenance and reconstruction of existing roadways) implies that increasingly, work will be done under traffic. In 1997, 47.6 percent of highway capital outlay was spent on system preservation (resurfacing, restoration, rehabilitation, reconstruction).

In addition to increased road construction, growing traffic, and increases in crashes, public frustration with work zones indicates that more effort is required to meet the needs and expectations of the American public. The results of a recent FHWA nationwide survey, reported in “Moving Ahead: The American Public Speaks on Roadways and Transportation in Communities,”  9 illustrate the American public's frustration with work zones. Work zones were cited as second only to poor traffic flow in causing traveler dissatisfaction. The top three improvements indicated by the public as a “great help” to improve roadways and transportation are related to roadway repairs and work zones. They are: (a) More durable paving materials (67 percent); (b) repairs made during non-rush hours (66 percent); and (c) reducing repair time (52 percent). The use of better traffic signs showing expected roadwork, and better guide signs for re-routing traffic to avoid roadwork, were also cited as being of “great help,” by 40 percent and 35 percent of the respondents, respectively. Many travelers indicated a preference to have the road closed completely for moderate durations in exchange for long-lasting repairs. About 67 percent of respondents expressed support for one-week long road closures, and 37 percent expressed support for one-month long road closures; while 16 percent of respondents expressed support for a three-month closing, and 10 percent or fewer would support longer closings (six months to a year).

Further, the contracting industry is under pressure to expedite construction and minimize disruption by reducing their work hours, compressing their schedules and shifts, and increasing night work. They have expressed concerns that these pressures affect worker safety, reduce productivity, and may compromise quality. Therefore, a balance must be achieved between construction needs and the safety and mobility needs of the traveling public.

While safety and mobility are two distinct challenges posed by the circumstances faced on highways, it is important to realize that both these elements are closely tied to one another. Studies and data analyses over time indicate that as congestion builds, crash rates increase; and as crashes increase, more congestion occurs. Therefore, it is important to develop comprehensive mitigation measures that alleviate the impacts of work zones and ultimately improve transportation safety and mobility.

Section 1051 of ISTEA required the Secretary of Transportation (Secretary) to develop and implement a highway work zone safety program to improve work zone safety at highway construction sites by enhancing the quality and effectiveness of traffic control devices, safety appurtenances, traffic control plans, and bidding practices for traffic control devices and services. The FHWA implemented this provision of ISTEA through non-regulatory action, by publishing a notice in the Federal Register on October 24, 1995 (60 FR 54562). (Hereinafter referred to as “the notice.”)

The purpose of this notice was to establish the National Highway Work Zone Safety Program (NHWZSP) to enhance safety at highway construction, maintenance and utility sites. In this notice, the FHWA indicated that having appropriate National and State standards and guidelines would contribute to improved work zone safety. To attain these National and State standards and guidelines, the FHWA identified the need to update its regulation on work zone safety, 23 CFR part 630, subpart J.

The notice indicated that the FHWA would review current work zone problems and update the regulation to better reflect current needs including reinforcement of guidance on bidding practices, work zone crash data collection and analysis at both project and program levels, compliance with traffic control plans, and work zone speed limits. While the focus of this notice was “work zone safety,” it also identified the need “to minimize disruptions to traffic during construction of highway projects.”

Since establishing the NHWZSP, the FHWA identified work zone safety and mobility as major concerns to the traveling public, businesses and transportation agencies. Therefore, the FHWA undertook several efforts to better address the unique safety and mobility challenges posed by work zones, including research and development, and compilation of best practices and guidelines. The FHWA is now in the process of updating 23 CFR part 630 subpart J, which governs traffic safety in highway and street work zones. An examination of the current provisions in 23 CFR part 630 subpart J indicate that they reflect the needs and issues that were relevant at the time the regulation was developed, but are no longer comprehensive enough to address the complex issues of today and the future.

The current regulation has a broadly stated purpose of providing guidance and establishing procedures to ensure that adequate consideration is given to motorists, pedestrians, and workers on all Federal-aid construction projects. However, the content of the current regulation is focused primarily on the development of traffic control plans (TCPs), the operation of work zones on two-lane, two-way roadways, and other provisions that address project responsibility, pay items, training and process review and evaluation. These provisions in the current regulation primarily address the issue of traffic control through the work zone itself. At the time this regulation was written, the TCP was an important concept that was and still is essential for work zone safety. Today's environment however, includes new challenges due to growing congestion, increasing reconstruction and public frustration with work zones.

More road work is being done under ever increasing traffic—this leads to further congestion, delays, and increases in fatalities and crashes, thereby placing contractors and workers under pressure and leading to public frustration with work zones. These circumstances and consequences call for a more broad-based examination of the current regulations. TCPs for work zones are still important and essential, but they are no longer a sufficient approach for managing work zone impacts that may extend to an area much bigger than the actual work area.

Through research conducted over the years, and based on feedback from State agencies and the public, the FHWA believes that in order to comprehensively improve work zone safety and mobility, there needs to be a systematic consideration of the safety and mobility impacts of work zones across the different project development stages, and the development of appropriate mitigation measures that help alleviate these impacts. The proposed amendments to 23 CFR part 630 subpart J are intended to facilitate consideration of the broader safety and mobility impacts of work zones in a coordinated and comprehensive manner across project development stages.

As a first step towards the consideration of amending 23 CFR part 630 subpart J, the FHWA issued an advance notice of proposed rulemaking (ANPRM), aimed at identifying the key issues that should be considered if the current regulation were to be updated. The ANPRM entitled “Work Zone Safety” was published in the Federal Register on February 6, 2002, at 67 FR 5532. The ANPRM comment period ended on June 6, 2002.

Pursuant to the end of the ANPRM comment period, we conducted several outreach sessions with the transportation community to discuss the issues addressed by the ANPRM and to provide a synopsis of the comments received on the ANPRM. The following is a list of the outreach efforts that were undertaken by the FHWA:

• ANPRM presentation and open forum at the 2002 annual meeting of the American Association of State Highway and Transportation Officials (AASHTO) Design Subcommittee, June 13, 2002, Savannah, Georgia;

• ANPRM presentation and open forum at the 2002 annual meeting of the AASHTO Subcommittee on Traffic Engineering annual meeting, June 17, 2002, Minneapolis, Minnesota;

• ANPRM presentation and open forum at the 2002 annual meeting of the AASHTO Maintenance Subcommittee, July 17, 2002, Mobile, Alabama;

• ANPRM presentation and open forum at the 2002 annual meeting of the AASHTO Subcommittee on Construction, August 6, 2002, Rehoboth Beach, Delaware;

• ANPRM public meeting at Chevy Chase, Maryland, September 19, 2002;

• ANPRM outreach meeting with North Carolina DOT, September 24, 2002; and

• ANPRM public meeting at Chevy Chase, Maryland, September 25, 2002.

Given today's issues and the feedback obtained from the ANPRM and continued outreach with the transportation community, the FHWA believes that it is in the Nation's best interest to amend the regulation to recognize the need to comprehensively consider work zone safety and mobility. Through this NPRM the FHWA seeks to embed full consideration of the safety and mobility impacts of work zones into the project development process, and provide for worker safety and efficient construction. The proposed changes seek to bring about such consideration in a manner that provides flexibility to States to apply the regulations to their unique operating environments, their policies and procedures, and individual project requirements.

In the ANPRM, the FHWA identified a broad range of work zone issues that apply to planning, designing, and implementing Federal-aid highway projects. The issues posed in the ANPRM correspond to an over-arching theme that aims to reduce the need for recurrent roadwork, the duration of work zones, and the disruption caused by work zones. These issues were posed as questions to elicit comments, guidance, and suggestions. The ANPRM indicated that in order to adequately meet the safety and mobility expectations of our customers (road users, workers, and all other affected properties), changes may be required to the project development process to fundamentally include consideration of the safety and mobility impacts of work zones, while providing for worker safety and efficient construction. Such a customer-oriented approach necessitates examination of the complete project development cycle. Therefore, the questions in the ANPRM were grouped into categories that generally correspond to the major steps in project development. These categories are:

• General (wide-ranging policy and regulatory considerations);

• Transportation Planning and Programming;

• Project Design for Construction and Maintenance;

• Managing for Mobility and Safety In and Around Work Zones;

• Public Outreach and Communications; and

• Analyzing Work Zone Performance.

Commenters were also encouraged to include discussion of any other issues they considered relevant to this effort.

The following discussion summarizes the comments received on the ANPRM and the subsequent outreach efforts conducted by the FHWA. The FHWA's responses to these comments and the proposed actions are also provided. The discussion provides a general sense of the issues addressed in the comments.

The ANPRM and associated documents are available in the docket at http://dms.dot.gov , under Docket No. 2001-11130. To better understand the summary of the ANPRM comments, reviewers are encouraged to download a copy of the ANPRM from the docket.

We received 84 responses to the docket. Of these, 67 provided responses to the specific questions raised in the ANPRM, while the remaining 17 provided a set of general comments only.

The general comments provided by the 17 respondents who did not answer the specific questions in the ANPRM were not directly attributable to any of the specific issues raised in the ANPRM—however, their comments were synthesized and summarized to provide a general understanding of their position on work zone safety and mobility issues.

The 67 respondents who provided comments on the specific questions raised in the NPRM provided both direct and indirect responses that indicated whether or not they were in support of a particular issue. A direct response constituted a definite “Yes” or “No” type response from the respondent, while an indirect response constituted a verbatim response to the question, which was then analyzed and interpreted as to what the respondent's position was. In cases where the respondent's position was not interpretable whether he/she was in support of an issue, we indicated that the respondent's position was unclear. Also, not all respondents answered all the questions in the ANPRM, which were indicated as “no response” in the summary of ANPRM comments.

The ANPRM comments analysis shows percentages of responses across several categories, for example, Yes—60 percent, No—20 percent, No Response—10 percent, Unclear—10 percent. The purpose of presenting the ANPRM responses along the lines of percentages is not to assign statistical significance to the responses, but to present a general cross-section of the responses and also to present a general idea of the respondents' position on different issues.

The percentages showing the profile of ANPRM respondents are based on all the responses (84), while the percentages showing the break-up of respondents' position on different issues is based on the 67 respondents who provided comments on the specific questions in the ANPRM.

About 70 percent of the respondents were from the public sector or represent public sector interests, 18 percent of the respondents were from the private sector or catered to private sector interests, 6 percent of the respondents represented both public and private sector interests, while the remaining 6 percent did not indicate their affiliation.

The break-up of the agency types of the different respondents present the following statistics. About 65 percent of the respondents belonged to Departments of Transportation (DOTs) (either State or local), 2 percent of the respondents represented private sector equipment/technology providers; 5 percent of the respondents belonged to other public agencies (Federal and other State agencies); 6 percent of the respondents were either private individuals or consultants or contractors; 15 percent of the respondents represented trade associations and special interest groups, including the American Traffic Safety Services Association (ATSSA), the American Road Transportation Builders Association (ARTBA) and the Associated General Contractors (AGC) of America; and 6 percent of the respondents did not indicate their agency affiliations.

The AASHTO compiled the ANPRM questions into a survey and distributed it amongst its member agencies. Several State DOTs provided their responses through AASHTO's survey, while others submitted their comments individually. AASHTO, as an agency, did not provide specific comments on the ANPRM, but stated its general position on work zone safety and mobility based on the responses from its member agencies. AASHTO indicated general agreement amongst its respondents on the need to have a National policy to improve safety and mobility in highway construction and maintenance, and that the policy should be issued in the form of guidance.

It was also noticeable that a majority of the respondents' primary job function involved either traffic, engineering, safety or design. There was very little participation from the planning community, contractors, and law enforcement personnel.

The “General” section in the ANPRM addressed wide-ranging policy and regulatory considerations regarding work zone safety and mobility. The ANPRM stated that the FHWA was considering a wide range of options, including revising and expanding the regulations in 23 CFR part 630, subpart J, and that, alternatively, the FHWA was also considering policy guidance. This section was therefore primarily aimed at identifying whether or not the FHWA should advocate a new National policy on work zone safety and mobility, and whether the policy should be advocated through regulation or through policy guidance.

When asked if there should be a National policy to promote improved safety and mobility in work zones, 81 percent of the respondents who commented on specific questions in the ANPRM, said yes; 16 percent said no; and about 3 percent did not respond. Of the respondents who said yes, 76 percent belonged to DOTs, 2 percent were from other public agencies, 4 percent represented private agencies, 13 percent were from trade associations, and 6 percent did not indicate their agency affiliation. When asked if the National policy (if it were to be developed), should be issued as regulation or in the form of best practices and guidance, 64 percent of the respondents who commented on specific questions in the ANPRM said that the policy should be advocated through guidance and best practices; 18 percent said that the policy should be advocated through regulation; about 4 percent of the responses were unclear; while 14 percent did not respond.

Of the respondents who indicated that the policy should be advocated through guidance and best practices, 90 percent belonged to DOTs, 2 percent represented other public agencies, 5 percent belonged to trade associations, and 2 percent did not indicate their agency affiliation. Further, a few respondents (about 16 percent of respondents who provided comments on specific ANPRM questions) indicated that there need not be a new policy. Instead, they suggested that existing regulations and guidelines need to be enforced better. In general, respondents also acknowledged that mobility considerations should be incorporated in planning, designing and implementing work zones.

When queried about the adequacy of the current regulations, about 40 percent of respondents who provided comments on specific questions in the ANPRM indicated that the current regulations are not adequate for addressing work zone safety and mobility concerns at all stages of project evolution; while 34 percent indicated that the current regulations are adequate. The remaining respondents who commented on specific questions in the ANPRM did not provide information that led to any conclusive inference as to whether the current regulations are adequate or not. Of the respondents who indicated that the current regulations are not adequate, 56 percent belonged to DOTs, 4 percent represented other public agencies, 7 percent were from private agencies, 30 percent belonged to trade associations, and 4 percent did not indicate their agency affiliations. All the respondents who stated that the current regulations are adequate belonged to DOTs.

In response to the need for stratifying work zone regulations according to varying levels and durations of risk to road users and workers, and disruptions to traffic, about 76 percent of respondents who provided comments on specific ANPRM questions recommended that work zone regulations should be stratified. Of these, 75 percent belonged to DOTs, 4 percent were from private agencies, 16 percent represented trade associations, and 6 percent did not indicate their agency affiliations. The different stratification factors that were presented in the ANPRM included: duration, length, lanes affected, Average Daily Traffic (ADT), road classification, expected capacity reduction, potential impacts on local network and businesses. Out of these factors, ADT, road classification and expected impacts /capacity reduction were often referred to as the most appropriate stratification factors. However, while it was evident that regulations should be stratified, several respondents also indicated that it may be cumbersome to implement such stratification, and it may lead to confusion in interpretation of regulations.

Currently there are four different definitions of the term “work zone”, as stated in the Manual on Uniform Traffic Control Devices (MUTCD), the National Committee on Uniform Traffic Laws and Ordinances (NCUTLO), the National Highway Traffic Safety Administration (NHTSA), and by the American National Standards Institute (ANSI) (proposed).

The MUTCD defines a work zone as an area of a highway with construction, maintenance, or utility work activities, and that it is typically marked by signs, channelizing devices, barriers, pavement markings, and/or work vehicles. The MUTCD also states that a work zone extends from the first warning sign or rotating/strobe lights on a vehicle to the END ROAD WORK sign or the last temporary traffic control device.

The NCUTLO adds to this definition by stating that a work zone may be for short or long durations, and may include stationary or moving activities. The NCUTLO also provides examples for the different types of work zones, and indicates that the work zone does not include private construction, maintenance or utility work outside the highway.

The NHTSA definition for work zone is very similar to that of the MUTCD, the difference being that NHTSA indicates work zones may or may not involve workers or equipment on or near the road, and that work zones may be stationary or moving, and short term or long term in nature.

The ANSI, in its Manual on Classification of Motor Vehicle Traffic Accidents, American National Standard—ANSI D-16, is proposing a definition for work zone, which is similar to the NCUTLO definition.

The ANPRM inquired whether there ought to be a common National definition for the term “work zone.” About 84 percent of the respondents who provided comments on the specific questions in the ANPRM indicated that there should be a common National definition for “work zone.” Of these, 77 percent belonged to DOTs, 2 percent were from other public agencies, 2 percent belonged to private agencies, 14 percent represented trade associations, and 5 percent did not indicate their agency affiliations. In response to specific language for a common national definition, a majority of the respondents suggested adopting either the MUTCD or the ANSI definition. Several respondents mentioned that adopting a common National definition for work zone will enhance and standardize work zone data collection and crash reporting processes.

The ANPRM comments indicate strong support for the development of a National policy on work zone safety and mobility and document the need to amend FHWA's current regulations in 23 CFR part 630 subpart J to address both safety and mobility issues associated with work zones. The respondents indicated that the preferred method for FHWA to advocate the regulation is by establishing a broad policy, supported by detailed guidelines for implementation. The FHWA therefore proposes to amend its regulation in 23 CFR part 630 subpart J to include the consideration of work zone mobility in addition to safety.

The proposed amendments would result in a broad regulation that addresses a wide range of issues, and provide implementation flexibility to States in meeting their individual program goals and needs. Therefore, the proposed amendments to the regulation recognize the need for stratification, and provide flexibility to States in applying the provisions of the regulation to different projects, based upon their respective program goals and their understanding of the needs and work zone impacts of individual projects.

With regard to the issue of a common National definition for work zone, the ANPRM comments indicate the need for a common National definition for work zone. However, the FHWA realizes that the four different definitions for work zone are essentially similar in content and implication. Therefore, for the purposes of this regulation, we propose to incorporate the MUTCD definition for work zone. Further, one of the reasons the FHWA raised the issue of a common National definition for the term “work zone,” was to gauge public opinion on whether there is any recognition that the impacts of work zones may not always be restricted to the work zone itself, and that the impacts may be felt in the advance area of the work zone, other roadway corridors, the regional transportation network and on other modes of transportation. This concept of broader impacts of work zones is however addressed in the proposed amendments by incorporating it into the definition of “work zone impacts,” rather than incorporating it in the definition of work zone itself.

The definition and explanation for the phrase “work zone impacts” is available in the section-by-section discussion of this NPRM and the “Definitions and explanation of terms” section of the proposed regulation language.

The purpose of the Transportation Planning and Programming section was to identify whether the road user safety and mobility impacts of work zones, and work zone safety requirements are considered in Statewide, metropolitan and corridor transportation planning and programming. Further, it also endeavored to assess the feasibility of incorporating such considerations in transportation planning and programming.

When asked if road user impacts of work zones are considered in transportation planning and programming, about 24 percent of respondents who provided comments on specific questions in the ANPRM indicated that user-impacts are not currently considered in transportation planning; 9 percent did not respond; 18 percent of the responses were unclear; while 49 percent indicated that user impacts are indeed considered in transportation planning. Even though 49 percent of the respondents said yes, many interpreted the question as addressing early project-level planning verses the transportation planning processes that develop long-range and short-term transportation plans (LRTP's and TIP's). Therefore, there is a significant amount of ambiguity in the responses to this question.

When asked if work zone impacts should be considered in metropolitan, statewide and corridor level transportation planning, on average, about 30 percent of the respondents who provided comments on specific questions in the ANPRM said yes to metropolitan and statewide planning, while 25 percent said no. Of the respondents who indicated that work zone impacts should be considered in metropolitan planning, 74 percent belonged to DOTs, 4 percent were from private agencies, 13 percent represented trade associations, and 9 percent did not indicate their agency affiliations. Of the respondents who indicated that work zone impacts should be considered in statewide planning, 86 percent belonged to DOTs, 5 percent were from private agencies, 5 percent represented trade associations, and 5 percent did not indicate their agency affiliations. On the other hand, a slightly higher number of respondents who provided comments on specific questions in the ANPRM, 48 percent, indicated that work zone impacts should be considered in corridor planning, while only 9 percent said no. It is noticeable that about 40 percent of the respondents who provided comments on specific questions in the ANPRM did not respond to any of these issues, which indicates the level of ambiguity in the responses.

There were mixed responses to the adoption of crosscutting policy level considerations to account for the safety and mobility impacts of work zones in transportation planning and programming. Examples of such crosscutting policy-level considerations include the use of more durable materials, life-cycle costing, complete closure of facilities, information sharing on utilities, etc. The purpose of adopting policies on such cross-cutting issues is to facilitate a streamlined approach to incorporate work zone considerations into transportation planning and programming, and to serve as decisionmaking tools that help make better decisions to mitigate the impacts of work zones, while planning, programming, designing, and implementing projects. Most respondents did not interpret the question appropriately, leading to several responses that did not address this issue directly.

The provisions in the proposed amendments do not have a direct effect on the transportation planning processes ( i.e. , LRTP and TIP) that consider and develop transportation plans at a regional or metropolitan level. The responses to the questions in the transportation planning and programming section were ambiguous, with several respondents either choosing not to answer the questions or misinterpreting the questions as addressing early project-level planning verses the transportation planning processes that develop long-range and short-term transportation plans (LRTP's and TIP's). Further, 23 CFR part 630 subpart J falls under the “Engineering and Traffic Operations” area, and does not exercise authority over the “Planning and Research” areas.

The proposed changes do not have any implications on the transportation planning processes that develop LRTP's and TIP's. However, based on current industry trends and needs and on ongoing research, the FHWA believes that it is important to consider the impacts of work zones while developing transportation plans by accounting for these impacts at the regional, network and corridor levels, and suitably coordinating projects so as to minimize these impacts. Certain State DOTs, for instance, the California Department of Transportation (Caltrans), consider the impacts of work zones at the systems planning level by evaluating the feasibility of the implementation of multiple projects in their respective districts. The FHWA intends to conduct further research and outreach to better understand how work zone impacts can be incorporated in the transportation planning and programming processes, and to further develop the necessary tools and guidelines that will help States implement such consideration.

The purpose of the Project Design for Construction and Maintenance section in the ANPRM was to identify strategies and practices to make better decisions on alternative project designs that may lead to reductions in the need for recurrent road construction and maintenance work, the duration of work zones and the disruption caused by work zones. Examples of such considerations include life-cycle cost analysis, alternative project scheduling and design strategies, such as, full road closures and night time work, using more durable materials, coordinating road construction, estimation of user costs/impacts, risk and reward sharing with contractors, and constructability reviews for projects.

The ANPRM queried the public on how the FHWA can encourage considerations in project design and decisionmaking that may lead to reductions in the need for recurrent road work, the duration of work zones and the impacts of work zones. Examples of such considerations include life-cycle cost analysis; alternative project scheduling and design strategies, such as, full road closures and night time work; using more durable materials; coordinating road construction; estimation of user costs/impacts; risk and reward sharing with contractors; and constructability reviews for projects. The following is a summary of suggested methods for FHWA to facilitate these considerations  10 :

• Several respondents suggested that FHWA develop procedures and practices and provide guidelines for States to be able to incorporate such considerations. A few respondents referred to the “Work Zone Best Practices Guide” as a good starting point.

• A few respondents (primarily State DOT's and a few trade associations) suggested that the FHWA provide funding incentives for States that adopt such practices.

• Very few respondents suggested mandatory requirements in this regard.

• Some of the respondents suggested regulations on use of life-cycle costing to make policy-level decisions on choice of highway material.

When asked if “user-cost” could be a useful factor in decisionmaking for alternative project designs, about 10 percent of the respondents who provided comments on specific questions in the ANPRM said no; 10 percent did not respond; 1 percent of the responses were unclear; while an overwhelming majority of 79 percent said yes. Of the respondents that said yes, 85 percent belonged to DOTs, 4 percent were from private agencies, 10 percent represented trade associations, and 2 percent did not indicate their agency affiliations. When asked if analytical tools should be used for the evaluation of various work zone design alternatives and their estimated impacts, 1 percent said no; 39 percent did not respond; 18 percent of the responses were unclear; while 42 percent said yes. Of the respondents that said yes, 79 percent belonged to DOTs, 3 percent were from private agencies, 14 percent represented trade associations, and 3 percent did not indicate their agency affiliations.

When asked whether utility delays have been cited as obstacles to efficient project delivery, several respondents said yes; while a smaller number said no. Several suggestions were made on how best to address utility delays in project design.

The ANPRM comments led the FHWA to conclude that the respondents acknowledge the need to account for work zone impacts of projects and the associated costs to the public; and to consider alternative strategies in project design and decisionmaking such as, choice of longer-lasting materials, complete road-closures, work during night-time and off-peak hours, innovative contracting techniques, and utility coordination. It is also clear that the respondents prefer guidance in this regard rather than regulation, and that very restrictive regulations may affect innovation and creativity in the development of work zone impact mitigation strategies. Therefore, the FHWA proposes to amend the current regulation by introducing a new section on work zone impacts analysis that will govern decisionmaking on project design strategies and work zone impacts mitigation alternatives. These proposed amendments provide flexibility to States in scaling the level of detail required for the impacts analysis and evaluation of alternative project options according to the unique characteristics of each project and their respective program goals.

Technology is constantly evolving and there are many methods that can be applied to managing traffic in and around work zones. The application of Intelligent Transportation Systems (ITS) for purposes, such as, traffic management, automated enforcement, and traveler information is a useful method to improve transportation safety and mobility. The current and future safety and mobility challenges presented by work zones may require Traffic Control Plans (TCPs) to include traffic management, enforcement and operations considerations (such as ITS based traffic control and traveler information, speed management and enforcement, incident and emergency management, etc. ), security considerations, and other considerations (for example, utility location and coordination information). The purpose of the managing for mobility and safety section was therefore to identify the need for expanding the content of TCPs and to outline improved methods and strategies to manage, operate, and enforce work zones.

In general, several respondents indicated the need for comprehensive traffic mitigation planning for work zones across all stages of project development and delivery that would reduce the safety and mobility impacts of work zones, by incorporating appropriate mitigation strategies.

About 70 percent of the respondents who commented on specific questions in the ANPRM indicated that the scope of TCPs should be expanded to consider sustained traffic management, operations and enforcement; about 12 percent said no; 12 percent did not respond; while 6 percent of the responses were unclear. Of the respondents that stated that the scope of TCPs should be expanded, 77 percent belonged to DOTs, 2 percent were from other public agencies, 4 percent were from private agencies, 15 percent represented trade associations, and 2 percent did not indicate their agency affiliations. Based on the general preference of the respondents to the ANPRM, and on subsequent outreach sessions conducted by the FHWA, it is evident that the scope of TCPs should be expanded to account for sustained traffic management, operations and enforcement for some projects.

With respect to the deployment of uniformed police officers in work zones, it was evident from the ANPRM comments that several States have increasingly been deploying uniformed police officers on roadway construction projects. Respondents indicated that these practices are successful in increasing motorist compliance, regulating work zone travel speeds, and in reducing crashes.

When asked if TCPs should consider the security aspects of the construction of critical transportation infrastructure, about 30 percent of the respondents who commented on specific questions in the ANPRM said no; 15 percent did not respond; 9 percent of the responses were unclear; while 46 percent said yes. Further, when asked if TCPs should consider the security aspects of work zone activity in the vicinity of critical transportation or other critical infrastructure, 33 percent of the respondents said no; 13 percent did not respond; 6 percent of the responses were unclear; while 48 percent said yes. Several respondents commented that TCP's may not be the most appropriate vehicles for security considerations. Security considerations, where applicable, need to be addressed to the extent possible in other comprehensive security planning efforts. Such security plans should involve work zone considerations. At the same time, many respondents also indicated that emergency-related traffic management implications do apply to work zones, e.g. , keeping work zone lanes open during emergency evacuations such as hurricanes, and other natural or man-made disasters.

When asked if more flexibility should be allowed in the development of TCPs, 30 percent of the respondents who commented on specific questions in the ANPRM said no; about 25 percent did not respond; 7 percent of the responses were unclear; while 37 percent said yes. Of the respondents that said yes, 80 percent belonged to DOTs, 4 percent were from other public agencies, 8 percent represented trade associations, and 8 percent did not indicate their agency affiliations. While a significant percentage of the respondents said “no”—they qualified their assertion by stating that flexibility should be allowed in terms of allowing participation from law enforcement, public, and contractors in TCP development, but it should ultimately be the project owner—State DOT or other transportation agency who should develop and approve TCPs. Further, it may be noted that § 630.1010(a)(4) of the current regulation states the following with regards to flexibility in TCP development: “Provisions may be made to permit contractors to develop their own TCP's and use them if the State and FHWA find that these plans are as good as or better than those provided in the plans, specifications, and estimates (P.S. & E.).” The current regulation also requires a responsible person from the State, at the project level, to ensure that the TCP and other safety aspects of the contract are effectively administered. Representatives of the contracting industry have also indicated that they are reluctant to develop their own TCPs primarily because of liability concerns, and because there is an impression that contractors may do this by cost-cutting at the risk of safety.

When asked if certification should be required for TCP developers, about 34 percent of the respondents indicated no; 27 percent did not respond; about 5 percent of the responses were unclear; while 34 percent said yes. All respondents who said no were from DOTs. Of the respondents that indicated yes, 78 percent belonged to DOTs, 17 percent represented trade associations, and 4 percent did not indicate their agency affiliations. Most States currently require TCPs to be signed and sealed by licensed Professional Engineers (P.E.). A few respondents recommended that all TCP developers be certified, or have undergone the Traffic Control Supervisor (TCS) training. Some respondents suggested the use of “pre-qualified” designers and contractors for the development of TCPs, to avoid the possibility of unsafe or inadequate TCPs. The regulation currently states that all persons responsible for the development, design, implementation, and inspection of traffic control shall be adequately trained.

When asked how TCPs should address considerations that are required by the Americans with Disabilities Act (ADA) (Pub. L. 101-336, July 26, 1990, 104 Stat 327, as amended), several respondents reasserted that TCPs should include ADA considerations  11 for urban projects with pedestrian and other urban issues. They recommended several ways for including ADA considerations in TCPs. Also, several respondents indicated that TCPs should address ADA considerations only when ADA considerations are already being met by the job-site (prior to deployment of the work zone).

When asked if mobility and safety audits should be required for work zones, 28 percent of the respondents who commented on specific questions in the ANPRM said no; about 13 percent did not respond; 3 percent of the responses were unclear; while 55 percent of the respondents said yes. About 95 percent of the respondents who said no belonged to DOTs. Of the respondents who said yes, 81 percent belonged to DOTs, 3 percent were from private agencies, 14 percent represented trade associations, and 3 percent did not indicate their agency affiliations. The current regulation mentions the need for training for personnel responsible for traffic control inspection, but there are no statements that require work zone safety inspections or mobility/safety audits. Several States have policies that require work zone traffic control and safety inspections to be performed by their construction and safety inspectors.

The responses to this section indicate strong support for expanding TCPs to address sustained traffic management, operations and safety to help mitigate the impacts of work zones. Sustained transportation management and operations strategies include transportation systems management, ITS, traveler information, incident management, procedures for work zone operations during emergencies, and conduct of mobility audits. Additional considerations include transportation operational safety considerations such as enforcement in work zones, speed monitoring and management, and conduct of safety audits.

The proposed amendments therefore include provisions that facilitate the consideration of transportation management and operations components that address sustained management, operations and safety. These amendments include provisions for flexibility in decisionmaking on the need for such strategies, and their scope and level of detail, based upon individual project requirements and work zone impacts. As suggested by the ANPRM comments, the proposed changes would provide for flexibility as to who develops the TCP and the transportation management and operations strategies, with ultimate responsibility belonging to the State.

The issue of certification for TCP developers and/or other personnel responsible for design, development and implementation of work zone safety and mobility requirements was addressed by proposing to include provisions in the regulation that require training for State personnel involved in work zone related decision making, with provisions that allow for flexibility in implementation commensurate with the State's needs.

Since security aspects of construction related to critical infrastructure are best addressed in other comprehensive security planning efforts, the proposed changes do not address this issue. With regard to ADA considerations for work zones, we propose language that refers to the appropriate sections of the Code of Federal Regulations (CFR) that address Federal ADA compliance.

To reduce the anxiety and frustration of the public, it is important to sustain effective communications and outreach with the public regarding road construction and maintenance activity, and the potential impacts of these activities. This also increases the public's awareness of such activities and their impacts on their lives. The lack of information is often cited as a key cause of frustration for the traveling public. Therefore, this section of the ANPRM attempted to identify the key issues that need to be considered from a public outreach and information perspective.

An overwhelming majority of the respondents were supportive of reaching out to the public and keeping them informed about planned and ongoing construction and maintenance activities. When asked if projects with substantial disruption should include a public communications plan, 10 percent of the respondents who commented on specific questions in the ANPRM said no; 9 percent did not respond, while 81 percent indicated yes. Of the respondents who indicated yes, 81 percent were from DOTs, 2 percent belonged to private agencies, 13 percent represented trade associations, and 4 percent did not indicate their agency affiliation. Several States have recognized the need for communicating with the public, both on an ongoing basis, and for specific projects, and have been using various communications techniques and media sources for getting the word out.

There is strong support for public outreach and communications with regard to work zones, and several transportation agencies are already undertaking concerted efforts to better inform the public about the safety and mobility aspects and impacts of work zones. The proposed changes to the regulation therefore facilitate the consideration of public information and outreach strategies as part of the work zone impacts mitigation mechanisms; with flexibility for States in the choice of the different strategies and their scope and level of detail, based upon individual project requirements and work zone impacts.

Evaluation is a necessary tool for analyzing failures and identifying successes in work zone operations. Work zone performance monitoring and reporting at a nationwide level has the potential to increase the knowledge base on work zones and help better plan, design and implement road construction and maintenance projects. The purpose of this section in the ANPRM was to identify the adequacy and appropriateness of the current data reporting, and the need for enhanced and increased reporting of data on work zones by States. The following data issues were addressed: work zone characteristics, work zone mobility performance, and work zone safety performance.

When asked if States should report information on work zone characteristics, about 46 percent of the respondents who commented on specific questions in the ANPRM said no; 12 percent did not respond; 12 percent of the responses were unclear; while 30 percent said yes. Of the respondents that said no, 91 percent belonged to DOTs. Of the respondents that said yes, 70 percent belonged to DOTs.

When asked if States should report information on work zone mobility performance, 40 percent said no; 21 percent did not respond; 1 percent of the responses were unclear; while 37 percent said yes. Of the respondents who said no, 89 percent belonged to DOTs. Of the respondents who said yes, 72 percent belonged to DOTs.

When asked if the current work zone safety data collection methods and efforts are adequate and appropriate, 36 percent said no; 28 percent did not respond; 3 percent of the responses were unclear; while 33 percent of the respondents said yes. Of the respondents who said no, 72 percent belonged to DOTs. Of the respondents who said yes, 95 percent belonged to DOTs. Most of the respondents indicated that the mobility measures mentioned in the ANPRM were appropriate, and that the currently used safety measures are appropriate as well. Several respondents indicated that although reporting information on work zone characteristics, mobility performance and safety performance would be useful, they cautioned against requiring unwieldy data collection by States that are already strapped for cash and personnel. A fair number of respondents also indicated the need for more standardized crash reporting policies and procedures.

While establishing the benefits of data collection and reporting on the safety and mobility performance of work zones, the ANPRM comments are mixed with respect to regulations that mandate such data collection and reporting. The current provisions in the regulation require States to analyze crashes and crash data to correct deficiencies on individual projects and improve the content of future TCPs. We propose to retain this provision, with the option to include other safety performance measures ( e.g. , speed variance) as appropriate. Since performance monitoring serves as a basis for process and content improvement in work zone impacts mitigation, we propose to add a new provision that encourages States to analyze work zone mobility data. There are no proposed requirements on the type of analysis or the actual mobility parameters that should be analyzed.

The following is a summary of the areas that are strongly supported by respondents to the ANPRM:

• There is support for a National policy on work zones that explicitly addresses both safety and mobility. The policy should be broad and address a wide range of issues. The FHWA should support the policy by providing appropriate guidance to States. There needs to be flexibility in the implementation of regulations, thereby enabling creativity and innovation in work zone impacts mitigation.

• The policy should stratify work zone regulations and allow flexibility to States in applying the regulations appropriately to individual projects, based on the State's program goals and the work zone impacts of the project.

• Work zone considerations should be mainstreamed and institutionalized in State procedures.

• Comprehensive work zone impacts mitigation plans should be developed. These plans should consider the work zone safety and mobility impacts of projects early in project level planning, and progress through the later stages of project development. Alternative project options including design, procurement and construction strategies that minimize these impacts should be developed and evaluated. We get strong validation that the costs borne by users as a result of the impacts of work zones could be a useful factor in decisionmaking for evaluating alternative project designs. Work zone induced user-costs are derivatives of the safety and mobility impacts of work zones. Therefore, as part of considering work zone safety and mobility in project development, there needs to be an analysis of the impacts of work zones, which will then lead to development and evaluation of alternative project designs and mitigation strategies. States should however have the flexibility to scale their work zone impacts analysis and evaluation of alternative project options and mitigation strategies, based on the severity of anticipated work zone impacts due to individual projects.

• The scope of TCPs should be expanded to address sustained traffic management and operations considerations. There needs to be flexibility for States in enlisting participation from law enforcement, the public and contractors in developing TCPs, but ultimate responsibility for the project should lie within the State.

The FHWA believes that the increasing pressures for work zone safety and mobility, growth of reconstruction, and the concern voiced by road users require reconsideration of how we plan, design and construct roadway projects to focus on highway and worker safety, as well as meet the mobility needs of our customers. Therefore, the purpose of the proposed regulation is to:

• Reduce the safety and mobility impacts of highway work zones on road users, workers, businesses, and society, and maximize the availability of the roadway for efficient traffic movement while ensuring worker safety and efficient construction.

• Enhance the way construction projects are currently conceived, planned, designed, and executed to more fully consider work zone impacts on road users, workers, and other affected parties.

We propose changing the title of 23 CFR part 630 subpart J to “Work Zone Safety and Mobility” to more accurately represent the impacts of work zones on the public. To this end, we propose to update the “Purpose” and “Policy” sections of the current regulation to emphasize the consideration of both the safety and mobility of work zones. We also propose to amend and relocate some of the language that is currently in the “Background” section to the “Purpose” section. The “Background” section of the current regulation contains a reference to the MUTCD, and its purpose and applicability. We propose to amend this reference to the MUTCD and include it in a new section entitled, “References”.

The current regulation indicates that its purpose is to assure that adequate consideration is given to all motorists, pedestrians, and construction workers on all Federal-aid construction projects. We propose language in this section to indicate that work zones have impacts on bicyclists, and persons with disabilities, in addition to motorists, pedestrians and workers. We propose to introduce the term “road users,” which encompasses motorists, pedestrians, bicyclists, and persons with disabilities. We also propose language to indicate that work zones impact other parties in addition to road users and workers. We therefore propose to introduce the phrase “other affected parties,” which may include public facilities like parks, recreational facilities, fire stations, police stations, and hospitals, and private parties such as businesses and residences.

Further, in the “Purpose” section we propose to provide a brief synopsis of the safety and mobility impacts that work zones have on road users, workers and other affected parties. We also propose to indicate that these safety and mobility impacts of work zones are exacerbated by growing congestion in many locations, and that addressing these issues requires considerations that start early in project development and continue through project completion.

The “Background” section of the current regulation recognizes the importance of traffic control for work zone safety, and presents the MUTCD as a guide that provides basic principles and standards for the design and application of traffic control devices. We propose to amend this reference to the MUTCD and include it in a new section entitled, “References”. We propose to retain the current language that refers to the MUTCD as a guide for traffic control, but augment it with language that recognizes that there are considerations in addition to traffic control that are required to comprehensively address the safety and mobility impacts of work zones.

We propose to add a new section entitled, “Definitions/Explanation of Terms” to explain the meaning and implications of certain terms that are key to understanding and interpretation of the proposed provisions in the regulation. The inclusion of this proposed new section results in a change in the section numbering scheme.

We propose minor changes to the current section on “Implementation” to clearly indicate the responsibilities of States and those of the FHWA Division Administrators, and to convey that States and their respective FHWA Divisions are encouraged to work together to ensure conformance with, and implementation of the requirements of this proposed regulation.

We propose reorganizing the requirements that are currently under the “Contents of the Agency's Procedures” into a new section entitled, “State Transportation Department Policy and Procedures.” The purpose of this reorganization is to clearly delineate policy level and project level requirements. The major proposed changes to the regulation are located in this section. Most of the proposed changes are developed around the consideration and analysis of the work zone safety and mobility impacts of projects, and the development of mitigation measures that are contained within a Transportation Management Plan (TMP) for projects.

The section on “State Transportation Department Policy” consists of proposed requirements that specify the following: development of a “Work Zone Safety and Mobility Policy'; provision of work zone related “Training” to personnel; conduct of “Process Review and Evaluation'; and collection and analysis of “Work Zone Performance Data.”

The proposed requirement for the development of a “Work Zone Safety and Mobility Policy” is new. We propose that States develop their own “work zone safety and mobility policies” that will support the systematic consideration of work zone impacts across all stages of project development; and address the safety and mobility needs of all road users, workers, and other affected parties on all Federal aid highway projects.

The proposed requirements on “Training” are part of the current regulation with proposed changes that encourage documentation of the training provided, and the provision of periodic training updates to appropriate personnel.

The “Process Review and Evaluation” requirements are in the current regulation, and we propose to modify the requirements to provide flexibility to States with regard to the conduct of the reviews, and the frequency and the type of reviews. We also propose to encourage States to address these reviews in their respective stewardship agreements with the FHWA Divisions.

We propose to remove the language on work zone crash data collection and analysis from the current “Process Review and Evaluation” section, and include it in a new paragraph entitled, “Work Zone Performance Data.” In this paragraph we propose changes that encourage the collection and analysis of work zone mobility performance data in addition to crash data.

In the project level requirements we propose a section that outlines systematic “Project Impact Analysis and Management Procedures” to include the following: conduct of “Work Zone Impacts Analysis'; development of a “Transportation Management Plan (TMP)”; development of provisions for “Pay Items” for work zone traffic control and management; and assignment of “Responsible Persons” for projects.

We propose a new section on Work Zone Impacts Analysis. It proposes to require an analysis of work zone impacts for projects, and provides flexibility to States in scaling the level of detail of the analysis based on the anticipated work zone impacts of individual projects. It also proposes that if States determine that a project is anticipated to have minimal sustained work zone impacts, they may exempt the project from the impacts analysis.

The TMP would be a new requirement and would include updated requirements on the Traffic Control Plan (TCP). We propose to delete the current language on TCP requirements for two-lane/two-way operations on highways as they are available in the MUTCD. In addition to the TCP, the TMP may consist of a Transportation Operations Plan (TOP), and a Public Information and Outreach Plan (PIOP). The proposed requirements indicate that TMPs are required for all projects, but the TCP is the only mandatory component of TMPs. The need for the other two components of the TMP, namely the TOP and the PIOP, is dependent upon the State's policy requirements and the severity of work zone impacts due to the project.

The “Pay Items” paragraph is an existing requirement with proposed changes that would allow both method based and performance based specifications for procurement. The “Responsible Persons” paragraph is an existing requirement with proposed changes that would require a responsible person for projects from the contractor in addition to the responsible person from the State.

By incorporating the proposed changes in 23 CFR 630 part subpart J, the FHWA intends to facilitate creative thinking and innovation by the States to mainstream work zone safety and mobility considerations in their policies and procedures, and in their normal project development process at appropriate levels. We believe that the approach we have adopted in our proposed changes will allow for flexibility to States in the application of the regulation according to their unique circumstances and operating environments, their program goals, and the needs of individual projects. The FHWA will continue to research best practices for work zone safety and mobility and share them with States. This will enable practitioners to modify best practices and incorporate creative and innovative approaches that best suit their needs.

Section 630.1002(a). The current regulation states that the purpose of this subpart is to provide guidance and establish procedures to assure that adequate consideration is given to motorists, pedestrians, and workers on all Federal-aid construction projects. We propose to restate that the purpose of this subpart is to address the safety and mobility needs of all road users (motorists, pedestrians, bicyclists, and persons with disabilities), workers, and other affected parties on all Federal-aid projects. These proposed changes are intended to achieve the following:

• Convey the notion that adequate consideration should be given to all road users, rather than just motorists, pedestrians and workers. Therefore we propose to add the term “all road users,” which is inclusive of “motorists, pedestrians, bicyclists, and persons with disabilities.”

• Convey the notion that, in addition to road users, work zones may have safety and mobility impacts on other parties that are affected by the highway or street project. We therefore propose to include the phrase “and other affected parties,” after “workers.” Affected parties may include: public facilities like parks, recreational facilities, fire stations, police stations, and hospitals; and private parties such as businesses and residences.

• Emphasize the importance of work zone safety and mobility, by restating the purpose statement to specifically indicate that adequate consideration should be given to the “safety and mobility” needs of road users (motorists, pedestrians, bicyclists, and persons with disabilities), workers, and other affected parties.

Section 630.1002(b). In this paragraph, we propose to indicate that work zones cause safety and mobility impacts on road users, workers, and affected properties. We propose to highlight one of the key issues that we face today and in the future by stating that work zone impacts are exacerbated by growing congestion in many locations. We therefore, propose to assert that addressing the safety and mobility issues of work zones requires considerations that go beyond the installation of appropriate traffic control devices, and that these considerations should start early in project development and continue through project completion.

We propose to include a new section entitled, “References” which contains amended language from the “Background” section of the current regulation.

The “Background” section of the current regulation recognizes the importance of traffic control for work zone safety, and presents the MUTCD as a guide that provides basic principles and standards for the design, application, installation, and maintenance of various types of traffic control devices during highway construction projects, maintenance operations, and utility work. Further, it discusses the limitations of the MUTCD, the efforts taken by transportation agencies in developing guidelines for work zone traffic control, and the need for greater uniformity in work zone traffic control and more attention to proper implementation of the MUTCD.

We propose to amend this reference to the MUTCD and include it in a new section entitled, “References”. We propose to retain the current language that refers to the MUTCD as a guide for traffic control, but augment it with language that recognizes that there are considerations in addition to traffic control that are required to comprehensively address the safety and mobility impacts of work zones.

We propose to retain the sentence that describes the content and implications of the MUTCD with regards to provision of guidelines and standards for traffic control. We identify that the MUTCD does not address the other actions that should be taken to help comprehensively mitigate the safety and mobility impacts of work zones. We recognize the efforts taken by transportation agencies to mitigate the safety and mobility impacts of work zones, but note that a more coordinated and comprehensive effort is required to bring about greater consideration of such work zone safety and mobility impacts.

This section is a new section which proposes to include definitions for the terms, “Work Zone,” “Work Zone Impacts,” “Transportation Management Plan (TMP),” “Traffic Control Plan (TCP),” “Transportation Operations Plan (TOP)”, and “Public Information and Outreach Plan (PIOP).” We propose to add these definitions because they are considered relevant to the proposed changes, and would have direct implications on the application of the regulation by States.

We propose to change the section number for the “Policy” section from § 630.1006 to § 630.1008. This section states FHWA's policy on work zone safety and mobility for all Federal-aid highway projects. We propose to include elements that would address the “mobility” needs in addition to those that would address the safety needs of all road users, workers, and other affected parties. We propose to amend the last sentence of the paragraph to indicate that States are encouraged to implement these procedures for non-Federal-aid projects, maintenance and utility operations as well.

We propose to change the section number for the “Implementation” section from § 630.1008 to § 630.1010. The proposed content of this section is very similar to that of the current regulation. This section outlines the role of the FHWA Division Office, and that of the State in implementing the provisions in the regulation. We propose to modify the first sentence of this section to convey that in addition to reviewing the State's implementation of its procedures, the FHWA shall also be responsible for reviewing the “conformance” of the State's procedures with this regulation. We also propose to append the same sentence with language to convey that the implementation of the regulations is a collaborative process between the State and the FHWA Division Office, by adding the words, “as agreed upon by the FHWA and the State.” This conveys that the State and the FHWA Division Office may work together to develop appropriate procedures and determine the most suitable intervals for the FHWA Division Administrator to review the State's implementation of its procedures. We do not propose any modifications to the second sentence in this section. We propose to modify the last sentence in this section of the current regulation by deleting the word “major” in “or revisions” so as to eliminate ambiguity in interpretation.

We propose to reorganize the section entitled “Contents of the agency procedures,” under a new title, “State Transportation Department Policy and Procedures.” The purpose of this reorganization is to clearly delineate policy level and project level requirements for States. We propose to change the section number for this section from § 630.1010 to § 630.1012. Our proposed changes to this section are explained in the following paragraphs.

This section consists of two main requirements, which are: § 630.1012(a) State Transportation Department Policy, and § 630.1012(b) Project Impact Analysis and Management Procedures.

In § 630.1012(a) “State Transportation Department Policy” we propose policy level requirements for States to support the consideration of work zone safety and mobility impacts in the project development process.

In § 630.1012(a) we propose to add the requirement for a “Work Zone Safety and Mobility Policy.” This would be a new requirement, where we propose that States shall develop their own “work zone safety and mobility policies” that will support the systematic consideration of work zone impacts across all stages of project development; and address the safety and mobility needs of all road users, workers, and other affected parties on all Federal-aid highway projects. All stages of project development include early project level planning through project design, traffic control and operations planning. Such policies would facilitate easier and more streamlined decision making during project development by providing a standardized approach, and by serving as an implementation guide to practitioners who are involved in planning, designing, and implementing road projects.

In § 630.1012(a)(1)(i) we propose to make these policies scaleable according to each State's unique requirements, and that the State may apply its policy to different projects based on the severity of work zone impacts of the project.

In § 630.1012(a)(1)(ii) we propose to recommend that the State involve personnel from different departments and representing the different project development stages in the development of the policy. The proposed language is general and would allow flexibility in the role and makeup of the team. Such a team may be responsible for the analysis and evaluation of the safety and mobility issues related to work zones, and the development, improvement, and institutionalization of the resultant project options as well as the work zone design and impact mitigation strategies for different types of projects. Such a multidisciplinary team may serve as a standing committee of experts on work zones, and may help make informed decisions during the appropriate stages of project development on how best to design and build projects, and mitigate the impacts of work zones. The State may include other stakeholders ( i.e. , other transportation agencies, police, fire, emergency medical services, and regional transportation management centers), and industry representatives ( i.e. , engineers, contractors) in developing these policies.

The content of the policy would be determined by the State. The following are examples of topics that may be addressed in these State policies:

• Project Classification. A project classification system would be a process to classify road projects into different types, based on the severity of work zone impacts. This classification process would allow the State to apply appropriate policies and practices for the design, implementation, and management of work zones and their impacts, that are best suited to specific project types. The different parameters that affect work zone impacts of projects include, but are not limited to: Road classification; area type (urban, suburban, rural); traffic demand and travel characteristics (lanes affected, Average Daily Traffic, expected capacity reduction, Level of Service); type of work; complexity of work being performed (duration, length, intensity); level of traffic interference with construction activity; and potential impacts on local network and businesses. Project classification systems may range from a simple scheme to classify projects into high impact and low impact, to a multi-dimensional matrix of projects that helps decisionmaking on appropriate work zones treatments for different types of projects. At this time, there are no recommended tiers of projects, and States may develop their own classification system that best suits their needs. It is noteworthy that a simple and straightforward classification system would ensure that it is practical and is also easy to adopt and apply.

• Work Zone Performance Standards. Performance standards would establish the safety and mobility performance requirements for work zones for different types of projects, and thereby drive appropriate planning, design and operational strategies that help achieve the set requirements. An example of a performance standard for work zones would be the establishment of a traffic management policy that outlines performance standards for different types of projects. Such a traffic management policy may also outline methods that prescribe limits on lane closures, thresholds on delays and queues due to work zones, and restrictions on work hours so as to achieve the mobility performance standards for different types of projects. The traffic management policy may also include safety performance standards that outline requirements for crash reduction.

For example, the Ohio Department of Transportation (ODOT) has developed and adopted a policy that sets limitations on the number of lanes that may be closed for construction activities on freeways and “freeway look-alikes” (other highways that are similar to freeways). Such performance standards for decisionmaking during the early project planning and preliminary design stages would provide designers and traffic control and operations planners an understanding of the limitations that they are working under, thereby resulting in more comprehensive and complete designs and traffic control and operations plans, which may not require extensive changes during the final stages of design, or during the actual construction phase.

• Development of Recommendations on Project Options, and Work Zone Design and Impacts Mitigation Alternatives that Suit Different Project Types. After the establishment of a project classification system and appropriate performance standards, the State may then develop recommendations on alternative project planning and design solutions and strategies that best minimize the work zone impacts for different project types. The availability of Statewide policies and procedures on the most suitable project options and work zone design and impacts mitigation strategies for the different types of projects would streamline decisionmaking, and ultimately make project delivery more efficient and effective, and work zones less disruptive. Examples of alternative project options and design strategies would include recommendations on work zone strategies ( e.g. , night work, full-closure); design strategies ( e.g. , traffic control, choice of materials, use of positive separation); contracting strategies ( e.g. , low bid, design-build, A+B bidding, incentive/disincentive contracting); and mitigation strategies ( e.g. , use of intelligent transportation systems, traveler information, real-time work zone monitoring, management and enforcement).

Section 630.1012(a)(2) “Training.” The proposed requirements in the “Training” section are part of the current regulation in § 630.1010(d). We propose to modify the current language in this section by adding the words “work zone related transportation management and” after the word inspection. This would indicate that training related to work zones is not limited to just subjects that address traffic control for work zones. The proposed language reads as follows: “All persons responsible for the development, design, implementation, operation, and inspection of work zone related transportation management and traffic control shall be adequately trained.” We propose to add another sentence that encourages documentation of the successful training received by the appropriate personnel, and the provision of periodic training updates that reflect changing industry practices. The proposed amendment would encourage States to keep records of training provided to personnel, and also to periodically provide training updates that are reflective of changing industry practices. The State may choose the most appropriate intervals for providing training updates.

Section 630.1012(a)(3) “Process Review and Evaluation.” The current requirements on “Process Review and Evaluation” are stated in § 630.1010(e) and we propose to relocate the current language to § 630.1012(a)(3). We propose to add language that would provide flexibility to States on the frequency and the type of reviews. The current regulation requires States to annually review randomly selected projects throughout their jurisdiction for the purpose of assessing the effectiveness of their procedures. We propose to lessen the burden on States by changing the word “shall” to “is encouraged”, and by changing the requirement for “annual” reviews to “periodic” reviews. With increasing construction activity, and demand for time and resources of State personnel, the requirement to conduct such reviews on an annual basis may overburden States, resulting in perfunctory reviews for the sake of meeting a regulatory requirement. We believe that it is in the States' best interest to conduct reviews of processes and projects at appropriate intervals, so that they can continually improve their processes with regards to work zones and meet the needs of their customers better.

Further, we also propose to remove the requirement for the review and approval of the State's review results by the FHWA Division Administrator. We believe that the process reviews and improvements would be better achieved by a cooperative agreement and understanding between the State and the FHWA Division, which may be addressed in the stewardship agreement. We also propose to encourage States to include an FHWA representative in the process reviews. An overarching proposal would be to include both “safety and mobility” considerations in the reviews.

Section 630.1012(a)(4) “Work Zone Performance Data.” The current regulation consists of requirements on analysis of construction zone accidents and accident data. These requirements are currently presented under the “Process Review and Evaluation,” § 630.1010(e)(2). We propose to relocate the language on work zone crash data collection and analysis from the current “Process Review and Evaluation” section and include it under the title, “Work Zone Performance Data.” In § 630.1012(a)(4)(i) we propose to retain the crash and crash data analysis requirements, but change “construction zone accidents and accident data” to “crashes and crash data.” We also propose that States may include other safety performance measures in the analysis. This would be to reflect the trend of increasingly deploying ITS and other automated systems for work zones that indirectly help collect better safety performance data on work zones. Such safety performance measures would include data on speed variance and video data on work zone traffic flow that may help identify potential safety improvements.

In § 630.1012(a)(4)(ii) we propose to add language that would encourage States to collect and analyze work zone mobility performance data to continually improve work zone practices and policies. Examples of mobility performance data would include delay, travel time, traffic volumes, speed, and queue lengths. The purpose of these proposed changes is to bring to the attention of States that both safety and mobility performance measurement and analysis is an essential part of ensuring that we develop and adopt the most effective and efficient practices for improving work zone safety and mobility, thereby delivering on the expectations of our customers.

In § 630.1012(b) “Project Impact Analysis and Management Procedures” we propose to require project level procedures that would analyze the work zone impacts of alternative project options and design strategies, and would develop mitigation measures that help manage the work zone impacts. The proposed requirements are: “Work Zone Impacts Analysis”, “Transportation Management Plan (TMP)”, “Pay Items”, and “Responsible Persons.”

Section 630.1012(b)(1) “Work Zone Impacts Analysis.” This would be a new requirement that would require States to analyze the work zone safety and mobility impacts of alternative project options and work zone design strategies, and develop appropriate measures to mitigate the work zone impacts. The purpose of this impacts analysis would be to understand the type, severity and the extent of the work zone impacts associated with the different project alternatives, and to incorporate appropriate mitigation measures and strategies in project design, traffic control, transportation management and operations, and construction. We propose to provide flexibility to States in the performance of these impacts analyses by indicating that the scope and level of detail of the analysis would vary based on the States' policies and their understanding of the anticipated severity of work zone impacts due to the project. For projects with minimal sustained work zone impacts, the State would be exempt from performing a detailed project specific impacts analysis.

States would be encouraged to start the impacts analysis early in project development, and depending on the anticipated severity of work zone impacts due to the project, continue the analysis through project design, and traffic control and operations planning. This means that States would be encouraged to adopt a gradual systematic process for the impacts analysis by initially identifying the anticipated work zone impacts of the project during early project level planning, and based on this identification determine whether a more detailed impacts analysis is required during the subsequent stages of project development. As proposed, States would be required to document the results of the work zone impacts analysis, the project options, the work zone design strategies, and mitigation measures identified during the process.

In § 630.1012(b)(1)(i) we propose to encourage States to establish a team that would include representatives of the project development stages to discuss, evaluate and document work zone issues, and take responsibility for the development of the project design and work zone mitigation strategies. The size and constitution of the multidisciplinary team and the level of involvement required may vary according to the anticipated work zone impacts. As proposed, we suggest that non-State personnel and affected parties may also be included in this team as appropriate. Such non-State personnel and affected parties may include other transportation agencies, such as counties, cities, local municipalities, Metropolitan Planning Organizations (MPOs), transit providers, police and other emergency response agencies, and representatives of affected businesses and residences.

In § 630.1012(b)(1)(ii) we propose language that states that the impacts analysis would be a systematic process that may require the use of appropriate analytical tools, depending on the degree of detail required for the analysis. Such tools would include transportation modeling and/or simulation software. We also propose that the impacts analysis consist of three main activities that are explained as follows:

In § 630.1012(b)(1)(ii)(A) we propose to include a requirement for States to understand the project, traffic and travel characteristics, and identify the work zone impacts of the project (including impacts of multiple projects at the corridor and network levels, as appropriate).

States may begin by fully understanding the project, traffic and travel characteristics and needs early on in project planning. Based on this understanding the work zone impacts and the parties affected by the work zone can be better identified. States may then develop an overall project design and impacts mitigation strategy. Based on the level of understanding gained from the early analysis, States may decide upon the level of detail that is required for analyzing the work zone impacts of alternative project options and design strategies, and developing the most appropriate mitigation measures. Project, travel, and traffic characteristics may include:

• Traffic demand and volumes, seasonal and temporal variations in demand (hourly, daily, weekly), occurrence of special events, percentages of different vehicular volumes (cars, trucks, buses), type of travel (commuter or tourist), freight corridor, transit corridor, business issues, and other such similar characteristics; and

• State policy requirements on impacts analysis and mitigation requirements for the specific project type and/or regional requirements on work zone impacts mitigation and management.

The work zone impacts of the project may include consideration of the following:

• Impacts of the project at both the corridor and network levels to include parallel corridors, alternate routes, the transportation network, and other modes of transportation, impacts of other work zones in the vicinity of the project, either at the corridor level or the network level;

• Impacts on nearby transportation infrastructure, such as, key intersections and interchanges, railroad crossings, public transit junctions, and other junctions in the transportation network;

• Impacts on evacuation routes in the vicinity of critical transportation or other infrastructure;

• Impacts on affected public properties, including parks, recreational facilities, fire stations, police stations, and hospitals; and

• Impacts of the project on affected private properties, including businesses and residences.

In § 630.1012(b)(1)(ii)(B) we propose to add language that discusses the development and evaluation of alternative project options including design, procurement, and construction strategies that minimize the work zone impacts of the project.

This activity would constitute the development of alternative project options and the evaluation of the respective work zone impacts, so as to mitigate and manage the impacts to the best extent possible. The number of alternative project options and design strategies and the level of detail of the analysis of the work zone impacts would depend on the State's understanding of the individual project needs and the anticipated severity of work zone impacts due to the project. Examples of alternative project options would include design, procurement, and construction strategies such as:

• Temporal alternatives for work performance such as season, month, day of week (weekend vs. weekday), and time of day (night time vs. day, off-peak vs. peak);

• Alternative lane closure strategies such as full-closure, partial closure, cross-overs, multiple lane closure, single lane closure; and impact of alternative traffic management strategies on lane-closure decisions;

• Alternative design solutions that address the durability and economy of maintenance of the roadway;

• Alternative design solutions and strategies that impact decision making on Right of Way (ROW) acquisition;

• Alternative construction staging plans, and construction techniques and methodologies ( e.g. , accelerated construction techniques) that may have varying types and severity of work zone impacts; and

• Alternative contracting methodologies such as low-bid, design-build, A+B bidding, and incentive/disincentive contracting.

In § 630.1012(b)(1)(ii)(C) we propose to add language that would address the development of transportation management recommendations that mitigate the work zone impacts of the project for the chosen project option, including traffic control, transportation operations and safety, and public information and outreach strategies.

As a final activity in the impacts analysis, this process would develop appropriate transportation management recommendations that would mitigate the work zone impacts of the project. Such transportation management recommendations would include traffic control requirements, transportation operations and safety requirements, and public information and outreach requirements. These requirements would be grouped and documented in the TMP, which is explained in the following paragraphs.

Traffic control requirements would include recommendations on strategies to safely and efficiently handle traffic flow through the actual work zone itself. Examples of traffic control requirements would include recommendations on lane closure widths, work zone and work area configuration, tapers, and the choice and positioning of traffic control and safety devices.

Examples of transportation operations recommendations would include the following:

• The deployment of Intelligent Transportation Systems (ITS) technologies for work zone traffic monitoring and management;

• Provision of real-time traveler information to the public, including information provision on Web sites;

• Application of transportation systems management (TSM) and corridor management strategies, including mitigation treatments for alternate routes (for e.g. , traffic signal timing adjustment on affected corridors), and alternate modes (for e.g. , public transit subsidies, incentives and special programs);

• Coordination of transportation management with existing regional Transportation Management Centers (TMCs);

• Conduct of mobility and safety reviews and audits;

• Speed enforcement and management in work zones using either police officers or through automated techniques;

• Incident management plans for work zones; and

• Policies on work zone traffic management during emergency situations, for e.g. , hurricane evacuations or other natural disasters.

Examples of public information and outreach recommendations may include the following communications requirements:

• Provision of project and work zone information prior to the commencement of the work in order to make the public aware of the expected work zone impacts and the State's actions to mitigate the impacts;

• Provision of recommendations to the public on commuter alternatives, such as information on alternate routes and alternate modes;

• Provision of information on changing conditions on the project during the course of its implementation (for e.g. , changes in lane closure scenarios, construction staging, construction times, alternate routing); and

• Obtaining public input into the development of appropriate work zone impacts mitigation strategies during the planning and design phases of the project; the refinement of work zone traffic management and mitigation strategies during the course of the project implementation; and public feedback on performance of the work zone and project after the completion of the project.

Examples of public information and outreach sources that the State may consider for the public information and outreach plan would include the following:

• Dissemination of information through brochures, pamphlets and media sources including newspapers, television and radio channels, and Web sites;

• Public meetings and hearings;

• Coordination and cooperation with affected public and private parties;

• Establishment of telephone hotlines; and

• Focus groups, surveys, and market research for obtaining input and feedback from the public.

In § 630.1012(b)(2) we propose to establish the requirement for a Transportation Management Plan (TMP). The TMP would be a new requirement with the current requirements on the Traffic Control Plan (TCP) updated and rolled into it. The TMP would document the work zone mitigation and management strategies recommended by the work zone impacts analysis.

In § 630.1012(b)(2) we propose language to indicate that a TMP would document the mitigation strategies identified during the work zone impacts analysis. We propose that a TMP would have three coordinated components, namely the Traffic Control Plan (TCP), the Transportation Operations Plan (TOP), and the Public Information and Outreach Plan (PIOP). We propose to indicate that the content and degree of detail of the TMP will vary according to the severity of work zone impacts due to the project. We propose to require that States shall develop TMPs for projects based on their policy requirements and the severity of work zone impacts due to the project. We then propose to outline the requirements for the individual TMP components in § 630.1012(b)(2)(i)—“TCP,” § 630.1012(b)(2)(ii)—“TOP,” and § 630.1012(b)(2)(iii)—“PIOP.” The proposed content for these sections are explained in the following paragraphs.

In § 630.1012(b)(2)(i) we outline the proposed requirements for a Traffic Control Plan (TCP). As proposed, the TMP would include a TCP or provisions that would allow contractors to develop a State approved TCP prior to the start of work. This means that TCPs would be developed for all projects. It also means that States may involve contractors in the development of TCPs based on their understanding of the construction staging and strategies.

We propose to retain the current language on the definition of TCPs, and include the consideration of mobility by stating that it is a plan for safely and efficiently handling traffic through a specific highway or street work zone or project. We propose that TCPs may range in scope from a very detailed TCP designed solely for a specific project, a section of the MUTCD, or reference to approved standard plans or State transportation department manual. We also propose that for projects that have minimal work zone impacts, the TCP would be the only component of the TMP.

The scope of the TCP would be determined by the anticipated construction staging and scheduling, and the traffic safety and control requirements identified in the work zone impacts analysis. The plans, specifications, and estimates (P.S. & E.s) would include either a State-prepared TCP; or provisions for contractors to develop a TCP, approved by the State, prior to start of the work. We also propose to retain the current language that the TCP shall be consistent with the provisions of the MUTCD.

We propose to delete the current language in the regulation that addresses TCP requirements for the work zone operations of two-lane, two-way highways as that language is available in the MUTCD. The reason why we propose to include the TCP as a component of the TMP is to present the need for a synergistic, coordinated approach to developing and implementing traffic control and transportation management strategies.

In § 630.1012(b)(2)(ii) we outline the requirements for a Transportation Operations Plan (TOP). We propose to include the development of a TOP as part of the TMP for projects. We propose that States would include a TOP in the TMP if recommended by the results of the work zone impacts analysis. A TOP would include considerations that address the safety and mobility of the transportation system by adopting strategies for the sustained operations and management of the work zone impact area. Such strategies would include transportation systems management; corridor management; and traffic management operations and safety ( i.e. , ITS based traffic control and traveler information, speed management and enforcement, incident and emergency management, safety reviews and audits). We propose to recommend that States coordinate the TOP with stakeholders ( i.e. , other transportation agencies, police, fire, emergency medical services, and regional transportation management centers).

We propose to indicate that the scope of the TOP would be determined by the transportation operations and safety requirements identified in the work zone impacts analysis. We propose that the TOP may be included in the P.S. & E.s. This would provide the State flexibility to contract the TOP as part of the overall contract for the project, or hire a separate contractor for implementing the TOP. We also propose that provisions may be made in the P.S.&E.s for contractors to develop a TOP, approved by the State, prior to the start of work. This would provide the State an opportunity to involve the contractor in the development of the TOP.

In § 630.1012(b)(2)(iii) we outline the requirements for a Public Information and Outreach Plan (PIOP). We propose to include the development of PIOPs as part of the TMP for projects. We propose that States would include a PIOP in the TMP, if recommended by the results of the work zone impacts analysis. A PIOP would consist of project level communications that would ensure that affected road users, the general public, residences and businesses, and the appropriate public entities are informed about the project, the expected work zone impacts, and the changing conditions of the project. Through the PIOP we propose to encourage States to provide adequate ( i.e. , frequent, current, and near-real-time where appropriate) information for the affected parties to make informed travel decisions that help alleviate the work zone impacts of the project.

We propose to identify that the scope of the PIOP would be determined by the public information and outreach requirements identified in the work zone impacts analysis. We propose that the State may choose to include the PIOP in the P.S.&E.s. This would provide the State the flexibility to contract the PIOP as part of the overall contract for the project, or hire a separate contractor for implementing the PIOP. We also propose that alternatively, States may choose to include provisions in the P.S.&E.s for contractors to develop a PIOP, approved by the State, prior to the start of work. This would provide the State an opportunity to involve the contractor in the development of the PIOP.

In § 630.1012(b)(3) we propose to amend the requirements for “Pay Items.” This is an existing requirement, with proposed changes that would allow both method based and performance based specifications for procurement, and emphasize the need for unit pay items in the case of method based procurement for TCPs. It also proposes to allow the State flexibility in including the other TMP components in the P.S.&E. package.

In § 630.1012(b)(4) we propose to amend the requirements for “Responsible Persons.” This is an existing requirement, with proposed changes that would require a responsible person at the project level from the contractor, in addition to the responsible person from the State.

We propose that the compliance date be 3 years after the effective date of the final rule. This would allow States time to implement the proposed requirements.

All comments received before the close of business on the comment closing date indicated above will be considered and will be available for examination using the docket number appearing at the top of this document in the docket room at the above address. We will file comments received after the comment closing date in the docket and will consider later comments to the extent practicable. We may, however, issue a final rule at any time after the close of the comment period. In addition to late comments, we will also continue to file, in the docket, relevant information becoming available after the comment closing date, and interested persons should continue to examine the docket for new material.

The FHWA has determined that the proposed rule would not be a significant regulatory action within the meaning of Executive Order 12866 and would not be significant within the meaning of Department of Transportation regulatory policies and procedures. It is anticipated that the economic impact of this action would be minimal.

These proposed changes are not anticipated to adversely affect, in a material way, any sector of the economy. In addition, these changes are not likely to interfere with any action taken or planned by another agency or to materially alter the budgetary impact of any entitlements, grants, user fees, or loan programs.

Based upon the information received in response to this NPRM, the FHWA intends to carefully consider the costs and benefits associated with this rulemaking. Accordingly, comments, information, and data are solicited on the economic impact of the changes described in this document or any alternative proposal submitted.

In compliance with the Regulatory Flexibility Act (Pub. L. 96-354, 5 U.S.C. 601-612), we have evaluated the effects of this rule on small entities. This rule applies to State departments of transportation in the execution of their highway program with respect to work zones. The implementation of the proposed provisions in this rule will therefore not affect the economic viability or sustenance of small entities. Accordingly, the FHWA certifies that the proposed action will not have a significant economic impact on a substantial number of small entities.

This proposed action does not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995, 109 Stat. 48). The actions proposed in this NPRM would not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year (2 U.S.C. 1532). Further, in compliance with the Unfunded Mandates Reform Act of 1995, the FHWA will evaluate any regulatory action that might be proposed in subsequent stages of the proceeding to assess the affects on State, local, and tribal governments and the private sector.

This proposed action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132, dated August 4, 1999, and it has been determined that this proposed action does not have a substantial direct effect or sufficient federalism implications on States that would limit the policymaking discretion of the States. Nothing in this document directly preempts any State law or regulation or affects the States' ability to discharge traditional State governmental functions.

Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501, et seq. ), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct, sponsor, or require through regulations.

The FHWA has determined that this proposed rule contains a requirement for data and information to be collected and maintained in the support of design, construction, and operational decisions that affect the safety and mobility of the traveling public related to highway and roadway work zones. In order to streamline the process, the FHWA intends to request that the OMB approve a single information collection clearance for all of the data in the proposed regulation.

The FHWA estimates that a total of 83,200 burden hours per year would be imposed on non-Federal entities to provide the required information for the proposed regulation requirements. Respondents to this information collection include State Transportation Departments from all 50 States, Puerto Rico, and the District of Columbia. The estimates here only include burdens on the respondents to provide information that is not usually and customarily collected.

The FHWA is required to submit this proposed collection of information to OMB for review and approval, and accordingly, seeks public comments. Comments regarding any aspect of these information collection requirement, including, but not limited to: (1) Whether the collection of information is necessary for the performance of the functions of the FHWA, including whether the information has practical utility; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility and clarity of the collected information; and (4) ways to minimize the collection burden without reducing the quality of the information collected.

The FHWA has analyzed this proposed action under Executive Order 13175, dated November 6, 2000, and believes that this proposed action will not have substantial direct effects on one or more Indian tribes; will not impose substantial direct compliance costs on Indian tribal governments; and will not preempt tribal law. This rulemaking primarily applies to urbanized metropolitan areas and National Highway System (NHS) roadways that are under the jurisdiction of State transportation departments. The purpose of this proposed action is to mitigate the safety and mobility impacts of highway construction and maintenance projects on the transportation system, and would not impose any direct compliance requirements on Indian tribal governments and will not have any economic or other impacts on the viability of Indian tribes. Therefore, a tribal summary impact statement is not required.

The FHWA has analyzed this proposed action under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution or Use. We have determined that this proposed action will not be a significant energy action under that order because any action contemplated will not be a significant regulatory action under Executive Order 12866 and will not be likely to have a significant adverse effect on the supply, distribution, or use of energy. Further, we believe that the implementation of the proposed provisions by State departments of transportation would reduce the amount of congested travel on our highways, thereby reducing the fuel consumption associated with congested travel. Therefore, the FHWA certifies that a Statement of Energy Effects under Executive Order 13211 is not required.

The FHWA has analyzed this proposed action for the purposes of the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4347 et seq. ) and has determined that this proposed action will not have any effect on the quality of the environment. Further, we believe that the implementation of the proposed provisions by State departments of transportation would reduce the amount of congested travel on our highways. This reduction in congested travel would reduce automobile emissions that are induced by congested travel, thereby contributing to a cleaner environment.

The FHWA has analyzed this proposed rule under Executive Order 12630, Governmental Actions and Interface with Constitutionally Protected Property Rights. The FHWA does not anticipate that this proposed action would affect a taking of private property or otherwise have taking implications under Executive Order 12630.

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

The FHWA has analyzed this proposed action under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. The FHWA certifies that this proposed action will not cause an environmental risk to health or safety that may disproportionately affect children.

A regulation identification number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN contained in the heading of this document can be used to cross reference this action with the Unified Agenda.

In consideration of the foregoing, the FHWA proposes to revise title 23, Code of Federal Regulations, part 630, subpart J as set forth below:

The collection of information contained in this notice of proposed rulemaking has been submitted to the Office of Management and Budget for review in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)). Comments on the collection of information should be sent to the Office of Management and Budget, Attn: Desk Officer for the Department of Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503, with copies to the Internal Revenue Service, Attn: IRS Reports Clearance Officer, W:CAR:MP:T:T:SP, Washington, DC 20224. Comments on the collection of information should be received by July 7, 2003. Comments are specifically requested concerning:

Whether the proposed collection of information is necessary for the proper performance of the functions of the IRS, including whether the information will have practical utility;

The accuracy of the estimated burden associated with the proposed collection of information (see below);

How the quality, utility, and clarity of the information to be collected may be enhanced;

How the burden of complying with the proposed collection of information may be minimized, including through the application of automated collection techniques or other forms of information technology; and

Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.

The collection of information in this proposed regulation was previously approved and reviewed by the Office of Management and Budget under control number 1545-1774. The collection of information is required to allow the taxpayer to make certain elections to determine the amount of allowable loss under § 1.337(d)-2T, § 1.1502-20 as currently in effect, or under § 1.1502-20 modified so that the amount of allowable loss determined pursuant to § 1.1502-20(c)(1) is computed by taking into account only the amounts computed under § 1.1502-20(c)(1)(i) and (ii); to allow the taxpayer to reapportion a section 382 limitation in certain cases; to allow the taxpayer to waive certain loss carryovers; and to ensure that loss is not disallowed under § 1.337-2T and basis is not reduced under § 1.337(d)-2T to the extent that the taxpayer establishes that the loss or basis is not attributable to the recognition of built-in gain on the disposition of an asset.

This collection of information is modified with respect to §§ 1.1502-20T and 1.1502-32T. Regarding § 1.1502-20T, the collection of information also is necessary to allow the common parent of the selling group to reapportion a separate, subgroup or consolidated section 382 limitation when the acquiring group amends its § 1.1502-32(b)(4) election. With respect to § 1.1502-32T, the collection of information also is necessary to allow the acquiring group to amend its previous § 1.1502-32(b)(4) election, so that it may use previously waived losses of its subsidiary.

The collection of information is required to obtain a benefit. The likely respondents are corporations that file consolidated income tax returns.

Estimated total annual reporting and/or recordkeeping burden: 30,400 hours.

Estimated average annual burden per respondent: 2 hours.

Estimated number of respondents: 15,200.

Estimated annual frequency of responses: once.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the Office of Management and Budget.

Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.

Temporary regulations in the Rules and Regulations section of this issue of the Federal Register amend the Income Tax Regulations (26 CFR part 1) relating to section 1502. The text of those regulations also serves as the text of these proposed regulations. The preamble to the temporary regulations contains a full explanation of the reasons underlying the issues of the proposed regulations.

These proposed regulations will be effective on the date they are published as final regulations in the Federal Register .

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It is hereby certified that these regulations do not have a significant economic impact on a substantial number of small entities. This certification is based on the fact that these regulations primarily will affect affiliated groups of corporations that have elected to file consolidated returns, which tend to be larger businesses, and, moreover, that any burden on taxpayers is minimal. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to § 7805(f) of the Internal Revenue Code, these regulations will be submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business.

Before these proposed regulations are adopted as final regulations, consideration will be given to any written (a signed original and eight (8) copies) or electronic comments that are submitted timely to the IRS. All comments will be available for public inspection and copying.

A public hearing has been scheduled for August 6, 2003, beginning at 10 a.m. in room 6718, Internal Revenue Building, 1111 Constitution Avenue, NW., Washington, DC. Due to building security procedures, visitors must enter at the Constitution Avenue entrance. In addition, all visitors must present photo identification to enter the building. Because of access restrictions, visitors will not be admitted beyond the immediate entrance area more than 30 minutes before the hearing starts. For information about having your name placed on the building access list to attend the hearing, see the FOR FURTHER INFORMATION CONTACT portion of this preamble.

The rules of 26 CFR 601.601(a)(3) apply to the hearing. Persons who wish to present oral comments must submit written or electronic comments and an outline of the topics to be discussed and the time to be devoted to each topic (a signed original and eight (8) copies) by July 16, 2003. A period of 10 minutes will be allotted to each person for making comments. An agenda showing the scheduling of the speakers will be prepared after the deadline for receiving outlines has passed. Copies of the agenda will be available free of charge at the hearing.

The principal author of these regulations is Jeffrey B. Fienberg, Office of Associate Chief Counsel (Corporate). However, other personnel from the IRS and Treasury Department participated in their development.

Accordingly, 26 CFR part 1 is proposed to be amended as follows:

A notice of proposed rulemaking and notice of public hearing that appeared in the Federal Register on Friday, January 24, 2003 (68 FR 3477), announced that a public hearing was scheduled for May 21, 2003, at 10 a.m. in room 4718 of the Internal Revenue Service building, 1111 Constitution Avenue, NW., Washington, DC. The subject of the public hearing is proposed regulations under section 368 of the Internal Revenue Code. The deadline for submitting outlines and requests to speak at the hearing for these proposed regulations expired on April 24, 2003.

The notice of proposed rulemaking and notice of public hearing, instructed those interested in testifying at the public hearing to submit a request to speak and an outline of the topics to be addressed. As of May 2, 2003, no one has requested to speak. Therefore, the public hearing scheduled for May 21, 2003, is cancelled.

The final regulations that are the subject of this correction are under section 4980F of the Internal Revenue Code and section 204(h) of the Employee Retirement Income Security Act of 1974 (ERISA).

As published, final regulations (TD 9052) contains errors that may prove to be misleading and are in need of clarification.

Accordingly, the publication of the final regulations (TD 9052), which is the subject of FR. Doc. 03-8290, is corrected as follows:

1. On page 17280, column 2, in the preamble, under the subject heading “Effective Date”, line 4, the language “is on or after September 2, 2003.” is corrected to read “is on or after September 1, 2003.”.

We encourage you to participate in this rulemaking by submitting comments and related material. If you do so, please include your name and address, identify the docket number for this rulemaking (CGD01-03-015), indicate the specific section of this document to which each comment applies, and give the reason for each comment. Please submit all comments and related material in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying. If you would like to know they reached us, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this proposed rule in view of them.

We do not now plan to hold a public meeting. But you may submit a request for a meeting by writing to the Waterways Oversight Branch at the address under ADDRESSES explaining why one would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register .

The City of Hudson, New York has submitted an application to hold a fireworks display from a barged moored at the Hudson Wharf. The proposed safety zone includes all waters of the Hudson River within a 100-yard radius of the fireworks barge in approximate position 42°15′21.0″ N 073°47′58″ W, about 495 feet east of Hudson River Lighted Buoy 133 (LLNR 38585).

Marine traffic would still be able to transit through the western 110 feet of the 400-foot wide channel and to the west of Middle Ground Flats. Additionally, vessels would not be precluded from mooring at or getting underway from piers in the vicinity of the proposed safety zone.

The proposed regulation would be effective from 9 p.m. to 10:30 p.m. on Saturday, June 14, 2003. In case of inclement weather the regulation would be effective from 9 p.m. to 10:30 p.m. on Sunday, June 15, 2003. It would prohibit all vessels and persons from transiting this portion of the Hudson River and is needed to provide for the safety of life on navigable waters during the event.

The proposed safety zone is for the City of Hudson Flag Day Festival Fireworks Display held on a barge moored to the Hudson Wharf. The event would be held on Saturday, June 14, 2003. In case of inclement weather the event would be held on Sunday, June 15, 2003. This rule is being proposed to provide for the safety of life on navigable waters during the event.

The proposed size of this safety zone was determined using National Fire Protection Association and New York City Fire Department standards for 4 inch mortars fired from a barge, combined with the Coast Guard's knowledge of tide and current conditions in the area.

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

We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary.

This finding is based on the minimal time that vessels will be restricted from the zone, vessels will still be able to transit through the western 110 feet of the 400-foot wide channel and to the west of Middle Ground Flats, and vessels would not be precluded from getting underway, or mooring at, any piers or marinas currently located in the vicinity of the proposed safety zone. Advance notifications will be made to the local maritime community by the Local Notice to Mariners, marine information broadcast, electronic mail distribution, and on the Internet at http://www.harborops.com.

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

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

This proposed rule would affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit or anchor in a portion of the Hudson River during the times this zone is activated.

This safety zone would not have a significant economic impact on a substantial number of small entities for the following reasons: Vessel traffic can still transit through the Hudson River during the event; vessels would not be precluded from getting underway, or mooring at, any piers or marinas currently located in the vicinity of the proposed safety zone. Before the effective period, we will ensure wide dissemination of maritime advisories widely available to users of the Hudson River by Local Notice to Mariners, marine information broadcasts, electronic mail distribution, and on the Internet at http://www.harborops.com.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Lieutenant Commander E. Morton, Waterways Oversight Branch, Coast Guard Activities New York at (718) 354-4012.

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

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

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

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

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

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

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

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

We have considered the environmental impact of this proposed rule and concluded that, under figure 2-1, paragraph (34)(g), of Commandant Instruction M16475.lD, this rule is categorically excluded from further environmental documentation. This proposed rule fits paragraph 34(g) as it establishes a safety zone. A “Categorical Exclusion Determination” is available in the docket where indicated under ADDRESSES.

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

We encourage you to participate in this rulemaking by submitting comments and related material. If you do so, please include your name and address, identify the docket number for this rulemaking, (COTP San Diego 03-011), indicate the specific section of this document to which each comment applies, and give the reason for each comment. Please submit all comments and related material in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying. If you would like to know they reached us, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this proposed rule in view of them.

In our final rule, we will include a concise general statement of the comments received and identify any changes from the proposed rule based on the comments. If as we anticipate, we make the final rule effective less than 30 days after publication in the Federal Register , we will explain our good cause for doing so as required by 5 U.S.C. 553(d)(3).

We do not now plan to hold a public meeting. But you may submit a request for a meeting by writing to Marine Safety Office San Diego at the address under ADDRESSES explaining why one would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a separate notice in the Federal Register .

The United States Navy conducts military outload operations from the National City Marine Terminal. These operations involve the loading of men and equipment onboard USNS ships and other Naval vessels for the furtherance of our national security. These onload evolutions are often short fused and are directed at a moments notice. In an effort to protect the onload evolutions and provide adequate notice to the public, the Captain of the Port of San Diego proposes to establish a permanent security zone around the National City Marine Terminal which will be enforced when such a military onload evolution occurs.

As part of the Diplomatic Security and Antiterrorism Act of 1986 (Pub. L. 99-399), Congress amended The Ports and Waterways Safety Act (PWSA) to allow the Coast Guard to take actions, including the establishment of security and safety zones, to prevent or respond to acts of terrorism against individuals, vessels, or public or commercial structures. 33 U.S.C. 1226. The terrorist acts against the United States on September 11, 2001, have increased the need for safety and security measures on U.S. ports and waterways.

In response to these terrorist acts, and in order to prevent similar occurrences, the Coast Guard proposes to establish a permanent security zone in the navigable waters of the United States adjacent to the National City Marine Terminal. The action proposed under this rule is necessary to protect the U.S. Naval vessel(s) and their crew(s) during these military outload evolutions at the National City Marine Terminal from sabotage, or other subversive acts, accidents, criminal actions or other causes of a similar nature.

Due to National Security interests, the implementation of this security zone is necessary for the protection of the United States and its people. The size of the zone is the minimum necessary to provide adequate protection for the U.S. Naval vessel(s), their crew(s), adjoining areas, and the public.

The military outload evolutions involve the transfer of military equipment from a shore side staging area to various Military Sealift Command vessels and other contracted vessels. The security zone will accompany other security measures implemented at the National City Marine Terminal waterfront facility.

Due to complex planning, national security reasons, and coordination with all military schedules, information regarding the precise location and date of the military outloads will not be circulated, however, prior to any outload evolution, the public will be notified that the security zone is in effect and will be enforced. The enforcement of the security zone will be announced via broadcast notice to mariners, local notice to mariners, or by any other means that is deemed appropriate.

This security zone is established pursuant to the authority of the Magnuson Act regulations promulgated by the President under 50 U.S.C. 191, including subparts 6.01 and 6.04 of Part 6 of Title 33 of the Code of Federal Regulations. Vessels or persons violating this section are subject to he penalties set forth in 50 U.S.C. 192 which include seizure and forfeiture of the vessel, a monetary penalty of not more than $12,500, and imprisonment for not more than 10 years.

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

Although this regulation restricts access to the zone, the effect of this regulation will not be significant because: (i) The zone will encompass only a small portion of the waterway; (ii) vessels will be able to pass safely around the zones; and (iii) vessels may be allowed to enter these zones on a case-by-case basis with permission of the Captain of the Port, or his designated representative.

Most of the entities likely to be affected are pleasure craft engaged in recreational activities and sightseeing. Any hardships experienced by persons or vessels are considered minimal compared to the national interest in protecting U.S. Naval vessel(s), their crew(s), and the public. Accordingly, full regulatory evaluation under paragraph 10(e) of the regulatory policies and procedures of the DHS is unnecessary.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. Most of the traffic in this area is recreational traffic and sightseers. The economic impact is minimal by having them gain permission to transit through the zone from the COTP or his representative. The Coast Guard has coordinated with known private business owners in an effort to reduce any substantial impact on business.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offer to assist small entities in understanding the rule so that they may better evaluate its effects on them and participate in the rulemaking process. If your small business or organization is affected by this rule or if you have questions concerning its provisions or options for compliance, please contact Lieutenant Commander Rick Sorrell, Chief of Port Operations, U.S. Coast Guard Marine Office San Diego at (619) 683-6495.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

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

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

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

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

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

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

This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. We invite your comments on how this proposed rule might impact tribal governments, even if that impact may not constitute a “tribal implication” under the order.

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

We have considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (34)(g), of Commandant Instruction M16475.lD, this rule is categorically excluded from further environmental documentation because we are establishing a security zone. A “Categorical Exclusion Determination” and checklist are available in the docket for inspection or copying where indicated under ADDRESSES. Comments on this section will be considered before we make the final decision on whether the rule should be categorically excluded from further environmental review.

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

This Advance Notice of Proposed Rulemaking (ANPR) is organized into four Units. Unit I. contains “General Information” about the applicability of this ANPR, how to obtain additional information, how to submit comments in response to the request for comments, and certain other related matters. Unit II. provides background and historic information pertaining to human subject research. Unit III. describes the rulemaking process, identifies relevant statutory provisions, and requests public comments and suggestions on a broad range of issues related to the Agency's consideration of or reliance on research with human subjects. Unit IV. describes procedures followed in the development of this ANPR and certain statutes and Executive Orders that the public may wish to consider in preparing comments.

This action is directed to the public in general. This action may, however, be of particular interest to those who conduct testing of substances regulated by EPA. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0132. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/.

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

Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.

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

i. EPA Dockets . Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. Once in the system, select “search,” and then key in docket ID number OPP-2003-0132. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

ii. E-mail . Comments may be sent by e-mail to opp-docket@epa.gov, Attention: Docket ID Number OPP-2003-0132. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

iii. Disk or CD ROM . You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I.C.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.

2. By mail . Send your comments to: Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency (7502C), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0132.

3. By hand delivery or courier . Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP-2003-0132. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I.B.1.

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT .

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Make sure to submit your comments by the deadline in this ANPR.

7. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

Over the years, scientific research with human subjects has provided much valuable information to help characterize and control risks to public health, but its use has also raised particular ethical concerns for the welfare of the human participants in such research as well as scientific issues related to the role of such research in assessing risks. Society has responded to these concerns by defining general standards for conducting human research. In the United States, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued in 1979 “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.” This document can be found on the web at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm.

For most federal agencies in the United States, the principles of the Belmont Report are implemented through the Common Rule, which was developed cooperatively by some 17 departments and agencies, including EPA, and which guides all research with human subjects conducted or supported by these departments and agencies of the federal government. The Common Rule as promulgated by EPA (40 CFR part 26) has guided human research conducted or supported by EPA since it was put in place in 1991.

More broadly, the international medical research community has developed and maintains ethical standards documented in the Declaration of Helsinki, first issued by the World Medical Association in 1964 and revised several times since then. These standards apply to research on matters relating to the diagnosis and treatment of human disease, and to research that adds to understanding of the causes of disease and the biological mechanisms that explain the relationships between human exposures to environmental agents and disease.

In addition, many public and private research and academic institutions and private companies, both in the United States and in other countries, including non-federal U.S. and non-U.S. governmental organizations, have their own specific policies related to the protection of human participants in research.

Much of the scientific research supporting EPA's actions, including a significant portion of the research with human subjects submitted to the Agency or retrieved by the Agency from published sources, is conducted by this broader research community, without direct participation or support by the U.S. government. Such research, referred to here as “third party” research, while it may be governed by specific institutional policies intended to protect research participants or may fall within the scope of the Declaration of Helsinki, is not subject to the Common Rule. In general, EPA cannot readily determine whether such policies are consistent with or as protective of human subjects as the Common Rule, nor the extent to which such policies or standards have been followed in the conduct of any particular study. Thus, even well-conducted third-party human studies may raise difficult questions for the Agency when it seeks to determine their acceptability for consideration.

Questions about the Agency's consideration of and reliance on third-party human research studies have arisen most notably, but not exclusively, in EPA's pesticides program. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA may require pesticide companies to conduct studies with human subjects, for example, to measure potential exposure to pesticide users or to workers and others who re-enter areas treated with pesticides, and to evaluate the effectiveness of pesticide products intended to repel insects and other pests from human skin. In addition, EPA sometimes encourages other research with human subjects, including tests of the potential for some pesticides--generally those designed for prolonged contact with human skin--to irritate or sensitize human skin, and tests of the metabolic fate of pesticides in the human system. These latter studies typically precede monitoring studies of agricultural workers and others to protect them from exposure to potentially dangerous levels of pesticide residues.

In addition to these kinds of research which have been required or encouraged by EPA, other kinds of studies involving human subjects intentionally exposed to pesticides have occasionally been submitted to the agency voluntarily. Among these voluntarily submitted studies have been tests involving intentional dosing of human subjects to establish a No Observed Adverse Effect Level (NOAEL) or No Observed Effect Level (NOEL) for systemic toxicity of certain pesticides to humans. Before passage of the Food Quality Protection Act (FQPA) in 1996, submission of such studies was rare. EPA considered and relied on human NOAEL/NOEL studies in a few regulatory decisions on pesticides made prior to 1996. Since the passage of FQPA, submission of these types of studies to the Office of Pesticide Programs has increased; the Agency has received some 20 studies of this kind since 1996.

In response to concerns about human testing expressed in a report of a non-governmental advocacy organization, the Environmental Working Group, in July 1998, the Agency began a systematic review of its policy and practice. In a press statement on July 28, 1998, EPA noted that it had not relied on any such studies in any final decisions made under FQPA; this remains true today.

In further response to growing public concern over pesticide research with human subjects, EPA convened an advisory committee under the joint auspices of the EPA Science Advisory Board (SAB) and the FIFRA Scientific Advisory Panel (SAP) to address issues of the scientific and ethical acceptability of such research. This advisory committee, known as the Data from Testing of Human Subjects Subcommittee (DTHSS), met in December 1998 and November 1999, and completed its report in September 2000. Their report is available in the Docket cited above in this ANPR, and on the web at: http://www.epa.gov/science1/pdf/ec0017.pdf

The DTHSS advisory committee heard many comments at their two public meetings, and further comments have been submitted in response to their published report. No clear consensus emerged from the advisory committee process on the acceptability of NOAEL or NOEL studies of systemic toxicity of pesticides to human subjects, and significant differences of opinion remain on both their scientific merit and ethical acceptability. A vigorous public debate continues about the extent to which EPA should accept, consider, or rely on third-party intentional dosing human toxicity studies with pesticides.

EPA is now interested in addressing these issues more broadly, and in all Agency programs. In December 2001, EPA asked the advice of the National Academy of Sciences (NAS) on the many difficult scientific and ethical issues raised by this debate, and also stated the Agency's interim approach on third-party intentional dosing human subjects studies. The Agency's press release on this subject is on the web at http://yosemite.epa.gov/opa/ admpress.nsf/b1ab9f485b098972 852562e7004dc686/c232a45f5473 717085256b2200740ad4? OpenDocument. At that time the Agency committed that when it receives the NAS report, “EPA will engage in an open and participatory process involving federal partners, interested parties and the public during its policy development and/or rulemaking regarding future acceptance, consideration or regulatory reliance on such human studies.” Since making that commitment, EPA has decided to initiate a rulemaking process by issuing this ANPR.

In early 2002, various parties from the pesticide industry filed a petition with the U.S. Court of Appeals for the District of Columbia for review of EPA's December 2001 press release. These parties argued that the Agency's interim approach constituted a “rule” promulgated in violation of the procedural requirements of the Administrative Procedure Act and the Federal Food, Drug, and Cosmetic Act. The court has denied motions concerning emergency relief and other matters, briefs have been filed, and oral argument of the merits of the case occurred on March 17, 2003.

Under a contract with EPA, the NAS has convened a committee to provide the requested advice. The committee met in December 2002, and again in January and March 2003. The membership, meeting schedule, and other information about the work of this committee can be found on the NAS website at: http://www4.nas.edu/webcr.nsf/ 5c50571a75df494485256a95007 a091e/ 9303f725c15902f685256c44005d8931? OpenDocument&Highlight=0,EPA. The committee's final report is due in December 2003.

Notwithstanding these many recent developments concerning human studies, some things have not changed. EPA remains committed to full compliance with the Common Rule for all research with human subjects conducted or supported by the Agency. This body of research has provided many important insights and has contributed significantly to the protection of human health. The Agency will continue to conduct and support such research, and to consider and rely on its results in Agency actions. EPA also remains committed to scientifically sound assessments of the hazards of environmental agents, taking into consideration available, relevant, and appropriate scientific research.

EPA intends to undertake notice-and-comment rulemaking on the subject of its consideration of or reliance on research involving human subjects. The Agency will particularly focus on third-party intentional dosing human studies, but recognizes that the principles applicable to third-party studies may also be relevant to studies conducted or supported by the federal government. The first step in this process is this ANPR which calls for comments and suggestions from all interested parties. The next step the Agency would expect to undertake would be to issue a proposed rule for public comment. In developing any proposed rule, EPA will consider the advice in the National Academy of Sciences committee report, along with comments received in response to this ANPR. Comments received on any proposed rule would then be taken into consideration in developing a final rule or policy.

In general, the Agency expects that any rule or policy coming out of this process may do one or more of the following:

• Specify, if and to the extent determined by EPA to be appropriate, whether EPA would accept, consider, or rely on results from particular types of studies involving intentional dosing of human subjects or from human studies with particular characteristics.

• Establish minimum standards relating to the protection of human subjects which would be required to be met in the design and conduct of a study with human subjects, in order for EPA to accept, consider, or rely on the results of the study.

• Establish procedures for ensuring that any minimum standards for the conduct of third-party research with human subjects had been adhered to in the conduct of any such study that EPA intended to accept, consider, or rely on.

Section 25(a) of FIFRA gives the Administrator authority to “prescribe regulations to carry out the purposes of [FIFRA].” Such a rule would implement EPA's authority to require data in support of registration of pesticides (see, for example, FIFRA sections 3(c)(1)(F) and 3(c)(2)(B)) and to interpret the provision making it unlawful for any person “to use any pesticide in tests on human beings unless such human beings (i) are fully informed of the nature and purposes of the test and of any physical and mental health consequences which are reasonably foreseeable therefrom, and (ii) freely volunteer to participate in the test.” (FIFRA section 12(a)(2)(P)). In addition, section 408(e)(1)(C) of the FFDCA authorizes the Administrator to issue a regulation establishing “general procedures and requirements to implement this section.”

The Clean Air Act gives EPA general rulemaking authority in 42 U.S.C. 7601(a). The Clean Water Act, 33 U.S.C. 1361, authorizes the Administrator to promulgate regulations necessary to carry out the Agency's functions under that Act. Section 42 U.S.C. 9615 in the Comprehensive Environmental Response, Compensation, and Liability Act authorizes the President to establish regulations to implement the statute; this authority has been delegated to EPA by Executive Order 12580. The Emergency Planning and Community Right-to-Know Act also contains a general rulemaking provision, 42 U.S.C. 11048, authorizing the Administrator to promulgate rules necessary to carry out the Act. The Resource Conservation and Recovery Act specifically authorizes the Administrator to prescribe regulations necessary to carry out EPA's functions under the Act, 42 U.S.C. 6912. The Safe Drinking Water Act contains similar language, authorizing the Administrator to prescribe such regulations “as are necessary and appropriate” to carry out EPA's functions under the Act, 42 U.S.C. 300j-9. In addition, EPA has authority under 5 U.S.C. 301 and 42 U.S.C. 300v-1(b).

Neither this ANPR nor the specific questions presented below for public comment are intended to indicate that EPA now favors any particular policy approaches regarding the Agency's consideration of or reliance on third-party intentional dosing human studies. Similarly, neither this ANPR nor the specific questions presented below for public comment are intended to indicate that EPA has decided on a particular scope for any potential future rulemaking. Nor is this ANPR intended to impede or otherwise delay any Agency assessments or actions. Rather, this ANPR is designed to encourage public input from all interested parties on a broad range of issues that could help inform any rule or policy that EPA eventually promulgates or issues, respectively.

The Agency fully appreciates the number, the range, and the interconnectedness of the scientific and ethical concerns raised especially by intentional dosing human studies of the wide range of environmental agents addressed by EPA's programs. Reflecting the breadth of issues that have been raised, the Agency has identified specific questions on which it particularly invites comment. These questions are intended to help organize and focus the discussion, but not to constrain it. Commenters should feel free to address any other relevant topics as well.

1. Applicability of existing standards —a. Is it appropriate to use a standard intended to guide the conduct of research (e.g., the Common Rule, Declaration of Helsinki, or the Nuremberg Code) to assess the acceptability for review of completed research?

b. Is it appropriate to use a standard intended to guide the conduct of therapeutic or diagnostic medical research or to clarify causes of disease, such as the Declaration of Helsinki, to assess the acceptability for review of other kinds of research without diagnostic or therapeutic intent, conducted with healthy subjects?

c. Should the Agency apply the same standard of acceptability independent of the type of substance tested (e.g., pharmaceutical, pesticide, pathogen, or environmental contaminant)? If not, how might differing standards be applied when a single substance has multiple uses, e.g., as both a pesticide and a drug?

d. Does it matter who maintains a standard, or by what process it is maintained? For example, would it be appropriate for EPA to accept and apply a standard maintained by a private, non-governmental organization, as is the Declaration of Helsinki?

e. Should the Agency extend the requirements of the Common Rule to the conduct of third-party research with human subjects intended for submission to EPA? What are the advantages and disadvantages of conducting a rulemaking or undertaking other Agency action for this purpose alone?

2. Should the standard of acceptability vary depending on the research design ?—a. Should the Agency apply the same standard of acceptability independent of whether the research design involves intentional exposure? For example, should the same standard apply to research involving intentional exposures to human subjects, to research designed to follow-up accidental exposure, and to studies of individuals occupationally or incidentally exposed?

b. Should the Agency apply the same standard of acceptability independent of the level of exposure of the human subjects? For example, does it matter if the level of exposure to a chemical is below the Reference Dose or other established health standard designed to protect the general public? Should the same standard apply if intentional exposure to an environmental pollutant occurs at ambient levels, or at elevated levels? If research involves intentional exposure to a pesticide, does it matter if exposure results from use of the pesticide in conformity with approved label directions?

c. Should the Agency apply the same standard of acceptability independent of the pathway of exposure? For example, should the same standard apply when exposure is oral, or dermal, or by inhalation?

d. Should the Agency apply the same standard of acceptability independent of the effects being evaluated? For example, should the same standard apply to a study measuring transitory changes in blood chemistry or levels of a substance in urine that applies to studies measuring longer-lasting changes? Should the same standard apply to a study of localized skin irritation that applies to a study of systemic dermal toxicity? Should the same standard apply to studies measuring organoleptic effects, such as taste or smell, that applies to studies of toxic effects? Should the same standard apply to measurements of toxic effects and to measurements through genomic or proteomic assessments?

e. Should conduct of research in compliance with the provisions of the Common Rule or another standard for the protection of human subjects be accepted as evidence of its ethical acceptability?

f. Should the Agency consider whether research has been performed consistent with an EPA guideline for data development in determining its acceptability? For example, EPA has published guidelines for certain kinds of human studies required for pesticide registration; should conduct of a required study in compliance with an EPA guideline be accepted as evidence of its acceptability?

g. Should the Agency apply the same standard of acceptability independent of a study's statistical power?

h. Should the Agency apply the same standard of acceptability whether or not a human study design is able to measure the same endpoints in humans that have been observed in animal testing of the same substance? For example, if the most sensitive adverse effects shown in animal studies have been detected through histopathological evaluation of brain tissue, is subsequent research involving intentional exposure of human subjects acceptable?

i. Should the Agency apply the same standard of acceptability to intentional dosing studies independent of whether there are alternative methods of obtaining data of comparable scientific merit that would not require deliberate exposure of humans? If not, to what extent, if any, should the cost of the alternate method be a factor?

j. What special considerations, if any, should the Agency apply in judging the acceptability of studies when some or all of the subjects are from populations likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons?

3. Should the standard of acceptability vary depending on the provenance of the research ?—a. Should the Agency apply the same standard of acceptability without regard to who or what organization sponsors or supports the research? Since 1991, human research conducted or supported by the U.S. government has been subject to the Common Rule. Should the same standard apply to research conducted or supported by others? Should a single standard apply independent of whether the sponsor is a commercial enterprise, a non-profit organization, another government in the United States (such as state, tribal, or local), or the government in another country? Should the same standard apply without regard to the test sponsor's interest in a regulatory matter that could be affected by EPA's consideration of the data?

b. Should the Agency apply the same standard of acceptability independent of who or what organization conducts the research? For example, a research organization--public or private--holding a “Federal-Wide Assurance” from the Department of Health and Human Services's Office of Human Research Protections usually promises to comply with the Common Rule in all its human research. Should third-party work conducted by a research organization holding a Federal-Wide Assurance be assessed by the same standard that applies to other third-party human research?

c. Should the Agency apply the same standard of acceptability without regard to where the research was conducted? For example, does it matter whether research is conducted entirely in the United States or partially in the United States? If it is conducted outside the United States, does it matter in what country it is conducted? What are the advantages and disadvantages of judging the acceptability of human studies based on a single uniform standard versus prevailing local standards (e.g., in different countries)?

d. Should the Agency apply the same standard of acceptability without regard to the reasons the research was conducted? If not, how might the Agency determine intent?

e. Should the Agency apply the same standard of acceptability to submitted research without regard to who submitted it? For example, should the same standard apply to submissions from regulated industry, from public interest groups, from the public, or from other governments? Should the Agency apply the same standard of acceptability independent of whether the study was submitted voluntarily, or in response to a particular regulatory requirement of EPA?

f. Should the Agency apply the same standard of acceptability to human research which is not submitted, but which the Agency obtains at its own initiative from the scientific literature or other sources, independent of how or where EPA obtains it?

4. Should the standard of acceptability vary depending on EPA's potential use of the data ?—a. Should the Agency apply the same standard of acceptability independent of whether the results of the study would support a more or less stringent regulatory position? For example, should the same standard apply whether the data indicate that the substance tested is more risky or less risky than is indicated by other available data?

b. Should the Agency apply the same standard of acceptability without regard to how EPA intends to use the results, e.g., to reduce or remove the traditional tenfold interspecies uncertainty factor, to provide an endpoint for use in calculating a Reference Dose or Reference Concentration for the test substance, to provide a dose-response function for use in quantitative risk assessment, or for some other purpose?

5. Should the standard of acceptability vary depending on EPA's assessment of the risks and benefits of the research to the subjects or to society ?—a. Should the Agency apply a standard of acceptability based on a comparison of the anticipated benefits of the research in relation to the risks to human subjects, provided the risks are minimized and informed consent is obtained?

b. Should the Agency independently assess the risks of the research to the subjects and the benefits of the research to the research subjects or to society, or should it defer to the judgment of Institutional Review Boards or similar oversight panels?

c. If EPA were to assess independently the risks and benefits of human research, on what range of information should it base its assessment? How might EPA obtain information relevant to such an assessment?

6. How should the Agency implement standards of acceptability ?—a. To what extent and how should the submitter of research with human subjects to EPA be required to document or otherwise demonstrate compliance with appropriate standards for the protection of human research subjects, e.g., fully informed and fully voluntary participation, and independent oversight of research design and conduct by an Institutional Review Board or comparable entity?

b. How should the Agency determine compliance with an appropriate standard for human research data which is not submitted, but which it obtains from the scientific literature or other sources?

c. To what extent should new standards be applied to research which has already been conducted, or is underway? Should a different standard be applied to such research? Does fairness require a period of transition to any new rule or standards of acceptability, or do other considerations override that factor?

d. Should the Agency apply the same standard of acceptability to research already submitted to or obtained by EPA and to research newly submitted to or obtained by EPA? Does it matter if the submitted research was conducted for the specific regulatory purpose at hand or for other purposes (even though the study was conducted after EPA issued a policy on human testing)? Does fairness require a period of transition to any new rule or standards of acceptability, or do other considerations override that factor?

e. Is rulemaking needed at all? Would it be better to address the issues surrounding acceptance of human research, or some of them, by other means, such as policy statements or internal guidelines?

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), it has been determined that this ANPR is a “significant regulatory action” under section 3(f) of the Executive Order. The Agency therefore submitted this document to OMB for the 10-day review period afforded under this Executive Order. Any changes made in response to OMB comments during that review have been documented in the public docket as required by the Executive Order.

Since this ANPR does not impose any requirements, and instead seeks comments and suggestions for the Agency to consider in developing a subsequent notice of proposed rulemaking, the various other review requirements that apply when an agency imposes requirements do not apply to this action.

As part of your comments on this ANPR you may include any comments or information that you have regarding these requirements. In particular, any comments or information that would help the Agency to assess the potential impact of a rule on small entities pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ); to consider voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note); or to consider environmental health or safety effects on children pursuant to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). The Agency will consider such comments during the development of any subsequent notice of proposed rulemaking as it takes appropriate steps to address any applicable requirements.

For further information, please see the information provided in the direct final action, with the same title, that is located in the “Rules and Regulations” section of this Federal Register publication. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

For further information, please see the information provided in the direct final action, Pennsylvania's Approval of VOC and NO X RACT Determinations for Two Individual Sources, that is located in the “Rules and Regulations” section of this Federal Register publication. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

This is a synopsis of the Commission's Report and Order, MM Docket No. 02-301, adopted April 15, 2003, and released April 17, 2003. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC, 20554. The document may also be purchased from the Commission's duplicating contractor, Qualex International, Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC, 20554, telephone 202 863-2893, facsimile (202) 863-2898, or via e-mail qualexint@aol.com.

On January 13, 2000, NHTSA issued a final rule establishing specifications and test procedures for a new, more advanced six-year-old child test dummy (H-III6C). 1 The agency determined that a new six-year-old dummy was needed to evaluate the risks of air bag deployment for children, particularly for unrestrained children. The agency adopted the H-III6C dummy because it had a more humanlike impact response than the six-year-old dummies that existed at that time, and because it allowed the assessment of the potential for more types of injuries. The agency also concluded that the H-III6C dummy would provide greater and more useful information in a variety of automotive impact environments to better evaluate child safety.

Research has shown that children, even those older than six years, do not fit properly in adult vehicle seats, and that adult belt restraint systems cannot be properly applied over the load bearing structural parts of children's torsos. 2 Moreover, both the National Transportation Safety Board (NTSB)  3 and the “Blue Ribbon Panel II: Protecting Our Older Child Passengers''  4 have recommended that older children be restrained in child safety seats, booster seats, or safety belts appropriate for their size and weight. Both recommended also that a universally acceptable crash test dummy approximating a ten-year-old child should be developed. In addition, child restraint manufacturers, while attempting to develop specialized child restraint systems and booster seats for larger children, have found themselves hampered in this effort by not having an appropriately sized dummy.

In March 2000, NHTSA responded to these needs by asking the Society of Automotive Engineers (SAE) to take the lead in developing a Hybrid III ten-year-old child size dummy. This effort received a further boost from Congress on November 1, 2000, when the Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act was enacted. 5 Section 14 of the TREAD Act directs NHTSA to consider whether to require the use of anthropomorphic test devices that “represent a greater range of sizes of children, including the need to require the use of an anthropomorphic test device that is representative of a ten-year-old child * * * .” Further, on December 4, 2002, Congress enacted Pub. L. 107-318 (Dec. 4, 2002; 116 Stat. 2772) (“Anton's Law”). Section 4 of Pub. L. 107-318 directs that—

Responding to NHTSA's call, the SAE designed and developed a Hybrid III ten-year-old child size dummy weighing approximately 76 pounds. In accordance with the agency's rulemaking and research plans and in furtherance of Section 4 of Pub. L. 107-318, NHTSA is evaluating the dummy for incorporation into Part 572. However, the evaluation will take time, as necessary design modifications are usually necessary for a dummy to be suitable for incorporation into 49 CFR part 572. In the meantime, child restraint system manufacturers will still need a dummy approximating children in the seven to eight year old age bracket, i.e. , children above 50 pounds. To meet this need, the agency is considering a weighted version of the current H-III6C dummy, one that weighs approximately 62 pounds instead of the 52-pound weight of the H-III6C dummy.

The agency issued an NPRM in May 2002 proposing a number of changes to Standard No. 213 in response to Section 14 of the TREAD Act, including a proposal to use the weighted dummy in the agency's compliance tests of child restraint systems recommended for use by larger children, i.e. , children from 50 to 65 pounds. (67 FR 21806; May 1, 2002; Docket No. 02-11707.) The use of the dummy was viewed as an interim measure until such time that the Hybrid III ten-year-old dummy becomes available. The agency proposed that the dummy would be used in Standard No. 213's dynamic testing to measure the forces that are sustained by the dummy's head, neck, and chest when restrained by the child restraint in a simulated crash. Standard No. 213 would require the child restraint to limit the forces to specified levels. In addition, it was proposed that the dummy would be used to assess the restraint's ability to maintain structural integrity in a crash when the dummy is restrained in it, and to limit excursion of the dummy's head, torso and knees.

Today's document proposes to incorporate into Part 572 the weighted six-year-old dummy that was described in the May 2002 NPRM. That dummy has extensive instrumentation to measure the potential for injuries to the head, the upper and lower ends of the neck, and the chest, as well as other areas of the dummy. Comments were requested and received by the agency on the suitability of the weighted, instrumented dummy for use in Standard No. 213 compliance tests of booster seats and other child restraints recommended for use by children weighing over 50 lb.

Some commenters on the May 2002 NPRM expressed concerns or questions about using the dummy's injury assessment capabilities in Standard No. 213 compliance tests. Some commenters suggested that the weighted dummy does not adequately represent a child in the seven- to eight-year-old age bracket, and that the dummy should thus not be used in the compliance tests because it would add little, if anything, to child passenger safety. Some suggested that the agency should focus on developing the Hybrid III ten-year-old dummy instead. Others suggested that the weighted six-year-old dummy be used only to assess the structural integrity of child restraints, and not to assess the crash forces imposed in the dynamic test.

The agency is considering all the comments on the May 2002 NPRM and will respond to them in the follow-on document to the NPRM. Today's NPRM proposes specifications for the weighted dummy simply to complement the May 2002 NPRM, i.e. , this document completes the dummy specifications called for in the May NPRM. By issuing this document, the agency does not intend to imply that it has concluded that the instrumented dummy will be fully used in Standard No. 213 compliance tests, with all its measurement capabilities. A final rule on the use of the weighted dummy in Standard No. 213 compliance tests, assuming the agency adopts such a provision in a final rule, will address all issues concerning the full or limited use of the dummy. Further, a final rule adopting the dummy into Part 572 will likely parallel NHTSA's final rule concerning use of the dummy in Standard No. 213.

The agency defined the following objectives for the weighted six-year-old child size dummy:

1. Develop a method for increasing the weight of the current H-III6C dummy from 52 pounds to over 60 pounds.

2. The system used to add weight to the H-III6C dummy must not interfere with the restraint system being used, and must not distort the kinematics and impact response of the dummy.

3. The weighted dummy must have sufficient durability in the intended impact exposures.

4. The weighted dummy must have repeatability and reproducibility in calibration and sled tests comparable to that of the H-III6C dummy.

5. The weighted dummy must be backed up with sufficient design and performance data to support its incorporation into 49 CFR part 572.

6. The weighted dummy must be useful in assessing the structural integrity of child restraints in dynamic testing.

The agency evaluated several weighting concepts for developing a weighted H-III6C dummy. Initially, the agency placed a weighted vest on the dummy. However, upon inspecting this system, the agency determined that use of such a vest would be unacceptable in compliance testing. Since the weights are not rigidly attached to the dummy, they could rattle or even slap during dynamic tests, possibly interfering with the dummy's instrumentation responses. In addition, the vest, loaded with weighting materials, was somewhat bulky. The agency was concerned that this bulkiness could affect the positioning of the dummy and compromise the effectiveness of the tested restraint system.

NHTSA then considered mounting ballasts directly on the dummy's interior structure. The agency designed carbon steel masses (about 9 pounds) that could be rigidly mounted on the dummy's spine and pelvis. However, this resulted in the elevation of the upper torso by 1 inch. The agency determined that a more uniform distribution of the added weight between the upper and lower torso halves, and less elevation of the upper torso with respect to the lower torso, were necessary.

The agency discovered that a more uniform mass distribution, and a lowering of the upper torso, could be achieved through the use of a dense Tungsten alloy material. The increased density of the Tungsten alloy allowed each of the weights to be reduced in size as compared to the carbon steel weights. The dummy's seated height was increased by only 0.7 inch, while the carbon steel weights increased the dummy's seated height by 1 inch. The agency also was able to design the Tungsten alloy weights to distribute the added weight more uniformly between the upper and lower torso halves. The Tungsten alloy material allowed the agency to increase the added weight of the bottom of the lumbar spine (hereinafter referred to as “pelvis”) from 3.8 pounds to 4.9 pounds while maintaining the thoracic spine weight increase at 5.2 pounds. 6

The agency's preliminary testing and evaluation of the dummy with the Tungsten alloy weights attached to the thoracic spine and pelvis has indicated responses comparable to the responses of the H-III6C dummy. Therefore, the agency has tentatively concluded that attaching Tungsten alloy weights to the H-III6C dummy's thoracic spine and pelvis met the agency's objectives for a weighted six-year-old child size dummy outlined above.

The agency subjected the weighted dummy to two types of impact evaluations in the laboratory environment: component calibration tests and sled tests.

Component calibration tests were conducted to compare the performance of the weighted dummy with that of the H-III6C dummy. The agency followed the calibration test procedures specified for the H-III6C dummy in 49 CFR part 572 subpart N. Since masses were added to the dummy's upper and lower torso, the agency limited its evaluation of the weighted dummy for certification responses to the thorax impact (specified in 49 CFR 572.124) and torso flexion (49 CFR 572.125) tests. Since the added weights would not influence the head drop, neck flexion and extension, and knee impact calibration tests, the agency did not conduct these tests with the weighted dummy.

The agency conducted ten high acceleration (HYGE) sled tests with both the H-III6C and the weighted dummies in seating configurations with adult restraint systems and belt positioning booster seats. All tests were performed using the Standard No. 213 pulse (24 G, 30 mph) and sled mounted seating buck. The dummies were seated in Century Breverra Metro and Graco Cherished Cargo booster seats and restrained with a 1999 Pontiac Grand Am rear seat lap/shoulder belts for all tests. One set of tests with the Century Breverra Metro booster seats was performed without belt retractors.

To evaluate the dummy's repeatability, structural integrity, and durability, the agency performed seven thorax impacts with the weighted dummy. The first four thorax calibration tests were conducted prior to a series of six Standard No. 213 sled tests. Three additional tests were conducted after the sled tests. The test results are detailed in NHTSA's Technical Report entitled “Evaluation of the Weighted Hybrid III Six-Year-Old Child Dummy” (October, 2001, Docket No. NHTSA-2002-11707-2). The results indicate the following responses.

The chest deflection responses of the weighted dummy met the calibration limits for the H-III6C dummy in all tests. However, the average chest deflection for the weighted dummy was approximately 41 mm, which is 1 mm below the target deflection of 42 mm specified for the H-III6C dummy. Since these results were based upon only one dummy, the agency has tentatively concluded that it should retain the 38-46 mm chest deflection specification.

The peak pendulum force responses in the weighted dummy's thoracic deflection range of 38-46 mm met the specifications for the H-III6C dummy in all tests. However, the average response was close to the upper limit of the specified corridor. Accordingly, the data suggest that, to assure better centering of the response specification, the H-III6C dummy corridor be changed from 1150-1380 N to 1225-1455 N for the weighted dummy.

The H-III6C specifications also require that the peak pendulum force during the thoracic deflection range of 12.5-38 mm not exceed by more than 5 percent the value of the peak force during the deflection range of 38-46 mm. The weighted dummy did not consistently meet this specification during NHTSA's testing. Accordingly, the data suggest that the H-III6C dummy limit be changed from 5 percent to 10 percent for the weighted dummy.

The internal hysteresis responses of the weighted dummy met the specifications for the H—III6C dummy in all tests. Accordingly, the data suggest that the H-III6C dummy specification for internal hysteresis of 65-85 percent be retained for the weighted dummy.

The agency performed six torso flexion tests with the weighted dummy, two tests prior to and four following a series of six Standard No. 213 sled tests. The test results are detailed in the October 2001 Technical Report noted above. The results indicate that the durability and structural integrity of the weighted dummy were not compromised by the added weight during the test series. However, the test data indicate that the weighted dummy did not meet the established flexion force corridors for the H-III6C dummy. The agency's torso flexion test responses with the weighted dummy also indicate the following.

The initial average torso setup angle for the weighted dummy in the absence of external support was 31.2 degrees. This is higher than the maximum value of 22 degrees specified for the H-III6C dummy. The additional mass located on the spine box of the weighted dummy is responsible for the increase in the initial torso setup angle. Accordingly, the data suggest that the following specification be added for the weighted dummy torso flexion test:

The agency also notes that the initial torso angle exhibited very good repeatability, with a coefficient of variation (CV) of 4.1 percent.

The weighted dummy torso in 45-degree flexion tests yielded an average resistance force of 103 N (23.2 lbf) with a standard deviation of 4 N (0.9 lbf). This is significantly lower than the resistance force of 173.5 ± 26.5 N (39 ± 6 lbf) specified for the H-III6C dummy. Accordingly, the data suggest that the H-III6C dummy resistance force specification be changed from 173.5 ± 26.5 N (39 ± 6 lbf) to 105 ± 20 N (23 ± 4.5 lbf) for the weighted dummy. 7 The agency also notes that the weighted dummy exhibited very good repeatability of resistance force in the flexion tests, yielding a CV of 3.8 percent.

The H-III6C dummy specifications require the torso to return within 8 degrees of the initial torso position upon removal of the flexion force. The weighted dummy met this specification in all tests. Accordingly, the data suggest that this specification be retained for the weighted dummy.

The agency conducted HYGE sled tests using the Standard No. 213 pulse (24 G, 30 mph). The sled buck was equipped with a Standard No. 213 bench seat. The H-III6C and weighted dummies were seated side by side in Century Breverra Metro booster seats and restrained with 1999 Pontiac Grand Am rear seat lap/shoulder belts for all the sled tests. No shoulder belt routing clips or top tethers were used with any of the booster seats. To determine possible variability that may occur with shoulder belt retractors, the agency performed three tests with each dummy in the Century Breverra Metro restraint system both with and without the shoulder belt retractors.

The response data of the H-III6C and weighted dummies are summarized in the table below. The CV for most of the measurements listed indicates relatively comparable responses for the two dummies. Differences, such as higher chest deflection and higher belt loading for the weighted dummy, can be explained by the weighted dummy's increased mass. The shapes of the response curves, found in the October 2001 Technical Report, reflect reasonably comparable tracking of the loading responses vs. time for the same dummy seating and restraint configuration.

Both the Head Injury Criteria (HIC) 15 and HIC unlimited average values were lower for the weighted dummy than for the H-III6C dummy. The weighted dummy measured average HIC 15 values of 177 and 261 for tests without and with a shoulder belt retractor, respectively, while the H-III6C dummy measured average values of 241 and 303. The weighted dummy measured average HIC unlimited values of 554 and 695 for tests without and with a shoulder belt retractor, respectively, while the H-III6C dummy measured average values of 657 and 733. It is to be noted that both dummies recorded higher HIC averages when a shoulder belt retractor was used. The agency believes this is due to the sudden jerking loads imposed on the dummies when the retractor locks.

Neck tension and neck injury criteria (Nij) averages also were lower for the weighted dummy than for the H-III6C dummy in tests with and without shoulder belt retractors. Without a shoulder belt retractor, the weighted dummy measured an average Nij value of 0.83 and a peak neck tension of 1858 N (418 lbf), while the H-III6C dummy measured an average Nij value of 1.01 and a peak neck tension of 2455 N (552 lbf). With a shoulder belt retractor, both the weighted dummy and the H-III6C dummy measured an average Nij value of 0.93, and their peak neck tension values were similar as well: 2276 N (512 lbf) for the weighted dummy and 2281 N (513 lbf) for the H-III6C dummy. Based on these responses, the agency has tentatively concluded that the weighted dummy will produce either very similar or somewhat lower neck response values than those of the H-III6C dummy.

The weighted dummy also measured a greater average chest deflection than the H-III6C dummy in tests without and with a shoulder belt retractor. In tests without a retractor, the weighted dummy average chest deflection was 8.2 mm greater than the H-III6C dummy average (38.0 mm compared to 29.8 mm). In tests with a retractor, the weighted dummy average chest deflection was 7.6 mm greater than the H-III6C dummy average (36.6 mm compared to 29.0 mm).

The weighted dummy recorded higher shoulder belt loads than the H-III6C dummy. The weighted dummy measured average shoulder belt loads of 5498 N and 5770 N in tests without and with a retractor, respectively, while the H-III6C dummy measured average loads of 4486 N and 4632 N. The agency believes that the weighted dummy's higher average chest deflection and shoulder belt loads can be attributed to greater torso mass.

The weighted dummy average chest acceleration was slightly greater than the H-III6C dummy average in tests without a retractor (48.58 g compared to 45.93 g). However, in tests with a retractor, the H-III6C dummy average chest acceleration was slightly greater than the weighted dummy average (50.15 g compared to 49.23 g).

The weighted dummy average forward head excursion value was 11 mm lower than the H-III6C dummy average value (483 mm compared to 494 mm) in tests without a retractor. In tests with a retractor, the weighted dummy average head excursion value was 31 mm less than the H-III6C dummy average value (492 mm compared to 523 mm).

Conversely, the weighted dummy average knee excursion value was 22 mm greater than the H-III6C dummy average value in tests without a retractor (652 mm compared to 630 mm). In tests with a retractor, the weighted dummy average knee excursion value was 29 mm greater than the H-III6C dummy average value (670 mm compared to 641 mm).

The head kinematics during the sled tests were similar for both dummies. The chins of both dummies exhibited contact into the chests in all tests. Furthermore, both dummies tended to shift into the “pike” position (legs and torso pitching forward) during the rebound response. However, this leg flexion did not seem to have a significant bearing on the dummies' performance.

NHTSA's evaluation of the two dummies has led the agency to the following tentative conclusions.

The weighted dummy response to thorax impacts and torso flexion tests was slightly different from that of the H-III6C dummy. Accordingly, the agency has tentatively concluded that to better fit the weighted dummy's response within the calibration corridors, the response boundaries for thorax impact and torso flexion would need to be slightly adjusted. However, the agency believes that the performance corridors for the head drop, neck flexion and extension, and knee impact tests would require no alteration.

The weighted dummy response to thorax impacts and torso flexion tests were similar before and after a series of six sled tests using the Standard No. 213 pulse. These tests indicate that the consistency of the dummy's impact response was not affected by the impact exposures during the sled tests.

The agency noted no structural integrity, durability, or noise and vibration issues during component and sled testing of the proposed weighted dummy.

In identical test environments, both the weighted dummy and the H-III6C dummy produced relatively comparable responses when the effects of the weighted dummy's increased mass in the upper and lower torso were taken into account.

Average HIC and neck tension values were lower for the weighted dummy than for the H-III6C dummy, while average chest deflection and shoulder belt loads were greater for the weighted dummy than for the H-III6C dummy.

HIC values were greater for both dummies when a shoulder belt retractor was used. Shoulder belt load averages and chest accelerations also increased slightly when a retractor was used.

The two dummies exhibited similar kinematics during sled testing. Chin-to-chest contact was observed in all tests with both dummies. No contact between the head and knees was detected in any of the tests. The dummies appeared to interface the structure of the child restraints in a similar manner.

Based on the results of the test and evaluation program discussed above, the agency has tentatively concluded that the weighted dummy is sufficient for evaluating the dynamic performance of child restraint systems designed for children over 50 pounds. If Standard No. 213 is amended to apply to child restraints for children over 50 lb as proposed in the May 2002 NPRM, the weighted dummy should be able to serve the interim needs of the agency until the Hybrid III ten-year-old size dummy is ready for incorporation. Accordingly, the agency is proposing to incorporate the weighted six-year-old size dummy into 49 CFR part 572 as subpart S.

The drawings and specifications for the weighted dummy would be the same as the drawings and specifications for the H-III6C dummy in 49 CFR part 572 subpart N, except for the following differences.

First, the drawings for the weighted dummy's upper torso assembly and lower torso assembly would be changed to include the spine box weighting plates and pelvis weighting spacer.

Second, in the thorax assembly and test procedure specifications (49 CFR 572.124(b)(1)); the peak force specification within the specified compression corridor would be changed from 1150-1380 N (259-310 lbf) to 1225-1455 N (275-327 lbf); and the peak force specification after 12.5 mm (0.5 in) of sternum displacement would be changed from not more than 5 percent of the value of the peak force measured within the required displacement limit to not more than 10 percent of that value.

Third, in the upper and lower torso assemblies specifications (49 CFR 572.125(b)(1)), the specification for the force applied as shown in Figure S2 would be changed from 147-200 N (33-45 lbf) to 85-125 N (18.5-27.5 lbf).

Fourth, in the upper and lower torso assemblies test procedure specifications (49 CFR 572.125(c)(5)), the initial torso orientation angle specification would be changed from 22 degrees to 32 degrees.

A copy of the Procedures for Assembly, Disassembly, and Inspection (September 2002) for the dummy, and copies of the Parts List and Drawings for the H-III6CW, Alpha Version (September 13, 2002) can be found in the docket for this NPRM.

The agency estimates that the base cost of the new weighted six-year-old child size dummy would be $31,170. The cost of an uninstrumented H-III6C dummy is approximately $30,000. 8 The cost difference of $1,170 is as follows: raw tungsten alloy materials for the weights is approximately $270 for the lumbar spacer weight and $240 for each of the two spine weights. The fabrication of the parts requires approximately 12 hours of machinist labor at a cost of $35 per hour, for a total of $420. Instrumentation would add approximately $25,000 to $41,000 to the cost of the dummy, depending on the amount of data desired.

At this time, the agency has not quantified any benefits to the public from this rulemaking. The availability of a weighted six-year-old child size dummy would provide a more suitable, repeatable, and objective test tool to the automotive safety community for development of improved safety environments for older children in motor vehicle crashes than the unweighted dummy. It also would facilitate the future certification of booster seats and child restraint systems designed for children up to approximately 65 pounds.

The agency believes that lead time is not a major factor for upweighting the H-III6C. The addition of the dummy to Part 572 will not affect manufacturers' compliance obligations with respect to the Federal motor vehicle safety standards.

Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), provides for making determinations whether a regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review and to the requirements of the Executive Order. The Order defines a “significant regulatory action” as one that is likely to result in a rule that may:

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

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

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

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

NHTSA has considered the impact of this rulemaking action under Executive Order 12866 and the Department of Transportation's (DOT) regulatory policies and procedures (44 FR 11034, February 26, 1979). The Office of Management and Budget did not review this rulemaking document under Executive Order 12866. This rulemaking action has been determined not to be significant under the DOT's Regulatory Policies and Procedures.

This document proposes to amend 49 CFR part 572 by adding design and performance specifications for a weighted six-year-old child dummy that the agency may use in the Federal motor vehicle safety standards. If this proposed rule becomes final, it would affect only those businesses that choose to manufacture or test with the dummy. It would not impose any requirements on anyone.

The cost of an uninstrumented H-III6C dummy is approximately $30,000. 9 The cost of the raw tungsten alloy materials for the weights is $270 for the lumbar spacer weight and $240 for each spine weight. The fabrication of the parts requires approximately 12 hours of machinist labor at a cost of $35 per hour. Accordingly, the agency estimates that the cost of an H-III6CW dummy is $31,170. Instrumentation would add approximately $25,000 to $41,000 to the cost of the dummy, depending on the amount of instrumentation.

Because the economic impacts of this proposal are so minimal, no further regulatory evaluation is necessary.

Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq. , as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996) whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e. , small businesses, small organizations, and small governmental jurisdictions). The Small Business Administration's regulations at 13 CFR part 121 define a small business, in part, as a business entity “which operates primarily within the United States.” (13 CFR 121.105(a)). No regulatory flexibility analysis is required if the head of an agency certifies the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities.

NHTSA has considered the effects of this rulemaking under the Regulatory Flexibility Act. I hereby certify that the proposed amendment would not have a significant economic impact on a substantial number of small entities. The proposed amendment would not impose or rescind any requirements on anyone. Therefore, it would not have a significant economic impact on a substantial number of small entities.

NHTSA has analyzed this rule for the purposes of the National Environmental Policy Act and determined that it will not have any significant impact on the quality of the human environment.

Executive Order 13132 requires NHTSA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, the agency may not issue a regulation with Federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, the agency consults with State and local governments, or the agency consults with State and local officials early in the process of developing the proposed regulation. NHTSA also may not issue a regulation with Federalism implications and that preempts State law unless the agency consults with State and local officials early in the process of developing the proposed regulation.

NHTSA has analyzed this proposed amendment in accordance with the principles and criteria set forth in Executive Order 13132. The agency has determined that this rule does not have sufficient federalism implications to warrant consultation and the preparation of a Federalism Assessment.

This proposed rule would not have any retroactive effect. Under 49 U.S.C. 30103, whenever a Federal motor vehicle safety standard is in effect, a State may not adopt or maintain a safety standard applicable to the same aspect of performance which is not identical to the Federal standard, except to the extent that the state requirement imposes a higher level of performance and applies only to vehicles procured for the State's use. 49 U.S.C. 30161 sets forth a procedure for judicial review of final rules establishing, amending, or revoking Federal motor vehicle safety standards. That section does not require submission of a petition for reconsideration or other administrative proceedings before parties may file suit in court.

Under the Paperwork Reduction Act of 1995, a person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid control number from the Office of Management and Budget (OMB). This proposed rule would not have any requirements that are considered to be information collection requirements as defined by the OMB in 5 CFR part 1320.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272) directs NHTSA to use voluntary consensus standards in its regulatory activities unless doing so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies, such as the Society of Automotive Engineers (SAE). The NTTAA directs NHTSA to provide Congress, through OMB, explanations when the agency decides not to use available and applicable voluntary consensus standards.

The H-III6C dummy, which is the dummy upon which the weighted dummy is based, was developed under the auspices of the SAE. All relevant SAE standards were reviewed as part of the development process. The following voluntary consensus standards have been used in developing the H-III6C dummy and the weighted dummy proposed in today's document: SAE Recommended Practice J211-1995 Instrumentation for Impact Tests—Parts 1 and 2, dated March, 1995; and SAE J1733 Information Report, titled “Sign Convention for Vehicle Crash Testing”, dated December 1994.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, Federal requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likly to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted for inflation with base year of 1995). Before promulgating a NHTSA rule for which a written statement is needed, section 205 of the UMRA generally requires the agency to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule.

This proposed rule would not impose any unfunded mandates under the UMRA. This proposed rule would not meet the definition of a Federal mandate because it would not impose requirements on anyone. It would amend 49 CFR part 572 by adding design and performance specifications for a weighted six-year-old child dummy that the agency may later use in the Federal motor vehicle safety standards. If this proposed rule becomes final, it would affect only those businesses that choose to manufacture or test with the dummy. It would not result in costs of $100 million or more to either State, local, or tribal governments, in the aggregate, or to the private sector. Thus, this proposed rule is not subject to the requirements of sections 202 and 205 of the UMRA.

Executive Order 12866 requires each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:

If you have any responses to these questions, please include them in your comments on this NPRM.

The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.

Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the docket number of this document in your comments.

Your comments must not be more than 15 pages long. (49 CFR 553.21). NHTSA established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary additional documents to your comments. There is no limit on the length of the attachments.

Please submit two copies of your comments, including the attachments, to Docket Management at the address given above under ADDRESSES.

You may also submit your comments to the docket electronically by logging onto the Dockets Management System Web site at http://dms.dot.gov. Click on “Help & Information” or “Help/Info” to obtain instructions for filing the document electronically.

If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.

If you wish to submit any information under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, NHTSA, at the address given above under FOR FURTHER INFORMATION CONTACT . In addition, you should submit two copies, from which you have deleted the claimed confidential business information, to Docket Management at the address given above under ADDRESSES. When you send a comment containing information claimed to be confidential business information, you should include a cover letter setting forth the information specified in our confidential business information regulation. (49 CFR part 512.)

NHTSA will consider all comments that Docket Management receives before the close of business on the comment closing date indicated above under DATES. To the extent possible, the agency will also consider comments that Docket Management receives after that date. If Docket Management receives a comment too late for the agency to consider it in developing a final rule (assuming that one is issued), the agency will consider that comment as an informal suggestion for future rulemaking action.

You may read the comments received by Docket Management at the address given above under ADDRESSES. The hours of the Docket are indicated above in the same location.

You may also see the comments on the Internet. To read the comments on the Internet, take the following steps:

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

2. On that page, click on “search.”

3. On the next page ( http://dms.dot.gov/search/ ), type in the four-digit docket number shown at the beginning of this document. Example: If the docket number were “NHTSA-1998-1234,” you would type “1234.” After typing the docket number, click on “search.”

4. On the next page, which contains docket summary information for the docket you selected, click on the desired comments. You may download the comments. Although the comments are imaged documents, instead of word processing documents, the “pdf” versions of the documents are word searchable.

Please note that even after the comment closing date, NHTSA will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, the agency recommends that you periodically check the Docket for new material.

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 in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit http://dms.dot.gov .

In consideration of the foregoing, NHTSA is proposing to amend 49 CFR part 572 as follows: