Background

The regulations in subchapter C of chapter I, title 9, of the Code of Federal Regulations contain provisions designed to prevent the dissemination of livestock or poultry diseases in the United States and to facilitate the control and eradication of such diseases. The regulations in 9 CFR part 71 (referred to below as the regulations) include general prohibitions on the interstate movement of animals that could spread livestock or poultry diseases.

The regulations in § 71.20 contain provisions under which livestock facilities may acquire and retain status as an approved facility. To obtain approval, facilities must enter into an agreement with the Animal and Plant Health Inspection Service (APHIS) in which they agree to follow certain procedures when handling livestock entering the facility. Part of this agreement states that documents such as weight tickets, sales slips, and records of origin, identification, and destination that relate to livestock that are in, or that have been in, the facility shall be maintained by the facility for a period of 2 years. Such records would be critical in the event that APHIS or State animal health officials needed to conduct a disease traceback investigation.

We are proposing to amend § 71.20 to extend the records retention period from 2 to 5 years. Due to increased globalization, the threat of an animal disease introduction has increased during the past few years. In the case of chronic livestock diseases like bovine tuberculosis, signs and symptoms of the disease may not appear for years and apparently healthy animals may be found to be infected only at slaughter. In these cases, being able to trace the animals' movements as far in the past as possible is important to identify any other potentially exposed or infected animals. Requiring the retention of certain records for 5 years would allow APHIS to trace the prior movements of diseased livestock further into the past than is currently possible, thus providing the opportunity to locate potentially infected or exposed livestock that might otherwise remain unidentified. We are not proposing to make any changes to the records which must be kept, only extending the time for which they must be kept.

We recognize that our current regulations require that livestock facilities keep records for no more than two years and that listed slaughtering and rendering establishments are not required to retain records for APHIS purposes. Therefore, we would not expect these establishments to start retaining records for a longer period prior to the adoption of a final rule establishing a longer retention period, only that they would extend their records retention to 5 years after such a final rule became effective.

The regulations § 71.21 are designed to enhance the level of animal disease surveillance in the United States. Specifically, these regulations state that livestock or poultry moving interstate for slaughter or rendering can only be moved to a slaughtering or rendering establishment that has been listed by the Administrator. In order for an establishment to be listed, the operator of the establishment must agree to a number of provisions, such as allowing access to the facility by APHIS and Food Safety and Inspection Service (FSIS) personnel, or APHIS contractors, for the purpose of taking blood and tissue samples from animals at the facility. These establishments must allow those personnel access to the processing line to collect the samples, and they must provide office and sample collection space, including sufficient lighting and adequate ventilation. They must also allow APHIS, FSIS, or APHIS contractors to record the identification of individual animals and retain any external or internal identification devices.

We are proposing to amend § 71.21 to require that the owner or operator of a slaughtering or rendering establishment sign a listing agreement in which he or she agrees, in writing, to meet the requirements of § 71.21 in order for the slaughtering or rendering establishment to be listed. Failure to sign a listing agreement would result in the establishment not being listed, or being de-listed if it is currently listed. APHIS already has a listing agreement that we make available to such establishments, but the regulations do not refer to this agreement nor do they require that the owner or operator of the establishment sign the agreement. Such listing agreements are currently required for approved livestock facilities but not for listed slaughtering and rendering facilities. The proposed change would eliminate that inconsistency.

The regulations in § 71.21 currently contain no provisions concerning the retention of records (such as sales slips) by listed slaughtering and rendering establishments. For the same reasons as discussed earlier in this document with respect to the records retention provisions of § 71.20, we believe it is necessary to amend the regulations regarding listed slaughtering and rendering establishments to require that these establishments retain certain records for 5 years. This would allow us to verify the disposition of herdmates or other animals exposed to the infected animal.

Specifically, we would add a new paragraph (a)(5) to § 71.21 that would require that the management of the slaughtering or rendering establishment agree to maintain, for 5 years, documents such as weight tickets, sales slips, and records of origin, identification, and destination that relate to livestock that are in, or that have been in, the establishment. We would also require that APHIS, APHIS contractors, and State animal health representatives be permitted to review and copy or scan these documents during normal business hours.

This proposed rule has been reviewed under Executive Order 12866. The rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget.

The proposed rule would extend the time period for which livestock facilities must retain records from 2 to 5 years. The proposed rule would also require that slaughtering facilities and rendering facilities retain records for 5 years. This would allow APHIS to trace the prior movements of diseased livestock for up to 5 years, thus enabling the Agency to locate livestock that have potentially been exposed to disease. The proposed rule would also require that operators of slaughtering and rendering establishments agree in writing to the listing requirements in 9 CFR 71.21.

For this proposed rule, we have prepared an economic analysis. The analysis, which is set out below, provides a cost-benefit analysis, as required by Executive Order 12866, as well as an initial regulatory flexibility analysis that considers the potential economic effects of this proposed rule on small entities, as required by the Regulatory Flexibility Act.

The proposed rule has the potential to benefit APHIS, other animal health authorities, and the operators of slaughtering and rendering facilities in the event that a traceback is required to locate the origin of a diseased animal. The livestock, slaughtering, and rendering industries may also benefit because the added information could decrease the traceback time, thus reducing the time a particular area may need to be quarantined pending the outcome of an investigation. The proposed changes could also result in benefits from a trade perspective when our ability to more rapidly conclude a disease traceback investigation allows us to provide timely reporting to our trading partners regarding the disposition of the animals associated with a particular disease outbreak and thus facilitates our efforts to retain market access.

As described previously, record documents such as weight tickets, sales slips, and records of origin, identification, and destination that relate to livestock that are in, or that have been in, an approved facility are required to be maintained by the livestock facility for a period of 2 years. Retention of such records is not currently required for slaughtering and rendering establishments. Under the proposed rule, approved livestock facilities and listed slaughtering and rendering establishments would be required to retain these records for 5 years.

The proposed provisions regarding the retention of records should not have a significant economic impact on affected entities. Any costs of retaining these records by approved livestock facilities for an additional 3 years are expected to be negligible. Although rendering and slaughtering facilities are not currently required to retain these records, most reportedly do so. APHIS therefore does not expect costs of records retention for these businesses to differ significantly from costs being borne at present. Records may be maintained in paper or electronic form.

For the reasons discussed above, costs of complying with the proposed requirements for records retention should be minimal in most cases, and may depend on the method of record retention (paper copy or electronic) and the size of the facility. Clearly, a large-scale operation that maintains paper records would be faced with higher potential recordkeeping costs than would be a smaller-scale operation that maintains records electronically. We welcome the submission of information from potentially affected entities or any other sources that would help us to better estimate any additional costs that may result from the proposed records retention provisions.

The proposed records retention provisions have the potential to benefit APHIS, other animal health authorities, and the operators of livestock, slaughtering, and rendering facilities in the event that a traceback is required to locate the origin of a diseased animal. Increasing the records retention time would extend the ability of State and Federal animal health authorities to trace the prior movements of diseased livestock for up to 5 years, thus enabling the Agency to locate other livestock that may have been exposed to diseases. This could prove particularly helpful during tracebacks connected to diseases with longer incubation periods such as some transmissible spongiform encephalopathies. The livestock, slaughter, and rendering industries would also benefit because the added information has the potential to reduce the amount of time needed to conduct a traceback investigation, thus reducing the time a particular area may need to be quarantined pending the outcome of an investigation. As noted previously, we expect these proposed provisions could also produce benefits in terms of helping our efforts to retain access to international markets in the aftermath of a disease outbreak by giving us the ability to more rapidly conclude a disease traceback investigation and subsequently provide timely reporting to our trading partners regarding the disposition of the animals associated with that disease outbreak.

APHIS has a listing agreement for slaughtering and rendering facilities; however, it is not currently required that operators agree in writing to meet the requirements in § 71.21 of the regulations for becoming a listed establishment. Under the proposal, they would have to agree in writing to meet the requirements in § 71.21 of the regulations to become a listed establishment.

The proposed requirement for signed listing agreements should not have a significant economic impact on slaughtering or rendering facilities. To the extent that these operations already follow listing requirements, there should not be any cost associated with signing a listing agreement. Requiring operators to agree in writing to meet the requirement for an approved slaughtering or rendering facility will increase accountability.

The proposed rule would affect approved livestock facilities and listed rendering and slaughtering establishments. This is because, at the present time, none of those entities are required to retain records for the proposed 5-year time period. The operators of listed slaughtering and rendering establishments are not currently required to sign a listing agreement to be listed by APHIS.

Livestock facilities include posted stockyards and bonded packers. In 2003, the U.S. Department of Agriculture's Grain Inspection, Packers, and Stockyards Administration (GIPSA) recorded a total of 2,658 posted stockyards and a total of 502 bonded packers. 1 While the employment numbers are not listed for these industries, APHIS employees who work closely with stockyards and packers estimate the majority of these industries employ 500 or fewer employees, and thus under the criteria established by the Small Business Association (SBA) would qualify as small entities.

The animal (except poultry) slaughtering industry (North American Industry Classification System [NAICS] 311611) is composed of 1,869 establishments, of which 96 percent can be classified as small entities. According to the SBA, establishments in NAICS 311611 that employ 500 or fewer employees are classified as small.

The rendering and meat byproduct processing industry (NAICS 311613) is composed of 231 establishments of which 100 percent can be classified as small entities. According to the SBA, establishments in NAICS 311613 that employ 500 or fewer employees are classified as small entities.

This proposed rule would require approved livestock facilities and listed slaughtering and rendering establishments to maintain certain records for 5 years, and would require the operators of slaughtering and rendering establishments to sign listing agreements to document their agreement to comply with the requirements of the regulations for listed slaughtering and rendering establishments. As noted previously, APHIS already has a listing agreement that we make available to such establishments, but the regulations do not refer to this agreement nor do they require that the owner or operator of the establishment sign the agreement. Such listing agreements are currently required for approved livestock facilities but not for listed slaughtering and rendering facilities. However, because having a listing agreement in place can facilitate the prompt resolution of APHIS disease investigations, thus allowing the resumption of normal business activities, many of these establishments have signed listing agreements.

Alternatives to the proposed rule would be to either leave the regulations unchanged, or require a different set of criteria than currently proposed. Leaving requirements for the retention of records unchanged would be unsatisfactory because it would not provide APHIS with information to expedite an animal disease traceback. It is also necessary that the operators of slaughtering and rendering facilities formally acknowledge accountability by agreeing in writing to meet the requirements for a listed facility.

APHIS considers the proposed set of criteria to be the minimum necessary to accomplish the proposed rule's objectives. Due to the threat of animal disease introductions and the realization that for certain diseases, such as tuberculosis, an infected animal may not show signs of illness for a number of years, it is essential that livestock records be retained for a longer period of time than is currently required.

For reasons discussed above, we expect that operating costs to comply with the proposed requirements for the signing of listing agreements should be negligible. However, we welcome public comment on this proposed rule, particularly any comments from potentially affected entities that would allow us to better estimate the costs associated with its implementation and suggestions for how the proposed rule could be modified to reduce expected costs for these small entities consistent with its objectives.

Estimates of the expected reporting and recordkeeping burden associated with the proposed changes are discussed below under the heading “Paperwork Reduction Act.”

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are in conflict with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. APHIS-2007-0039. Please send a copy of your comments to: (1) Docket No. APHIS-2007-0039, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue, SW., Washington, DC 20250. A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this proposed rule.

Disease surveillance plays an important role in APHIS' mission of protecting the health of livestock populations in the United States, and testing animals for disease is an important surveillance tool. To enhance APHIS' surveillance capabilities, we are proposing to amend the regulations regarding the movement of livestock to require approved livestock facilities and listed slaughtering and rendering establishments to maintain certain records for 5 years. Currently, approved livestock facilities are required to retain certain records for 2 years, and there are no record retention provisions that apply to listed slaughtering and rendering establishments.

Requiring the retention of certain records for 5 years would allow APHIS to trace the prior movements of diseased livestock further into the past than is currently possible, thereby providing the opportunity to locate potentially infected or exposed livestock that might otherwise remain unidentified. We are also proposing to require the operators of slaughtering and rendering establishments to sign listing agreements to document their agreement to comply with the requirements of the regulations for listed slaughtering and rendering establishments. Such listing agreements are currently required for approved livestock facilities, but not for slaughtering or rendering facilities. The proposed change would eliminate that inconsistency.

We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:

(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses).

Estimate of burden: Public reporting burden for this collection of information is estimated to average 0.0830985 hours per response.

Respondents: Livestock auction market, slaughtering, and rendering plant personnel.

Estimated annual number of respondents: 710.

Estimated annual number of responses per respondent: 1.

Estimated annual number of responses: 710.

Estimated total annual burden on respondents: 59 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

Copies of this information collection can be obtained from Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

Accordingly, we propose to amend 9 CFR part 71 as follows:

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-0729; Directorate Identifier 2008-NM-052-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2008-0013, dated January 24, 2008 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

Dassault has issued Service Bulletins F900-360 and F900EX-261, both dated July 20, 2005; and F2000-316, dated July 27, 2005. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD.

Based on the service information, we estimate that this proposed AD would affect 335 products of U.S. registry. We also estimate that it would take 4 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $107,200, or $320 per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General Requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We 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 this 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. Will 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 regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

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

This proposed rule implements section 701 of the John Warner National Defense Authorization Act for Fiscal Year 2007, which establishes coverage of contracted medical care with respect to forensic examinations following a sexual assault or domestic violence. TRICARE currently pays for and will continue to pay for all emergency room services delivered to a victim. TRICARE does not reimburse for the forensic examination, which presented a problem for beneficiaries in the past. Although most States have laws that designate payment sources to cover the costs of forensic examinations for sexual assault victims (some States even prohibit billing victims), some beneficiaries who were victims of a sexual assault have received a bill for the forensic examination.

Currently, forensic examinations are not covered for beneficiaries in civilian health care facilities through TRICARE medical plan contracts because TRICARE, under 10 U.S.C. 1079(a)(13), may cost share only medically or psychologically necessary services or supplies. Forensic examinations are not conducted for medical treatment purposes, but for preservation of evidence in any future criminal investigation and/or prosecution. However, there is a dual purpose of the examination process. One purpose is to address the needs of the individual disclosing sexual assault, which include evaluating and treating injuries; conducting prompt examinations; providing support, crisis intervention, and advocacy; providing prophylaxis against sexually transmitted diseases; assessing female patients for pregnancy risk and discussing treatment options, including reproductive health services; and providing follow-up care for medical and emotional needs. The other purpose is to address justice system needs. The needs for justice system are: obtaining a history of the assault, documenting exam findings, properly collecting, handling, and preserving evidence, and interpreting and analyzing findings (post exam) and subsequently, presenting findings and providing factual and expert opinion related to the exam and evidence collection.

A rape kit is used to collect and preserve the evidence. Rape kits (also known as early evidence kits) typically include forms for documentation of what is observed, tubes for blood samples, a urine sample container (for detecting drugs that may have been used to facilitate a sexual assault), cotton swabs for biological evidence collection, sterile water, sterile saline, glass slides, unwaxed dental floss, a wooden stick for fingernail scrapings, envelopes or boxes for individual evidence samples, labels for each item and paper bags for clothing collection and a large sheet of paper for patient to undress over. The victim's clothing is collected for any external evidence and new clothes are provided. Forensic examinations can take up to 4 hours.

Forensic examinations are currently paid for active duty members with supplemental care, which under 10 U.S.C. 1074(c)(1), does not have the same requirement for medical or psychological necessity. All beneficiaries are covered if they are examined in a military treatment facility. The forensic examination becomes an issue when services are provided in a civilian health care facility. Eighteen States have mechanisms in place that require civilian health care facilities to bill a State agency directly. Certain other States, to some degree, have mechanisms to minimize the possibility of invoicing the beneficiary. This proposed rule puts into place a mechanism that allows civilian health care facilities to invoice TRICARE for reimbursement of forensic examinations.

We believe that a large portion of the costs for the examinations are probably already being paid by TRICARE as most services associated with a forensic exam are covered benefits under any circumstance; and if a claim from a health care facility is submitted with the appropriate procedure code the claim would be paid. What is not being cost-shared are the examinations to gather information for the justice system. In a civilian facility, the victim's private insurance should not be billed for the cost of the examination. This stipulation has been made pursuant to the Federal Victims of Crime Act (VOCA). A reimbursement request from a provider under the VOCA should only be submitted for a victim who is not covered by a Federal or federally funded program, such as Medicare, Medicaid, TRICARE or the Department of Veterans Affairs. This proposed rule amends the regulation to ensure that forensic examinations following sexual assault or domestic violence are specifically listed as a covered benefit.

It has been certified that 32 CFR 199.4(e)(27) does not:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a section 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 this Executive Order.

It has been certified that 32 CFR 199.4(e)(27) does not contain a Federal mandate that may result in the expenditure by State, local and tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year.

It has been certified that 32 CFR 199.4(e)(27) is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities.

It has been certified that 32 CFR 199.4(e)(27) does not impose reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995.

It has been certified that 32 CFR 199.4(e)(27) does not have federalism implications, as set forth in Executive Order 13132. This rule does not have substantial direct effects on:

(1) The States;

(2) The relationship between the National Government and the States; or

(3) The distribution of power and responsibilities among the various levels of Government.

Accordingly, 32 CFR part 199 is proposed to be amended as follows:

The Department of the Navy is amending 32 CFR part 726 to comport with current policy as stated in Chapter XIV of the JAGMAN governing the authority and procedures to designate trustees for members of the Naval service who have been determined to be mentally incompetent in accordance with 37 U.S.C. Chapter 11. As a result of organizational change in the Office of the Judge Advocate General, the functions under Chapter XIV were transferred from the Judge Advocate General to the Defense Finance and Accounting Service—Cleveland Center (DFAS-CL), Office of Continuing Government Activity (CGA). The transfer of functions and the responsibilities of DFAS have been incorporated into the JAGMAN. The proposed rule will update the existing section to reflect current agency regulations. Interested persons are invited to comment in writing on this amendment. All written comments received will be considered in making the proposed amendments to 32 CFR part 726. It has been determined that this proposed rule amendment is not a major rule within the criteria specified in Executive Order 12866, as amended by Executive Order 13258, and does not have substantial impact on the public.

It has been determined that 32 CFR part 726 is not a significant regulatory action. The rule does not:

(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 the 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 this Executive Order.

It has been certified that 32 CFR part 726 does not contain a Federal Mandate that may result in the expenditure by State, local, and tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year.

It has been certified that 32 CFR part 726 does not impose any reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

It has been certified that 32 CFR part 726 does not have federalism implications, as set forth in Executive Order 13132. This rule does not have substantial direct effects on:

(1) The States;

(2) The relationship between the National Government and the States; or

(3) The distribution of power and responsibilities among the various levels of government.

For the reasons set forth in the preamble, the Department of the Navy proposes to amend 32 CFR part 726 as follows:

On July 7, 2006, the Architectural and Transportation Barriers Compliance Board (Access Board) made available for public comment a revised draft of the accessibility guidelines for passenger vessels (70 FR 38563; July 7, 2006). In addition to receiving comment, the Board used the provisions in the revised draft to conduct 10 passenger vessel case studies to help determine the cost impacts of the provisions on newly constructed passenger vessels. From comments received on the 2006 draft and draft case study results, changes were made to the 2006 draft (and the case studies were revised to reflect current provisions). To complete development of a notice of proposed rulemaking (NPRM) regarding passenger vessel accessibility guidelines, the Board needs to complete its regulatory assessment and regulatory flexibility act analysis.

Two information meetings are planned to assist the Board in completing these activities. The meetings will focus on possible approaches and methodologies for the regulatory assessment and regulatory flexibility act analysis, the baselines for determining costs, the identification of major and minor cost impacts, estimated unit costs (where feasible), development of aggregate annual industry costs, and benefits generated by the guidelines.

The meeting on August 11, 2008, will focus on large cruise ships. Other passenger vessels subject to the guidelines will be addressed in a similar meeting that has not yet been scheduled but will be announced in the Federal Register . To support the August 11 meeting and future second meeting, the Board has placed in its docket and on its Web site ( http://www.access-board.gov/pvaac/index.htm ) a 2008 draft of the guidelines, current drafts of the 10 vessel case studies, a preliminary agenda for the August 11 meeting, and other related material.

The August 11 meeting is open to the public. Interested persons are requested to register by e-mail at pvag@access-board.gov by July 31, 2008, for space planning purposes. The Board is not accepting comment on the content of the 2008 draft, and is only making it available to support the meetings. When the NPRM is published, the Board will then solicit comments on the guidelines at that time. However, comments which identify provisions that trigger major costs and include the applicable costs will be accepted.

The meeting site is accessible to individuals with disabilities. Sign language interpreters, an assistive listening system, and computer assisted real-time transcription (CART) will be provided. Persons attending the meeting are requested to refrain from using perfume, cologne, and other fragrances for the comfort of other participants.

On August 13, 2007, the Architectural and Transportation Barriers Compliance Board (Access Board) established an advisory committee to make recommendations on issues related to the effectiveness of emergency alarm systems for individuals with hearing loss or deafness on passenger vessels. (72 FR 45200; August 13, 2007). The advisory committee recommendations will assist the Access Board in developing accessibility guidelines under the Americans with Disabilities Act for passenger vessels. The next meeting of the committee will take place on August 12 and 13, 2008. The preliminary meeting agenda, along with information about the committee, is available at the Access Board's Web site ( http://www.access-board.gov/pvaac/alarms ).

Committee meetings are open to the public and interested persons can attend the meetings and communicate their views. Members of the public will have opportunities to address the committee on issues of interest to them during public comment periods scheduled on each day of the meeting. Additionally, all interested persons will have the opportunity to comment when proposed rules regarding passenger vessel accessibility are issued in the Federal Register by the Access Board.

The meeting site is accessible to individuals with disabilities. Sign language interpreters, an assistive listening system, and computer assisted real-time transcription (CART) will be provided. Persons attending the meeting are requested to refrain from using perfume, cologne, and other fragrances for the comfort of other participants.

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

Under section 107(d)(1)(C) of the Clean Air Act (CAA), the Chicago-Gary-Lake County, IL-IN area was designated nonattainment for the 1-hour ozone NAAQS by operation of law upon enactment of the 1990 CAA amendments. Under section 181(a) of the CAA, each ozone area designated nonattainment under section 107(d) was also classified by operation of law as “marginal,” “moderate,” “serious,” “severe-15,” “severe-17”, or “extreme,” depending on the severity of the area's air quality problem and the number of years to reach attainment from the 1990 CAA amendments. These nonattainment designations and classifications were codified in title 40 of the Code of Federal Regulations (CFR) part 81 (see 56 FR 56994, November 6, 1991).

The ozone design value for an area, which characterizes the severity of the air quality problem, is represented by the highest ozone design value at any of the individual ozone monitoring sites in the area. Table 1 in section 181(a) of the CAA provides the design value ranges for each nonattainment classification. Ozone nonattainment areas with design values between 0.190 parts per million (ppm) and 0.280 ppm for the three-year period, 1987-1989, were classified as severe-17. Because the Chicago-Gary-Lake County, IL-IN area's 1988 ozone design value fell between 0.190 and 0.280 ppm, this area was classified as severe-17 nonattainment for the 1-hour ozone NAAQS. Under section 182(c) of the CAA, states containing areas that were classified as severe-17 nonattainment were required to submit State Implementation Plans (SIPs) to provide for certain emission controls, to show progress toward attainment, and to provide for attainment of the ozone NAAQS as expeditiously as practicable, but no later than November 15, 2007.

In 1997, EPA adopted a new 8-hour ozone NAAQS. The implementation rule for the standard, referred to as the Phase 1 Implementation Rule, was published on April 30, 2004 (69 FR 23951).

On December 22, 2006, the U.S. Court of Appeals for the District of Columbia Circuit (the Court) vacated the Phase 1 Implementation Rule. South Coast Air Quality Management Dist. v. EPA, 472 F.3d 882 (DC Cir. 2006). On June 8, 2007, in South Coast Air Quality Management Dist. v. EPA, Docket No. 04-1201, in response to several petitions for rehearing, the Court clarified that the Phase 1 Rule was vacated only with regard to those parts of the rule that had been successfully challenged. With respect to the challenges to the anti-backsliding provisions of the rule, the Court vacated three provisions that would have allowed States to remove from the SIP or to not adopt three 1-hour obligations once the 1-hour ozone NAAQS was revoked to transition to the implementation of the 8-hour ozone NAAQS: (1) Nonattainment area new source review (NSR) requirements based on an area's 1-hour nonattainment classification (a separate NSR policy is being developed); (2) section 185 penalty fees for 1-hour severe or extreme nonattainment areas that fail to attain the 1-hour ozone NAAQS by the 1-hour attainment date; and (3) measures to be implemented pursuant to section 172(c)(9) or 182(c)(9) of the CAA, on the contingency of an area not making reasonable further progress toward attainment of the 1-hour ozone NAAQS or for failure to attain the 1-hour ozone NAAQS. The Court clarified that 1-hour conformity determinations are not required for anti-backsliding purposes.

In 1991, the Chicago-Gary-Lake County, IL-IN area was classified as severe-17 for the 1-hour ozone NAAQS. The Illinois portion of the area consists of the following counties: Cook; Du Page; Grundy (part) [Aux Stable Township and Goose Lake Township]; Kane; Kendall (part) [Oswego Township]; Lake; McHenry; and Will. The Indiana portion of the area consists of Lake and Porter Counties.

An area is considered to have attained the 1-hour ozone NAAQS if there are no violations of the standard, as determined in accordance with the regulation codified at 40 CFR 50.9, based on three consecutive calendar years of complete, quality-assured monitoring data. A violation occurs when the ozone air quality monitoring data show greater than one (1.0) average expected exceedance per year at any site in the area. An exceedance occurs when the maximum hourly ozone concentration during any day exceeds 0.124 ppm. The data should be collected and quality-assured in accordance with 40 CFR part 58, and recorded in the Air Quality System so that they are available to the public for review.

The finding of attainment for the Chicago-Gary-Lake County, IL-IN area is based on an analysis of 1-hour ozone air quality data from 2004-2006. Table 1 below summarizes these data.

Based on ambient ozone season (April-October) 1-hour ozone air quality data for the years 2004, 2005 and 2006, EPA proposes to find that the Chicago-Gary-Lake County, IL-IN area attained the 1-hour ozone NAAQS prior to its attainment deadline of November 15, 2007. Note that the analysis of the Chicago-Gary-Lake County, IL-IN area also reflects monitoring data from a monitoring site at the Chiwaukee Prairie site in Wisconsin. Although this particular site is outside of the Chicago-Gary-Lake County, IL-IN area, it is a critical site toward demonstrating air quality impacts for the area because it is a primary design value site for measuring peak ozone levels primarily produced by ozone precursors emitted in the subject area. This site demonstrated that the subject area attained of the 1-hour ozone NAAQS during the 2004-2006 period.

EPA is proposing to determine that the Chicago-Gary-Lake County, IL-IN area attained the 1-hour ozone NAAQS by its attainment date, November 15, 2007. Under Section 181(b)(2) of the CAA, EPA must determine whether ozone nonattainment areas have attained the ozone NAAQS by their attainment date. This determination must be based on the area's design value as of the attainment date. 1

Because the area has attained the 1-hour ozone NAAQS by the applicable attainment date, it is not subject to the requirement to implement contingency measures for failure to attain the standard by its attainment date. Since the area has met its attainment deadline, even if the area subsequently lapses into nonattainment, it would not be required to implement the contingency measures for failure to attain the standard by its attainment date.

If a severe or extreme 1-hour ozone nonattainment area attains by its attainment date, it is not required to implement the section 185 penalty fees program. Section 185(a) of the CAA states that a severe or extreme ozone nonattainment must implement a program to impose fees on certain stationary sources of air pollution if the area “has failed to attain the national primary ambient air quality standard for ozone by the applicable attainment date.” Consequently, if such an area has attained the standard as of its applicable attainment date, even if it subsequently lapses into nonattainment, the area would not be required to implement the section 185 penalty fees program. Because EPA is proposing to find that the area has attained the 1-hour ozone NAAQS by its applicable attainment date, we also propose to find that the area is not subject to the imposition of the section 185 penalty fees.

Please note that Indiana has made a request for a clean data finding. 2 The action we are proposing today, however, is a determination of attainment, which differs from a clean data finding. A clean data finding results in the suspension of planning requirements for ozone, such as attainment demonstrations and rate-of-progress plans. Indiana has already complied with such requirements for the 1-hour ozone NAAQS in Lake and Porter counties and EPA approved them on July 18, 1997 (62 FR 38457), January 16, 2000 (65 FR 4126), and November 13, 2001 (66 FR 56944). Therefore, EPA is not making a clean data finding in this proposed rule because the 1-hour ozone NAAQS was revoked for this nonattainment area effective June 15, 2005. See 40 CFR 81.315.

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

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

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

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

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

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

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

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

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

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

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

Table of Contents I. Background Information Why Is EPA Taking This Action? II. EPA's Evaluation What Criteria Were Used To Evaluate Rules Submitted To Be Incorporated Into 40 CFR part 55? III. Administrative Requirements A. Executive Order 12866: Regulatory Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Coordination With Indian Tribal Government G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act I. Background Information Why Is EPA Taking This Action?

On September 4, 1992, EPA promulgated 40 CFR part 55, 1 which established requirements to control air pollution from OCS sources in order to attain and maintain Federal and State ambient air quality standards (AAQS) and to comply with the provisions of part C of title I of the CAA. Part 55 applies to all OCS sources offshore of the States except those located in the Gulf of Mexico west of 87.5 degrees longitude.

Section 328(a) of the CAA requires that EPA establish requirements to control air pollution from OCS sources located within 25 miles of States' seaward boundaries that are the same as onshore requirements. To comply with this statutory mandate, EPA must incorporate applicable rules in effect for onshore sources into part 55. This limits EPA's flexibility in deciding which requirements will be incorporated into part 55 and prevents EPA from making substantive changes to the requirements it incorporates. As a result, EPA may be incorporating rules into part 55 that do not conform to all of EPA's state implementation plan (SIP) guidance or certain requirements of the CAA. Inclusion in the OCS rule does not imply that a rule meets the requirements of the CAA for SIP approval, nor does it imply that the rule will be approved by EPA for inclusion in the SIP.

EPA reviewed the rules that New Jersey submitted for inclusion in part 55 to ensure that they are rationally related to the attainment or maintenance of Federal or State AAQS or part C of title I of the CAA and that they are not designed expressly to prevent exploration and development of the OCS and that they are applicable to OCS sources. 40 CFR 55.1. EPA has also evaluated the rules to ensure they are not arbitrary or capricious. 40 CFR 55.12 (e). In addition, EPA has excluded New Jersey's administrative or procedural rules, 2 and requirements that regulate toxics that are not related to the attainment and maintenance of Federal and State AAQS.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.”

This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. )

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

This rule will not have a significant economic impact on a substantial number of small entities. This rule implements requirements specifically and explicitly set forth by the Congress in section 328 of the CAA, without the exercise of any policy discretion by EPA. These OCS rules already apply in the COA, and EPA has no evidence to suggest that these OCS rules have had a significant economic impact on a substantial number of small entities. As required by section 328 of the CAA, this action simply incorporates the existing rules in the COA. Therefore, EPA certifies that this action will not have a significant economic impact on a substantial number of small entities.

Under section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded Mandates Act), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated costs to State, local, and tribal governments in the aggregate; or to the private sector, of $100 million or more in any one year. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that today's proposed rule contains no Federal mandates that may result in expenditures of $100 million or more for State, local, or tribal governments, in the aggregate, or to the private sector in any one year. This action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local or tribal governments, or to the private sector, result from this action.

Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612 (Federalism) and 12875 (Enhancing the Intergovernmental Partnership). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, 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. Thus, Executive Order 13175 does not apply to this rule.

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

This proposed rule is not subject to Executive Order 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

This proposed rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.

Section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use voluntary consensus standards (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable laws or otherwise impractical.

The EPA believes that VCS are inapplicable to this section. Today's action does not require the public to perform activities conducive to the use of VCS.

Title 40, chapter I of the Code of Federal Regulations, is proposed to be amended as follows:

This is a synopsis of the Commission's Report and Order , MB Docket Nos. 04-348 and 04-407, adopted June 11, 2008, and released June 13, 2008. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Information Center (Room CY-A257), 445 12th Street, SW, Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or http://www.BCPIWEB.com .

The withdrawal of these rulemaking petitions and counterproposal complies with Section 1.420(j) of the Commission's rules because the withdrawing parties are not receiving any money or other consideration in return for the withdrawals. See 69 FR 55547 (September 15, 2004) and 69 FR 67882 (November 22, 2004).

This document is not subject to the Congressional Review Act. (The Commission, is, therefore, not required to submit a copy of this Report and Order to GAO, pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A) because the petitions for rulemaking and counterproposal were dismissed).

The Hazardous Materials Regulations (49 CFR parts 171-180) authorize a variety of packaging types for the transportation of hazardous materials in commerce. Combination packagings are the most common type of packaging used for the transportation of hazardous materials by aircraft. A combination packaging consists of one or more inner packagings secured in a non-bulk outer packaging. (A non-bulk outer packaging is one that has a maximum capacity of 450 liters (119 gallons) as a receptacle for a liquid or a maximum net mass of 400 kg (882 pounds) or less and a maximum capacity of 450 liters (119 gallons) or less as a receptacle for a solid; see 49 CFR 171.8.) Combination packagings are used for the transportation of both solid and liquid hazardous materials, including materials such as sodium hydroxide, paint, and sulfuric acid and articles such as lithium batteries.

When used to transport liquid hazardous materials, a combination packaging must conform to one of the specifications ( i.e., “Specification Packaging”) in part 178 of the HMR or an authorized UN Standard; the packaging must be tested to ensure that it conforms to the applicable specification or standard. Inner packagings within a combination packaging must be closed in preparation for testing, and tests must be carried out on the completed package in the same manner as if prepared for transportation. See 49 CFR 178.602.

Under the HMR, certain classes and quantities of hazardous materials may be transported in non-specification combination packagings. A non-specification packaging is not required to meet specific performance requirements. Rather, a non-specification packaging must meet general packaging requirements. For example, a non-specification packaging must be designed, constructed, filled, and closed so that it will not release its contents under conditions normally incident to transportation. In addition, the effectiveness of the packaging must be maintained for temperature changes, changes in humidity and pressure, and shocks, loadings, and vibrations normally encountered during transportation. See 49 CFR 173.24. In addition, a non-specification packaging authorized for transportation by aircraft must be designed and constructed to prevent leakage that may be caused by changes in altitude and temperature. See 49 CFR 173.27. Non-specification packagings need not be tested to demonstrate that they conform to applicable HMR requirements.

Incident data and testing indicate that a number of combination packaging designs authorized for the transportation of liquid hazardous materials are not able to withstand conditions normally incident to air transportation. The packagings of most concern to PHMSA and FAA are non-specification combination packagings that must be “capable” of meeting pressure differential requirements but are not required to be certified as meeting a specific performance test method to verify compliance with pressure differential performance standards.

We are aware that there are a number of contributing factors that may cause packaging failures and releases in air transport, including non-compliance with existing requirements and lack of function specific training of hazmat employees. In this ANPRM, we are soliciting comments on cost-effective measures that can be taken to reduce or eliminate the number of liquid hazardous materials releases from combination packagings in air transport. As discussed in more detail below, PHMSA and FAA developed this ANPRM, in part, utilizing data and information provided by stakeholders in a meeting on June 21, 2007. PHMSA's review of incident data is discussed in section III.E. of this notice. A summary of the meeting, including presentations by participants, is available for review in the public docket for this rulemaking.

In 1990, PHMSA's predecessor agency, the Research and Special Programs Administration (RSPA), published a final rule under Docket HM-181 (55 FR 52402; December 21, 1990), revisions and response to petitions for reconsideration (56 FR 66124; December 20, 1991) to align the HMR with international standards applicable to hazardous materials packagings. See 49 CFR part 178, subparts L and M, adopted at 55 FR 52716-28. That final rule adopted non-bulk hazardous material packaging standards based on performance criteria rather than the detailed construction specifications that applied prior to 1990 and were phased out in 1996. See former 49 CFR 171.14(b)(1), adopted at 55 FR 52473-74. Under these performance-oriented packaging requirements, packaging strength and integrity are demonstrated through a series of performance tests that a packaging must pass before it is authorized for the transportation of hazardous materials. The performance criteria provide packaging design flexibility that is not possible with detailed design specifications.

In the HM-181 rulemaking, we adopted requirements that all non-bulk packaging “must be capable of withstanding * * * the vibration test procedure” set forth in 49 CFR 178.608 (55 FR at 52727) and that metal and plastic and composite packagings “intended to contain liquids” must pass a hydrostatic pressure test. 49 CFR 178.605 (55 FR at 52726). However, we did not adopt our proposal in the notice of proposed rulemaking to require a hydrostatic pressure test to be performed on all inner packagings of combination packages containing liquids intended for transportation by aircraft, which would have addressed pressure differentials potentially encountered during air transportation. (See 52 FR 16482, May 5, 1987). Instead, consistent with the International Civil Aviation Organization Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions), we adopted a requirement that all packagings intended to contain liquids “must be capable of withstanding without leakage” a specified internal pressure depending on the hazard class/division and packing group. 49 CFR 173.27(c)(2)(i), adopted at 55 FR 52612.

The ICAO Technical Instructions include guidance that indicates in more precise terms what is meant by “ being capable, ” but specific test methods have not been adopted. The ICAO Technical Instructions suggest that the capability of packaging to meet the pressure differential performance standard should be determined by testing, with the appropriate test method selected based on packaging type. See “Note” following 4.1.1.6.

The HMR, at 49 CFR 173.27(c), specify that inner packagings of combination packagings for which retention of liquid is a basic function must be capable of withstanding the greater of: (1) An internal pressure which produces a gauge pressure of not less than 75 kPa for liquids in Packing Group III of Class 3 or Division 6.1 or 95 kPa for other liquids; or (2) a pressure related to the vapor pressure of the liquid to be conveyed as determined by formulae in subsequent paragraphs.

When packages reach high altitudes during transport, they experience low pressure on the exterior of the package. This results in a pressure differential between the interior and exterior of the package since the pressure inside remains at the higher ground-level pressure. Higher altitudes will create lower external pressures and, therefore, larger pressure differentials. This condition is especially problematic for packages containing liquids.

When a packaging, such as a glass bottle or receptacle, is initially filled and sealed, the cap must be tightened to a certain level to obtain sealing forces sufficient to contain the liquids in the packaging. This will require certain forces to be placed upon the bottle and cap threads as well as the sealing surface of the cap or cap liner to ensure the packaging remains sealed throughout transportation. Once at altitude, due to the internal pressure of the liquid acting upon the closure, combined with the reduced external air pressure, the forces acting on the threads and the forces acting on the sealing surfaces may not be the same as when the packaging was initially closed. Under normal conditions encountered in air transport (26 kPa @ 8000 ft), conditions are not overly severe. However, if the compartment is depressurized at altitude or if the compartment is not pressurized at all ( e.g. , feeder aircraft), the pressure differential (55 kPa-90 kPa) may be severe enough to cause package failure and release of contents.

When first closed, and if closed properly, the typical cap and bottle do not deform to the point where sealing integrity is immediately compromised, although studies have demonstrated that plastic bottles and caps do begin to exhibit stress relaxation and a reduction in sealing force immediately after the bottles are sealed. When the bottle is closed in a manner that accounts for the initial stress relaxation of the cap and threads, and there is no altitude induced pressure differential in the packaging, no pressure change inside the bottle and no change in the spacing between the top of the cap and the rim of the bottle, there will be no immediate change in the sealing force that affects the bottle's ability to maintain a seal. An increase in altitude will cause an increase in the thread contact force, but no immediate change in the sealing force. These conditions persist for as long as the pressure differential is maintained. Even though the sealing force remains unchanged, the increased thread forces could distort the cap and cause the cap threads to expand over the bottle threads.

Vibration further complicates the force on the bottle. The net effect of the vibration force intermittently compresses and decompresses the closure in rapid succession. This can temporarily reduce the sealing force to zero. A rapid removal of the compression force, which occurs naturally during vibration, may not allow the closure to recover quickly enough to maintain a seal. It may take several seconds, even minutes, for the closure to return to its original configuration, if it returns to the original configuration at all. Thus, while the bottle and cap are intermittently compressing and decompressing, there may be a gap, which could result in a leak of material from the package.

Finally, the effect of internal pressure and stress relaxation after initial closure of the inner receptacle, particularly with thermoplastic bottles and caps, can lead to a reduction of sealing force on the inner receptacle and may also cause failure of a packaging during air transport. Studies reviewed in section III of this notice demonstrate that when a thermoplastic bottle and cap are initially closed, stress relaxation can account for a reduction of nearly 50% in removal torque within minutes of application and an 80% reduction of removal torque over several days or weeks. Loss of sealing force due to the combination of creep and stress relaxation can also contribute to packages leaking in air transportation. As can be understood, the combination of stress relaxation, vibration, and low pressure at high altitudes may reduce the overall sealing force, thereby compromising the closure integrity of a packaging and resulting in leakage from the packaging. The air transportation of small parcels typically includes multiple flights to reach destination. Therefore, this stress cycle on the closure systems of inner packagings repeats itself multiple times from origination to destination.

The following studies simulated the stresses of low external pressure and vibration on combination package integrity and performance before, during, and while in-flight. These same stresses induced by low external pressure and vibration are encountered in-flight when cargo and feeder aircraft transport combination packages in non-pressurized or partially-pressurized cargo holds. These conditions result in substantial changes in pressure when compared to combination packages being transported at or near sea level and require a higher level of integrity as a result.

In 1999, the FAA began a detailed study of hazardous material package failures in air transportation. FAA analyzed incident data from the DOT Hazardous Materials Information System (HMIS) during 1998 and 1999 and focused on properly declared hazardous material shipments. The study concluded that of 1,583 air incidents reported to PHMSA, a failure of inner packagings in combination packaging designs contributed to 333 spills or leaks. Further study of the spill or leak incidents concluded that package closure/seal failure rates were as high as 65% for plastic and metal inner packagings and 23% for glass inner packagings. All failed inner packagings were packaged in outer UN 4G marked fiberboard boxes. Based on these study results, FAA concluded that either the inner packagings were not closed properly as specified in the packaging manufacturer's closure instructions or that the inner packagings were not capable of meeting the pressure differential requirement or vibration standard of the HMR or both. In addition, because the majority (85%) of the materials that spilled or leaked during flight were toxic, corrosive or flammable, they could have released potentially harmful fumes or vapors into the cabin posing a threat to passengers and crew members. FAA determined that further research on the actual effects of vibration and pressure differential in air transport was warranted.

As a result of the conclusions of FAA's study of combination packaging failures in 2000, FAA conducted extensive laboratory research and public outreach in multiple fora to analyze the problem and develop potential solutions. Conclusions reached as a result of the following laboratory studies indicate problems exist under the current regulatory standards for which solutions need to be developed and implemented.

UPS presented a study in 2000 to the American Society of Testing and Materials (ASTM) outlining the conditions that packages experience in the air transport environment. A copy of the UPS study is available for review in the public docket for this rulemaking. The study resulted in the following key observations related to air transport as described in ASTM D 6653-01:

1. Aircraft cargo compartments are typically pressurized to an altitude of 8,000 ft resulting in a pressure differential of approximately 26kPa on packages filled at or near sea level. Temperature is maintained at approximately 20°-23 °C (68 °-74 °F).

2. Non-pressurized “feeder aircraft” typically fly at approximately 13,000-16,000 feet. The highest recorded altitude in a non-pressurized feeder aircraft was 19,740 ft. Temperatures ranged from approximately 4° to 24 °C (25 °-75 °F). Based on these findings, it is evident that packaged products transported by the feeder aircraft network used by air cargo carriers may experience potential altitudes as high as 20,000 feet, resulting in a pressure differential of approximately 55 kPa. An inadequate packaging design containing liquids at this pressure differential can fail in transportation.

In 2002, the FAA initiated a study with Michigan State University (MSU) to replicate actual air and pre- and post-truck transportation conditions to determine which conditions contribute to package failures. FAA examined the effects of vibration alone, altitude alone, and a combination of vibration and altitude on the performance of UN standard hazardous material combination packages containing liquids. In the study, the combination packages were placed in various orientations, not all of which are authorized in the HMR. The study did not include temperature effects because the temperatures in cargo holds are not unusual or extreme. Each test condition in Table 1 represents a different combination of low pressure and vibration that packages may be exposed to while in, or pre- or post-air transport:

• UN standard liquid hazardous material combination packagings leaked under a combined vacuum and vibration test which simulated the characteristics of air transportation and high altitude.

• One study concluded laboratory testing for pressure differential capability without exposure to vibration may not be a realistic replication of the air transportation environment. When both forces are applied to a package simultaneously, the failure rate increases to 50%.

• Altitude is more important than the length of time in flight; higher altitude is more severe than lower altitude.

• Results of combined truck and air vibration are more severe than truck vibration alone.

• Vibration periodically reduces the sealing force on a liner or gasket and may produce intermittent gaps that open and close at concentrated pressure points.

• The study was based on the conditions normally encountered by a package in truck and air transport.

In 2003, PHMSA also initiated a study with MSU to compare the HMR requirements and the testing used in the FAA/MSU Study discussed previously. To provide for a more thorough evaluation of the performance of liquid hazardous materials combination packagings, this phase of testing was conducted on a smaller number of packaging designs; however, a much greater number of packagings of each design were tested in this study. In the 2002 FAA/MSU study, two packagings of each design were tested; for this study, PHMSA tested thirty packagings from each of eleven designs. With the exception of three packaging designs, all of the packagings tested during this phase had been tested for the 2002 FAA/MSU study. See Table 2 below. A copy of this report is available for review in the public docket.

The conclusions from this testing supported MSU's previous testing conducted for FAA:

• Packages performed unsatisfactorily when tested in the orientation required by the HMR; when the packages were oriented improperly, the leakage rate was even greater.

• Proper package orientation is a critical factor in reducing leaks from packages.

• UN standard combination packagings did not pass the combined pressure differential and random vibration while in the HMR required orientation. Of the 99 bottles subjected to this test, 87 successfully passed the test.

• Laboratory package failure rate is greater than 10% and would be considered unacceptable based on industry standards with a lower safety risk ( i.e. , non-hazmat packagings). Acceptable failure rates for consumer products is less than 5%; electronics is less than 1%; food/pharmaceutical less than 3-5%; the average failure rate of this controlled study was 13%.

• Packages that utilized a secondary means of closure had a lower rate of failure.

• Testing in a horizontal orientation that simulated air transport combining random vibration and a pressure differential (vacuum) of 59.5 kPa (14,000 ft), for one hour, resulted in an 18% failure rate.

During the first half of 2007, PHMSA conducted a comprehensive assessment of hazardous materials transportation incidents occurring in air transportation from 1997 through 2006. This study and its corresponding data may be accessed in the public docket for this rulemaking. The study concluded that there has been no appreciable reduction in package failures over the past 10 years. It is estimated that 191,429 tons of liquid hazardous materials are transported by aircraft annually contained in 7,657,152 combination packaging shipments. Of that total, our analysis concluded that out of approximately 483 failures (.00006%) in air transportation involving combination packagings containing liquids each year, 20 are reported as “serious.” An incident is considered serious if it involves one or more of the following: (1) A fatality or major injury caused by the release of a hazardous material; (2) the evacuation of 25 or more persons as a result of release of a hazardous material or exposure to fire; (3) a release or exposure to fire which results in the closure of a major transportation artery; (4) the alteration of an aircraft flight plan or operation; (5) the release of radioactive materials from Type B packaging; (6) the release of over 45 liters (11.9 gallons) or 40 kilograms (88.2 pounds) of a severe marine pollutant; and (7) the release of a bulk quantity (over 450 liters (119 gallons) or 400 kilograms (882 pounds)) of a hazardous material. We want to emphasize that any incident, such as a package failure, involving hazardous materials in air transportation is unacceptable. In air transportation, any incident could quickly escalate and result in irreversible, possibly catastrophic, consequences.

Accounting for approximately 80 percent of all packages transported by air, combination packagings containing liquids are involved in 44 percent (483) of all package failures annually. Inner packaging closure failures within a combination outer packaging are the primary cause of incidents involving combination packagings in air transportation. Such failures could be the result of pressure differential (packages closed at sea level subjected to lower pressure on planes), “backing off” of the closure (closures that appear tight but loosen during transportation), improper closures, or some other cause. Our analysis also suggests that most incidents involve combination packagings that contain flammable liquids ( e.g. , paint and paint related material) of varying degrees of hazard. Some additional statistical data from the 2007 incident review include:

• Incident trends are similar to earlier FAA studies.

• Laboratory research validates the conclusion that inner receptacles ( e.g. , bottles and caps) leak as indicated in the incident data.

• Leaking (failing) closures and inner receptacles are not the leading cause of incidents in air transportation; however, over 40% of combination packages containing liquids that fail in air transportation do involve closures and inner receptacles.

• Flammable liquids are the most common liquid hazardous materials released from failed packages in air transportation. Such materials or its vapor would seek and could find an ignition source resulting in fire or explosion.

• In years 2005-2006, 18 of 953 incidents involving combination packagings containing liquids, or 2%, occurred on passenger-carrying aircraft. Although low when compared to incidents occurring on cargo-carrying aircraft, this percentage of package failure continues to be a troubling statistic.

• Combination packages containing liquids that fail in air transportation release on average 0.5 gallons of liquid hazardous materials.

PHMSA presented the results of this review at a June 21, 2007 meeting with stakeholders to discuss air packaging issues. The 44 participants included cargo and passenger air carriers, packaging manufacturers and testing laboratories, FAA and PHMSA personnel, and representatives of industry trade associations. The shippers, air carriers, and enforcement personnel present generally agreed that the current capability requirements for air packagings are difficult to comply with and suggested that specific test methods designed to demonstrate that packagings will withstand the air transportation environment should be specified in the HMR.

Stakeholders at the meeting also suggested that increased outreach through industry partnership and targeted enforcement for habitual offenders would significantly enhance achievement of PHMSA and FAA safety goals without additional regulation.

As previously noted, to enhance aviation safety, PHMSA and FAA are seeking to identify cost-effective solutions that can be implemented to reduce incident rates and potentially detrimental consequences without placing unnecessary burdens on the regulated community. We are soliciting comments on how to accomplish these goals, including measures to: (1) Enhance the effectiveness of performance testing for packagings used to transport hazardous materials on aircraft; (2) more clearly indicate the responsibilities of shippers that offer packages for air transport in the HMR; and (3) authorize alternatives for enhancing package integrity. Based on PHMSA and FAA analyses, it appears that some combination packaging designs used to transport hazardous materials by aircraft may not meet the pressure differential and vibration capability standards mandated under the HMR. Indeed, the testing suggests that the capability standards themselves may not be sufficiently rigorous to ensure that packagings maintain their integrity under conditions normally incident to air transportation. Because aircraft accidents caused by leaking or breached hazardous materials packages can have significant consequences, the air transport of hazardous materials requires exceptional care and attention to detail. Therefore, we are considering measures to reduce the incidence of package failures and to minimize the consequences of failures should they occur.

The fact that specific test methods are not specified in the HMR or the ICAO Technical Instructions leads to inconsistencies in package integrity and results in varying levels of compliance among shippers. For example, we understand that, because the pressure differential and vibration capability standards for combination packagings are not required to be verified by a test protocol, some shippers (self-certifiers) or manufacturers have used historical shipping data, computer modeling, analogies to tested packagings, engineering studies, or similar methods to determine that their packagings meet pressure differential and vibration capability standards. Further, some less experienced shippers or manufacturers may not understand that their packagings must withstand pressure differential and vibration requirements. In addition, some shippers or manufacturers may not realize that both UN Standard packaging and packagings that are not required to be certified as meeting a specification or standard are subject to the pressure differential capability requirement. This would include packagings for products, such as limited quantities and consumer commodities, where non-specification packagings are authorized. A significant percentage of aircraft incidents involving hazardous materials appear to result from failures of non-specification packagings.

As indicated above, a non-specification packaging is not required to meet specific performance requirements. Rather, a non-specification packaging must meet general packaging requirements and, for air transportation, must be capable of withstanding pressures encountered at altitude. We invite comments on how to enforce this “capability” standard for non-specification packagings and ask whether a test of some sort should be required to verify packaging integrity.

A complicating factor that appears to be contributing to packaging failures and non-compliance is that assembly of packages in some cases is not consistent with the design type that was originally tested. In some cases, manufacturers change components without informing the shipper; in other cases, shippers specify or change components without appropriate verification and testing to determine compliance with the applicable performance standard. The numerous variables that exist in the interaction of closures, liners, and container neck finishes preclude the use and validity of general assumptions about equivalent pressure performance capabilities of similar containers.

As an alternative to regulation, the FAA implemented an aggressive public outreach program over the past seven years targeted at specific stakeholder audiences, including thousands of shippers, packaging laboratories, industry research and training institutes, airline operators, and chemical manufacturers. In addition, several voluntary industry standards (test protocols) were either created or revised as a result of the public (independent) and private funding of the studies detailed in the previous sections above. A copy of the report listing the specific public outreach efforts conducted by FAA on this issue can be found in the docket for this rulemaking.

Some regulatory solutions under consideration in this rulemaking process are explained in more detail in the following sections.

(1) Pressure differential test . Currently in the HMR, all packagings containing liquids and intended for transport by air must be capable of withstanding, without leakage, an internal gauge pressure of at least 75 kPa for liquids in Packing Group III of Class 3 or 6.1 or 95 kPa for all other liquids, or a pressure related to the vapor pressure of the liquid to be conveyed, whichever is greater (see 49 CFR 173.27(c)). This requirement is also applicable to liquids excepted from specification or UN Standard packaging, such as those authorized for limited quantities and consumer commodities. This would include eligible liquids of Classes 3 (flammable) and 8 (corrosive), and Divisions 5.1 (oxidizer), 5.2 (organic peroxide), and 6.1 (poisonous). Liquids contained in inner receptacles that do not meet the minimum pressure requirements in the current § 173.27(c) may be overpacked into receptacles that do meet the pressure requirements.

In this ANPRM, we are soliciting comments on whether we should require mandatory pressure differential testing for all specification or UN Standard combination packaging designs containing liquids transported or intended for transportation aboard aircraft. In addition, because many incidents are attributed to non-specification package failures, we are soliciting comments on potential solutions to this problem that may or may not include the mandatory pressure differential testing of inner receptacles intended to contain liquids. One approach would be to incorporate by reference a number of acceptable test methods and to simplify the regulations by removing the requirement for calculating the test pressure in § 173.27(c). Shippers (offerors) would be responsible for using inner receptacles that have been certified as passing one of the following test methods:

(a) 49 CFR 178.605— Low Pressure Hydrostatic Pressure Test Method Suitable for Air Inner Packages. This test is currently required for all single and composite packagings intended to contain liquid, but it is not currently required for inner packagings of combination packaging. This test, which uses the hydrostatic test method, pumps high-pressure water into a packaging to create a pressure differential. Failure is determined if there is leakage of liquid from the package during the test. This could be observed as a stream of liquid exiting the package or rupture of the package.

(b) ASTM D6653-01— Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method. This method uses a vacuum chamber to determine the effects of pressure differential on packages. Upon completion of the test, the package is removed and checked for damage in the form of package failure, closure failure, material failure, internal packaging failure, product failure, or combinations thereof. If these are all free of damage, then the packaging should be reassembled for testing in accordance with an industry accepted packaged product performance test, such as Practice D 4169. This will help determine if the pressure differential conditioning had an effect on the performance of the packaging system.

(c) ASTM D4991-94 (Re-approved 1999) Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method. This test is applied to empty packagings to check for resistance to leakage under differential pressure conditions, such as those that can occur during air transport. Instead of pumping high-pressure air into the packaging, the air pressure on the exterior of the packaging is reduced using a vacuum. The package is considered to fail if it leaks a continuous stream or recurring succession of bubbles or if fluid is found within the test specimen after the test.

(d) ASTM F 1140— Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications. This test applies to flexible packaging ( e.g. , bags).

(2) Vibration testing. When packages travel through the transportation and distribution environment, they are subject to vibration by automated sorting systems and during transit aboard aircraft, railcars, or trucks. As packages move on conveyor systems during automated sorting, they experience a low level of vibration at a constant frequency. Aircraft-induced vibration typically is very high frequency and low amplitude for 30 minutes to 12 hours on domestic shipments, depending on origin, destination, and the carrier's network. Vibration on trucks occurs at lower frequencies, but at much higher amplitudes than on aircraft. This duration can last anywhere from 5 minutes to several days depending upon the route and the distance from origin to destination. Vibrations from these various sources can result in damage, including scuffing, abrasion, loosening of fasteners and closures, and package fatigue. There are two main types of vibration testing used for packages: Fixed frequency vibration and random vibration. Random vibration provides the most realistic representation of actual transport conditions, but requires equipment that is more expensive.

The HMR require non-bulk packagings to be capable of withstanding, without rupture or leakage, the vibration test in 49 CFR 178.608. In this ANPRM, we are soliciting comments concerning whether the HMR should be revised to require all specification or UN Standard combination packaging design types containing liquids transported or intended to be transported aboard aircraft to be vibration tested and whether alternative vibration test methods should be authorized for non-bulk packagings. We invite comments on whether the random vibration encountered during the “sorting” process and multiple flight segments of today's expedited shipping environment contributes to package failure and whether more representative vibration test methods should be specified in the HMR.

Alternative test methods for determining package vibration capability are described in the following table:

(a) ASTM D999-01: Standard Test Methods for Vibration Testing of Shipping Containers

(b) ASTM D4169 04a Paragraph 12.4 or Paragraph 13.1: Standard Practice for Performance Testing of Shipping Containers and Systems

(c) ASTM D4728-01: Standard Test Method for Random Vibration Testing of Shipping Containers

(3) “Combination” Pressure Differential and Vibration Tests. In this ANPRM, we are soliciting comments concerning whether sequential pressure and vibration testing are sufficient to ensure packaging integrity, i.e. , a “combination” of both pressure and vibration testing. The vibration testing would be followed by pressure testing, which is considered less severe than simultaneous testing, which subjects a packaging to vibration and pressure at the same time. Simultaneous testing under the combination test standards involves rather sophisticated, extensive, and expensive equipment, and relatively skilled operators. In this ANPRM we are soliciting comment on whether these methods should be authorized, given our understanding that a number of companies are already voluntarily applying these tests. We invite commenters to address successful completion of these tests as an alternative means of compliance with existing pressure differential and vibration capability requirements.

The following three combination tests are voluntary industry standards that we may consider as alternatives for conducting vibration testing and pressure differential testing on the same inner packaging:

(a) ISTA 3A —This is part of a series of general simulation tests that are meant to recreate the hazards of a distribution environment. It is similar to ASTM 4169 because it requires rather sophisticated, extensive, and expensive equipment (such as a random vibration table with appropriate instrumentation) and relatively skilled operators. Unlike D4169, however, there are a number of specific procedures, covering a number of packaged products and distribution systems, so much less interpretation is required. This procedure includes shock and vibration testing with an option to include simultaneous pressure testing during one of the random vibration phases.

(b) ASTM 4169 Distribution Cycle 12 —This is the only ASTM standard devoted to packaged product performance in distribution. It is a pre-shipment general simulation test covering a range of packaging types and distribution scenarios. For example, it lists 18 distribution cycles that each represents a different mode or environment. There is a prescribed sequence of performance tests for each of these distribution cycles. Air transportation is covered in Distribution Cycles 12 and 13. These cycles include several types of vibration and pressure testing. However, these are performed sequentially, unlike ISTA 3A, which has the option to perform vibration and pressure testing simultaneously. Distribution Cycle 12 tests are for unitized freight that weighs over 100 lbs. More details on the sequence of testing can be found in the previous table.

(c) ASTM 4169 Distribution Cycle 13 —Distribution Cycle 13 tests are for loose-load freight weighing under 100 lbs. The prescribed tests specify an additional vibration test to simulate the more aggressive shipping environment. More details on the sequence of testing can be found in the previous table.

(4) Elimination of Selective Testing Variations. The HMR currently provide selective testing variations—that is, inner packagings that differ in only minor respects from a tested inner packaging design type may be used without further testing under the conditions specified in 49 CFR 178.601(g) (selective testing variation 1). In this ANPRM, we invite commenters to address whether this variation should be revised, restricted or eliminated for packagings intended for air transportation. In addition, we are concerned that the use of different components ( e.g. , bottle, cap, liner) than what were originally tested may result in less than effective closure systems and may result in packagings that are not representative of the originally tested design type. The numerous variables that exist in the interaction of closures, liners and container neck finishes are complex and the use and validity of general assumptions about equivalent pressure performance capabilities of similar containers is not straightforward. On the basis of compliance reviews and incident investigations, we believe that this selective testing provision may result in the use of packaging systems that are not capable of withstanding conditions encountered in air transport and at high altitude. Changes in quality control measures and materials may also adversely affect packaging performance. For example, changing the type of resin used in plastic bottle manufacturing can significantly contribute to the ability of the packaging system to perform as intended. Packaging manufacturers may not readily recognize the complexity and importance of controlling component and manufacturing variations. We invite comments on how best to address this issue and whether certain changes in packaging components or variations in materials of construction should be reevaluated or tested and retested as a new design.

(1) Liners and Absorbent Material. Packages containing liquid hazardous materials must include a method for containing the liquid, whether it is a leak-proof liner, plastic bag, absorbent material or other equally effective means. Liners are currently required in the following circumstances:

• Packages containing certain types of hazardous materials liquids ( e.g. , Class 3, 4, or 8, or Division 5.1, 5.2, or 6.1) when absorbent materials are required and the outer packagings are not liquid-tight and transported by aircraft (49 CFR 173.27(e)).

• Either the inner or outer packagings when mercury is transported by aircraft (49 CFR 173.164).

It is our understanding, based on discussions with shippers, that many shippers already use protective liners with liquid hazardous materials packages. These shippers suggest that liners are included only if the packages are intended for transportation by air. However, many of these shippers do not have automated processes for assembling combination packagings and, therefore, manually insert liners when needed.

As an alternative to testing, we are considering requiring the use of a liner for packagings that are not liquid-tight ( e.g. , fiberboard), whether absorbent material is required or not (for all liquid hazardous materials, regardless of hazard class). We are soliciting comments on whether the use of liners with or without absorbent material would be an effective means of preventing leaks from packages. In addition, we invite commenters to provide data and information concerning the costs that may be associated with the use of liners for various hazardous materials packaging configurations.

(2) Secondary Means of Closure . Currently, the HMR require a secondary means of closure only when inner packagings are closed with stoppers, corks or other such friction-type closures. This secondary means of closure must be held securely, tightly and effectively in place by positive means. We are soliciting comment on the types of secondary closures currently being used and their relative effectiveness in preventing leaks. We are interested in whether requiring a secondary means of closure for certain packaging configurations has merit. We are also aware the ICAO Technical Instructions, beginning in January 2011, will require a secondary means of closure on all inner packagings containing liquids in a combination packaging design. As an alternative to this requirement, the ICAO Technical Instructions will allow a leakproof liner in its place. Commenters are invited to provide data and information concerning the costs that may be associated with a requirement to apply a secondary means of closure for inner packagings containing liquids intended for transportation by aircraft.

We invite comments, data, and information that will help PHMSA and FAA determine the degree to which the packaging problems outlined in this ANRPM pose a transportation safety risk and the parameters of that risk. Commenters are also invited to suggest strategies that would help enhance the safe transportation of hazardous materials, particularly by air, including regulatory amendments, systems risk analysis, enhanced outreach and training efforts, aggressive enforcement, and combinations of these measures. In reviewing the public comments on these measures, PHMSA and FAA will consult with the Transportation Security Administration on security-related hazardous materials transportation requirements to ensure that any proposed amendments would be consistent with the overall security policy goals and objectives established by the Department of Homeland Security and would not confront the regulated community with inconsistent security guidance or requirements promulgated by multiple agencies. In addition, we ask commenters to address the following questions:

1. The air transportation environment has changed considerably since the current packaging requirements were adopted. For example, overnight and second day parcel delivery has become a common shipping method. Do the current transportation conditions ( e.g. , multiple flight segments) need to be reevaluated and regulations updated accordingly to accommodate the current conditions experienced during normal transportation?

2. Does a combination packaging design problem exist unique to air transportation? Are inner packagings of combination packaging designs used to transport hazardous materials in air transportation adequate? Are the requirements clearly understood, and if not, how could this be improved?

3. Are current “capability” requirements in the HMR sufficient to prevent or mitigate combination package failures in air transportation?

4. Should we strengthen the structure and wording of the regulations to more clearly specify the applicability of the general packaging requirements in 49 CFR 173.22, 173.24, 173.24a, and 173.27 to both specification and non-specification packagings?

5. Would incorporation of the more explicit language that is used in ICAO TI clarify some of the relevant test methods and responsible parties? Should the respective responsibilities of packaging manufacturers and shippers be clarified?

1. Should a standardized test regimen be adopted in the HMR for combination packaging intended for air transport in addition to what is already required?

2. Should new test methods be considered for vibration and pressure differential as part of the design qualification test sequence? Are there alternative cost-effective test methods for ensuring combination packaging integrity in air transportation?

3. Are the 95 kPa and 75 kPa pressure requirements sufficient or should the vapor pressure calculation specified in 49 CFR 173.27(c) continue to be required? Would simplifying the requirements enhance compliance?

1. Would a liner or similar approach be an acceptable alternative to required testing for pressure differential or vibration capability?

2. Would approaches such as new test methods, secondary closure methods, and cap/bottle design be possible solutions for reducing package leaks?

3. Should the 49 CFR 178.601(g)(1) Selective Testing Variation 1 be eliminated or restricted for combination packagings containing liquids and offered for transportation by air? If not, how could uniform compliance and an appropriate level of safety be addressed while continuing to allow this variation?

4. Should a secondary means of closure be mandated for all inner packagings or specific types of inner packagings containing liquids in combination packagings intended for transportation by aircraft?

5. Should current package marking requirements be expanded to include a shipper verification and certification that a packaging conforms to applicable air packaging requirements?

6. Should inner receptacles that are proven to meet pressure differential requirements be required to bear an indicative mark?

1. Should changes to test protocols in the HMR apply to packagings used for the air transportation of all liquids including those in non-specification packagings ( e.g. , paint, adhesives, and consumer commodities)?

2. Should high-risk/high-consequence liquid hazardous materials be restricted even further than currently required? Is there a better risk-based approach not yet developed?

3. Is there a way to reduce risk by focusing on the interrelation between packaging components and evaluating the relationship between the packaging design and preparation of the package from a systems perspective?

4. Would a combination of regulatory solutions, including a systems-wide risk analysis based on package design, package volume and transportation methods, be an effective approach as a means of reducing package leaks?

5. Are there opportunities to reduce risk through government-private industry partnership?

1. What can be done to reduce the number of package failures due to human factors such as over-tightening or under-tightening of closures? Closures loosened during long shelf storage due to both liner set and finish or closure relaxation may be a cause of a significant number of leaking bottles. Should a method be developed for a distributor to open a sealed specification package, check and re-torque closures then re-close the package for shipment in a manner that is consistent with the regulations? This would also allow inspection for other degradation caused by storage.

2. Are production tolerances of bottle caps and neck finishes suitable to ensure packages will not leak when the tolerances are at the opposite extremes, i.e., a large bottle cap on a small bottle?

3. Are the common bottles and caps currently used for the transportation of hazardous materials manufactured with sufficient quality control to ensure that all components meet the requirements for effective sealing?

4. Should the bottle threads, caps and cap liners be considered a system and, as such, a single component of the design type? Should testing be required if the system is changed? If not, what component or components of a closure system should be allowed to be changed without testing and under what conditions?

5. If actual testing is needed, what standard or standards should be adopted or allowed?

6. Should “capability” be clearly defined in the HMR to improve compliance and reduce package failures?

1. Would additional outreach or training be helpful in reducing the number of package failures? Should specific outreach brochures be developed?

2. What is the best way to reach those hazmat employees that have the greatest need for this information?

3. Are there other enforcement strategies that could be used to ensure compliance with “capability” requirements in order to reduce package failures?

1. Are packages containing liquid hazardous materials being loaded in unit load devices according to their orientation markings? If not, should this practice be considered a condition normally incident to transportation? Is better enforcement of this requirement necessary?

2. Should an article ( e.g. , electric storage battery containing acid or alkali) be required to be successfully tested for pressure differential capability? What articles, if any, should be excepted from such a requirement?

3. To what extent are there similar issues in international air commerce related to the package failures discussed in this notice? What steps have been taken to eliminate or reduce such failures?

4. How many small business entities would be impacted by a regulation that requires actual vibration and pressure differential testing rather than the current capability standard in the HMR? How many small business entities would be impacted by a regulation that requires actual testing to verify pressure differential capability only?

5. What costs to small business entities would be associated with required testing for vibration and pressure differential capability? What costs to small business entities would be associated with required testing for pressure differential capability only?

6. What alternatives, regulatory or otherwise, should PHMSA consider with regard to impact on small business entities while meeting its goal to reduce or eliminate incidents involving combination packagings in air transportation?

PHMSA and FAA will base any proposed changes on both suggestions and comments provided by interested persons in response to this ANRPM as well as the initiative of the agencies. These include the analyses required under the following statutes and executive orders in the event we determine that rulemaking is appropriate:

A. Executive Order 12866: Regulatory Planning and Review . E.O. 12866, as amended by E.O. 13258, requires agencies to identify the specific market failure (such as externalities, market power, lack of information) that warrant new agency action, as well as assess the significance of that problem, to enable assessment of whether any new regulation is warranted. When an agency determines that a regulation is the best available method of achieving the regulatory objective, E.O. 12866 also directs agencies to regulate in the “most cost-effective manner,” to make a “reasoned determination that the benefits of the intended regulation justify its costs,” and to develop regulations that “impose the least burden on society.” We therefore request comments, including specific data if possible, concerning the costs and benefits that may be associated with revisions to the HMR on air packaging integrity. A rule that is considered significant under E.O. 12866 must be reviewed and cleared by the Office of Management and Budget before it can be issued.

The number of affected combination package design types requiring certification under any required testing regimen is estimated as a function of the number of package manufacturers producing pre-certified designs, the number of shippers using self-certified designs, and the number of designs certified by each group. PHMSA estimates that 75 to 85 percent of air shippers exclusively purchase and use pre-certified combination packaging designs, that is, combination packaging designs that have been tested to existing regulatory standards. The remaining 15 to 25 percent of air shippers have sufficient shipment volumes to make it economical for them to use combination packaging designs that they have certified themselves. Combination packaging designs that are pre-certified for air transportation should already reflect any costs associated with testing performed on them to verify integrity. For self-certifiers who choose not to invest in equipment to verify combination packaging design integrity and outsource that function, the cost is approximately $300 for a standard vibration test and $200 for a standard pressure differential test. Multiple designs may be certified from a single test. There may be as many as 21,000-36,000 different UN specification combination packaging designs for liquids that would require testing if PHMSA adopts new or enhanced testing requirements for combination packagings. Total costs for testing could amount to $10.5M-$18.0M if both tests are required. Benefits under any rulemaking action would be assessed based on incident avoidance and the consideration of consequences involving a high-consequence/low probability accident. We invite commenters to address the potential costs of new or enhanced testing requirements, including the number of designs that would be affected and the total costs associated with such testing.

Additional regulatory options under consideration include requiring a secondary means of closure applied to inner packagings or receptacles containing liquid hazardous materials within a combination package or the required use of a liner in all combination packages containing liquid hazardous materials intended for air transportation when the outer packagings are not liquid tight. For the liner alternative, the economic impacts of this requirement would stem from the cost of inclusion of a liner for all combination packagings containing liquids. Shippers would absorb the costs of including a liner; however, many shippers already include a liner in these types of packagings. Informal industry surveys indicate that shippers use a protective liner with an estimated 70 to 90 percent of all liquid hazardous materials combination packages; prices for a standard 1 mm or thinner Poly Bag line range from $0.06 to $0.08 per liner. Because of the uncertainty regarding the potential designs for secondary means of closure and the costs associated with them, we invite comments on the efficacy of such an alternative and whether it should be considered in addition to, or as an alternative to, the required use of a liner.

B. Executive Order 13132: Federalism . E.O. 13132 requires agencies to assure meaningful and timely input by state and local officials in the development of regulatory policies that may 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. We invite state and local governments with an interest in this rulemaking to comment on any effect that revisions to the HMR relative to air packaging will cause.

C. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments . E.O. 13175 requires agencies to assure meaningful and timely input from Indian tribal government representatives in the development of rules that “significantly or uniquely affect” Indian communities and that impose “substantial and direct compliance costs” on such communities. While we do not anticipate an impact on Indian tribal governments if we move forward with a regulatory action, we invite Indian tribal governments to provide comments if they believe there will be an impact.

D. Regulatory Flexibility Act . Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ), we must consider whether a proposed rule would have a significant economic impact on a substantial number of small entities. “Small entities” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations under 50,000. If you believe that revisions to the HMR relative to air packaging integrity could have a significant economic impact on small entities, please provide information on such impacts.

E. Paperwork Reduction Act

It is possible that a rulemaking action could impose new or revised information collection requirements.

This ANPRM is considered a significant regulatory action under section 3(f) of Executive Order 12866 and, therefore, was reviewed by the Office of Management and Budget. This ANPRM is considered significant under the Regulatory Policies and Procedures of the Department of Transportation (44 FR 11034).

A regulation identifier 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 number contained in the heading of this document can be used to cross-reference this action with the Unified Agenda.

Periodic Review of Federal Regulations

NHTSA has long recognized the importance of regularly reviewing its existing regulations to determine whether they need to be revised or revoked. NHTSA undertakes reviews of its regulations under, inter alia, the Department's 1979 Regulatory Policies and Procedures, under Executive Order 12866 “Regulatory Planning and Review,” and under section 610 of the Regulatory Flexibility Act (5 U.S.C. section 501 et seq. ). In addition, NHTSA conducts reviews pursuant to internal operating procedures. During a periodic review of its regulations, NHTSA has identified FMVSS No. 219, Windshield Zone Intrusion, as a regulation that could possibly be removed as unnecessary.

The purpose of FMVSS No. 219 is to reduce crash injuries and fatalities that result from occupants contacting vehicle components displaced near or through the windshield. The standard applies to passenger cars, multipurpose passenger vehicles, trucks, and buses with a gross vehicle weight rating of 4,536 kilograms (kg) (10,000 pounds) or less, except for forward control vehicles, walk-in van-type vehicles or to open-body-type vehicles with fold-down or removable windshields. The final rule establishing FMVSS No. 219 was published on June 16, 1975 (40 FR 25462), and took effect on September 1, 1976.

FMVSS No. 219 specifies limits on the displacement of vehicle parts from outside the occupant compartment into the windshield area during a 48 kilometer per hour (km/h) (30 mile per hour (mph)) frontal barrier crash test. The standard establishes a protected zone at the daylight opening (DLO) portion of the vehicle windshield. The protected zone is an area encompassing the width of the windshield and protrudes about 76 mm from the outer surface of the windshield. In the crash test, a protected zone template cut or formed from Styrofoam is affixed to the vehicle so that it delineates the protected zone and remains affixed throughout the crash test. The standard specifies that in a 48 km/h (30 mph) frontal rigid barrier crash test, no part of the vehicle outside the occupant compartment, except windshield molding and other components designed to be normally in contact with the windshield, shall penetrate the protected zone template to a depth of more than 6 mm (0.25 inches) and no such part of a vehicle shall penetrate the inner surface of that portion of the windshield, within the DLO, below the protected zone. The standard was developed to decrease the likelihood of injury resulting from the intrusion of a part of the vehicle, such as the hood, into the occupant compartment through the windshield opening, or into the zone slightly forward of the windshield aperture.

The agency has tentatively concluded that the safety need that FMVSS No. 219 addresses is being met by certain other FMVSSs. FMVSS No. 219 was necessary in 1975, when NHTSA had no safety standard in which it specified crash testing to assess any hazards to which occupants were exposed as a result of such intrusion. Manufacturers responded to the standard to ameliorate windshield zone intrusions, and as a result there has not been a compliance issue with FMVSS No. 219 since shortly after its inception. Subsequently, in May 2000, NHTSA issued and substantially enhanced FMVSS No. 208, Occupant Crash Protection , to incorporate an unbelted test of 50th percentile male and 5th percentile female dummies at 40 km/h (25 mph) and a belted test of those two dummy sizes at 56 km/h (35 mph). We tentatively conclude that the dummy performance requirements of FMVSS No. 208 frontal crash tests will reflect any blunt impact injuries due to zone intrusions at the windshield. Likewise, we tentatively conclude that the air bag will aid in preventing any lacerative injuries due to zone intrusions at the windshield, and so there is no continuing need for a standard to specifically assess intrusion hazards to occupants from vehicle components external to the vehicle compartment during a frontal crash.

Because we believe that FMVSS No. 219 may be testing similar aspects of safety as FMVSS No. 208, we are concerned that the former may be redundant of the latter standard and may be imposing unnecessary costs or burdens in the manufacture of motor vehicles. Moreover, FMVSS No. 113, Hood Latch System , requires a hood latch system for all hoods, and a second position on that system to reduce incidents of inadvertent hood openings and to help limit displacement into the windshield area of motor vehicle components during a crash. Thus, given both the effect of FMVSS No. 208 and FMVSS No. 113 in limiting windshield zone intrusion into the passenger area, we tentatively conclude that a safety need no longer exists to maintain FMVSS No. 219 as a safety standard. We thus propose rescinding the safety standard. NHTSA tentatively concludes that if a final rule is issued rescinding the standard, States would be free to regulate this aspect of performance formerly occupied by FMVSS No. 219. Comments are requested on these issues.

We propose that if the change proposed in this NPRM is made final, that it take effect 180 days after the publication of the final rule in the Federal Register . Comment is requested on this proposed lead time.

This rulemaking document was not reviewed by the Office of Management and Budget under E.O. 12866, “Regulatory Planning and Review.” The rulemaking action is also not considered to be significant under the Department's Regulatory Policies and Procedures (44 FR 11034; February 26, 1979).

This rulemaking would rescind FMVSS No. 219 Windshield Zone Intrusion , in order to alleviate motor vehicle manufacturers from requirements that may already be addressed by other Federal motor vehicle safety standards, notably FMVSS No. 208, Occupant Crash Protection , and FMVSS No. 113, Hood Latch Systems .

Any cost savings resulting from the rescission of FMVSS No. 219 would be so minimal that the savings cannot be calculated. FMVSS No. 219 specifies the same crash test conditions as the 30 mph test condition in FMVSS No. 208. When NHTSA crash tests a vehicle to the test conditions of FMVSS No. 208, the agency also assesses the vehicle's compliance with FMVSS No. 219. NHTSA believes that vehicle manufacturers that conduct FMVSS No. 208 crash testing are also simultaneously testing vehicles to FMVSS No. 219. Because manufacturers will continue to crash test vehicles to FMVSS No. 208, removing FMVSS No. 219 would not result in a marked cost savings to manufacturers. Rescinding FMVSS No. 219 would only result in minimal cost savings for manufacturers as an assessment of the windshield zone intrusion would no longer have to be made.

NHTSA has examined today's proposed rule pursuant to Executive Order 13132 (64 FR 43255, August 10, 1999) and concluded that no additional consultation with States, local governments or their representatives is mandated beyond the rulemaking process. The agency has concluded that the proposed rule does not have federalism implications because the proposal does not have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

Further, no consultation is needed to discuss the preemptive effect of today's proposed rule. As a general matter NHTSA rules can have preemptive effect in at least two ways. First, the National Traffic and Motor Vehicle Safety Act contains an express preemptive provision: “When a motor vehicle safety standard is in effect under this chapter, a State or a political subdivision of a State may prescribe or continue in effect a standard applicable to the same aspect of performance of a motor vehicle or motor vehicle equipment only if the standard is identical to the standard prescribed under this chapter.” 49 U.S.C. 30103(b)(1). This proposed rule, if made final, would result in regulatory relief for motor vehicle manufacturers, and would have no effect on the States or local governments. NHTSA tentatively concludes that if the agency rescinds FMVSS No. 219, States would be free to regulate this aspect of motor vehicle performance.

Second, in addition to the express preemption noted above, the Supreme Court has also recognized that State requirements imposed on motor vehicle manufacturers, including sanctions imposed by State tort law, can stand as an obstacle to the accomplishment and execution of a NHTSA safety standard. When such a conflict is discerned, the Supremacy Clause of the Constitution makes their State requirements unenforceable. See Geier v. American Honda Motor Co. , 529 U.S. 861 (2000). NHTSA has not outlined such potential State requirements in today's rulemaking, however, in part because this proposed rule, if made final, would rescind FMVSS No. 219. We have tentatively concluded that if NHTSA rescinds FMVSS No. 219, States would be free to regulate this aspect of motor vehicle performance.

Pursuant to Executive Order 12988, “Civil Justice Reform,” we have considered whether this proposed rule would have any retroactive effect. We conclude that it would not have such an 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.

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). However, no regulatory flexibility analysis is required if the head of an agency certifies the rule would 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 would not have a significant economic impact on a substantial number of small entities.

The Head of the Agency has considered the effects of this rulemaking action under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) and certifies that this proposal would not have a significant economic impact on a substantial number of small entities. The statement of the factual basis for the certification is that since NHTSA proposes to remove FMVSS No. 219, any small manufacturers of passenger cars, multipurpose passenger vehicles, trucks or buses would be provided regulatory relief. Accordingly, the agency believes that this proposal would at most, have a minimal beneficial cost effect for small business manufacturers of motor vehicles subject to FMVSS No. 219.

We have analyzed this proposal for the purposes of the National Environmental Policy Act and determined that it would not have any significant impact on the quality of the human environment.

NHTSA has determined that, if made final, this proposed rule would not impose any “collection of information” burdens on the public, within the meaning of the Paperwork Reduction Act of 1995 (PRA). In this NPRM, we propose to remove FMVSS No. 219, which has no collection of information requirements associated with it. This rulemaking action would not impose any filing or recordkeeping requirements on any manufacturer or any other party.

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 us to use voluntary consensus standards in our 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). There are no available and applicable voluntary consensus standards that we can use in this notice of proposed rulemaking.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires Federal agencies to prepare a written assessment of the costs, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million in any one year (adjusted for inflation with base year of 1995). This proposal 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 proposal 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. 1 We 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 your comments by any of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov . Follow the online instructions for submitting comments.

• Mail: Docket Management Facility, M-30, U.S. Department of Transportation, West Building, Ground Floor, Rm. W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590.

• Hand Delivery or Courier: West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. Eastern Time, Monday through Friday, except Federal holidays.

• Fax: (202) 493-2251.

Please note that pursuant to the Data Quality Act, in order for substantive data to be relied upon and used by the agency, it must meet the information quality standards set forth in the OMB and DOT Data Quality Act guidelines. Accordingly, we encourage you to consult the guidelines in preparing your comments. OMB's guidelines may be accessed at http://www.whitehouse.gov/omb/fedreg/reproducible.html . DOT's guidelines may be accessed at http://dmses.dot.gov/submit/DataQualityGuidelines.pdf .

If you submit your comments by mail and 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 . 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. 2

In addition, you should submit a copy, from which you have deleted the claimed confidential business information, to the Docket by one of the methods set forth above.

We will consider all comments received before the close of business on the comment closing date indicated above under DATES . To the extent possible, we will also consider comments received after that date. Therefore, if interested persons believe that any new information the agency places in the docket affects their comments, they may submit comments after the closing date concerning how the agency should consider that information for the final rule.

If a comment is received too late for us to consider in developing a final rule (assuming that one is issued), we will consider that comment as an informal suggestion for future rulemaking action.

You may read the materials placed in the docket for this document (e.g., the comments submitted in response to this document by other interested persons) at any time by going to http://www.regulations.gov . Follow the online instructions for accessing the dockets. You may also read the materials at the Docket Management Facility by going to the street address given above under ADDRESSES . The Docket Management Facility is open between 9 am and 5 pm Eastern Time, Monday through Friday, except Federal holidays.

In consideration of the foregoing, it is proposed that the Federal Motor Vehicle Safety Standards (49 CFR part 571), be amended as set forth below.

On June 15, 2006, President Bush established the Northwestern Hawaiian Islands Marine National Monument (Monument) by issuing Presidential Proclamation 8031 (Proclamation; 71 FR 36443, June 26, 2006) under the authority of the Antiquities Act (Act) (16 U.S.C. 431). The Proclamation reserves all lands and interests in lands owned or controlled by the Government of the United States in the Northwestern Hawaiian Islands (NWHI), including emergent and submerged lands and waters, out to a distance of approximately 50 nautical miles (nmi) from the islands. The outer boundary of the Monument is approximately 100 nmi wide and extends approximately 1200 nmi around coral islands, seamounts, banks, and shoals. The area includes the Northwestern Hawaiian Islands Coral Reef Ecosystem Reserve, the Midway Atoll National Wildlife Refuge/Battle of Midway National Memorial, and the Hawaiian Islands National Wildlife Refuge. The Monument was renamed the Papahanaumokuakea Marine National Monument by Proclamation 8112 (72 FR 10029, February 28, 2007).

The Proclamation provides that the Secretary of Commerce, through NOAA, has primary responsibility regarding the management of the marine areas of the Monument, in consultation with the Secretary of the Interior. The Secretary of the Interior, through the USFWS, has sole responsibility for management of the areas of the Monument that overlay the Midway Atoll National Wildlife Refuge, the Battle of Midway National Memorial, and the Hawaiian Islands National Wildlife Refuge, in consultation with the Secretary of Commerce. Further, the Proclamation provides that nothing in the Proclamation diminishes or enlarges the jurisdiction of the State of Hawaii. The Monument includes state waters, including the Northwestern Hawaiian Islands State Marine Refuge and State Seabird Sanctuary at Kure Atoll. The State currently holds the submerged and ceded lands of the NWHI in trust. This public trust is overseen by the Office of Hawaiian Affairs through an amendment to the Constitution of the State of Hawaii. The State of Hawaii has primary responsibility for managing the State waters of the Monument.

In 2006 NOAA and USFWS published joint regulations codifying the provisions of the Proclamation (71 FR 51134, August 29, 2006). With certain exceptions, the Proclamation and the joint regulations restrict access to the Monument to persons who have been issued Monument permits. Vessels that do not have permits cannot enter the Monument except for uninterrupted passage through the Monument and notice must be provided to NOAA by telephone, fax, or e-mail not less than 72 hours and not more than one month prior to passing through the Monument. Notice must also be provided not more than twelve hours after the vessel has exited the Monument. All of the terms of the Proclamation and the regulations are applied in accordance with international law.

The Proclamation directed the Secretary of State, in consultation with the Secretaries of Commerce and the Interior, to take appropriate action to enter into negotiations with other governments to make necessary arrangements for the protection of the Monument and to promote the purposes for which it was established. The Proclamation further directed the Secretary of State to seek the cooperation of other governments and international organizations in furtherance of the purposes of the Proclamation and consistent with applicable regional and multilateral arrangements for the protection and management of special marine areas.

In April 2007 and in accordance with the Proclamation, the United States proposed to the International Maritime Organization (IMO), a specialized agency of the United Nations, that the Monument be designated as a Particularly Sensitive Sea Area (PSSA) to protect the attributes of the fragile and integrated coral reef ecosystem from potential hazards associated with international shipping activities. The U.S. noted in its proposal that the burden on international shipping by the proposed PSSA and its associated protective measures would be minimal while its objectives—increased maritime safety, protection of the fragile environment, preservation of cultural resources and areas of cultural importance significant to Native Hawaiians, as well as facilitation of the ability to respond to developing maritime emergencies—would be significantly furthered. PSSA designation had been granted previously to only ten marine areas globally, including the marine areas around the Florida Keys, the Great Barrier Reef, and the Galapagos.

On April 3, 2008, the IMO designated the Monument as a PSSA. As part of the PSSA designation process, the IMO adopted U.S. proposals for associated protective measures consisting of (1) expanding and consolidating the six existing recommendatory Areas To Be Avoided (ATBA's) in the Monument into four larger areas and enlarging the class of vessels to which they apply; and (2) establishing a ship reporting system for vessels transiting the Monument, which is mandatory for ships 300 gross tons or greater that are entering or departing a U.S. port or place and recommended for other ships. The system requires that ships notify the U.S. shore-based authority (i.e., the U.S. Coast Guard; NOAA will be receiving all messages associated with this program on behalf of the Coast Guard) at the time they begin transiting the reporting area and again when they exit. Notification is made by e-mail through the Inmarsat-C system or other satellite communication system. It is estimated that almost all commercial vessel traffic will be able to report via Inmarsat-C.

The PSSA and associated protective measures were adopted to provide additional protection to the exceptional natural, cultural and historic resources in the Monument. Requiring vessels to notify NOAA upon entering the reporting area will help make the operators of these vessels aware that they are traveling through a fragile area with potential navigational hazards such as the extensive coral reefs found in many shallow areas of the Monument. The PSSA is now in effect, and the IMO has provided for an effective date for the associated protective measures of May 1, 2008.

NOAA and USFWS are establishing the infrastructure that will be required to maintain an international ship reporting system and to ensure that information regarding PSSA designation will be incorporated into nautical charts and other information sources. This proposed rule would implement the mandatory ship reporting system as adopted by IMO, establish the reporting area using the IMO boundary coordinates, and publish the coordinates of the four ATBA's.

These regulations would apply to vessels that do not have permits to enter the Monument and that would pass through the Monument without interruption. The regulations propose the following actions:

(1) Modify the current notification requirements (at 50 CFR 404.4) for passing through the Monument without interruption and add several new associated terms and definitions (at § 404.3);

(2) establish a reporting area around the Monument, extending outward ten nautical miles from the Monument boundary but excluding the ATBA's within the Monument;

(3) describe the categories of vessels to which the reporting requirement would apply;

(4) specify the type of information regarding the vessel, its location, etc. that would be required in the e-mail to NOAA and would be sent in a reporting format that is consistent with the reporting system adopted by IMO;

(5) allow for vessels that do not have e-mail capability to continue compliance with the current prior notification requirements;

(6) recommend voluntary participation in the reporting system for all other vessels that are not required to notify NOAA; and

(7) publish the revised boundaries of the four voluntary ATBA's.

Each of these elements of the proposed regulations is described below.

Current Monument regulations at 50 CFR 404.4 prohibit entry into the Monument except in certain situations. One of the exceptions is for vessels passing through the Monument without interruption. Those vessels, however, are currently required to provide notice prior to entering and after leaving the Monument. Notification of entry must be provided at least 72 hours, but no longer than 1 month, prior to the entry date. Notification of departure from the Monument must be provided within 12 hours of leaving. Notification may be made by e-mail, telephone, or fax and must include the following information: position when making the report; vessel name and IMO identification number; name, address, and telephone number of owner and operator; United States Coast Guard documentation, state license, or registration number; home port; intended and actual route through the Monument; general categories of any hazardous cargo on board; and length of vessel and propulsion type (e.g., motor or sail).

The proposed regulations would replace the current notification requirements for vessels that have e-mail capability. Vessels without e-mail capability would continue to provide notification as required currently but the type of information to be provided would be modified by these regulations as described below.

The following terms would be added to the definitions in the regulations at 50 CFR 404.3 to facilitate implementation of the proposed ship reporting requirements: “Areas to be avoided”; “Categories of hazardous cargoes”; “IMO”; and “Reporting area.” The definitions to these terms are contained in the text of the proposed regulations.

The proposed regulations would create a reporting area extending ten miles out and entirely around the Monument boundary. The coordinates of the proposed area are set forth in Appendix D of the proposed regulations and are the same as the coordinates that were adopted by IMO when it accepted the PSSA in principle and adopted the associated protective measures for the PSSA in 2007. Certain categories of vessels (described below) that intend to pass through the Monument without interruption would be required to e-mail certain information at the time they cross the reporting area boundary and again when they exit the reporting area after having passed through the Monument.

The reporting area would not include the ATBA's within the Monument. As such, vessels that pass through an ATBA while passing through the Monument would be required to notify NOAA at the time they exit the reporting area and enter the ATBA, and again when they exit the ATBA and re-enter the reporting area.

There are three large areas of the Monument (within the reporting area) that are not within the IMO-designated ATBA's. These breaks between the four ATBA's allow for primarily north-south passage through the Monument. From west to east, these areas are in the following locations and are shown in Figure 1: between the ATBA's extending around Pearl and Hermes Atoll and Lisianski Island; between the ATBA's around Maro Reef and Gardner Pinnacles; and between the ATBA's around Mokumanamana (Necker Island) and Nihoa Island. It is anticipated that vessels will navigate through the Monument via these areas. Vessels passing through the Monument in these areas would only send e-mail notification upon entering the reporting area and again upon leaving it.