On November 25, 2002, the President signed the Homeland Security Act of 2002 (Act), Public Law 107-296, into law. This Act provides Federal agencies with a number of human resources (HR) flexibilities. These flexibilities include direct-hire authority and alternative (that is, category) rating and selection procedures, which will aid in recruitment and hiring. The Act also provides Federal agencies with the authority to pay or reimburse employees for the costs of academic degree training.

Title 5 U.S.C. 3304 provides agencies with the authority to appoint candidates directly to jobs for which OPM determines that there is a severe shortage of candidates or a critical hiring need. The requirements and justification for the direct hire authorities are presented separately and distinct from each other in these interim regulations.

We are soliciting comments on whether we should combine the requirements and justification for a severe shortage of candidates and critical hiring needs into a single section or keep them in separate sections as written.

OPM may decide, on its own, that a severe shortage of candidates or a critical hiring need exists, either Governmentwide or in specified agencies, for one or more specific occupational series, grades (or equivalent), or geographic locations. Alternatively, an agency may, in a written request to OPM, identify the position(s) for which it believes a severe shortage or a critical hiring need exists. The agency must include relevant evidence, as described below, to support its request. Agencies that use this direct-hire authority must adhere to public notice requirements, as set forth in 5 U.S.C. 3327 and 3330, and 5 CFR part 330, subpart G.

To demonstrate that a severe shortage of candidates exists for a position or group of positions, an agency must provide information showing that it is unable to identify candidates possessing the competencies required to perform the necessary duties of the position despite extensive recruitment, extended announcement periods, and the use, as applicable, of hiring flexibilities such as recruitment and relocation incentives. In determining whether there is a severe shortage of candidates for a position or group of positions, OPM will consider all relevant evidence, including an agency's demonstrated recruitment efforts, human capital management strategic plans that forecast agency workforce needs, relevant analyses made in connection with an agency's workforce planning efforts, labor market data, and employment trends. OPM will also consider whether a nationwide or geographical skills shortage exists, as well as the extent to which the position(s) at issue are located in an undesirable geographic location, will require the incumbent to perform onerous or undesirable duties, or will require the incumbent to work under extraordinary or extreme conditions.

To prove that a critical hiring need exists, an agency must demonstrate that it has a critical need to fill the position or positions to meet mission requirements brought about by an exigency such as a national emergency, threat or potential threat, environmental disaster, or other unanticipated or unusual event or mission requirement. A critical hiring need may also be triggered by the need to conform to requirements of law, Presidential directive or Administration initiative, or a congressional or other mandate to meet new or expanded mission requirements by a particular date. In a request for direct-hire authority due to a critical hiring need, an agency must provide sufficient evidence to demonstrate that filling the position(s) is critical to the agency's mission and that the use of other hiring authorities is impracticable or ineffective.

To provide agencies with the ability to use the new direct-hire authority, as appropriate, for temporary and term appointments, emergency-indefinite appointments in a national emergency, and overseas limited appointments, OPM is revising 5 CFR 230.402, Agency Authority to Make Emergency-indefinite Appointments in a National Emergency; 5 CFR part 301, subpart B, Overseas Limited Appointments; 5 CFR 316.302, Selection of Term Employees; and 5 CFR 316.402, Procedures for Making Temporary Appointments.

This interim regulation will add subpart B to 5 CFR part 337 and amends 5 CFR parts 230, 301 and 316.

OPM is eliminating 5 CFR part 333, Recruitment and Selection for Temporary and Term Appointments Outside the Register, based on its conclusion that this hiring authority is now obsolete.

The current outside-the-register procedure is available for use only when there is an insufficient number of eligibles on the appropriate register. OPM initially established these procedures to give agencies an alternative to traditional examining methods when there were not enough qualified eligibles on a particular register. The Act, however, provides OPM with the authority to permit agencies to utilize an alternative to traditional examining methods ( i.e. , direct-hire authority) when there is a severe shortage of candidates possessing the competencies to perform the job requirements or a critical hiring need. Currently, agencies using outside-the-register procedures are required to provide public notice, apply veterans' preference, and provide selection priorities to certain displaced employees. These requirements are essentially the same as those for the new direct-hire authority. Based upon the foregoing, the current procedures for outside-the-register appointments under 5 CFR part 333 are duplicative and no longer needed, and we are therefore eliminating this regulation.

This interim regulation removes 5 CFR part 333.

Based on the elimination of the outside-the-register authority, OPM is also eliminating the Temporary Appointments Pending the Establishment of a Register (TAPER) authority. The TAPER authority was proposed for elimination in 1996, but was ultimately retained to provide agencies with a simplified examining process when filling Worker-Trainee (GS-1 and WG-1 and 2) positions with applicants who had limited education and experience. The decision to retain this authority thus was in response to the Governmentwide need, in connection with the “Welfare to Work” initiative, to provide opportunity for welfare recipients to enter the workforce.

Within the past several years, OPM has authorized the use of a number of alternative hiring flexibilities to assist agencies when recruiting individuals with limited education and experience. For example, in 1999, OPM gave agencies authority to use alternatives to the written test normally required when making appointments to clerical positions. These changes, combined with the flexibilities provided by the Act, give agencies the authority to bypass the selection procedures established in title 5 of the United States Code in appropriate circumstances, and therefore obviate the need for an authority to temporarily appoint an individual pending establishment of a register.

Eliminating this regulation will not adversely affect employees currently serving under TAPER appointments. These individuals will continue to work under these appointments until they have completed the 3 years of service that entitles them, under 5 U.S.C. 3304a, to be converted to career appointments. Based on the foregoing, there is no longer a need to retain the TAPER authority.

This interim regulation eliminates 5 CFR part 316, subpart B.

Title 5 U.S.C. 3319 provides agencies with the authority to develop a category-based rating method as an alternative way of assessing and rating job applicants for positions filled through the competitive examining process. Traditionally, applicants for Federal jobs are assigned numerical scores, including veterans' preference points, if appropriate, and are considered for selection based on the “rule of three” (5 U.S.C. 3318(a)). The category rating system prescribed by the Act does not add veterans' preference points or apply the “rule of three” but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. For all positions other than scientific and professional positions at GS-9 (and equivalent) or higher, otherwise qualified preference eligibles who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category. This requirement is similar to the provisions of 5 U.S.C. 3313, which are used in numerical rating.

Under a category rating system, the agency assesses candidates against job-related criteria and then places candidates into two or more pre-defined categories. The categories are defined through a job analysis conducted in accordance with the “ Uniform Guidelines on Employee Selection Procedures, ” at 29 CFR part 1607 and 5 CFR part 300. The categories must be distinct from one another and clearly differentiate between the relative quality of candidates in each. For example, an agency could adopt a two-category system in which the higher category is used for those candidates who meet minimum qualifications and are highly proficient in all the requirements of the job, while the lower category is reserved for those candidates who meet the minimum qualifications and are proficient in some, but not all, of the requirements of the job. For each position to be filled, an agency must decide in advance if they will assess candidates using the traditional numerical ranking and “rule of three” procedures or category rating, and must publish this information in the job announcement. When using the category rating procedure, the job announcement must then clearly define the categories.

Specific guidance on using the category rating process will be included in OPM's Delegated Examining Operations Handbook ( www.opm.gov/deu/ ).

The category rating process provides for selections to be made from the highest category or, if fewer than three candidates have been assigned to the highest quality category, in a merged category consisting of the highest and the second-highest quality categories. If a preference eligible is in the category, an agency may not select a non-preference eligible unless the agency requests to pass over the preference eligible, and its request is approved. Objections to a preference eligible must be processed by the agency's delegated examining office in accordance with 5 U.S.C. 3318(b) and 5 CFR 332.406. In addition, agencies are required to follow the provisions of 5 CFR 330.606 and 330.705, pertaining to order of selection.

The Act requires agencies to submit an annual report to Congress on the use of their category rating and selection procedures. For oversight purposes, OPM has required agencies to forward a copy of these reports to OPM.

This interim regulation adds subpart C to 5 CFR part 337.

Section 1331(a) of the Act amends the provisions of 5 U.S.C. 4107 by expanding the authority of an agency to pay or reimburse employees for the cost of academic degree training when such training contributes significantly to meeting an identified agency training need, resolving an identified agency staffing problem, or accomplishing goals in the agency's human capital management strategic plan. Such training must be part of a planned, systemic, and coordinated agency employee development program linked to accomplishing strategic human capital goals. According to 5 U.S.C. 4107(b)(2) agencies may not provide such training for the sole purpose providing an academic degree or as a means of qualifying for a position that requires an academic degree. However, an agency may provide an employee with the opportunity to obtain an academic degree or qualify for an appointment to a particular position for which the degree is required provided that the training is consistent with the agency's human capital management strategic plan and that selection for such training follows established competitive procedures. The academic training program must be provided by a college or university that is accredited by a nationally recognized body. OPM is amending its regulations to reflect these changes.

Agencies that pay or reimburse employees for academic degree training must generally require the employee benefiting from such training to enter into a continued service agreement with the agency prior to attending the training. Continued service agreement requirements apply to both tuition reimbursement programs and academic degree training programs.

This interim regulation revises subpart C of 5 CFR part 410.

This interim rule has been reviewed by the Office of Management and Budget in accordance with Executive Order 12866.

Pursuant to 5 U.S.C. 553(d)(3), I find that good cause exists to waive the delay in effective date and make these regulations effective in less than 30 days. The delay in the effective date is being waived because the program changes do not mandate but will give agencies needed flexibilities to recruit, hire and retain high quality candidates quickly and effectively to respond to changing and critical mission requirements. The General Accounting Office has designated strategic human capital management as a Governmentwide high-risk area citing serious human capital shortfalls that erode the ability of agencies to “economically, efficiently and effectively perform their missions.” The President's Management Agenda calls for agencies to “flatten the Federal hierarchy, reduce the time to make decisions, and increase the number of employees that provide services to citizens. The reform also will pursue targeted civil service reforms, such as performance-based compensation and management flexibilities to recruit, retain, and reward a high-quality workforce.” With 50% of Federal employees eligible for retirement in the coming years, agencies must have contemporary, flexible tools for workforce management. Recent media articles have highlighted the public perception that getting a Federal job takes too long and is far too complicated. The Government needs the very best applicants; in turn applicants deserve a streamlined, understandable application process. These changes will accommodate that need.

None of the three flexibilities proposed by these regulations are new or untried. In fact, category rating has been used successfully by some agencies for a decade or more under demonstration authority and enabling legislation. Studies of category rating as implemented by the Department of Agriculture indicate that employment of veterans increases and diversity is not reduced. Private-sector companies routinely use tuition payment as a strategy to attract and retain high quality employees.

These flexibilities were proposed after broad consultation with a variety of stakeholders including employees, managers and the human resources community. They long have been advocated by numerous public and private groups including the Merit Systems Protection Board and the Partnership for Public Service as forward thinking, solid human capital strategies that should be available Governmentwide rather that to a few select agencies.

Direct hire, in particular, is critical if agencies are to respond effectively to the needs of the Nation. With a nationwide shortage of nurses and other healthcare workers, the Government must be able to move quickly and efficiently to hire excellent candidates—direct hire would provide that flexibility. Without it, the staffing to provide care to veterans and others in Federal medical facilities is diminished. Similarly, the critical need to hire talented, highly skilled workers to respond to a national crisis including an environmental threat such a raging wildfire can not be left to traditional hiring methods designed decades ago.

The alternatives provided by these regulations are not mandatory but may be used strategically by agencies to improve the management of human capital, to meet mission requirements and to respond to the President's call for a Government that is citizen focus and results oriented. There is a compelling need to provide these flexibilities without delay.

Finally, OPM will issue final regulations within 1 year of the publication of these interim regulations or these regulations will sunset.

I certify that these regulations would not have a significant economic impact on a substantial number of small entities (including small businesses, small organizational units, and small governmental jurisdictions) because they would only apply to Federal agencies and employees.

Section 1313(b) of the “Homeland Security Act of 2002” (Public Law 107-296, 116 Stat. 2135) provides agencies the option to offer voluntary early retirement when restructuring as well as when downsizing. Previously, voluntary early retirement was only available in downsizing situations.

Subsection 1313(b)(1) of Public Law 107-296 covers employees under the Civil Service Retirement System (CSRS), and is codified in 5 U.S.C. 8336(d)(2). Section 831.114 is revised to implement the new voluntary early retirement provisions under CSRS.

Subsection 1313(b)(2) of Public Law 107-296 covers employees under the Federal Employees Retirement System (FERS), and is codified in 5 U.S.C. 8414(b)(1). Section 842.213 is revised to implement the new voluntary early retirement provisions under FERS.

The voluntary early retirement provisions are the same under CSRS and FERS. The revised regulations explain which employees are potentially eligible for voluntary early retirement, how an agency requests voluntary early retirement authority from OPM, and how the agency manages the voluntary early retirement authority after approval.

Under the interim regulations, an agency's human capital plan and/or voluntary separation incentive plan may be used to satisfy the requirements for requesting a voluntary early retirement authority if it contains the information required in the VERA regulations.

Pursuant to 5 U.S.C. 553(b)(3)(B), I find that good cause exists for waiving the general notice of proposed rulemaking. Also, pursuant to 5 U.S.C. 553(d)(3), I find that good cause exists to make this rule effective in less than 30 days.

OPM has already promulgated interim regulations regarding use of the Voluntary Separation Incentive Payment (VSIP) authority pursuant to Congressional mandate. While agencies may now receive OPM approval to use VSIP to reshape their workforces, they cannot use VERA for that purpose until these regulations are available. In this case, compliance with notice and comment procedures, as well as with the 30-day waiting period, would severely undercut the usefulness of the VSIP authority and would deny employees who have not attained full retirement eligibility the opportunity to be considered for VSIPs. The alternative to reshaping the workforce through voluntary measures such as early retirement is generally reduction in force—a tool that is disruptive and costly both to employees and agencies. The inability of agencies to offer this option to employees undermines the intent of Congress and the Administration in providing agencies with the ability to use both the VERA and VSIP flexibilities for workforce reshaping and impacts employee options for “soft landings.”

This regulation is needed to allow agencies to immediately use the VERA flexibilities that Congress accorded to them in the Homeland Security Act (Act). Prior to the enactment of this Act, agencies could obtain from OPM the authority to offer individuals voluntary early retirement based on a need to downsize. Also, if they had their own VSIP law, they could offer VSIP to their employees on the same basis. In the Act, however, Congress introduced the ability to request authority from OPM to offer VERA or VSIP, or both, based on a need for workforce reshaping. This is a flexibility that Congress deemed necessary to ensure that agencies could accomplish their respective missions, which, in many cases, have changed significantly since September 11, 2001. The VERA flexibility is designed so that it may be used in tandem with the VSIP flexibility. In fact, the VSIP authority may be ineffective in some instances, or not fully effective, if there is not a corresponding VERA authority to allow employees to retire early.

Moreover, delaying the effective date for OPM's VERA regulations could lessen the usefulness of VSIPs for reshaping this year. The financial advantage of VSIP rapidly diminishes the later it is used in a fiscal year, because the cost of the VSIP payment and the payout for accrued leave is more likely to exceed the amount of the employee's salary for the remainder of the year. Congress's inclusion of the new VERA flexibilities in the Homeland Security Act indicates that it intended for agencies to use these flexibilities this year. Waiver of the requirements regarding notice, comment, and the effective date is necessary to ensure that Congress' intent is honored.

Finally, OPM will issue final regulations within 1 year of the publication of these interim regulations or these regulations will sunset.

I certify that this regulation will not have a significant economic impact on a substantial number of small entities because it affects only certain Federal employees.

This rule has been reviewed by the Office of Management and Budget in accordance with Executive Order 12866.

First, the final rule expands the definitions of the terms “Service,” “Commissioner,” and “director” at 8 CFR 1.1. Definitions for the terms “Department,” “Secretary,” and “Bureau” have been added. Definitions have also been added for “BCIS,” “CBP,” and “ICE,” which are the acronyms for the bureaus within DHS that have been delegated the authorities of the former Service. The definitions provide clarification that the functions of the legacy components of the Service continue under the Department. The definitions refer to the “Service” in recognition that the term “Service” continues to be used throughout Title 8 of the Code of Federal Regulations, and this final rule amends only limited portions of that title.

Second, the term “immigration enforcement agent” has been added to 8 CFR 103.1(b) in recognition of an ongoing modification to the field structure of the Bureau of Immigration and Customs Enforcement (ICE). As part of a position reclassification the immigration agent position (within the investigations program of ICE) and the detention enforcement officer position (within the detention and removal program of ICE) will be combined and reclassified into the immigration enforcement agent position. Immigration enforcement agents will have responsibilities that include the identification and processing of detained criminal aliens within the institutional removal program.

Third, the final rule revises the regulation at 8 CFR 239.1 that delegates authority to issue notices to appear. In his discretion, the Secretary of Homeland Security has published this delegation of authority to issue notices to appear in the Code of Federal Regulations, cross-referencing his general delegation authority under 8 CFR 2.1. The list of officers authorized to issue notices to appear is amended to reflect the ongoing reorganization of functions of the former Service among the Bureau of Citizenship and Immigration Services, the Bureau of Customs and Border Protection, and the Bureau of Immigration and Customs Enforcement. Removed from the list of those authorized to issue a notice to appear is the Director of Juvenile Affairs, based on the transfer of functions with respect to the care of unaccompanied alien children to the Department of Health and Human Services pursuant to section 462 of the Homeland Security Act of 2002, as amended, 6 U.S.C. 279.

Fourth, the final rule revises 8 CFR 287 part 1 with respect to the powers and authority of officers and employees of these three bureaus. Deportation officers have been provided the authority to execute search warrants under 8 CFR 287.5(e)(1).

In recognition of the position reclassification of detention enforcement officers to immigration enforcement agents, the term “immigration enforcement agent” is added to the existing term of “detention enforcement officer” in 8 CFR 103.1(b), 287.5(c)(6), 287.5(e)(3), 287.5(f), 287.8(a)(1)(iv) and 287.8(a)(2)(iii). Pursuant to their duties and responsibilities within the institutional removal program, immigration enforcement agents are delegated the authority to make arrests under 8 CFR 287.5(c)(1), and 8 CFR 287.5(c)(2), to conduct searches under 8 CFR 287.5(d), to execute search warrants under 287.5(e)(1), to serve warrants of arrest for non-immigration violations under 287.5(e)(4), and to issue detainers under 8 CFR 287.7(b).

Fifth, the final rule revises the regulation at 8 CFR 287.10 regarding the internal review process for alleged violations of the standards for enforcement activities to replace the references to offices within the Department of Justice that had been responsible for reviewing such allegations with the appropriate offices within DHS.

Sixth, the final rule revises or removes several paragraphs in 8 CFR 239.2 (cancellation of notices to appear), 8 CFR 287.3 (aliens arrested without warrant), and 8 CFR 287.4 (subpoenas), to reflect the recodification of regulations governing immigration proceedings. Under the HSA, the Executive Office for Immigration Review (EOIR), including the immigration judges and the Board of Immigration Appeals, remain in the Department of Justice, and the regulations pertaining to proceedings before EOIR have been codified in Chapter V of 8 CFR. Accordingly, this final rule makes conforming changes to 8 CFR 239.2, 287.3, and 287.4 in recognition that the regulations governing immigration proceedings before the immigration judges and the Board are now codified at 8 CFR 1003 et seq. (including with reference to this rule, 8 CFR 1003.14, 1239.2, 1287.4, and 1292.2).

Finally, the rule revises the regulation at 8 CFR 287.8 by adding a new subsection (g) which states that the criminal law enforcement activities authorized under this rule will be exercised in a manner consistent with all applicable DHS and Department of Justice guidelines and policies.

Compliance with 5 U.S.C. 553 as to notice of proposed rulemaking or delayed effective date is unnecessary as this rule relates to agency organization and management. Accordingly, it is not a “rule” as that term is used by the Congressional Review Act (Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA)), and the reporting requirement of 5 U.S.C. 801 does not apply.

This rule making is limited to agency organization, management or personnel matters, and therefore is not a regulation or rule as defined by Executive Order 12866. It has also been determined that this rulemaking is not a significant regulatory action for the purposes of Executive Order 12866. Accordingly, a regulatory impact analysis is not required.

Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. chapter 6) do not apply.

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

This rule meets the applicable standards set forth in section 3(a) and (b)(2) of Executive Order 12988.

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

This rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, the Department of Homeland Security has determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

Under the Paperwork Reduction Act of 1995, Public Law 104-13, all Departments are required to submit to the Office of Management and Budget (OMB), for review and approval, any reporting requirements inherent in a final rule. This rule does not impose any new reporting or recordkeeping requirements under the Paperwork Reduction Act.

The Virus-Serum-Toxin Act regulations in 9 CFR part 113 (referred to below as the regulations) prescribe standard requirements for the preparation and testing of veterinary biological products. Standard requirements consist of test methods, procedures, and criteria that define the standards for purity, safety, potency, and efficacy for a given type of veterinary biological product. When a standard procedure for testing veterinary biological products is validated and approved by the Animal and Plant Health Inspection Service (APHIS) for general use, it is proposed for codification in the regulations. Sections 113.100 and 113.200 of the regulations prescribe the requirement for determination of residual free formaldehyde content in inactivated bacterial products and killed virus vaccines, respectively.

On April 5, 2002, we published in the Federal Register (67 FR 16327-16329, Docket No. 01-091-1) a proposal to amend to amend the regulations for determination of residual free formaldehyde content in inactivated bacterial products and killed virus vaccines to specify that such determinations be made using the ferric chloride method, and that the residual free formaldehyde content be measured in grams per liter. The proposed rule was intended to reduce the differences in technical requirements for veterinary biologics among regulatory agencies in different countries and further ensure the safety and shelf life of veterinary biologics by adopting a method which has been standardized and accepted internationally.

We solicited comments concerning our proposal for 60 days ending on June 4, 2002. We received one comment by that date, from a national trade association representing veterinary biologics manufacturers. The commenter expressed support for the efforts of APHIS and the International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) to harmonize the technical requirements for product registration among the participating regions and recommended that APHIS adopt the provisions of the proposed rule.

Therefore, for the reasons given in the proposed rule, we are adopting the proposed rule as a final rule, without change.

This rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

We are amending the Virus-Serum-Toxin Act regulations for determination of residual free formaldehyde content in biological products to require that such free formaldehyde determinations be made using the ferric chloride method, which determines residual free formaldehyde content by measuring the quantity of coloring matter in solution by the quantity of light absorbed in passing through the solution. In addition, this rule provides that the maximum allowable residual free formaldehyde content of veterinary biologics be measured in grams per liter, rather than equivalent percent or parts per million. The effect of this action will be to provide a standardized method that has been shown to be more accurate than the basic fuchsin method and that has been standardized and adopted internationally.

This rule will affect all licensed manufacturers of veterinary biologics that test inactivated bacterial products and killed virus vaccines for free formaldehyde content. Currently, there are approximately 135 veterinary biologics establishments, including permittees. According to the standards of the Small Business Administration, most veterinary biologics establishments would be classified as small entities.

We do not expect that this rule will impose any additional testing or economic burden on these manufacturers because manufacturers currently test their products for free formaldehyde content using the basic fuchsin and other methods, and the reagents and equipment necessary to perform the ferric chloride test for free formaldehyde content that will be required under this rule are expected to be comparable in cost.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

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 final rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. The Act does not provide administrative procedures which must be exhausted prior to a judicial challenge to the provisions of this rule.

This final rule contains no new information or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq ).

On September 19, 2002, the OCC published the final rule governing DCCs and DSAs. 1 The final rule establishes consumer protection standards and safety and soundness requirements that apply with respect to DCCs and DSAs entered into by national banks in connection with extensions of credit they make to customers. The rule prohibits national banks from engaging in certain practices, such as tying and misleading marketing or advertising. It also requires, among other things, that national banks provide standardized disclosures about the DCC and DSA products they offer; that they obtain a customer's acknowledgment of receipt of those disclosures; and that they obtain the customer's affirmative election to purchase the product. In addition, the rule requires a national bank that offers a customer the option to pay the fee for a DCC or DSA in a single payment also to offer that customer a bona fide option to pay the fee on a periodic basis (“periodic payment option”). The final rule takes effect on June 16, 2003.

The OCC recently has received information that the periodic payment option requirement may present unique issues, of which the OCC was previously unaware, in connection with DCCs and DSAs offered by national banks through unaffiliated, non-exclusive agents, with respect to certain types of consumer purchase transactions, most notably car loans made available through automobile dealers.

Accordingly, we have determined that it is appropriate to delay the mandatory compliance date for the periodic payment option in the case of transactions where unaffiliated, non-exclusive agents of a national bank offer that bank's DCC or DSA in connection with closed-end consumer credit, until the OCC has an opportunity to further evaluate the feasibility of approaches to providing appropriate customer protections in connection with that type of transaction. Because the availability of the periodic payment option also triggers certain disclosures, we also are delaying the time for compliance with certain other provisions in the DCC/DSA final rule that are linked to the requirement to offer a periodic payment option, including the requirement to provide the long form disclosures.

Banks offering DCCs and DSAs through non-affiliated, non-exclusive agents thus remain subject to the following requirements:

• The bank may not extend credit or alter the terms or conditions of an extension of credit conditioned upon the customer's purchase of a DCC or DSA.

• The bank may not engage in any practice or use any advertisement that could mislead or otherwise cause a reasonable person to reach an erroneous belief with respect to information that must be disclosed under this part.

• The bank may not offer DCCs or DSAs that contain terms giving the bank the right unilaterally to modify the contract unless the modification is favorable to the customer and is made without additional charge to the customer; or the customer is notified of any proposed change and is provided a reasonable opportunity to cancel the contract without penalty before the change goes into effect.

• If a DCC or DSA is terminated, the bank must refund to the customer any unearned fees paid for the contract unless the contract provides otherwise.

• The bank shall calculate the amount of a refund using a method at least as favorable to the customer as the actuarial method.

• If the bank offers the customer the option to finance the fee for a DCC or DSA, the bank must disclose to the customer whether and, if so, the time period during which, the customer may cancel the agreement and receive a refund.

• A national bank must provide to the customer at the time of the initial solicitation of the DCC or DSA, the short form disclosures described in Appendix A to part 37, as modified to reflect delay of the compliance date for providing the periodic payment option and related changes. The form of the short form disclosures must be readily understandable and meaningful. The short form disclosures also must be included in advertisements and other promotional material for DCCs and DSAs, unless they are of a general nature.

• Before entering into a contract, the bank must obtain a customer's written affirmative election to purchase the DCC or DSA. The written election must be conspicuous, simple, direct, readily understandable, and designed to call attention to its significance.

• A national bank must manage the risks associated with DCCs and DSAs in accordance with safe and sound banking principles.

As a result of today's actions, compliance with the following provisions will not be required, until further notice, when a national bank, in connection with closed-end consumer credit  2 extended by that bank, offers a DCC or DSA through an unaffiliated, non-exclusive agent:

• The requirement to offer a periodic payment option set forth in 12 CFR 37.5.

• The requirement set forth in 12 CFR 37.4(a) that a bank that offers a customer a DCC or DSA without a refund provision also must offer that customer a bona fide option to purchase a comparable DCC or DSA that provides for a refund.

• The long-form disclosure requirement set forth in 12 CFR 37.6.

• The second disclosure set forth in Appendix A to part 37 (Short Form Disclosures), entitled “Lump sum payment of fee,” informing the customer that he or she has the option to pay the fee in a single lump sum or in periodic payments.

• The third disclosure set forth in Appendix A to part 37 (Short Form Disclosures), entitled “Lump sum payment of fee with no refund,” informing the customer that he or she has the option to purchase a DCC or DSA with a refund provision.

• The fifth disclosure set forth in Appendix A to part 37 (Short Form Disclosures), entitled “Additional disclosures,” indicating that the customer will receive additional information before being required to pay for the DCC or DSA. 3

• The requirement to obtain a customer's written acknowledgment of receipt of disclosures set forth at 12 CFR 37.7(a).

The OCC expects that national banks that do not provide long forms disclosures will conspicuously inform customers that they will receive a copy of the contract before they are required to pay for the product.

As we have indicated, the purpose of this delay in the time for compliance is to permit the OCC to consider how best to address compliance issues that arise under the circumstances described in this notice. To aid our review of these issues, we invite comment on the following specific questions, as well as on any other aspect of this notice that commenters wish to address:

1. Please comment on any compliance issues or problems posed by providing the periodic payment option and the associated short and long form disclosures for DCCs or DSAs sold by unaffiliated, non-exclusive agents in connection with closed-end loans.

2. Please explain the types of loan products, e.g. , car loans, where this issue arises.

3. What alternative approaches are available to provide appropriate consumer protections?

4. In the case of closed-end loans, should the requirement in the long form disclosures to disclose the total fee for a DCC paid on a monthly or periodic basis be modified? Is there an alternative, effective way to disclose that information that could be added to the rule?

Public Law 100-656, enacted on November 15, 1988, incorporated into the Small Business Act the previously existing regulation that recipients of Federal contracts set aside for small businesses or SBA's 8(a) Program must provide the product of a small business manufacturer or processor, if the recipient is other than the actual manufacturer or processor. This requirement is commonly referred to as the Nonmanufacturer Rule. The SBA regulations imposing this requirement are found at 13 CFR 121.406 (b). Section 303(h) of the law provides for waiver of this requirement by SBA for any “class of products” for which there are no small business manufacturers or processors in the Federal market.

To be considered available to participate in the Federal market on these classes of products, a small business manufacturer must have submitted a proposal for a contract solicitation or received a contract from the Federal government within the last 24 months. The SBA defines “class of products” based on a six digit North American Industry Classification System (NAICS) and the four digit Product and Service Code established by the Federal Procurement Data System.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 98-12-07, Amendment 39-10563 (63 FR 31340, June 9, 1998), which is applicable to Pratt & Whitney JT8D-1, -1A, -1B, -7, -7A, -7B, -9, -9A, -11, -15, -15A, -17, -17A, -17R, and -17AR turbofan engines was published in the Federal Register on January 24, 2003 (68 FR 3475). That action proposed to require removal and replacement of protective coating of 7th, 8th, 9th, 10th, 11th, and 12th stage HPC disks, initial and repetitive inspections for corrosion pits and cracks, and removal from service as required in accordance with Pratt & Whitney (PW) Alert Service Bulletin (ASB) No. JT8D A6431, dated November 27, 2002. Since the publication of the proposed rule, PW ASB No. JT8D A6431 was reissued as Revision 1 on March 7, 2003.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received.

One commenter states that the effective date of the AD should coincide with the revision of the Standard Practices Manual to incorporate the disk preservation and storage instructions.

The FAA does not agree. The Standard Practice Manual will be updated to incorporate the disk preservation steps specified in PW ASB No. JT8D A6431, Revision 1, dated March 7, 2003; however until that time, the steps specified in the accomplishment instructions, Paragraphs 8.A. through 8.H. of the ASB, are sufficient to properly perform the preservation technique. Therefore, no changes will be made to the AD.

One commenter states that the operational impact on the operators of the proposed requirements is underestimated. The commenter believes that the more stringent inspection requirements on certain 9th stage HPC disks will increase the demand on other 9th stage HPC disks creating industry shortages.

The FAA agrees. The FAA and the original equipment manufacturer (OEM) are aware that the demand for new 9th stage HPC disks will increase because of the more stringent re-inspection requirements imposed on older 9th stage disks. As a result, steps have been initiated at the OEM to meet the increased demand. The FAA expects that the steps the OEM has taken will prevent industry shortages significant enough not to change the economic impact of this AD. Therefore, no changes will be made to the AD.

One commenter states that the costs associated with a new HPC disk are underestimated. The commenter notes that the $7,000 cost of a replacement disk specified in the proposed rule is too low, and that new disk prices range from $11,920 to $23,190.

The FAA does not agree. The FAA believes that it is not necessary to include the full cost of the disk in the economic analysis because the disks must be replaced before reaching their certified life, which would be part of the normal costs of operation. The $7,000 figure is the prorated replacement cost of the disk. This figure is the estimated average residual value of disks lost due to removal before reaching the full certified life of the disk. Therefore, no changes will be made to the AD.

One commenter requests that the AD include a provision to allow spare engines and disks not to accumulate time if placed in a preservation status in accordance with the JT8D Maintenance Manual. The commenter believes that once the engine is installed, then time will accumulate from the installation date, and this will allow the operators to maintain spare equipment and comply with the AD.

The FAA agrees. As the proposed rule is currently worded, an engine or disk does not accumulate time while in storage if preserved in accordance with procedures described in the compliance section of PW ASB No. JT8D A6431, Revision 1, dated March 7, 2003. Paragraphs 1.C. and 1.D of the compliance section of the ASB explain the storage requirements for the full engine and disk piece-parts respectively, and the associated time credits allowed for each storage method. Therefore, no changes will be made to the AD.

After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

This final rule does not have federalism implications, as defined in Executive Order 13132, because it 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. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.

For the reasons discussed above, I certify that this action (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. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

The FAA published this direct final rule with a request for comments in the Federal Register on April 15, 2003 (68 FR 18115). The FAA uses the direct final rulemaking procedure for a non-controversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on August 7, 2003. No adverse comments were received, and thus this notice confirms that this direct final rule will become effective on that date.

The FAA published this direct final rule with a request for comments in the Federal Register on April 23, 2003 (68 FR 19945). The FAA uses the direct final rulemaking procedure for a non-controversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on July 10, 2003. No adverse comments were received, and thus this notice confirms that this direct final rule will become effective on that date.

The FAA published this direct final rule with a request for comments in the Federal Register on April 17, 2003 (Vol. 68, No. 74, FR 18860). The FAA uses the direct final rulemaking procedure for a non-controversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on July 10, 2003. No adverse comments were received, and thus this notice confirms that this direct final rule will become effective on that date.

On May 15, 2003, Docket No. FAA 2002-13362; Airspace Docket No. 02-ASO-7, FR Doc. 03-12049, was published revising seven VOR Federal airways and four jet routes in the vicinity of Savannah, GA. The legal description of Federal Airway V-437 contained an incorrect radial from the Savannah VORTAC. Due to an error in rounding decimal places, the affected radial was published as the “Savannah 053°” radial instead of the correct value which is the “Savannah 054°” radial. This action corrects that error by inserting the correct radial in the legal description.

Accordingly, pursuant to the authority delegated to me, the legal description for V-437 as published in the Federal Register on May 15, 2003 (68 FR 26202); FR Doc. 03-12049, and incorporated by reference in 14 CFR 71.1, is corrected as follows:

The FAA is making some technical or administrative changes to its commercial space transportation regulations. These changes do not affect the substance of the existing regulations, impose no new requirements, and have no impact on activities carried out under the regulations.

The Secretary of Transportation has delegated commercial space licensing authority, which had previously been a function within the Office of the Secretary, to the Federal Aviation Administration. As a result, the address of the Office of Commercial Space Transportation changed. The title of the head of the office changed. Also, the official who designates a legal officer for a regulatory hearing changed. Today's amendments reflect these changes.

The Commercial Space Act of 1998 (Pub. L. 105-303) expanded the jurisdiction of the Office of Commercial Space Transportation. In addition to its previous responsibility, the office now licenses launch of a reusable launch vehicle, operation of a reentry site, and reentry of a reentry vehicle. Previously, the FAA amended the regulations to add parts addressing these areas. The FAA is now amending 14 CFR 413.1 by adding a chart that guides the applicant to the appropriate part.

Under the Administrative Procedure Act (APA), 5 U.S.C. 553, agencies must generally publish regulations for public comment and give the public at least 30 days notice before adopting regulations. There is an exception to these requirements if the agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest. In this case, the FAA finds that notice and comment requirements are unnecessary due to the administrative nature of the changes. The changes do not affect the rights or obligations of any regulated entity. It is in the public interest that the changes take effect promptly.

Coverage regarding unsolicited proposals awarded as grants or cooperative agreements is set out in different sections of NASA's Grant and Cooperative Agreement Handbook. This change consolidates and clarifies that coverage in a new § 1260.17.

NASA certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., because the changes merely consolidates existing guidance.

The Paperwork Reduction Act does not apply because this final rule does not impose any new recordkeeping or information collection requirements, or collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et. seq.

Accordingly, 14 CFR part 1260 is amended as follows:

In the Federal Register of October 21, 1993 (58 FR 54458), FDA published a final monograph for OTC skin protectant astringent drug products in part 347 (21 CFR part 347), subpart A (the 1993 skin protectant final monograph). In the Federal Register of June 4, 2003 (68 FR 33362), FDA published a final rule for OTC skin protectant drug products (the 2003 skin protectant final monograph) and revised the format of part 347. Subpart A was redesignated as “General Provisions,” and the astringent active ingredients (§ 347.10) and labeling (§ 347.50) were redesignated as §§ 347.12 and 347.52, respectively.

Two ingredients (colloidal oatmeal and sodium bicarbonate) added to the skin protectant monograph are used as a soak, compress, or wet dressing similar to the astringent active ingredient aluminum acetate. In the 2003 skin protectant final monograph, the agency included a warning about soaking too long (§ 347.50(c)(7)) and included directions for colloidal oatmeal (§ 347.50(d)(2)) and sodium bicarbonate (§ 347.50(d)(3)) that are shorter than the directions for aluminum acetate (§ 347.52(d)(1)) and that are in the new OTC drug labeling format. In this direct final rule, the agency is adding this warning, shortening the directions for aluminum acetate drug products, and arranging these directions in the new OTC drug labeling format.

Section 201.66(d)(10) (21 CFR 201.66(d)(10)) of the OTC drug labeling rule (64 FR 13254 at 13286, March 17, 1999) establishes a modified labeling format for small packages that need more than 60 percent of their total surface area available to bear labeling to meet the requirements of § 201.66(c)(1) through (c)(9) and (d)(1) through (d)(9). The agency stated in that rule that it would consider additional approaches for accommodating certain products in their respective monographs, taking into consideration the risks and benefits of the drug, the intended use, and the need to communicate limitations or restrictions about the use of the product to the target population (64 FR 13254 at 13270, March 17, 1999). The 2003 skin protectant final monograph included additional labeling exemptions for certain small packages (lip protectant products) that meet the size criteria established in § 201.66(d)(10). The agency determined that lip protectant/lip balm products are typically packaged in small amounts, applied to limited areas of the body, have a high therapeutic index, carry extremely low risk in actual consumer use situations, provide a favorable public health benefit, require no specified dosage limitation, and require few specific warnings and no general warnings (e.g., pregnancy or overdose warnings).

Consequently, the agency is now including additional labeling exemptions for certain small packages of skin protectant astringent drug products (styptic pencils) that meet the criteria established in § 201.66(d)(10), taking into consideration the risks and benefits of the drug, the intended use, and the need to communicate limitations or restrictions about the use of the product to the target population. For the safety profile of styptic pencils, the agency considered the recommendations of the Advisory Review Panel on OTC Miscellaneous External Drug Products (the Panel). The Panel noted that “In 75 years of marketing styptic pencils there have been [no] reported instances of human toxicity” (47 FR 39412 at 39429, September 7, 1982). (The word “no” was inadvertently left out of the September 7, 1982, publication, and the agency corrected this error in its notice of proposed rulemaking for OTC skin protectant astringent drug products (54 FR 13490 at 13493, April 3, 1989).) The Panel also stated that aluminum sulfate (the active ingredient in styptic pencils) “has little, if any, cell permeability and exerts its effect on the cell surface.” The only side effect the Panel noted was that application of the styptic pencil on a cut may result in some stinging. Thus, these products have an extremely low risk in actual consumer use situations, and the monograph only requires two general warnings (§ 347.50(c)(1)) and no ingredient specific warnings.

The agency also considered the factors listed previously that were the basis for labeling modifications for OTC lip protectant/lip balm drug products. Like those products, styptic pencils are packaged in small amounts, have a high therapeutic index and a favorable public health benefit (stop bleeding), would be used infrequently and on very limited areas of the body to stop bleeding of minor cuts from shaving, require minimal warnings (there is no pregnancy warning because this is a topical product), and have no specified dosage limitation (the directions for use are to apply to the affected area). For these reasons, the agency is including specific labeling provisions for certain small packages of skin protectant astringent drug products (styptic pencils) in this direct final rule.

The warning in § 347.50(c)(7), when the colloidal oatmeal or sodium bicarbonate product is labeled for use as a soak, compress, or wet dressing, states: “When using this product [bullet] in some skin conditions, soaking too long may overdry.” The agency is adding this warning in new § 347.52(c)(4) for products containing aluminum acetate when labeled for use as a soak, compress, or wet dressing. Our decision to revise the warning set forth in this direct final rule is based upon a finding that bathing can dry the skin out and exacerbate some conditions (as discussed in the 2003 skin protectant final monograph, 68 FR 33362 at 33367). Mandating a warning does not require a finding that any or all of the astringent drug products actually caused an adverse event, and FDA does not so find. Nor does FDA's mandate of a warning repudiate the OTC drug monograph under which the affected drug products have been lawfully marketed. Rather, as a consumer protection agency, FDA has determined that this revised warning is necessary to ensure that these OTC drug products continue to be safe and effective for their labeled indications under ordinary conditions of use as those terms are defined in the Federal Food, Drug, and Cosmetic Act.

FDA's decision to act in an instance such as this one need not meet the standard of proof required to prevail in a private tort action ( Glastetter v. Novartis Pharmaceuticals, Corp. , 252 F.3d 986, 991 (8th Cir. 2001)). To mandate a warning, or take similar regulatory action, FDA need not show, nor do we allege, actual causation.

The agency is revising the directions in § 347.52(d)(1)(i) for aluminum acetate used as a soak to read: “For use as a soak: [bullet] soak affected area for 15 to 30 minutes as needed, or as directed by a doctor [bullet] repeat 3 times a day or as directed by a doctor [bullet] discard solution after each use”. The agency is revising the directions in § 347.52(d)(1)(ii) for aluminum acetate used as a compress or wet dressing to read: “For use as a compress or wet dressing: [bullet] soak a clean, soft cloth in the solution [bullet] apply cloth loosely to affected area for 15 to 30 minutes [bullet] repeat as needed or as directed by a doctor [bullet] discard solution after each use”. The agency is also shortening the directions in § 347.52(d)(3) for products containing witch hazel to read: “apply as often as needed”.

The agency is adding new § 347.52(e) for products containing aluminum sulfate formulated as a styptic pencil. This section allows products that meet the criteria established in § 201.66(d)(10) to be marketed with reduced labeling.

FDA has determined that the subject of this rulemaking is suitable for a direct final rule. This direct final rule revises several older labeling warnings and directions for OTC skin protectant astringent drug products for consistency with recently issued labeling for OTC skin protectant drug products and updates the labeling to the new OTC drug labeling format. The actions taken should be noncontroversial, and the agency does not anticipate receiving any significant adverse comment on this rule.

If FDA does not receive significant adverse comment by 75 days after the date of publication in the Federal Register , the agency will publish a document in the Federal Register confirming the effective date of the direct final rule. A significant adverse comment is one that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment recommending a rule change in addition to this rule will not be considered a significant adverse comment unless the comment states why this rule would be ineffective without the additional change. If timely significant adverse comments are received, the agency will publish a notice of significant adverse comment in the Federal Register withdrawing this direct final rule.

Elsewhere in this issue of the Federal Register , FDA is publishing a companion proposed rule, identical to the direct final rule, that provides a procedural framework within which the proposed rule may be finalized in the event the direct final rule is withdrawn because of significant adverse comment. The comment period for the direct final rule runs concurrently with that of the companion proposed rule. Any comments received under the companion proposed rule will be treated as comments regarding the direct final rule. Likewise, significant adverse comments submitted to the direct final rule will be considered as comments to the companion proposed rule and the agency will consider such comments in developing a final rule. FDA will not provide additional opportunity for comment on the companion proposed rule.

If a significant adverse comment applies to part of this direct final rule and that part may be severed from the remainder of the rule, FDA may adopt as final those parts of the rule that are not the subject of a significant adverse comment. A full description of FDA's policy on the direct final rule procedures may be found in a guidance document published in the Federal Register of November 21, 1997 (62 FR 62466).

FDA has examined the impacts of the direct final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Under the Regulatory Flexibility Act, if a rule has a significant economic impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of the rule on small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement and economic analysis before proposing any rule that may result in an expenditure in any one year by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation). The rule that led to the development of this direct final rule was published on October 21, 1993, before the Unfunded Mandates Reform Act of 1995 was enacted. The agency explains in this direct final rule that the direct final rule will not result in an expenditure in any one year by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million.

The agency concludes that this direct final rule is consistent with the principles set out in the Executive order and in these two statutes. The direct final rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order. FDA has determined that the direct final rule does not have a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act does not require FDA to prepare a statement of costs and benefits for this final rule, because the final rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation. The current inflation adjusted statutory threshold is about $110 million.

The purpose of this direct final rule is to make some minor labeling revisions in the previously issued astringents portion of the skin protectant drug products monograph to make the labeling consistent with the rest of the monograph and to add small package labeling provisions for aluminum sulfate marketed as a styptic pencil.

Current manufacturers of these products should incur only minor costs to relabel their products to meet the monograph. Some manufacturers will have to add a warning and revise the directions in their labeling. The agency is providing either 24 months from the date of publication of this direct final rule or the date of the first major labeling revision after the 135-day effective date of this direct final rule, whichever occurs first, for the manufacturers to use up existing labeling and print new labeling that incorporates the labeling in this direct final rule. Further, the labeling in the direct final rule is in the new OTC drug labeling format. Therefore, no additional professional skills are needed and manufacturers will not incur expenses determining how to state the product's labeling.

The agency believes that relabeling costs of the type required by this direct final rule generally average about $2,000 to $3,000 per stock keeping unit (SKU) (individual products, packages, and sizes). Assuming that there are about 25 affected OTC SKU's in the marketplace, total one-time costs of relabeling would be $50,000 to $75,000. The agency believes that the actual cost could be lower for the reasons stated in the previous paragraph.

For the reasons stated previously and under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commissioner certifies that this direct final rule will not have a significant economic impact on a substantial number of small entities.

FDA concludes that the labeling requirements in this document are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Rather, the labeling statements are a “public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)).

The agency has determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has analyzed this direct final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies 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. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

Interested persons may submit to the Dockets Management Branch (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or three hard copies of any written comments, except that individuals may submit one hard copy. Comments are to be identified with the docket number found in brackets in the heading of this document and may be accompanied by a supporting memorandum or brief. Received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

The ASCA of 1990 (Title XIX of Pub. L. 101-647) placed anabolic steroids into Schedule III of the CSA (21 U.S.C. 812). Section 1903 of the ASCA provides that the Attorney General may exempt products which contain anabolic steroids from all or any part of the CSA (21 U.S.C. 801 et seq. ) if the products have no significant potential for abuse. The authority to exempt these products was delegated from the Attorney General to the Administrator of the Drug Enforcement Administration (28 CFR 0.1009b), who, in turn, redelegated this authority to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (28 CFR appendix to subpart R, Section 7, paragraph (g)). The procedure for implementing this section of the ASCA is found in § 1308.33 of Title 21 of the Code of Federal Regulations.

In conformance with § 1308.33 of Title 21 of the Code of Federal Regulations, an application was received from Syntho Pharmaceuticals to exempt two of their anabolic steroid products, Syntest H.S. and Syntest D.S. This application was forwarded to the Secretary of Health and Human Services (HHS) for his evaluation. Upon the recommendation of HHS and other relevant information, the DEA published an interim rule and request for comments (68 FR 1964, January 15, 2003) in which the Deputy Assistant Administrator ordered the products to be added to the list of exempt anabolic steroids.

DEA received two comments from interested persons that raised significant issues regarding findings of fact or conclusions of law upon which this order was based. As set forth in 21 CFR 1308.33(d), the Deputy Assistant Administrator hereby immediately suspends the effectiveness of this order until she may reconsider the application in light of the comments and objections filed. Thereafter, the Deputy Assistant Administrator will reinstate, revoke, or amend her original order as she determines appropriate.

The PBGC's regulations prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits of terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions are intended to reflect current conditions in the financial and annuity markets.

Three sets of interest assumptions are prescribed: (1) A set for the valuation of benefits for allocation purposes under section 4044 (found in appendix B to part 4044), (2) a set for the PBGC to use to determine whether a benefit is payable as a lump sum and to determine lump-sum amounts to be paid by the PBGC (found in appendix B to part 4022), and (3) a set for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology (found in appendix C to part 4022).

Accordingly, this amendment (1) adds to appendix B to part 4044 the interest assumptions for valuing benefits for allocation purposes in plans with valuation dates during July 2003, (2) adds to appendix B to part 4022 the interest assumptions for the PBGC to use for its own lump-sum payments in plans with valuation dates during July 2003, and (3) adds to appendix C to part 4022 the interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology for valuation dates during July 2003.

For valuation of benefits for allocation purposes, the interest assumptions that the PBGC will use (set forth in appendix B to part 4044) will be 4.30 percent for the first 20 years following the valuation date and 5.25 percent thereafter. These interest assumptions represent a decrease (from those in effect for June 2003) of 0.40 percent for the first 20 years following the valuation date and are otherwise unchanged.

The interest assumptions that the PBGC will use for its own lump-sum payments (set forth in appendix B to part 4022) will be 3.00 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. These interest assumptions represent a decrease (from those in effect for June 2003) of 0.50 percent for the period during which a benefit is in pay status and are otherwise unchanged.

For private-sector payments, the interest assumptions (set forth in appendix C to part 4022) will be the same as those used by the PBGC for determining and paying lump sums (set forth in appendix B to part 4022).

The PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect, as accurately as possible, current market conditions.

Because of the need to provide immediate guidance for the valuation and payment of benefits in plans with valuation dates during July 2003, the PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

The PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

We did not publish a notice of proposed rulemaking (NRPM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Publishing an NPRM would be impracticable and contrary to the public interest. Publishing an NPRM and delaying the effective date of the rule would adversely affect public safety by delaying the contractor's ability to safely repair the bridge.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

The Sheridan Street Bridge, mile 1070.5 at Hollywood, Broward County, Florida, has a vertical clearance of 22 feet at mean high water and a horizontal clearance of 45 feet between the down span and the fender system. The existing operating regulations in 33 CFR 117.5 require the bridge to open on signal.

On February 28, 2003, PCL Contractors requested that the Coast Guard modify the bridge opening schedule because of safety issues including, but not limited to, welding deck plates and modifying counterweight girders. Specifically, they requested that the bridge open only a single leaf no more than every 20 minutes with double-leaf openings available, during certain periods, with two hours advance notice given to the bridge tender. Double-leaf openings, however, will not be available from June 5 until July 3, 2003, because painting tarps will be in position to catch lead paint. Also, workers will be modifying the bridge's counterweights at that time. The contractor will be working 24 hours a day, seven days a week to complete bridge repairs as quickly as possible. This rule is necessary to ensure worker safety during repairs to the bridge and does not significantly hinder navigation. During this time of year, the majority of vessels that would normally require a double-leaf opening will be traversing the open ocean and not using the Intracoastal Waterway.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). The Coast Guard expects the economic impact of this rule to be so minimal that a full Regulatory Evaluation is unnecessary, because the regulations affect a limited amount of marine traffic and only for certain periods. Most vessels will be able to safely transit through a single span of the bridge, and both spans of the bridge will open with two hours advance notice to the bridge tender, except from June 5 until July 3, 2003.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this temporary rule will not have a significant economic impact on a substantial number of small entities. Most vessels will be able to safely transit through a single span of the bridge, and both spans of the bridge can be opened with two hours advanced notice to the bridge tender, except from June 5 to July 3, 2003.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this temporary rule so that they can better evaluate its effects on them and participate in the rulemaking. If this temporary rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in FOR FURTHER INFORMATION CONTACT.

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (32)(e), of the Instruction, from further environmental documentation. Under figure 2-1, paragraph (32)(e), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:

This document sets forth the VA regulation to exempt from certain provisions of the Privacy Act an additional VA Privacy Act system of records (see, 38 CFR 1.582) by adding a new system of records, “Police and Security Records—VA (103VA07B),” to that VA system of records already exempt under § 1.582.

In a document published in the Federal Register on December 19, 2002 (67 FR 77737), VA proposed to amend VA regulations governing the confidentiality and release of VA records subject to the Privacy Act to exempt certain records from the provisions of the Privacy Act authorized under 5 U.S.C. 552a(j)(2) and (k)(2). This proposal would have allowed VA to exempt a new Privacy Act system of records relating to police and security records. The public comment period ended on February 18, 2003. Since VA did not receive any comments or response on the proposed rule for RIN 2900-AL33, we are now adopting this proposal as a final rule without change.

Under title 5 United States Code (U.S.C.) 552a(j)(2), the head of any agency may exempt any system of records within the agency from certain provisions of the Privacy Act, if the agency or component that maintains the system of records performs as its principal function activities pertaining to the enforcement of criminal laws. The function of the Office of Security and Law Enforcement's Police and Security Service is to provide for the maintenance of law and order and the protection of persons and property on VA property.

The system of records “Police and Security Records—VA (103VA07B)” was created in major part to support the criminal law related activities assigned to the Police and Security Service under the authority of 38 U.S.C. 901. These activities constitute the principal function of this staff. In addition to the principal functions pertaining to the enforcement of criminal laws, the Police and Security Service may receive and investigate complaints or information from various sources concerning the possible existence of activities constituting non-criminal violations of law, rules or regulations or substantial and specific danger to public safety.

Based upon the foregoing, VA exempts this system of records to the extent that it encompasses information pertaining to criminal law related activities from the following provisions of the Privacy Act of 1974, as permitted by 5 U.S.C. 552a(j)(2):

Also, VA exempts this system of records to the extent that it does not encompass information pertaining to criminal law related activities under 5 U.S.C. 552a(j)(2) from the following provisions of the Privacy Act of 1974 as permitted by 5 U.S.C. 552a(k)(2):

The exemption of information and material in this system of records is necessary in order to accomplish the law enforcement functions of the Police and Security Service, to prevent subjects of investigations from frustrating the investigatory process, to prevent the disclosure of investigative techniques, to fulfill commitments made to protect the confidentiality of sources, to maintain access to sources of information and to avoid endangering these sources and Police and Security personnel.

Based on the rationale set forth in the proposed rule, we now adopt the proposed rule as a final rule without change.

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

This document contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).

This document has been reviewed by the Office of Management and Budget under Executive Order 12866.

The Secretary hereby certifies that this rule does not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. The rule applies only to individuals. Accordingly, pursuant to 5 U.S.C. 605(b), this rule is exempt from the initial and final regulatory flexibility analyses requirements of sections 603 and 604.

There is no Catalog of Federal Domestic Assistance number for this final rule.

Throughout this document wherever “we”, “us”, or “our” are used we mean the EPA.

Section 129 of the CAA requires us to develop new source performance standards (NSPS) and emission guidelines (EG) for each category of solid waste incineration units which includes these categories addressed in today's notice: (1) Existing large municipal waste combustion units; (2) existing hospital/medical/infectious waste incinerator units, (3) existing small municipal waste combustion units, and (4) existing commercial and industrial solid waste incinerator units. Such standards shall include emissions limitations and other requirements applicable to new units and guidelines required by section 111(d) of the CAA.

Section 111(d) of the CAA requires states to submit plans to control certain pollutants (designated pollutants) at existing facilities (designated facilities) whenever standards of performance have been established under section 111(b) for new sources of the same type, and EPA has established emission guidelines for such existing sources. A designated pollutant is “any air pollutant, emissions of which are subject to a standard of performance for new stationary sources but for which no air quality criteria has been issued, and which is not included on a list published under section 108(a) or section 112(b)(1)(A) of the CAA.” 40 CFR 60.21(a).

Section 129(b) of the CAA also requires us to develop an EG for each category of existing solid waste incineration units. Under section 129 of the CAA, the EG is not federally enforceable. Section 129(b)(2) requires states to submit State Plans to EPA for approval. State Plans must be at least as protective as the EG, and they become Federally enforceable upon EPA approval.

Emission guidelines and compliance times for large municipal waste combustion units constructed on or before September 20, 1994, were promulgated on December 19, 1995 (60 FR 65387) at 40 CFR part 60, subpart Cb. The Federal plan was promulgated on November 12, 1998 (63 FR 63191) at 40 CFR Part 62, subpart FFF.

Emission guidelines and compliance times for hospital/medical/infectious waste incinerators constructed on or before June 20, 1996, were promulgated on September 17, 1997 (62 FR 48348) at 40 CFR part 60, subpart Ce. The Federal plan was promulgated on August 15, 2000 (65 FR 49868) at 40 CFR Part 62, subpart HHH.

Emission guidelines and compliance standards for small municipal waste combustion units constructed on or before August 30, 1999, were promulgated on December 6, 2000 (65 FR 76350) at 40 CFR part 60, subpart BBBB. The Federal plan was promulgated on January 31, 2003 (68 FR 5144) at 40 CFR part 62, subpart JJJ.

The emission guidelines and compliance times for existing commercial and industrial solid waste incineration units that commenced construction on or before November 30, 1999, were promulgated December 1, 2000 (65 FR 75338) at 40 CFR part 60, subpart DDDD. The Federal plan has not been promulgated as of the date of this notice. EPA proposed approval of the Federal plan on November 25, 2002 (67 FR 70640).

The status of our approvals of State plans for designated facilities (often referred to as “111(d) plans” or “111(d)/129 plans”) is given in separate subparts in 40 CFR part 62, “Approval and Promulgation of State Plans for Designated Facilities and Pollutants.” The Federal plan requirements for existing solid waste incineration units are also codified in separate subparts at the end of part 62.

Procedures and requirements for development and submission of state plans for controlling designated pollutants are given in 40 CFR part 60, “Standards of Performance for New Stationary Sources,” subpart B, “Adoption and Submittal of State Plans for Designated Facilities” and in 40 CFR part 62, subpart A, “General Provisions.” If a State does not have any existing sources of a designated pollutant located within its boundaries, 40 CFR 62.06 provides that the State may submit a letter of certification to that effect, or negative declaration, in lieu of a plan. The negative declaration exempts the state from the requirements of 40 CFR Part 60, subpart B, for that designated facility. In the event that a designated facility is located in a State after a negative declaration has been approved by EPA, 40 CFR 62.13 requires that the Federal plan for the designated facility, as required by section 129 of the CAA and 40 CFR 62.02(g), will automatically apply to the facility.

This Federal Register action approves negative declarations for the following: existing large municipal waste combustion units, existing hospital/medical/infectious waste incinerators, existing small municipal waste combustion units, and existing commercial and industrial solid waste incineration units.

The City of Albuquerque (Bernalillo County) submitted a letter dated September 10, 2002 certifying there are no existing municipal waste combustion units in Bernalillo County on lands under the jurisdiction of the Albuquerque/Bernalillo County Air Quality Control Board subject to 40 CFR part 60, subpart Cb. This negative declaration meets the requirements of 40 CFR 62.06.

The New Mexico Environment Department and the City of Albuquerque (Bernalillo County) have submitted letters certifying that there are no existing hospital/medical/infectious waste incinerators subject to 40 CFR part 62, subpart Ce, under their jurisdictions in the State of New Mexico, and Bernalillo County, New Mexico. These negative declarations meet the requirements of 40 CFR 62.06. The dates that these letters were submitted are identified in the table below.

The Louisiana Department of Environmental Quality, the New Mexico Environment Department, the Oklahoma Department of Environmental Quality, and the City of Albuquerque (Bernalillo County) have submitted letters certifying that there are no existing small municipal waste combustion units under their jurisdictions in their respective States or in Bernalillo County, New Mexico subject to 40 CFR part 60, subpart BBBB. These negative declarations meet the requirements of 40 CFR 62.06. The dates that these letters were submitted are identified in the table below.

The New Mexico Environment Department submitted a letter dated November 13, 2001, certifying that there are no existing commercial and industrial solid waste incinerators subject to 40 CFR part 62, subpart DDDD, under its jurisdiction in the State of New Mexico (excluding tribal lands and Bernalillo County). This negative declaration meet the requirements of 40 CFR 62.06.

We are approving a negative declaration submitted by the City of Albuquerque (Bernalillo County), New Mexico certifying that there are no existing municipal waste combustion units in Bernalillo County on lands under the jurisdiction of the Albuquerque/Bernalillo County Air Quality Control Board subject to 40 CFR part 60, subpart Cb.

We are approving negative declarations submitted by the New Mexico Environment Department and the City of Albuquerque Environmental Health Department certifying that there are no existing hospital/medical/infectious waste incinerators subject to 40 CFR part 60, subpart Ce.

We are also approving negative declarations submitted by the Louisiana Department of Environmental Quality, the New Mexico Environment Department, the Oklahoma Department of Environmental Quality, and the City of Albuquerque Environmental Health Department certifying that there are no existing small municipal waste combustion units subject to 40 CFR part 60, subpart BBBB, within the jurisdictions of the respective State and local agencies.

Finally, we are also approving a negative declaration submitted by the New Mexico Environment Department that there are no existing applicable commercial and industrial solid waste incineration units subject to 40 CFR part 60, subpart DDDD, under its jurisdiction in the State of New Mexico (excluding tribal lands and Bernalillo County).

If a designated facility is later found within any of the noted jurisdictions after publication of this Federal Register action, then the overlooked facility will become subject to the requirements of the Federal plan for that designated facility, including the compliance schedule. The Federal plan will no longer apply if we subsequently receive and approve the 111(d)/129 plan from the jurisdiction with the overlooked facility.

Since the States of Louisiana, New Mexico, and Oklahoma have not submitted a demonstration of authority over “Indian Country,” (as defined in 18 U.S.C. 1151) we are limiting our approval to those areas that do not constitute Indian Country. Under this definition, EPA treats as reservations, trust lands validly set aside for the use of a Tribe even if the trust lands have not been formally designated as a reservation. Any existing designated facility that may exist on “Indian Country” is subject to the Federal plan for the designated facility. See 40 CFR 62.13.

The EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial action and anticipates no adverse comments. However, in the “Proposed Rules” section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve these rules should relevant adverse comments be filed. This action will be effective August 12, 2003 unless EPA receives adverse written comments by July 14, 2003.

If EPA receives such comments, then it will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on August 12, 2003 and no further action will be taken on the proposed rule.

Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to EO 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state and local declarations that rules implementing certain federal standards are unnecessary. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves state and local declarations that rules implementing certain federal standards are unnecessary, it 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).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by EO 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it 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, as specified in EO 13132 (64 FR 43255, August 10, 1999). This action merely approves state and local declarations that rules implementing certain federal standards are unnecessary, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to EO 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing State plan submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a State plan submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a State plan submission, to use VCS in place of a State plan submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. 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 Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 12, 2003. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (See 42 U.S.C. 7607(b)(2)).

You may be potentially affected by this action if you an are agricultural producer, food manufacturer, and pesticide manufacturer Potentially affected entities may include, but are not limited to:

• Crop production (NAICS 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0103. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of February 5, 2003 (68 FR 5880) (FRL-7287-5) and March 5, 2003 (68 FR 10464) (FRL-7291-1) EPA issued notices pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of pesticide petitions (PP1E6268, 1E6254, 1E6237, 1E6225, 0E6203, 2E6403, 2E6406, 2E6409, 2E6417, 2E6421, 2E6435, 2E6414, 2E6458, and 2E6506) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390 and PP 0E6074 Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709. Those notices included summaries of the petitions prepared by Bayer CropScience, the registrant. One comment was received in response to the notice of filing of February 5, 2003, from an individual who requested that information about pesticide tolerances be available in grocery stores next to the food labels.

The petitions requested that 40 CFR 180.472 be amended by establishing tolerances for residues of the insecticide imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]- N -nitro-2-imidazolidinimine, and its metabolites containing the 6-chloropyridinyl moiety, all expressed as imidacloprid in or on the raw agricultural commodities as follows: Bushberry subgroup 13B, lingonberry, juneberry and salal at 3.5 parts per million (ppm) (PP 1E6268), okra at 1.0 ppm (PP 1E6254), watercress at 3.5 ppm (PP 1E6237), artichoke at 2.5 ppm (PP 1E6225), cranberry at 0.05 ppm (PP 0E6203), vegetable, legume, except soybean, group 6 at 4.0 ppm (PP 2E6403), avocado, papaya, star apple, black sapote, mango, sapodilla, canistel, and mamey sapote at 1.0 ppm, and lychee, longan, Spanish lime, rambutan, pulasan and persimmon at 3.0 ppm (PP 2E6406), vegetable, leaves of root and tuber, group 2 at 4.0 ppm (PP 2E6409), strawberry at 0.5 ppm (PP 2E6417), fruit, stone, group 12 at 3.0 ppm (PP 2E6421), guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, and acerola at 1.0 ppm (PP 2E6435), corn, pop, grain at 0.05 ppm and corn, pop, stover at 0.2 ppm (PP 2E6414), mustard seed at 0.05 ppm (PP 2E6458), and vegetable, root and tuber, except sugar beet, group 1, except sugar beet, at 0.4 ppm (PP 2E6506); imported banana at 0.01 ppm (0E6074). The petition for imported banana was subsequently amended to propose a tolerance at 0.02 ppm.

EPA is also deleting several established tolerances in § 180.472(a) and § 180.472(b) that are no longer needed, as a result of this action. The tolerance deletions under § 180.472(b) are time-limited tolerances established under section 18 emergency exemptions that are superceded by the establishment of general tolerances for imidacloprid and its metabolites under § 180.472(a).

The revisions to § 180.472(a) are as follows:

1. Delete bean, edible, podded at 1.0 ppm and bean, succulent, shelled at 1.0 ppm. Replaced with vegetable, legume, group 6, except soybean at 4.0 ppm.

2. Delete dasheen, leaves at 3.5 ppm and turnip greens at 3.5 ppm. Replaced with vegetable, leaves of root and tuber, group 2 at 4.0 ppm.

3. Delete mango at 0.2 ppm. Replaced with mango at 1.0 ppm.

4. Delete potato at 0.3 ppm and vegetable, tuberous and corm, subgroup at 0.3 ppm. Replaced with vegetable, root and tuber, group 1, except sugar beet at 0.4 ppm.

The revisions to § 180.472(b) are as follows:

1. Delete the time-limited tolerance for fruit, stone at 3.0 ppm. Tolerance for fruit, stone, group 12 at 3.0 ppm is established by this action under 180.472(a).

2. Delete the time-limited tolerance for strawberry at 0.1 ppm. Tolerance for strawberry at 0.5 ppm is established by this action under 180.472(a).

3. Delete the time-limited tolerance for turnip, roots at 0.3 ppm. Tolerance for vegetable, root and tuber, group 1, except sugar beet at 0.4 ppm is established by this action under 180.472(a).

4. Delete the time-limited tolerance for turnip, tops at 3.5 ppm. Tolerance for vegetable, leaves of root and tuber, group 2 at 4.0 ppm is established by this action under 180.472(a).

EPA has received objections to a time-limited tolerance it established for residues of imidacloprid on blueberries in connection with an emergency exemption for such use under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq . published in the Federal Register of January 18, 2002 (67 FR 2580)(FRL-6817-6). The objections were filed by the Natural Resources Defense Council (NRDC) and raised several issues regarding aggregate exposure estimates and the additional safety factor for the protection of infants and children. NRDC's objections raise complex legal, scientific, policy, and factual matters and EPA has initiated a public comment period on them in the Federal Register of June 19, 2002 (67 FR 41628) (FRL-7167-7), which ended on October 16, 2002. Although that proceeding remains ongoing, prior to acting on this current tolerance action, EPA reviewed the imidacloprid-specific objections raised by NRDC and has addressed them at relevant points throughout this preamble. Since EPA review of the objections to the time-limited tolerance for blueberry is ongoing, EPA is not establishing the proposed tolerance for blueberry at this time. Individual commodity tolerances for the other members of the bushberry subgroup (currant, elderberry, gooseberry and huckleberry) are established by this action.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that“ there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for tolerances for combined residues of imidacloprid on banana (import) at 0.02 ppm; cranberry; mustard, seed; corn, pop, grain at 0.05 ppm; corn, pop, stover at 0.20 ppm; vegetable, root and tuber, group 1, except sugar beet at 0.40 ppm; strawberry at 0.50 ppm; acerola; avocado; canistel; feijoa; guava; jaboticaba; mango; okra; papaya; passionfruit; sapodilla; sapote, black; sapote, mamey; star apple; starfruit; wax jambu at 1.0 ppm; artichoke, globe at 2.5 ppm; fruit, stone, group 12; lychee; longan; Spanish lime; rambutan; pulasan; persimmon at 3.0 ppm; currant; elderberry; gooseberry; huckleberry; juneberry; lingonberry; salal; watercress at 3.5 ppm; vegetable, leaves of root and tuber, group 2; vegetable, legume, group 6, except soybean at 4.0 ppm.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by imidacloprid are discussed in Table 1 of this unit as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factors (SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.

For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 - 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for imidacloprid used for human risk assessment is shown in Table 2 of this unit:

In its objections to a separate imidacloprid tolerance action, NRDC claims that EPA erred by regulating on the basis of a LOAEL for acute and chronic toxicity. As can be seen from the above table, NRDC is mistaken with regard to use of a LOAEL for estimating the RfD for chronic risk. The acute toxicity endpoint was based upon a LOAEL of 42 mg/kg/day from an acute neurotoxicity study in rats. This value was adjusted with a safety factor of 3X to approximate the value of a NOAEL. EPA has high confidence that this value of 3x is sufficient for several reasons. The effect seen at the LOAEL in the acute neurotoxicity study (decreased motor activity), occurred only in one sex of the rat (females), was characterized as minimal, and may have been a result of the use of the gavage dosing in the study. The decreased motor activity was not replicated following repeated dietary administration (non-gavage) at lower and higher doses (10, 70 or 200 mg/kg/day) in the subchronic neurotoxicity study in the same species (rats). Further, using a safety factor of 3X produces a regulatory endpoint lower than the acute effect levels in other standard studies for determining an acute endpoint, developmental toxicity studies in two species, and in another study that is on occasion used for such a purpose, the developmental neurotoxicity study in rats.

Also in these objections, NRDC claims that EPA failed to calculate residential risks for some scenarios, based on low toxicity (no endpoints were chosen). On October 8, 2002, the Health Effects Division (HED), Hazard Identification Assessment Review Committee (HIARC) reviewed the hazard database for imidacloprid and established additional endpoints. Endpoints were chosen for each of the following exposure scenarios: acute dietary, chronic dietary, short-term oral, intermediate-term oral, short-term dermal, intermediate-term dermal, long-term dermal, short-term inhalation, intermediate-term inhalation, and long-term inhalation. In the current risk assessment (Unit E of this document), EPA calculated short-term residential risks (oral, dermal, and inhalation) for both adults and children for a wide-range of representative scenarios, including applications to lawns, ornamental plantings, indoor and outdoor potted plants, and dogs and cats. Based on current residential use patterns for imidacloprid, EPA expects the duration of exposure to be short-term (1-30 days), and would not result in intermediate or long-term exposure. EPA also conducted human health aggregate risk assessments for the following exposure scenarios: acute aggregate (food + drinking water), short-term aggregate exposure (food + drinking water + residential), and chronic aggregate exposure (food + drinking water).

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.472) for the combined residues of imidacloprid, in or on a variety of raw agricultural commodities. Meat, milk, poultry and egg tolerances have also been established for the combined residues of imidacloprid. In conducting dietary exposure assessments EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID T ) which incorporates food consumption data as reported by respondents in the USDA [1994-1996 and 1998] nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The 1994-96 and 1998 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days. Consumption data are averaged for the entire U.S. population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment. Risk assessments were conducted by EPA to assess dietary exposures from imidacloprid in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA [1994-1996/1998] nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: A Tier 1, deterministic acute dietary exposure assessment was conducted using tolerance-level residues, 100% crop treated (CT) information for registered and proposed commodities; and modified DEEMTM (version 7.76) processing factors for some commodities based on guideline processing studies. EPA estimated exposure based on the 95th percentile value from this deterministic exposure assessment.

In its objections to a separate imidacloprid tolerance action, NRDC asserts that EPA erred by relying on the exposure value for the 95th percentile of the population in estimating exposure. NRDC claims that this approach leaves 5 percent of the population unprotected. These comments by NRDC represent a misunderstanding of EPA's exposure assessments. Although EPA estimated exposure using the 95th percentile, EPA most definitely was not, however, acting in a manner designed to protect only 95 percent of the population. To the contrary, EPA's exposure estimates were designed to reasonably capture the full range of exposures in each population subgroup.

As explained in its science policy paper on this subject, EPA, in estimating exposure for population subgroups, generally considers various population percentiles of exposure between 95 and 99.99, depending on the extent of overestimation in the residue data used in the assessment. In each exposure assessment EPA is attempting to reasonably estimate the full range of exposures in a subgroup. Accordingly, as EPA noted in its policy paper, just as when OPP uses the 95th percentile with non-probabilistic exposure assessments OPP is not suggesting that OPP is leaving 5 percent of the population unprotected, OPP is not by choosing the 99.9th percentile for probabilistic exposure assessments concluding that only 99.9 percent of the population deserves protection. Rather, it is OPP's view that, with probabilistic assessments, the use of the 99.9th percentile generally produces a reasonable high-end exposure such that if that exposure does not exceed the safe level, OPP can conclude there is a reasonable certainty of no harm to the general population and all significant population groups. (Office of Pesticide Programs, EPA, Choosing a Percentile of Acute Dietary Exposure as a Threshold of Regulatory Concern 31 (March 22, 2000)). Importantly, EPA generally uses a population percentile of 95 when EPA relies on worst case residue values - i.e., all crops covered by the tolerance contain residues at the tolerance value. Even at the 95th percentile of estimated exposure, actual exposure, when based on this assumption tends to be significantly overstated. For example, EPA has found that when it uses realistic residue information (e.g., data from monitoring of the food supply), that exposure estimates are generally substantially lower even at the 99.99th percentile.

As noted above, EPA did use the worst case assumption that all food covered by imidacloprid tolerances would bear residues at the tolerance level. Hence, EPA believes its exposure estimate is unlikely to understate exposure; rather, in all likelihood, the estimate probably substantially overstates exposure.

ii. Chronic exposure . The following assumptions were made for the chronic exposure assessments: The chronic dietary exposure assessment was performed using published and proposed tolerance levels, DEEM default processing factors, and percent crop treated information on some commodities.

iii. Cancer . A quantitative cancer aggregate risk assessment was not performed because imidacloprid is not carcinogenic.

Section 408(b)(2)(F) of the FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of percent CT as required by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to submit data on percent CT.

The Agency used CT information as follows:

For the acute assessment, 100% CT was assumed for all registered and proposed commodities. For the chronic assessment, average weighted percent CT information was used for the following commodities: Apple 34%; brussels sprouts 56%; broccoli 35%; cabbage 14%; cantaloupe 31%; cauliflower 52%; collards 10%; corn, field 1%; cotton 3%; cucumber 2%; eggplant 36%; grapefruit 3%; grape 32%; mustard greens16%; honeydew 26%; kale 30%; lemon 1%; lettuce, head 49%; lime 5%; orange 1%; pear 16%; pepper 62%; pumpkin 7%; spinach 15%; squash 7%; sugarbeet 1%; tangerine 9%; tomato 9%; watermelon 6%; wheat 1%. A default value of 1% was used for all commodities which were reported as having < 1% CT.

The Agency believes that the three conditions listed in Unit. III.E. have been met. With respect to Condition 1, percent CT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. EPA uses a weighted average percent CT for chronic dietary exposure estimates. This weighted average percent CT figure is derived by averaging State-level data for a period of up to 10 years, and weighting for the more robust and recent data. A weighted average of the percent CT reasonably represents a person's dietary exposure over a lifetime, and is unlikely to underestimate exposure to an individual because of the fact that pesticide use patterns (both regionally and nationally) tend to change continuously over time, such that an individual is unlikely to be exposed to more than the average percent CT over a lifetime. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which imidacloprid may be applied in a particular area.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for imidacloprid in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of imidacloprid.

The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI-GROW model is used to predict pesticide concentrations in shallow groundwater. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. FIRST and PRZM/EXAMS incorporate an index reservoir environment, and include a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a screen for sorting out pesticides for which it is unlikely that drinking water concentrations would exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to imidacloprid they are further discussed in the aggregate risk sections in Unit.III.E.

Analysis of monitoring data for degradates (ground water only) shows that imidacloprid parent is the dominant residue with imidacloprid urea the most likely degradate. Based on the available information, modeling of total residue results in only modest increases over the exposure estimates with parent alone. Based on the FIRST and SCI-GROW models the estimated environmental concentrations (EECs) of imidacloprid (total residue) for acute exposures are estimated to be 36.04 parts per billion (ppb) for surface water and 2.09 ppb for ground water. The EECs for imidacloprid (parent only) for acute exposures are estimated to be 35.89 parts per billion (ppb) for surface water and 1.43 ppb for ground water. The EECs for imidacloprid (total residue) for chronic exposures are estimated to be 17.24 ppb for surface water and 2.09 ppb for ground water. The EECs for imidacloprid (parent only) for chronic exposures are estimated to be 16.52 ppb for surface water and 1.43 ppb for ground water.

The New York State Department of Environmental Conservation, Division of Solid and Hazardous Materials has submitted extensive water monitoring information from Nassau and Suffolk Counties of New York. Nassau and Suffolk counties have ground water that is exceptionally vulnerable to pesticide contamination and have a long history of a number of pesticides being banned from use in these counties over the years. In general, the kinds of concentrations of imidacloprid (parent only) found in the monitoring/observation and private drinking water wells are in the range expected in highly vulnerable ground water. Imidacloprid has been detected in approximately 20 (including some clusters of wells in the same immediate area) out of about 2,000 public and private water supply and monitoring wells. Imidacloprid was detected in 24 of the approximately 3,500 well samples analyzed for imidacloprid in Nassau and Suffolk Counties. Although detection of imidacloprid in about 20 of 2,000 wells in an area with highly vulnerable ground water does not demonstrate particularly widespread ground water contamination, 3 of 2000 wells in this highly vulnerable ground water have at least one detection greater than the SCI-GROW groundwater screening concentration for imidacloprid (parent only) at 1.43 ppb. The three samples that exceed the SCI-GROW groundwater ECs are reported at 2.06 ppb, 5.98, ppb and 6.69 ppb. Since the surface water model screening levels are greater than the ground water model screening levels and the detection levels reported from the water monitoring from Nassau and Suffolk Counties, New York, the Agency will use the surface water ECs for imidacloprid total residue as a worse case estimate for drinking water in the aggregate risk assessment.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Imidacloprid is currently registered for use on the following residential non-dietary sites: Granular products for application to lawns and ornamental plants; ready-to-use spray for application to flowers, shrubs and house plants; plant spikes for application to indoor and outdoor residential potted plants; ready-to-use potting medium for indoor and outdoor plant containers; liquid concentrate for application to lawns, trees, shrubs and flowers; ready-to-use liquid for directed spot application to cats and dogs. In addition, there are numerous registered products intended for use by commercial applicators to residential sites. These include gel baits for cockroach control; products intended for commercial ornamental, lawn and turf pest control; products for ant control; and products used as preservatives for wood products, building materials, textiles and plastics. As these products are intended for use by commercial applicators only, they are not be addressed in terms of residential pesticide handler. The risk assessment was conducted using the following residential exposure assumptions: EPA has determined that residential handlers are likely to be exposed to imidacloprid residues via dermal and inhalation routes during handling, mixing, loading, and applying activities. Based on the current use patterns, EPA expects duration of exposure to be short-term (1-30 days). EPA does not expect imidacloprid to result in exposure durations that would result in intermediate- or long-term exposure.

The scenarios likely to result in adult dermal and/or inhalation residential handler exposures are as follows:

Dermal and inhalation exposure from using a granular push-type spreader.

Dermal exposure from using potted plant spikes.

Dermal exposure from using a plant potting medium.

Dermal and inhalation exposure from using a garden hose-end sprayer (dermal and inhalation exposure from using a RTU trigger pump spray is expected to be negligible).

Dermal and inhalation exposure from using a water can/bucket for soil drench applications.

Dermal exposure from using pet spot-on.

EPA has also determined that there is potential for short-term (1 to 30 days), post-application exposure to adults and children/toddlers from the many residential uses of imidacloprid. Due to residential application practices and the half-lives observed in the turf transferable residue study, intermediate- and long-term post-application exposures are not expected. The scenarios likely to result in dermal (adult and child/toddler), and incidental non-dietary (child/toddler) short-term post-application exposures are as follows:

Toddler oral hand-to-mouth exposure from contacting treated turf.

Toddler incidental oral ingestion of granules.

Toddler incidental oral ingestion of pesticide-treated soil.

Toddler incidental oral exposure from contacting treated pet.

Toddler dermal exposure from contacting treated turf.

Toddler dermal exposure from hugging treated pet/contacting treated pet.

Adult dermal exposure from contacting treated turf.

Adult golfer dermal exposure from contacting treated turf.

Adolescent golfer dermal exposure from contacting treated turf.

Adult dermal exposure from contacting treated pet]

4. Cumulative effects from substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA does not have, at this time, available data to determine whether imidacloprid has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to imidacloprid and any other substances and imidacloprid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that imidacloprid has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

1. In general . Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity . There is no quantitative or qualitative evidence of increased susceptibility of rat and rabbit fetuses to in utero exposure in developmental studies. There is no quantitative or qualitative evidence of increased susceptibility of rat offspring in the multi-generation reproduction study. There is evidence of increased qualitative susceptibility in the rat developmental neurotoxicity study, but the concern is low since:

i. The effects in pups are well-characterized with a clear NOAEL;

ii. The pup effects occur in the presence of maternal toxicity with the same NOAEL for effects in pups and dams; and,

iii. The doses and endpoints selected for regulatory purposes are protective of the pup effects noted at higher doses in the developmental neurotoxicity study. Therefore, there are no residual uncertainties for pre-/post-natal toxicity in this study.

3. Conclusion . There is a complete toxicity data base for imidacloprid and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X SF to protect infants and children should be reduced to 1X for the following reasons:

The toxicological database is complete for FQPA assessment.

The acute dietary food exposure assessment utilizes existing and proposed tolerance level residues and 100% CT information for all commodities. By using these screening-level assessments, actual exposures/risks will not be underestimated.

The chronic dietary food exposure assessment utilizes existing and proposed tolerance level residues and % CT data verified by the Agency for several existing uses. For all proposed uses, 100% CT is assumed. The chronic assessment is somewhat refined and based on reliable data and will not underestimate exposure/risk.

The dietary drinking water assessment utilizes water concentration values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations which will not likely be exceeded.

The residential handler assessment is based upon the residential standard operating procedures (SOPs) in conjunction with chemical-specific study data in some cases and the Pesticide Handlers Exposure Database (PHED) unit exposures in other cases. The majority of the residential post-application assessment is based upon chemical-specific turf transferrable residue data or other chemical-specific post-application exposure study data. The chemical-specific study data as well as the surrogate study data used are reliable and also are not expected to underestimate risk to adults as well as to children. In a few cases where chemical-specific data were not available, the SOPs were used alone. The residential SOPs are based upon reasonable worst-case assumptions and are not expected to underestimate risk. These assessments of exposure are not likely to underestimate the resulting estimates of risk from exposure to imidacloprid.

In its objections to a separate imidacloprid tolerance action, NRDC argues that in light of the outstanding data requirement for prospective groundwater monitoring studies, EPA should have retained a 10X FQPA factor for imidacloprid. EPA disagrees. Two small- scale prospective ground-water monitoring studies were originally requested by the Agency in 1994. This request predates the development of the Tier 1 ground-water screening model in 1997 and the Food Quality Protection Act of 1996. The field phase of these prospective ground-water monitoring studies commenced in 1996. Results from these studies have now been received and the levels of imidacloprid observed (0.1 ppb) are below the screening concentration of 2.09 ppb calculated on the basis of the SCI-GROW, the Tier 1 ground-water screening model. In any event, as noted above, since higher values are predicted for imidacloprid residues in surface water, these higher values were used in conducting the risk assessment.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water [e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure)]. This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and groundwater are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to imidacloprid will occupy 25% of the aPAD for the U.S. population, 17% of the aPAD for females 13 to 49 years, 54% of the aPAD for infants < 1 year old and 64% of the aPAD for children 1-2 years. In addition, there is potential for acute dietary exposure to imidacloprid in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in Table 3 of this unit:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to imidacloprid from food will utilize 11% of the cPAD for the U.S. population, 26% of the cPAD for infants < 1 year and 35% of the cPAD for children 1-2 years. Based the use pattern, chronic residential exposure to residues of imidacloprid is not expected. In addition, there is potential for chronic dietary exposure to imidacloprid in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 4 of this unit:

3. Short-term risk . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Short-term aggregate risk assessments are needed for adults as there is potential for both dermal and inhalation handler exposure, and dermal post-application exposure from the residential uses of imidacloprid on turf and pets. In addition, short-term aggregate risk assessments are needed for children/toddlers because there is a potential for oral and dermal, post-application exposure resulting from the residential uses of imidacloprid on turf and pets. The pet-treatment scenario resulted in the lowest combined MOE for adults (MOE = 400; handler and post-application) and children (MOE = 260; post-application). The turf-treatment resulted in much lower exposures for both adults (MOE = 15,000; handler and post-application) and children (MOE = 1,500; post-application). Therefore, the pet-treatment exposure estimates were aggregated with the chronic dietary (food) to provide a worst-case estimate of short-term aggregate risk for the U.S. population and children 1-2 years old (the child population subgroup with the highest estimated chronic dietary food exposure).

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 320 for the U.S. population, and 170 for children 1-2 years. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of imidacloprid in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern, as shown in Table 5 of this unit:

4. Aggregate cancer risk for U.S. population . There is no evidence of carcinogenicity to humans based on carcinogenicity studies in male and female rats and mice. The Agency concludes that pesticidal uses of imidacloprid are not likely to pose a cancer risk to humans.

5. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to imidacloprid residues.

Adequate enforcement methods are available for determination of imidacloprid residues of concern in plant (Bayer Gas Chromatography/Mass Spectrometry (GC/MS) Method 00200) and livestock commodities (Bayer GC/MS Method 00191). These methods have undergone successful EPA petition method validations (PMVs), and the registrant has fulfilled the remaining requirements for additional raw data, method validation, independent laboratory validation (ILV), and an acceptable confirmatory method (high performance liquid chromatography/ultraviolet (HPLC/UV) Method 00357). The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

There are no established Codex maximum residue limits (MRLs) for imidacloprid in/on the commodities in the subject petitions. There are currently Canadian and Mexican MRLs for imidacloprid and metabolites containing the 6-chloropicolyl moiety in potatoes at 0.3 ppm. The Mexican and Canadian MRLs are not equivalent to the US-recommended tolerance level. Therefore, harmonization is not possible at this time.

Therefore, the tolerances are established for combined residues of imidacloprid, its metabolites containing the 6-chloropyridinyl moiety, all expressed as the parent, in or on banana (import) at 0.02 ppm; cranberry; mustard, seed; corn, pop, grain at 0.05 ppm; corn, pop, stover at 0.20 ppm; vegetable, root and tuber, group 1, except sugar beet at 0.40 ppm; strawberry at 0.50 ppm; acerola; avocado; canistel; feijoa; guava; jaboticaba; mango; okra; papaya; passionfruit; sapodilla; sapote, black; sapote, mamey; star apple; starfruit; wax jambu at 1.0 ppm; artichoke, globe at 2.5 ppm; fruit, stone, group 12; lychee; longan; Spanish lime; rambutan; pulasan; persimmon at 3.0 ppm; currant; elderberry; gooseberry; huckleberry; juneberry; lingonberry; salal; watercress at 3.5 ppm; vegetable, leaves of root and tuber, group 2; vegetable, legume, group 6, except soybean at 4.0 ppm.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0103 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 12, 2003.

1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA-. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2003-0103, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes a tolerance under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, entitled Federalism (64 FR 43255, August 10, 1999). 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.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 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.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule 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, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

You may be potentially affected by this action if you manufacture (including import), process, or use products that contain living microorganisms subject to jurisdiction under TSCA, especially if you know that your products contain or may contain members of Bcc. Potentially affected entities may include, but are not limited to:

•  Chemical manufacturers (NAICS 325), e.g., Persons manufacturing, importing, or processing products for commercial purposes containing Bcc for biofertilizers; biosensors; biotechnology reagents; commodity or specialty chemical production; energy applications; and other TSCA uses.

•  Waste management and remediation (NAICS 562), e.g., Waste treatment or pollutant degradation.

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the list of substances excluded by TSCA section (3)(2)(B), and the applicability provisions in 40 CFR 725.105(c) for SNUR related obligations. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPPT-2002-0041. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is (202) 566-1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is (202) 566-0280.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/. The OPPTS harmonized test guideline referenced in this document is available at http:/www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated electronic version of 40 CFR part 725 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr725_00.html, a beta site currently under development.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket identification number.

This SNUR will require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of any member of Bcc, a group of naturally occurring microorganisms, for any use other than research and development in the degradation of chemicals via injection into subsurface groundwater.

TSCA section 5(a)(2) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” See also, 40 CFR part 725, subparts L-M. EPA must make this determination by rule after considering all relevant factors, including those listed in section 5(a)(2) of TSCA. Section 5(a)(2) of TSCA lists the following as potentially relevant factors for EPA to consider:

Once EPA promulgates a rule designating “significant new uses” for a given chemical substance, section 5(a)(1)(B) of TSCA requires persons to submit a notice to EPA at least 90 days before they manufacture, import, or process the substance for that use. The mechanism for reporting under this requirement is established under 40 CFR 725.105(c).

EPA has interpreted the TSCA section 3(2) definition of “chemical substance ” as authorizing EPA to regulate microorganisms under TSCA. See the Federal Register of April 11, 1997 (62 FR 17910 and 17913) (FRL-5577-2). Microorganisms that are not intergeneric are implicitly included on the TSCA Inventory, which would include naturally-occurring microorganisms such as Bcc (40 CFR 725.8(b)). Thus, such microorganisms are only subject to TSCA section 5 notification requirements upon promulgation of a SNUR, pursuant to TSCA section 5(a)(2).

General provisions for SNURs appear under subpart L of 40 CFR part 725. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. Persons subject to this SNUR must comply with the same notice requirements and EPA regulatory procedures as submitters of Microbial Commercial Activity Notices (MCANs) or TSCA Experimental Release Applications(TERAs) under section 5(a)(1)(A) of TSCA. In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the conditions necessary to qualify for the exemptions under TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), as codified in the regulations at 40 CFR part 725. In contrast to the provisions of 40 CFR part 721, under 40 CFR part 725, EPA has adopted a narrow interpretation of the TSCA section 5(h)(3) exemption for small quantities used in research. Under 40 CFR 725.3, EPA has defined small quantities solely for research and development as “quantities of a microorganism manufactured, imported, or processed or proposed to be manufactured, imported, or processed solely for research and development that meet the requirements of § 725.234.” Any other research and development activity of a microorganism subject to a SNUR must comply with the section 5(a)(1)(A) notification requirements unless that activity has been excluded from coverage under the SNUR. See 40 CFR 725.3, subparts E and F of 40 CFR part 725, and the Federal Register of April 11, 1997 (62 FR 17921-17926).

Once EPA receives an MCAN or TERA, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities on which it has received the MCAN or TERA. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.

Persons who intend to export a substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707. Persons who intend to import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements, which are codified at 19 CFR 12.118 through 12.127 and 127.28. Such persons must certify that they are in compliance with SNUR requirements. The EPA policy addressing the import certification appears at 40 CFR part 707.

On July 31, 2001, the Cystic Fibrosis Foundation (CFF) submitted a petition under section 21 of TSCA which requested EPA to “establish regulations prohibiting the manufacture, processing, distribution in commerce, use, and improper disposal of bacterial species within the Burkholderia cepacia complex.” On November 6, 2001 (66 FR 56105) (FRL-6808-7), EPA published in the Federal Register a notice denying that petition. EPA also stated in the notice that it intended to issue a SNUR for Bcc. On January 9, 2002 (67 FR 1179) (FRL-6809-2) EPA proposed a SNUR for Bcc, where the significant new use for Bcc was designated as any use other than research and development in the degradation of chemicals via injection into subsurface groundwater. EPA received comments regarding the proposed SNUR only from CFF. EPA's response to those comments is contained in the next paragraph. No one identified any other ongoing commercial uses of Bcc other than those identified by EPA. In addition, no new data were submitted or identified that would change EPA's findings regarding the SNUR for Bcc. Therefore, EPA is issuing the SNUR as proposed. This final rule requires persons who intend to manufacture, import, or process Bcc for any use other than research and development in the degradation of chemicals via injection into subsurface groundwater notify EPA at least 90 days before commencing such activity.

As noted earlier, the only comments submitted on the proposed SNUR were from CFF. CFF did not challenge or object to any of the provisions proposed by the Agency in the proposed SNUR, but instead suggested that the final rule should be expanded beyond what was proposed in two ways. First, CFF stated that EPA should designate as a significant new use all research and development activities that result in potential environmental release of Bcc. Second, CFF stated that EPA should require manufacturers of microoganisms that may contain Bcc to test their products for the presence of Bcc. Leaving aside the fact that these comments go beyond the scope of the proposed SNUR, the changes proposed by CFF are not appropriate for inclusion in a Significant New Use Rule under section 5 of TSCA.

As to CFF's first comment, CFF asks the Agency to require notification even for “research and development in the degradation of chemicals via injection into subsurface groundwater.” In the proposed SNUR, EPA identified “research and development in the degradation of chemicals via injection into subsurface groundwater” as an existing use. CFF did not present any information to suggest that this particular use is not an existing use, or that new research and development activities would be significantly different in kind or quantity than existing activities. Under the circumstances, the Agency continues to believe that the particular research and development activities excluded from the proposed SNUR constitute an ongoing use of Bcc, and therefore do not constitute a “significant new use” for purposes of section 5(a)(2) of TSCA. Only significant new uses may be included in a Significant New Use Rule.

As to CFF's request that the SNUR require manufacturers of microorganisms to test their products to determine whether they contain Bcc. EPA concurs that manufacturers of microorganisms are responsible for knowing whether their products contain Bcc and EPA encourages manufacturers to test their products if they are uncertain whether the products contain Bcc. EPA's regulations exempt “chemical” impurities from SNUR reporting requirements (40 CFR 721.45(d)), but those regulations do not provide a similar exemption for “microorganisms” produced as impurities (see 40 CFR 725.912). When this SNUR becomes a final effective rule, all commercial uses of Bcc, except research and development in the degradation of chemicals via injection into subsurface groundwater, will require notification to EPA at least 90 days before commencing the manufacturing (including import) or processing of Bcc. Any manufacturer, importer, or processor of microorganisms that actually contain Bcc, even if the Bcc is present unintentionally as an impurity, will be required to submit a notification before commencing activities subject to this final SNUR. However, the Agency does not believe that a requirement to test products is appropriate for inclusion in a SNUR under section 5 of TSCA.

If a manufacturer, importer, or processor does decide to test its products, the Agency encourages conformity with OPPTS Product Analysis Test Guideline 885.1100 for product identity. Because identification of members of the Bcc may be difficult due to complexities of the taxonomy of this group, EPA believes it advisable to consult experts in this matter prior to testing. EPA encourages any manufacturer, importer, or processor considering such testing to consult the Agency for further guidance or questions.

In determining what would constitute a significant new use for the microorganisms that are the subject of this SNUR, EPA considered relevant information on the toxicity of the microorganisms, likely exposures associated with potential uses, information provided by industry sources, and the relevant factors listed in TSCA section 5(a)(2) and Unit II.B. Based on these considerations, EPA has determined that all uses other than research and development in the degradation of chemicals via injection into subsurface groundwater, are significant new uses.

EPA's considerations under each of the relevant factors are discussed below:

1. Projected volume of manufacturing and processing of a chemical substance . At present there is little manufacturing and processing of Bcc, so almost all exposure to Bcc today is from its presence in the natural environment. Any new use of Bcc could result in a significant increase in manufacturing and processing of the compound, and of exposure to it. Microorganisms may reproduce and increase beyond the number initially introduced and may spread beyond the site of manufacture or processing. Thus, what begins as a small localized population of microorganisms may become a large widespread population which could contribute to increased exposure potential for Bcc beyond that which occurs naturally. These facts complicate the Agency's ability to project the potential volume and processing of Bcc. However, Bcc is typically found in the environment in soils at a concentration of 10 2 to 10 4 colony forming units (cfu)/g. Manufacture of Bcc would result in production of batches of 10 16 cfu of Bcc. Depending on the type and duration of use these batches could be even larger. (See Reference 16, 67 FR 1185, January 9, 2002 (FRL-6809-2))

2. Extent to which a use changes the type or form of exposure to human beings or the environment to a chemical substance . Currently, human beings are exposed to Bcc because of its presence in soil, where it is found at concentrations significantly lower than might be seen if it is cultivated for commercial use. In addition to the fact that these uses would likely involve much higher concentrations of Bcc than are naturally found in the environment, some of the potential uses identified for Bcc, including bioremediation (degradation of toxic chemicals), degradation of grease in drains, turf management, and specialty chemicals production, could also significantly increase direct dermal and inhalation exposures of Bcc to human beings and release of Bcc to the environment. (See Reference 16, 67 FR 1185, January 9, 2002). This would be especially true for individuals involved directly in or near the manufacturing or application of formulations containing Bcc. These are types and forms of exposures to which human beings and the environment are exposed on a limited basis during field studies of Bcc in the biodegradation of chlorinated solvents in groundwater.

3. Extent to which a use changes the magnitude and duration of exposure to human beings or the environment to a chemical substance . Currently, human beings are exposed to Bcc because of its presence in soil, where it is found at concentrations significantly lower than might be seen if it is cultivated for commercial use. In addition to the fact that these uses would likely involve much higher concentrations of Bcc than are naturally found in the environment, some of the potential uses identified for Bcc, including bioremediation (degradation of toxic chemicals), degradation of grease in drains, turf management, and specialty chemicals production, could also significantly increase direct dermal and inhalation exposures of Bcc to human beings and release of Bcc to the environment. Releases from typical manufacturing could result in releases to surface waters of 10 9 to 10 13 cfu in water and 10 5 cfu in the air. Inhalation exposures of 450 cfu and dermal exposures of 10 11 cfu to exposed workers could also result from typical manufacturing. (See Reference 16, 67 FR 1185, January 9, 2002) Exposures from various uses would be the same or higher depending on the method of application. For example, if spray-applied, the potential for inhalation exposure would be higher due to potential inhalation of mist. All Bcc produced for uses such as bioremediation (degradation of toxic chemicals), degradation of grease in drains, and turf management would eventually be released to the environment. New uses could also significantly increase the duration of exposure. Use in bioremediation for research and development could be limited to a few days/yr. In instances where manufacturing and application of formulations containing Bcc are repeated or continuous this increased level of exposure could occur on a daily basis throughout the year. In addition, repeated or continuous applications of formulations containing Bcc at the same location would increase the likelihood that a small localized population could become a larger and more widespread population. All of these factors would contribute to a change in the magnitude and duration of exposure to which human beings and the environment are not currently exposed.

4. The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance . EPA has not currently identified any general commercial use of Bcc. EPA has identified field studies of Bcc in the biodegradation of chlorinated solvents in groundwater. (See Reference 15, 67 FR 1185, January 9, 2002) EPA expects only limited exposures from the identified field studies of Bcc as only technically qualified individuals are growing and injecting Bcc directly into groundwater. Other potential uses identified for Bcc which include bioremediation (degradation of toxic chemicals), degradation of grease in drains, turf management, and specialty chemicals production, could significantly increase dermal and inhalation exposures of Bcc to human beings as well as releases to the environment. Currently, there are no exposures to human beings and no releases to the environment from these uses. In most cases these exposures would be higher than typically found in nature and more likely to be encountered by a member of a sensitive population.

EPA wants to achieve the following objectives with regard to the significant new uses that are designated in this rule. EPA wants to ensure that:

•  EPA will receive notice of any company's intent to manufacture, import, or process Bcc for a significant new use before that activity begins.

•  EPA will have an opportunity to review and evaluate data submitted in an MCAN or TERA before the notice submitter begins manufacturing, importing, or processing Bcc for a significant new use.

•  EPA would be able to regulate prospective manufacturers, importers, or processors of Bcc before a significant new use occurs, provided such regulation is warranted pursuant to TSCA section 5(e) or section (5)(f).

Before issuing this SNUR, EPA considered the following alternative regulatory actions for Bcc. In addition, EPA determined that Bcc is currently not subject to Federal notification requirements.

1. Promulgate a TSCA section 8(a) reporting rule for Bcc . Under a TSCA section 8(a) rule, EPA could require any person to report information to the Agency when they intend to manufacture or import Bcc. However, the use of TSCA section 8(a) rather than the SNUR authority, would not provide the opportunity for EPA to review human and environmental hazards and exposures associated with the new uses of these substances and, if necessary, to take immediate regulatory action under TSCA section 5(e) or section 5(f) to prohibit or limit the activity before it begins. In addition, EPA may not receive important information from small businesses, because those firms generally are exempt from TSCA section 8(a) reporting requirements. In view of EPA's concerns about Bcc and its interest in having the opportunity to review these substances and regulate them as appropriate, pending the development of exposure and/or hazard information should a significant new use be initiated, the Agency believes that a TSCA section 8(a) rule for Bcc would not meet all of EPA's regulatory objectives.

2. Regulate Bcc under TSCA section 6 . EPA must regulate under TSCA section 6 if there is a reasonable basis to conclude that the manufacture, import, processing, distribution in commerce, use, or disposal of a chemical substance or mixture “presents or will present” an unreasonable risk of injury to human health or the environment. Based on EPA's findings that there is currently no general commercial use of Bcc, EPA concluded that risk management action under TSCA section 6 is not necessary at this time. This SNUR will allow the Agency to address the potential risks associated with any intended significant new use of Bcc.

EPA recognizes that section 5 of TSCA does not require the development of any particular test data before submission of a MCAN or TSCA Experimental Release Application (TERA). Persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 725.160).

However, in view of the potential health risks posed by the significant new uses of Bcc, EPA requests that potential MCAN or TERA submitters include data that would permit a reasoned evaluation of risks posed by Bcc when used for an intended significant new use. EPA also requests that potential MCAN or TERA submitters include data that demonstrate that the bacteria which would be the subject of the MCAN or TERA are in fact in the Bcc. EPA encourages persons to consult with the Agency before submitting an MCAN or TERA for Bcc. As part of this optional pre-notice consultation, EPA will discuss specific data it believes are necessary to evaluate a significant new use of Bcc. EPA urges MCAN or TERA submitters to provide detailed information on human and environmental exposures that would result or could reasonably be anticipated to result from the significant new uses of Bcc. In addition, EPA encourages persons to submit information on risks posed by Bcc compared to risks posed by possible substitutes. An MCAN or TERA submitted without sufficient data to reasonably evaluate risks posed by a significant new use of Bcc may increase the likelihood that EPA will take action under TSCA section 5(e).

EPA believes that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant new use as of the proposal date of the SNUR, rather than as of the effective date of the final rule. If uses begun after publication of the proposed SNUR were considered to be ongoing, rather than new, it would be difficult for EPA to establish notification requirements, because any person could defeat the SNUR by initiating the proposed significant new use before the proposed rule became final, and then argue that the use was ongoing.

Any person who, after publication of the proposed SNUR, began commercial manufacture, import, or processing of Bcc, for the significant new use in this SNUR, must stop such activity before the effective date of the final rule. To resume commercial manufacture, import or processing of Bcc, those persons will have to meet all applicable MCAN or TERA requirements and wait until the notice review period, including all extensions, expires before engaging in any commercial manufacture, import, or processing of Bcc for a significant new use. If, however, persons who began commercial manufacture or import of Bcc for a significant new use between the proposal and the effective date of the final SNUR met the conditions of advance compliance as codified at 40 CFR 725.912, those persons would be considered to have met the requirements of the final SNUR for those activities.

EPA has evaluated the potential costs of establishing a SNUR for potential manufacturers, importers, and processors of Bcc. These potential costs are related to the submission of MCANs, TERAs, and the export notification requirements of TSCA section 12(b). EPA notes that, the costs of submission of MCANs or TERAs will not be incurred by any company unless that company decides to pursue a significant new use as defined in this SNUR. The Agency's economic analysis is available in the public docket for this rule.

Because of uncertainties related to predicting the number of MCANs or TERAs that will be submitted as a result of this SNUR, EPA is unable to calculate the total annual cost of compliance with the final rule. However, EPA estimates that the cost for preparation and submission of an MCAN ranges from approximately $7,582 to $42,736, which includes the $2,500 user fee required by the Agency. EPA notes that small businesses with annual sales of less than $40 million are subject to a reduced user fee of $100. The cost of a TERA is estimated to range from $6,905 to $73,562.

Based on past experience with SNURs and the low number of Significant New Use Notices (SNUNs) which are submitted on an annual basis, EPA believes that there would be few, if any, MCANs or TERAs submitted as a result of this SNUR. Furthermore, no company is required to submit an MCAN or TERA for Bcc unless the company decides to begin manufacture, import, or processing of Bcc for any use other than research and development in the degradation of chemicals via injection into subsurface groundwater. As a result, EPA expects that companies would be able to determine if the burden of submitting an MCAN or TERA would be likely to create significant adverse economic impacts for the company prior to incurring MCAN/TERA-related costs.

As noted in Unit II.C., persons who intend to export a microorganism identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)). These provisions require that a company notify EPA of the first shipment to a particular country of an affected microorganism. The estimated cost of the TSCA section 12(b)(1) export notification, which would be required for the first export to a particular country of a microorganism subject to this rule, is estimated to be $158.35 for the first time that an exporter must comply with TSCA section 12(b)(1) export notification requirements, and $14.43 for each subsequent export notification submitted by that exporter.

EPA is unable to estimate the total number of TSCA section 12(b) notifications that will be received as a result of this SNUR, or the total number of companies that will file these notices. However, EPA expects that the total cost of complying with the export notification provisions of TSCA section 12(b) will be limited based on historical experience with TSCA section 12(b) notifications and the fact that no companies have currently been identified that currently market Bcc commercially. If companies were to manufacture the microorganisms covered by this SNUR for export only, these companies would incur costs associated with export notification even if these companies decided to forgo any domestic significant new use. EPA is not aware of any companies in this situation, and expects that any potential impact would be limited to the small burden of export notification.

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined that SNURs are not a “significant regulatory action” subject to review by OMB, because they do not meet the criteria in section 3(f) of the Executive Order.

According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations, after initial display in the preamble of the final rule and in addition to its display on any related collection instrument, are listed 40 CFR part 9.

The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070-0012 (EPA ICR No. 1188.06). This action does not impose any burden requiring additional OMB approval. If an entity were to submit an MCAN or TERA to the Agency, the annual burden is estimated to average between 98.96 and 118.92 hours per response at an estimated reporting cost between $5,957 and $7,192 per MCAN. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review and submit the required MCAN or TERA. This burden estimate does not include the $2,500 user fee submission of an MCAN ($100 for businesses with less than $40 million in annual sales).

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, OP Regulatory Information Division (2137), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is as follows. A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a “significant new use.” By definition of the word “new,” and based on all information currently available to EPA, it appears that no small or large entities presently engage in such activity. Since a SNUR only requires that any person who intends to engage in such activity in the future must first notify EPA by submitting an MCAN or TERA, no economic impact will even occur until someone decides to engage in those activities. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of over 1000 SNURs, the Agency receives fewer than 10 SNUNs per year. Of those SNUNs submitted, none appear to be from small entities in response to any SNUR. In addition, the estimated reporting cost for submission of an MCAN or TERA (see Unit VIII.A.) are minimal regardless of the size of the firm. Therefore, EPA believes that the potential economic impact of complying with this SNUR is not expected to be significant or adversely impact a substantial number of small entities. This rationale has been provided to the Chief Counsel for Advocacy of the Small Business Administration.

Based on EPA's experience with SNURs, State, local, and tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or tribal government will be impacted by this rulemaking. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action will not have a substantial direct effect on 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, entitled Federalism (64 FR 43255, August 10, 1999).

This rule does not have tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This does not significantly or uniquely affect the communities of Indian tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000), which took effect on January 6, 2001 do not apply to this rule.

This action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

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

In addition, since this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does not apply to this action.

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order.

In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996).

The Congressional Review Act, 5 U.S.C. 801 et seq ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).