On March 9, 2000, the U.S. Department of Agriculture (USDA or we) published a rule in the Federal Register (65 FR 12429) updating the requirements for using vegetable protein products in the Child Nutrition Programs. Among the provisions of that rule, we removed the requirement that the meat/meat alternate component of the food-based menu planning approaches could consist of no more than 30 percent fully hydrated vegetable protein products (of the hydrated soy and meat total).

Subsequent to the publication of the final rule, concerns have been raised about the possibility that blended beef, pork, poultry or seafood products or dishes containing more than 30 percent fully hydrated vegetable protein products (of the hydrated soy and meat total) might be presented as beef, pork, poultry or seafood.

While these blended products and dishes fulfill an essential role in the programs, misrepresentation or misperception of the nature of those products serves neither industry nor program participants well. In addition to the primary mission of providing nutritious meals to school children, the lunch and breakfast programs serve as vehicles for nutrition and consumer education. Children and their parents must be aware of what is in the foods offered in the lunch and breakfast programs if they are to make informed food choices.

Thus, to the extent that school food authorities identify foods in the menu, or on the serving line or through other available means of communicating with program participants, they must identify beef, pork, poultry or seafood products and dishes containing more than 30 percent fully hydrated vegetable protein products (of the hydrated soy and meat total) in a manner which does not characterize the products or dishes solely as beef, pork, poultry or seafood. This interim rule revises 7 CFR 210.10(h) and 220.8 (m) to effect this change.

This interim rule requires school food authorities to advise children and their parents of the use of these blended products and dishes through whatever means they currently use. If a school sends menus home, blended products and dishes must not be portrayed solely as beef, pork, poultry or seafood products or dishes on the menu. If a school uses point of service menu identification, it must not portray blended products and dishes solely as beef, pork, poultry or seafood products or dishes so that students and their parents can make choices that meet their dietary needs.

Commentors will note that the term “vegetable protein product” has been used in the preamble since this term reflects common usage; however, for technical reasons, the term “alternate protein products” is used in the regulatory text. The reasons for this change in terminology are discussed in the preamble to the proposed rule published in the Federal Register (64 FR 38839) on July 20, 1999.

This action is being issued as an interim rule without prior notice or public comment under authority of 5 U.S.C. 553(b)(3)(A) and (B). The Department has determined in accordance with 5 U.S.C. 553(b) that Notice of Proposed Rulemaking and opportunity for public comments prior to issuing this interim rule is unnecessary and contrary to the public interest. The Department believes that program participants should be given the opportunity to make informed menu choices about the foods they eat without undue delay. However, the Department is encouraging interested parties to comment during the public comment period.

This interim rule was determined to be non-significant and is not subject to review by the Office of Management and Budget under Executive Order 12866.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, the Food and Nutrition Service (FNS) generally prepares a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, or tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. When such a statement is needed for a rule, section 205 of the UMRA generally requires FNS to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, more cost-effective or least burdensome alternative that achieves the objectives of the rule.

This interim rule contains no Federal mandates (under regulatory provisions of Title II of the UMRA) for State, local, and tribal governments or the private sector of $100 million or more in any one year. Thus, this interim rule is not subject to the requirements of sections 202 and 205 of the UMRA.

This interim rule was reviewed with regard to the requirements of the Regulatory Flexibility Act (5 U.S.C. 601 through 612). The Administrator of FNS has certified that this rule will not have a significant economic impact on a substantial number of small entities. This rule makes no changes to the National School Lunch and School Breakfast Program meal patterns. However, when certain products are used, this rule would require schools to use existing methods of communication to advise children and their parents of the use of such products.

The National School Lunch Program and the School Breakfast Program are listed in the Catalog of Federal Domestic Assistance under Nos. 10.555 and 10.553, respectively. Each is subject to the provisions of Executive Order 12372 which requires intergovernmental consultation with State and local officials. (7 CFR Part 3015, Subpart V and final rule related notice at 48 FR 29112, June 24, 1983.)

This interim rule was reviewed under Executive Order 12988, Civil Justice Reform. This interim rule is intended to have preemptive effect with respect to any State or local laws, regulations or policies which conflict with its provisions or which would otherwise impede its full implementation. This interim rule is not intended to have retroactive effect unless so specified in the “Dates” section of this preamble. Prior to any judicial challenge to the provisions of this interim rule or the application of the provisions, all applicable administrative procedures must be exhausted. This includes any administrative procedures provided by State or local governments and, for disputes involving procurements by State agencies and sponsors, any administrative appeal procedures to the extent required by 7 CFR Part 3016.

For the National School Lunch Program and School Breakfast Program, the administrative procedures are set forth under the following regulations: (1) School food authority appeals of State agency findings as a result of an administrative review must follow State agency hearing procedures as established pursuant to 7 CFR 210.18(q); (2) school food authority appeals of FNS findings as a result of an administrative review must follow FNS hearing procedures as established pursuant to 7 CFR 210.30(d)(3); and (3) State agency appeals of State Administrative Expense fund sanctions (7 CFR 235.11(b)) must follow FNS Administrative Review Process as established pursuant to 7 CFR 235.11(f).

Sections 210.10(h) and 220.8(m) of this interim rule contain third-party disclosure requirements. In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), USDA has submitted a copy of these sections to the Office of Management and Budget for its review.

Written comments must be received on or before July 10, 2000.

Comments concerning the third-party disclosure of this interim rule should be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Room 3208, New Executive Office Building, Washington, DC 20503, Attention: Manish Desai, Desk Officer for FNS. A copy of these comments may also be sent to Mr. Eadie at the address listed in the ADDRESSES section of this preamble. Commentors are asked to separate their comments on the third-party disclosure aspects from their comments on the remainder of this interim rule.

OMB is required to make a decision concerning the third-party disclosure aspects contained in this interim regulation between 30 and 60 days after the publication of this document in the Federal Register . Therefore, a comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication. This does not affect the deadline for the public to comment to the Department on the interim regulation.

Comments are invited on: (a) Whether the third-party disclosure is necessary for the proper performance of the functions of the agency, including whether the disclosure will have practical utility; (b) the accuracy of the agency's estimate of the burden of the third-party disclosure aspects, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the third-party disclosure; and (d) ways to minimize the burden of the third-party disclosure, including through the use of appropriate automated, electronic, mechanical, or other techniques.

The title, description, and respondent description of the third-party disclosure are shown below with an estimate of the annual burden. Included in the estimate is the time for making the third-party disclosure.

In order to give schools enhanced flexibility in planning menus, we now allow them to offer foods that may consist of up to 100 percent vegetable protein products. This interim rule requires that, to the extent a method (such as a menu) is already in place to communicate what foods are offered, school food authorities identify products or dishes with more than 30 percent vegetable protein products in a manner which does not characterize the products or dishes solely as beef, pork, poultry or seafood products or dishes. This is done in the interest of allowing program participants to make informed decisions about their choices under the school meals programs. Please note that we are only requiring this modification for school food authorities that already provide menus or otherwise communicate with program participants. This could include information provided on serving lines. This interim rule does not require that school food authorities use menus or other methods of communication.

In accordance with the Paperwork Reduction Act of 1995, the Department is providing the public with the opportunity to provide comments on the third-party disclosure aspects of the interim rule as noted below:

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to Allison Engine Company AE 3007A and AE 3007C series turbofan engines was published in the Federal Register on August 17, 1999 (64 FR 44667). That action proposed to require revisions to the Airworthiness Limitations Section in the Allison Engine Company AE 3007A and AE 3007C Engine Manuals to include required enhanced inspection of selected critical life-limited parts at each piece-part exposure. It also proposed to require an air carrier's approved continuous airworthiness maintenance program to incorporate these inspection procedures.

The FAA has deleted the phrase “of this chapter” from the first sentence of paragraph (e) to eliminate confusion.

Interested persons have been afforded an opportunity to participate in the making of this amendment. One commenter supports the rule as written. No comments were received on the FAA's economic analysis. The FAA has determined that air safety and the public interest require the adoption of the rule with the change described previously.

Since the FAA issued the notice of proposed rulemaking (NPRM), the Allison AE3007A and AE3007C engine fleet has increased to 660 engines worldwide, but the U.S. fleet has decreased to 429 engines. The FAA continues to estimate that it will take approximately one work hour per engine to accomplish the required fan inspections and that the average labor rate is $60 per work hour. Assuming every engine underwent an inspection every year, based on these figures the total cost impact of this AD would be $60 per engine per year, for a total annual cost on U.S. operators of $25,740.

This rule does not have federalism implications, as defined in Executive Order 13132, because it does 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 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 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 is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

In the Federal Register of May 12, 1993 (58 FR 28194), the agency published a notice of proposed rulemaking in the form of a tentative final monograph (TFM) for OTC sunscreen drug products. The TFM proposed the conditions under which sunscreen drug products would be considered generally recognized as safe and effective, under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(p)), and not misbranded under section 502 of the act (21 U.S.C. 352).

The TFM proposed labeling for products that claim to protect against UVB radiation and discussed the types of labeling claims that could be used for products that contain UVA-absorbing ingredients. The TFM included a list of proposed sunscreen active ingredients, including ingredients that were believed to have absorption spectra extending into the UVA range.

The TFM proposed a set of testing procedures for measuring a product's sun protection factor (SPF). The SPF value measures the performance of sunscreens that absorb erythema-causing UV radiation, but does not fully describe a product's UVA protection. As the agency acknowledged in the TFM, “currently there is no generally acceptable method for determining a meaningful UVA protection factor that is analogous to the SPF” (58 FR 28194 at 28249).

Following publication of the TFM, the agency continued to work closely with interested parties to develop standardized UVA testing procedures and an accurate, helpful way to present information about UVA protection in product labeling. The agency held a public meeting, on May 12, 1994, to discuss UVA testing procedures. The agency also reopened the administrative record to allow additional submissions on UVA-related issues until July 31, 1994 (59 FR 16042, April 5, 1994).

In the Federal Register of September 16, 1996 (61 FR 48645) and October 22, 1998 (63 FR 56584), the agency amended the TFM to add the UVA-absorbing sunscreen ingredients avobenzone and zinc oxide to the proposed list of monograph ingredients. The agency proposed indications for these ingredients, such as “provides broad spectrum protection” and “provides protection from the UVA rays that may contribute to skin damage and premature aging of the skin” (61 FR 48645 at 48655 and 63 FR 56584 at 56589).

On November 21, 1997, Congress enacted the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA section 129 provided as follows:

Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue regulations for over-the-counter sunscreen products for the prevention or treatment of sunburn.

Section 129 of FDAMA prompted FDA to identify those parts of the TFM for OTC sunscreen drug products that could be finalized within the timeframe set by FDAMA. In late 1997, FDA was still working on the development of testing standards and labeling for UVA radiation protection. As recently as January 27, 1999, the agency held a public meeting to continue developing UVA testing methods and labeling (Ref. 1). Given these outstanding issues, the agency decided to address the FDAMA deadline by finalizing the UVB portions of the monograph (and related provisions on water resistant test methods and cosmetic labeling).

In the Federal Register of May 21, 1999 (64 FR 27666), FDA published a final rule in the form of a final monograph for OTC sunscreen drug products. The monograph included 16 active ingredients, required labeling for products that contain one or more of these active ingredients, a standardized test for measuring SPF values, and standard methods for measuring the water resistant properties of sunscreens. The monograph included modifications to the agency's general OTC drug product labeling rule in § 201.66 (21 CFR 201.66) to accommodate certain sunscreen drug products that are packaged in small containers, are intended to be applied to limited areas of the face, and otherwise meet the factors discussed in the OTC drug product labeling rule for monograph-specific modifications (64 FR 27666 at 27681 to 27682 and 64 FR 13254 at 13270). The monograph did not, however, address active ingredients, labeling, and test methods for products intended to provide UVA protection.

The agency set a 2-year effective date (May 21, 2001) for part 352 and the related nonmonograph conditions in § 310.545(a)(29). The agency also set a 2-year effective date for new § 700.35, which addresses cosmetic products that contain sunscreen active ingredients for nontherapeutic, nonphysiologic uses (e.g., as a color additive or to protect the color of the product). The agency set a 1-year effective date (May 22, 2000) for new § 740.19 (21 CFR 740.19), which addresses a warning statement for cosmetic suntanning preparations that do not contain a sunscreen active ingredient. The extension of the effective date in this document does not apply to § 740.19.

Prior to publication of the sunscreen final rule, a citizen petition (Ref. 2) requested the agency, among other things, to initiate an administrative process for publishing a “comprehensive” sunscreen final monograph that addresses formulation, labeling, and testing for both UVB and UVA radiation protection.

On July 22, 1999, the agency held a public meeting to hear the views of interested parties regarding the sunscreen final monograph (Ref. 3). At the meeting, the petitioner requested that FDA defer the effective date of the final rule until 2 years after it completes a comprehensive final monograph that includes UVA radiation protection. After several subsequent meetings with the agency (Ref. 4), the petitioner proposed that a 19-month extension of the effective date of the sunscreen final monograph would be sufficient time for it to submit the appropriate data to assist FDA in completing a comprehensive final monograph in time for a target December 2002 effective date.

FDA granted the petition in part by agreeing to extend the effective date of the monograph to December 31, 2002, with the expectation that appropriate data would be received within a reasonable timeframe so that a comprehensive UVA-UVB monograph could be issued in advance of that date. Accordingly, the agency is issuing this document to extend the effective date of the sunscreen final monograph for the reasons set forth in its October 1, 1999, response to the citizen petition (Ref. 5). Copies of the petition and the agency's response are on file in the Dockets Management Branch (address above) and are available through a freedom of information request.

The agency has requested at public meetings on January 27, July 22, and October 26, 1999 (Refs. 1, 3, and 6, respectively), and in letters of July 16, and September 2, 1999, and March 20, 2000, to the petitioner (Refs. 7, 8, and 9, respectively), the type of specific data and information that would be helpful for the completion of a comprehensive final monograph for OTC sunscreen drug products. These data and information concerned: (1) Testing and labeling of high SPF products, (2) testing and labeling for UVA radiation protection and, (3) integration of UVA and UVB indications for use and performance statements. To date, the agency has received only a portion of this requested information (Ref. 9). As part of this reopening of the administrative record, the agency is including the above information and any other information submitted to the sunscreen docket related to the completion of a comprehensive UVA-UVB final monograph.

In order to complete a comprehensive final monograph by the target December 31, 2002, effective date, the agency intends to move forward and publish a proposed rule for a comprehensive final monograph, receive comments on that proposal, and issue a final rule by December 31, 2001. That final rule would then have a 1-year effective date of December 31, 2002. Therefore, in order not to delay this process, the agency has determined that all data and information to be considered for the proposed rule must be received by the close of the administrative record as stated in this document. After the administrative record closes on September 6, 2000, the agency will use the information in the administrative record to prepare a proposed rule for a comprehensive final monograph for OTC sunscreen drug products. The agency has determined that 90 days provides industry with a reasonable amount of time to prepare and submit the data requested in this document.

The agency stated in the sunscreen final rule that SPF values above 30 are not supported at this time and that sunscreen drug products with SPF values above 30 should be limited to one collective term, i.e., SPF 30 “plus” or “+” (64 FR 27666 at 27675). While the agency believes that the sunscreen final monograph test procedures for measuring SPF values up to 30 represent a straightforward, well-understood, and sound method for measuring these values, a number of comments submitted in response to the May 12, 1993, tentative final monograph for OTC sunscreen drug products (58 FR 28194) questioned the ability of current testing methods to accurately and reproducibly determine SPF values for high SPF (i.e., above SPF 30) sunscreen drug products (64 FR 27666 at 27680).

Most of the comments' concerns related to potential interlaboratory variation when utilizing SPF test methodology. Primary concerns included the potential for overestimation of high SPF values due to the spectra of currently used solar simulators and the need for one or more high SPF standard sunscreens (i.e., as laboratory controls). Long radiation exposures necessitated by SPF values well above 30 and the use of a relatively low SPF laboratory control may significantly increase the potential for decreased interlaboratory accuracy and reproducibility for high SPF sunscreen drug products. The agency invited interested persons to continue developing the test methods needed to measure high SPF values and to provide FDA data to support such methods. The agency is currently evaluating data and information subsequently received from two comments (Refs. 10 and 11) concerning this issue.

In the final rule, the agency discussed the difficulty in explaining the nonlinearity (i.e., percent reduction in erythemogenic UV radiation) of the SPF rating system in the limited space on a product label (64 FR 27666 at 27675). The agency also invited interested persons to consider proposed methods for communicating in labeling the level of protection associated with high SPF values. To date, the agency has not received any proposals relative to the labeling of sunscreens with high SPF values.

After review of the comments concerning the adequacy of current testing procedures for determining high SPF numbers, the agency has identified eight areas in which it seeks additional data and information. The agency is requesting further comment in these areas to provide interested parties the opportunity to submit data and information to address these issues. It is not necessary to resubmit data and information previously provided to the agency. A cross-reference to an earlier submission will be sufficient.

The agency has received several comments, including a recent citizen petition (Ref. 10), suggesting the adoption of a spectral power distribution that specifies the proportion of erythema-effective radiation in a table format. The comments suggested that the spectra of currently used solar simulators (especially around 290 nanometers (nm) and above 350 nm) could cause overestimation of SPF values for high SPF sunscreens. Because shorter wavelengths can make a very large contribution to erythema, the comments stated that small errors in the 290 nm region of solar simulator spectra could have considerable effects. In addition, the comments noted that spectral power deficiencies above 350 nm may give artificially high SPF values for sunscreen drug products that absorb poorly in the long wavelength UVA region. The comments suggested that the agency replace the specifications in § 352.71 of the sunscreen monograph that state “sun at a zenith angle of 10 1/2 ” and “less than 1 percent shorter than 290 nm” with the European Cosmetic, Toiletry, and Perfumery Association (COLIPA) table of “percent erythemal contribution” (Ref. 10) as the spectral power distribution standard for the light source used in the SPF test procedures.

The agency is requesting comment on whether the solar simulator spectral distribution specifications contained in the COLIPA standard are appropriate for use in SPF testing procedures. The agency would also like comment on a potential modification of the standard that would modify the erythema-effective radiation contribution of wavelengths below 290 nm to less than 0.1 percent (to prevent overestimation of SPF values). The agency believes that this specification is readily obtainable with commercially available cut-off filters. In addition, the agency is interested in comment concerning the practicality of lowering the below-290 nm specification to 0.01 percent. Therefore, a solar simulator using the following modification of the COLIPA standard for determining the SPF of a sunscreen drug product would be filtered so that it provides a continuous emission spectrum from 290 to 400 nm with the following percentage of erythema-effective radiation in each specified range of wavelengths:

The testing of high SPF sunscreen drug products necessitates longer exposure times than testing of lower SPF values. Such increases in irradiance levels have the potential to produce thermal overloading of the skin and influence the UV radiation dose reciprocity relationship (and therefore SPF values). The comments suggested that limits such as 1,250 to 1,500 watts/meter 2 be placed on the total irradiance delivered to the skin for all wavelengths. Several comments, including a recent citizen petition (Ref. 10), also suggested that the “out of band” specification in § 352.71 of the sunscreen monograph (i.e., that not more than 5 percent of a solar simulator's total energy output can be contributed by wavelengths longer than 400 nm) is not obtainable from many devices currently utilized for evaluating sunscreens.

The agency considers it important to limit total energy delivered to the skin so that skin temperature does not reach a point that influences the UV dose reciprocity relationship when encountering the long exposure times necessary to test high SPF sunscreen drug products. The agency is requesting comment on whether replacing the “out of band” specifications in § 352.71 with a limit on total solar simulator irradiance for all wavelengths may be an appropriate modification of current testing procedures that will improve the testing of high SPF sunscreens. In addition, the agency is also requesting comment on an appropriate irradiance limit for this modification.

The agency received several comments suggesting that standard sunscreens (i.e., controls) with SPF values of 15 or higher be developed for testing high SPF sunscreen drug products. Studies submitted by the comments tend to support the conclusion that a specific control(s) may be needed to accurately test high SPF sunscreen drug products. However, these studies lacked sufficient numbers of subjects, did not address suitability of a standard across different laboratories, and did not document the following properties required in a standard sunscreen: (1) Low level of interlaboratory variation, (2) sensitivity to experimental error, and (3) ease of preparation with a reasonable degree of accuracy.

One comment supplied “round-robin,” collaborative SPF testing data from 7 laboratories on 153 subjects, with 2 possible SPF 15 standard sunscreens, “Formulation A” and “Formulation B” (Refs. 12 and 13). The agency believes that the data could support “Formulation B” as an appropriate SPF 15 standard sunscreen if additional information is submitted and found acceptable. Because the formulation was supplied to all laboratories by a single source, there are no data to demonstrate that multiple laboratories can prepare, assay, and utilize the standard successfully. Further, the standards were not analyzed by the spectrophotometric method in § 352.70(c) of the sunscreen monograph, but rather by an alternate proposed method (see section IV.D of this document). The agency is requesting the submission of the additional data necessary to document the suitability of Formulation “B” and the analytical method.

In addition, the agency is requesting comment and any supporting data and information concerning the need for additional standard sunscreens (with SPF values higher than 15) as well as the use of specific standard sunscreens for specific ranges of SPF values (i.e., bracketing).

As discussed in section IV.C of this document, data supplied in support of an SPF 15 standard sunscreen preparation included the use of an HPLC assay instead of the spectrophotometric assay in § 352.70(c). The comment suggested that the HPLC protocol is now commonly used by analytical laboratories for the assay of sunscreen formulations (and that it can also be used for the homosalate standard sunscreen). The agency invites specific comment and data from analytical laboratories as to which assay method they use and why they use that particular method.

Before the agency can evaluate the HPLC method supplied with the SPF 15 standard sunscreen data, method validation data are necessary. The agency is requesting a validation package that documents specificity, accuracy, limit of detection, linearity, precision, and reproducibility of the method. The agency is especially concerned that the presence of any impurities (particularly UV radiation-absorbing impurities) in the standard sunscreen and product formulations can be detected by the HPLC method, because interfering substances could affect the SPF determination. The validation package should include chromatograms and demonstrate that the HPLC method is suitable for both the SPF 4 (homosalate) and SPF 15 standards (or other standard sunscreens, if appropriate). The chemistry guideline entitled “Reviewer Guidance, Validation of Chromatographic Methods” explains these requirements in greater detail and is available on the agency's Internet website for the Center for Drug Evaluation and Research (CDER) (http://www.fda.gov/cder/guidance/index.htm), or may be obtained from the Drug Information Branch (HFD-211), CDER, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573.

Several comments suggested that the “limitation” of 20 to 25 subjects in the SPF test in § 352.72(g) may be an issue for sunscreen drug products with high SPF values due to potential for high variability in the responses obtained. The comments indicated that more than 20 to 25 subjects may be necessary. The agency is requesting data and information on the testing of SPF values over 30 in relation to this issue and suggestions for an appropriate number of test subjects to be used in such testing.

Determination of the minimal erythemal dose on protected skin (MED(PS)) is described in § 352.73(c) of the SPF testing procedures as follows:

* * * A series of seven exposures shall be administered to the protected test sites to determine the MED of the protected skin (MED(PS)). The doses selected shall consist of a geometric series of five exposures, where the middle exposure is placed to yield the expected SPF plus two other exposures placed symmetrically around the middle exposure. * * *

The agency proposed this format in the tentative final monograph (58 FR 28194 at 28269 to 28272), in the context of SPF values up to 30, because of its concern that a widely-spaced geometric progression offers less accuracy and precision in the upper SPF ranges and may produce overestimation of the true SPF. Exposure dose intervals in the above geometric series decrease as expected SPF values increase.

The agency is requesting comment and any supporting data and information concerning the adequacy of the current exposure dose format in the testing of sunscreen drug products claiming to have SPF values over 30.

In the sunscreen final rule (64 FR 27666 at 27675), the agency stated that the nonlinearity (i.e., percent reduction in erythemogenic UV radiation) of the SPF rating system is a concept difficult to explain in the limited space on a product label. The agency noted the relatively small difference in additional sunburn protection for most people provided by SPF 30 and SPF 50 sunscreens in terms of their absorption of erythemal UV radiation. The agency has a continuing concern about consumers' perception and understanding of the difference in screening abilities between, for example, an SPF 4 and SPF 15 as opposed to an SPF 30 and SPF 50.

The agency is concerned that an average sunscreen consumer may ascribe more to high SPF values than is clinically relevant and that such products may further encourage the use of sunscreens as a safe way to prolong sun exposure. The concept of increasing SPF values has been described in the context of increasing the time for which a person could be exposed to the sun without burning. While such a description may be true, it omits essential information about skin cancers and photoaging that may occur from different (i.e., nonerythemogenic) wavelengths and/or at suberythemal doses of UV radiation in the erythemogenic wavelength region. Sunscreen use alone will not prevent all of the possible harmful effects of the sun for all consumers, even with the use of high SPF sunscreen drug products. Variation between individuals, UV radiation absorption and substantivity of sunscreen drug products, exposure conditions, and conditions of use (e.g., inadequate application/reapplication) preclude a precise result for each individual. Sunscreens are part of a sun protection program in which it is clear that the goal is to limit sun exposure even with the use of a sunscreen. Without adequate labeling, high SPF numbers may dilute the desired public health message. In addition, previously submitted labeling comprehension data, which were discussed at a public meeting (Ref. 14), indicated a fair amount of confusion concerning consumer comprehension of the SPF rating system.

The agency is requesting comment on any proposed methods for meaningfully communicating in product labeling the level of sun protection associated with high SPF sunscreen drug products. In addition to this information, the agency is also requesting comment relative to the use of professional labeling (and what that labeling might state) specifically to provide high SPF value information to health professionals.

The agency is aware that the testing of sunscreen drug products with high SPF values necessitates the use of longer ultraviolet radiation exposure times. Such exposures can result in test subjects remaining in front of the light source for several hours, especially when a standard sunscreen and water resistance test are also included (Ref. 11).

Considering the generally available SPF test equipment currently used in testing laboratories, the agency is requesting comment on the practical human limitations of the test relative to high SPF values. Is the determination of an SPF value routinely practicable for SPF values of, for example, 60 or higher? What total exposure times would be involved at such SPF levels? What is the practical limit in terms of the SPF value?

In its October 1, 1999, citizen petition response (Ref. 5), the agency set forth in detail its finding that a stay of the effective date for the sunscreen final monograph, until December 31, 2002, would be in the public interest. Since the agency is extending the effective date of the sunscreen final monograph based on the citizen petition response, it finds, for good cause, that this extension of the effective date of the final monograph does not require further notice and comment procedures (5 U.S.C. 553(b)). More than 6 months have passed since the agency issued the petition response and the agency has received no adverse correspondence or comments with respect to its decision. Therefore, the agency is now extending the effective date of the final rule. However, in accordance with 21 CFR 10.40(e)(1), the agency will accept comment on this extension for a period of 90 days.

The economic impact of the final monograph was discussed in the final rule (64 FR 27666 at 27683). This extension of the effective date provides additional time for companies to relabel, retest, and reformulate affected products and will reduce label obsolescence, as there will be additional time to use up more existing labeling. This extension will also eliminate a second relabeling of sunscreen drug products when UVA labeling is included in the monograph. Thus, extending the effective date of the final rule until December 31, 2002, and the compliance date for products with annual sales less than $25,000 to December 31, 2003, will significantly reduce the economic impact on industry.

FDA has examined the impacts of this final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq .). 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 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 purpose of the final rule is to reopen the administrative record and to extend the effective date which will provide manufacturers additional time to use up existing product labeling. The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive Order. In addition, the 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.

Under the Unfunded Mandates Reform Act, FDA is not required to prepare a statement of costs and benefits for this final rule because this final rule is not expected to result in any one-year expenditure that would exceed $100 million adjusted for inflation.

The agency also certifies that this final rule will not have a significant economic impact on a substantial number of small entities. Therefore, under the Regulatory Flexibility Act, no further analysis is required.

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.

The following references are on display in Docket No. 78N-0038 in the Dockets Management Branch (address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Comment No. MM16.

2. Comment No. CP11.

3. Comment No. MM21.

4. Comment No. MM17, MM18, and MM19.

5. Comment No. PAV2.

6. Comment No. MM22.

7. Comment No. LET168.

8. Comment No. ANS6.

9. Comment No. Let170

10. Comment No. CP12.

11. Comment No. C557

12. Comment No. C111 and RPT7.

13. Letter from T. J. Donegan, The Cosmetic, Toiletry, and Fragrance Association, to J. D. Lipnicki, FDA, in OTC Vol. 06FREXT.

14. Comment No. MM14.

Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 310 is amended as follows:

The act (21 U.S.C. 301 et seq .), as amended by the 1976 amendments (Public Law 94-295), the SMDA (Public Law 101-629), and the FDAMA (Public Law 105-115), established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under section 513 of the act, devices that were in commercial distribution before May 28, 1976 (the date of enactment of the 1976 amendments), generally referred to as preamendments devices, are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

Devices that were not in commercial distribution prior to May 28, 1976, generally referred to as postamendments devices, are classified automatically by statute (section 513(f) of the act (21 U.S.C. 360c(f))) into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval, unless and until: (1) The device is reclassified into class I or II; (2) FDA issues an order classifying the device into class I or II in accordance with new section 513(f)(2) of the act, as amended by the FDAMA; or (3) FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously offered devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations.

A preamendments device that has been classified into class III may be marketed, by means of premarket notification procedures, without submission of a premarket approval application (PMA) until FDA issues a final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) requiring premarket approval.

Consistent with the act and the regulations, FDA consulted with the General Hospital and Personal Use Devices Panel (the Panel), an FDA advisory committee, regarding the classification of these devices.

The FDAMA added a new section 510(l) to the act. New section 510(l) of the act provides that a class I device is exempt from the premarket notification requirements under section 510(k) of the act, unless the device is intended for a use which is of substantial importance in preventing impairment of human health or it presents a potential unreasonable risk of illness or injury. Hereafter, these are referred to as “reserved criteria.” FDA has considered the general purpose disinfectants in accordance with the reserved criteria and determined that these devices do not require premarket notification. Such an exemption permits manufacturers to introduce into commercial distribution generic types of devices without first submitting a premarket notification to FDA.

In the Federal Register of November 6, 1998 (63 FR 59917), FDA proposed to classify both liquid chemical sterilants intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use into class II and general purpose disinfectants intended to process noncritical medical devices and equipment surfaces into class I. In the same issue of the Federal Register , FDA proposed to exempt the general purpose disinfectants from the premarket notification requirements. FDA recognizes a “high level disinfectant” as a potential separate or subordinate condition of use of a sterilant and has included it in the final rule to clarify its classification status. Initially, interested persons were given until February 4, 1999, to comment on the proposed regulation. Subsequently, FDA extended the comment period to March 8, 1999, in response to an extension request.

FDA received one comment on the proposed rule from a non-profit trade association.

As required by 21 CFR 860.84(g)(1) of the regulations, FDA is classifying liquid chemical sterilants/high level disinfectants into class II with the following special controls: The 510(k) guidance document (Ref. 1) and user information and training. FDA is also classifying general purpose disinfectants into class I and exempting these devices from premarket notification.

Persons interested in obtaining a copy of the guidance (Ref. 1) may do so using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with access to the Internet. The CDRH home page may be accessed at http://www.fda.gov/cdrh. “Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants” available at http://www.fda.gov/cdrh/ode/397.pdf.

The one comment FDA received requested that general purpose disinfectants, in addition to being exempt from the premarket notification procedures, also be exempt from the good manufacturing practice (GMP) requirements set forth in the Quality System Regulation (21 CFR part 820). The comment stated that general purpose disinfectants should be exempt from the GMP requirements because the Environmental Protection Agency (EPA) and state controls on them are sufficient to assure their quality for commercial distribution.

FDA disagrees with the comment. The agency recognizes the dual regulatory functions and responsibilities of the FDA and EPA, but the functions and responsibilities of these agencies address different aspects of the product. Because of the continued classification of the general purpose disinfectants as a medical device, they remain subject to the GMP requirements of the act.

General purpose disinfectants are also regulated by EPA as environmental pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The EPA controls (EPA product registration, Good Laboratory Practices, State registration and testing, maintenance of records, and EPA establishment registration) focus on the quality and integrity of pesticide data. Although some States have programs regulating the sale and use of general purpose disinfectants as pesticides, not all States have adopted the same enforcement programs. This lack of uniformity does not provide the additional safeguard needed for the national use of these products for disinfection of medical devices.

Therefore, under section 513 of the act, FDA is adopting the summary of reasons for the Panel's recommendation and the summary of data upon which the Panel's recommendation is based, in their entirety. FDA also agrees with the assessment of the risks to public health stated in the proposed rule published on November 6, 1998. FDA is issuing this final rule, which classifies these generic types of devices as follows: Liquid chemical sterilants/high level disinfectants into class II and general purpose disinfectants into class I.

The following reference has been placed on display in the Dockets Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. FDA, Center for Devices and Radiological Health, Office of Device Evaluation, “Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants,” January 3, 2000.

The agency has determined under 21 CFR 25.34(b) 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 examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended by subtitle D of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), 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). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive Order. In addition, the 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.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. The classification of these devices formalizes the current process for the class I and II devices. For the class I devices, FDA is not adding any additional burden, because they are effectively regulated as class I devices now. For the class II devices, they are in compliance with the guidance. The agency therefore certifies that this final rule will not have a significant economic impact on a substantial number of small entities. In addition, this final rule will not impose costs of $100 million or more on either the private sector or State, local, and tribal governments in the aggregate and, therefore a summary statement or analysis under section 202(a) of the Unfunded Mandates Reform Act of 1995 is not required.

FDA concludes that this final rule contains no information that is subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995. The special controls do not require the respondent to submit additional information to the public.

Temporary regulations (TD 8740) relating to the safe harbor deposit rule based on look-back quarter liability and to floor stock taxes were published in the Federal Register on December 29, 1997 (62 FR 67568) along with a notice of proposed rulemaking (REG-102894-97) cross-referencing the temporary regulations (62 FR 67589). Written comments and requests for a public hearing were solicited. However, no comments or requests were received and no public hearing was held.

The proposed regulations are adopted without revision by this Treasury decision.

The following publication is obsolete as of June 8, 2000:

Notice 97-15, 1997-1 C.B. 387.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations and, because these regulations do not impose on small entities a collection of information requirement, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Therefore, a Regulatory Flexibility Analysis is not required. Pursuant to section 7805(f) of the Internal Revenue Code, the notice of proposed rulemaking was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

The principal author of these regulations is Susan Athy, Office of Assistant Chief Counsel (Passthroughs and Special Industries). However, other personnel from the IRS and Treasury Department participated in their development.

The EEOC is rescinding several sentences of the Interpretive Guidance on Title I of the Americans with Disabilities Act, found in the Appendix to 29 CFR 1630.2(h) and (j), that address mitigating measures used by persons with impairments. The guidance set forth in those sentences is no longer valid in light of the Supreme Court's rulings in Sutton v. United Airlines, Inc., 527 U.S. __(1999), and Murphy v. United Parcel Service, Inc., 527 U.S.—(1999). In those cases, the Supreme Court held that the determination of whether an individual has an impairment that substantially limits a major life activity under the ADA must be made by considering any mitigating measures (such as medications or assistive devices) that the individual uses to eliminate or reduce the effects of an impairment.

In accordance with the Regulatory Flexibility Act (Public Law 96-354, as amended by Public Law 104-121), the Commission has reviewed this regulation, and by approving it, certifies under 5 U.S.C. 605(b) that this regulation will not have a significant economic impact on a substantial number of small entities.

This rule is not a significant regulatory action as defined in Executive Order 12866 and is therefore not subject to review by the Office of Management and Budget.

The final regulations that are the subject of these corrections supersede 30 CFR 250, subpart A, General, regulations on the effective date and affect all operators and lessees on the Outer Continental Shelf.

The published final regulations contained a complete listing of all of the documents MMS has incorporated by reference in the 30 CFR part 250 regulations. The rulemaking also included revisions and reaffirmations of several documents. The table of documents incorporated by reference in § 250.198(e) of the published final rule contained an error, which we are correcting.

As published, the final regulations contain an error which may prove to be misleading and is in need of clarification.

On May 20, 1982, the Secretary of the Interior conditionally approved the Alabama program. You can find background information on the Alabama program, including the Secretary's findings, the disposition of comments, and the conditions of approval in the May 20, 1982, Federal Register (47 FR 22062). You can find later actions concerning the Alabama program and previous amendments at 30 CFR 901.15, 901.16, and 901.17.

By letter dated August 17, 1999 (Administrative Record No. AL-0589), Alabama submitted an amendment to its approved permanent regulatory program according to the Federal regulations at 30 CFR 732.17(b). Alabama sent the amendment at its own initiative.

We announced the proposed rulemaking in the September 7, 1999, Federal Register (64 FR 48573). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the amendment. The public comment period closed on October 7, 1999. We held a public hearing in Birmingham, Alabama, on October 4, 1999. We reopened the public comment period in the October 15, 1999, Federal Register (64 FR 55878) in order to allow the public additional time to submit comments. The public comment period closed on November 1, 1999.

During our review of the amendment, we identified concerns regarding section 9-16-91(f) of ASMCRA, remedies for subsidence damage and subsidence damage agreements. We notified Alabama of these concerns by letter dated February 3, 2000 (Administrative Record No. AL-0627). By letter dated February 15, 2000, and May 3, 2000 (Administrative Record Nos. AL-0629 and AL-0634, respectively), Alabama sent us additional explanatory information. Because the explanatory information did not make any change to Alabama's amendment regarding remedies for subsidence damage and subsidence damage agreements, we did not reopen the public comment period.

Below, in accordance with SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17, are the Director's findings concerning the amendment on the Alabama permanent regulatory program. Any revisions that we do not discuss below are about minor wording changes, or revised cross-references and paragraph notations to reflect organizational changes resulting from this amendment.

A. Alabama proposed to revise section 9-16-91(e)(1) of ASMCRA to read as follows:

The above proposed revision involves minor wording changes to this previously approved statute and it does not change its meaning. Therefore, we are approving the revision because it is no less stringent than the Federal statute at section 720(a)(1) of SMCRA.

B. Alabama proposed to add new section 9-16-91(e)(3) of ASMCRA to read as follows:

We do not have a counterpart Federal statute in SMCRA for this proposed addition. However, the provision is consistent with requirements in section 516(b)(1) of SMCRA and is found in the Federal regulations at 30 CFR 817.121(c)(1). We are approving the addition of this provision to Alabama's statutes because it is consistent with our Federal regulations and SMCRA and will not make the Alabama statutes less stringent than the Federal statutes.

C. Alabama proposed to add new section 9-16-91(e)(4) of ASMCRA to read as follows:

This provision that Alabama proposed to add to its statutes is not found in our Federal statutes. Alabama's intent by adding this provision is to make it clear that it has the power to enforce the provision of section 9-16-91 of ASMCRA. We are approving this statute because it is not inconsistent with our Federal regulations or statutes and will not make the Alabama statutes less stringent than the Federal statutes.

D. Alabama proposed to add new section 9-16-91(f) to read as follows:

The above provision establishes that the remedies outlined in section 9-16-91 of ASMCRA are the sole and exclusive remedies available to a surface owner for subsidence damages, unless the operator violates the conditions or provisions of a permit issued under the authority of ASMCRA. It also allows a surface owner and mineral owner or lessee to enter into a subsidence damage agreement that establishes the manner and means that the mineral owner or lessee will provide repair or compensation.

1. Remedies for Subsidence Damage. Section 720(a) of SMCRA provides two remedies to surface landowners for material damage caused by subsidence to protected structures and water supplies. First, a coal operator must promptly repair or compensate a surface landowner for any material damage, caused by subsidence, to any occupied dwelling and related structures or non-commercial buildings. Second, a coal operator must promptly replace any drinking, domestic, or residential water supplies that are damaged as a result of subsidence.

Sections 9-16-91(e)(1) and (2) of ASMCRA provide the same remedies to surface landowners for material damage caused by subsidence to protected structures and water supplies that section 720(a) of SMCRA provides. Alabama's amendment at 9-16-91(f) establishes that these remedies found in 9-16-91 are the sole and exclusive remedies available to the surface owner for such damage and its effects as long as the operator is conducting longwall mining or other mining process employing a planned subsidence method in substantial compliance with a permit issued under the authority of ASMCRA. If the operator is found to have engaged in intentional, willful, or wanton conduct that is not in substantial compliance with a permit, the ability to seek additional damages is preserved. We interpret “substantial compliance with the permit” to be equivalent to “compliance with all rules, regulations, orders, and permits.”

In a letter dated February 15, 2000 (Administrative Record No. AL-0629), Alabama confirmed that section 9-16-91(f) of ASMCRA does not limit any other remedies available under SMCRA.

The Alabama program contains all the remedies provided for under SMCRA for material damage caused to protected structures and water supplies. In addition, Alabama has stated that the provision does not limit any other remedies available under SMCRA. Therefore, we are approving the above provisions concerning remedies for subsidence damage in section 9-16-91(f) of ASMCRA, as clarified by the above interpretations, because the remedies are consistent with and are no less stringent than the remedies provided by section 720(a) of SMCRA. We note that Alabama has established conditions under which a surface owner may obtain additional damages. However, comparable provisions are not found in SMCRA and they do not conflict with any requirements of SMCRA. Therefore, the provisions do not render the Alabama program less stringent than SMCRA and we are approving them.

2. Subsidence Damage Agreements. Section 9-16-91(f) of ASMCRA provides for subsidence damage agreements between surface owners and mineral owners or lessees, and further contains a sentence that reads as follows:

The reference to subsidence damage agreements in the above quoted sentence would be inconsistent with and less stringent than SMCRA if interpreted to allow a surface landowner and mineral owner or lessee to enter into subsidence damage agreements that diminish or waive the surface landowner's right to the remedies prescribed in section 9-16-91 of ASMCRA. This is because sections 515(b)(2) and 516(b)(1) of SMCRA, as well as the implementing Federal regulations at 30 CFR 817.121(c)(1), establish that a permittee has a duty under SMCRA to maintain the value and reasonably foreseeable use of the surface land and to restore all land which is materially damaged by subsidence. Also, section 720(a)(1) of SMCRA and the implementing Federal regulations at 30 CFR 817.121(c)(2) provide that a permittee has a duty to repair or compensate for material damage to non-commercial buildings and occupied residential dwellings. Finally, section 720(a)(2) of SMCRA and its implementing Federal regulation at 30 CFR 817.41(j) provide that a permittee must promptly replace any drinking, domestic or residential water supply that is contaminated, diminished or interrupted by underground mining activities. Nothing can exempt a permittee from any one of these duties.

We stated in a June 1, 1983, Federal Register (48 FR 24644) final rule that “the duty to restore land materially damaged by subsidence will apply irrespective of the operator's liability under State law.” In addition, in a March 31, 1995, Federal Register (62 FR 16735) final rule, we stated, “[a]ny permittee/owner agreements cannot negate the requirement of the Energy Policy Act to repair or compensate for subsidence-related material damage to occupied residential dwellings and related structures as well as non-commercial buildings.”

Further, in the March 31, 1995, Federal Register (62 FR 16733) final rule, we stated that “the terms of the Energy Policy Act unequivocally require replacement” of water supplies adversely affected by underground mining operations. In other words, surface landowners and mineral owners or lessees may enter into private subsidence damage agreements, but these agreements cannot diminish or waive the surface landowner's right to the remedies prescribed in section 9-16-91 of ASMCRA. To do so would be inconsistent with and less stringent than sections 515(b)(2), 516(b)(1), and 720(a) of SMCRA and its implementing Federal regulations at 30 CFR 817.121(c)(1) and (2) and 817.41(j).

In its letter dated February 15, 2000 (Administrative Record No. AL-0629), Alabama responded to our concerns about the subsidence damage agreements provision in 9-16-91(f) of ASMCRA. The State asserted that the United States Court of Appeals for the District of Columbia had addressed the validity of subsidence damage agreements in its ruling in the case of National Mining Association (NMA) v. Babbit , No. 98-5320, decided April 27, 1999. Alabama interpreted the court's decision as saying that while a coal operator has an obligation to make full repair or compensation, the affected parties may agree among themselves as to what constitutes full repair or compensation.

In ruling on this issue, the court clearly confirmed OSM's longstanding policy that waiver agreements between surface landowners and underground coal operators cannot diminish or waive the surface landowner's right to full compensation for subsidence related damages to protected structures and water supplies.

We agree with Alabama's interpretation of the court's opinion that a mineral owner or lessee and a surface landowner may execute a pre-subsidence damage agreement in which they agree as to what constitutes full repair or compensation with the stipulation that such agreements do not constitute a waiver of the surface landowner's rights under the Energy Policy Act.

In addition, in a letter dated May 3, 2000 (Administrative Record No. AL-0634), Alabama stated that it recognizes that the Energy Policy Act mandates full compensation or repair for subsidence damage to protected structures and the prompt replacement of water for subsidence damage to protected water supplies. Alabama stated that it does not interpret section 9-16-91(f) to mean that a subsidence damage agreement can negate a surface owner's right to full and fair compensation or repair for subsidence damage to protected structures or replacement of water for subsidence damage to protected water supplies as provided for by the Alabama statutory equivalent to the Energy Policy Act requirements. Alabama further stated that it would take appropriate enforcement action against an operator who fails to fully repair or compensate for subsidence damage to protected structures or who fails to fully replace water for subsidence damage to protected water supplies.

Therefore, based on (1) Alabama's interpretation that the provisions of section 9-16-91(f) allow subsidence damage agreements only insofar as those agreements are consistent with the Energy Policy Act and do not purport to diminish or waive the surface landowner's right to full compensation for subsidence related damages to protected structures and water supplies and (2) Alabama's assurance that it will take appropriate action against an operator who fails to fully repair or compensate for subsidence damage to protected structures or who fails to fully replace water for subsidence damages to protected water supplies, we are approving section 9-16-91(f) of ASMCRA because it is no less stringent than SMCRA.

On August 25, 1999, we asked for comments from various Federal agencies who may have an interest in the Alabama amendment (Administrative Record No. AL-0590). We requested comments in accordance with section 503(b) of SMCRA and 30 CFR 732.17(h)(11)(i) of the Federal regulations. We did not receive any comments.

According to 30 CFR 732.17(h)(11)(ii), we are required to get a written agreement from the EPA for those provisions of the proposed program amendment that relate to air or water quality standards put into force under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). None of the revisions that Alabama proposed to make in this amendment pertain to air or water quality standards. Therefore, we did not ask the EPA to agree on the amendment.

According to 30 CFR 732.17(h)(11)(i), we requested comments on the amendment from the EPA in a letter dated August 25, 1999 (Administrative Record No. AL-0590). The EPA did not respond to our request.

According to 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On August 25, 1999, we requested comments on Alabama's proposed program amendment (Administrative Record No. AL-0590), but neither responded to our request.

We received comments on Alabama's proposed amendment from fourteen individuals and twelve representatives of various groups. The comments consisted of both supporting and opposing statements about the amendment in general, as well as supporting and opposing statements about the specific provisions of the amendment. Further, several of these comments pertained to the impact of SMCRA on Alabama common law. Therefore, for ease of discussion, we will first discuss the comments pertaining to the impact of SMCRA on Alabama common law. Then, we will discuss general comments in favor of Alabama's amendment and general comments opposing Alabama's amendment. Finally, we will discuss comments on specific provisions of the amendment.

We received several comments, both opposing and supporting the Alabama amendment, that pertained to the impact of SMCRA on Alabama common law. As commenters have informed us, Alabama's common law gives a surface owner an absolute right to subjacent support of the surface absent an express waiver of that right. See Williams v. Gibson, 4 So. 350 (Ala.1888), West Pratt Coal Co. v. Dorman, 49 So. 849 (Ala.1909), Bibby v. Bunch, 58 So. 916 (Ala.1912), and Alabama Clay Products Co. v. Black, 110 So.151 (Ala.1926). The commenters, however, disagree on the impact that the enactment of SMCRA, including the Energy Policy Act, has on the respective rights of surface owners and the holders of mineral interests.

Citing section 505(a) of SMCRA, supporters of Alabama's amendment argue that the enactment of section 516 of SMCRA and the Alabama counterpart at section 9-16-91 of ASMCRA have preempted the state law pertaining to subjacent support. According to these commenters the state property law is inconsistent with SMCRA since it provides for land use and environmental controls and regulations that are different from those required by SMCRA.

Opponents, on the other hand, argue that the enactment of SMCRA did not impact Alabama's common law. They argue that common law provides more stringent land use and environmental controls and regulations than do the provisions of SMCRA or its implementing regulations. Accordingly, as section 505(b) of SMCRA states, any State law that provides for more stringent land use and environmental controls can not be construed to be inconsistent with SMCRA.

Response: We think that the use of section 505 of SMCRA, whether it be subsection 505(a) or 505(b), to resolve this debate over whether SMCRA preempts the common law of Alabama, however, is inappropriate. Section 505 of SMCRA applies to State laws that directly address matters covered under SMCRA—such as environmental protection standards, reclamation standards, and the like. Section 505(a) was not intended to invalidate as “inconsistent” with SMCRA State common law of property rights which affords protection to surface owners by establishing the property right of the subjacent support.

Generally, preemption analysis is informed by two basic presumptions: (1) that historic police powers of the States are not superseded by the Federal act unless that was the clear and manifest purpose of Congress, and (2) the purpose of Congress is the ultimate touchstone in every preemption case. Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992). Congress' intent is primarily discerned from the statutory text and from a “fair understanding” of the statute as a whole by looking at the statutory framework, the structure and purpose of the statute and the way in which Congress intended the statute and its surrounding regulatory scheme to affect business, consumers, and the law. Medtronic v. Lohr, 518 U.S. 470, 485 (1996).

The text and history of SMCRA reveal no “clear and manifest” congressional intent to modify the State common law pertaining to subjacent support. To the contrary, it is an express purpose of SMCRA to establish uniform national standards that will “fully protect the rights of the nation's surface landowners.” 30 U.S.C. 1202 (b). It would hardly protect the rights of surface landowners for SMCRA to be interpreted as extinguishing their property right of subjacent support in exchange for more limited protection under SMCRA. Congress expressly indicated, moreover, that the respective property rights of the mineral interest holder and the surface owner are matters beyond the scope of SMCRA. Two separate sections of SMCRA state that SMCRA does not authorize a regulatory authority to resolve property rights disputes. Section 507(b)(9) of SMCRA provides in pertinent part:

30 U.S.C. 1257(b)(9). Section 510(b)(6)(C) of SMCRA contains an almost identical proviso:

30 U.S.C. 1260(b)(6)(C). The legislative history of SMCRA indicates that the proper forum for resolving property rights disputes is the State courts and that it is the State common law that delineates the extent and scope of property rights. See H.R. Conf. Rep. No. 95-493, at 105,106 (1977). Consequently, contrary to the fears of at least one commenter, SMCRA does not authorize the regulatory authority to make a permitting decision that adjudicates a property rights dispute so as to augment the property rights of the mineral interest holder at the expense of the surface owner. See Citizens Organized Against Longwalling v. Division of Reclamation, 535 N.E.2d 687, 699-700 (Ohio App. 1987) where the Ohio court held that a permit obtained by a coal mine operator to continue longwall mining would not resolve property disputes between the operator and the owners of surface estates, and would not immunize the operator from liability for damages caused by mining pursuant to the permit. If, under Alabama's common law, a particular surface owner in fact possesses the absolute right to subjacent support of the surface absent an express waiver, SMCRA does not authorize a decision by the regulatory authority to extinguish that right.

We received comments in favor of Alabama's amendment from five representatives of various coal companies, the Alabama Coal Association, and the State of Alabama Surface Mining Commission (ASMC). All the comments assert that we should approve Alabama's amendment because it is consistent with, and no less stringent than, SMCRA and the existing Alabama program. The comments are discussed below.

1. Several commenters assert that the proposed amendment reflects the Alabama Legislature's intent to modify state law, a power which is entirely within their discretion. Because this is a state matter, the amendment does not run afoul of any federal regulatory purpose. The proposed amendment deals only with a surface owner's right to recover punitive damages in state court, and as such, is entirely a State law matter.

Response: We agree that the amendment reflects the Alabama Legislature's intent to modify state law. However, we disagree that the amendment only deals with a surface owner's right to recover punitive damages in state court. The amendment concerns the repair or compensation to any occupied residential dwelling and related structures or any noncommercial building for material damage caused by subsidence resulting from underground coal mining operations. It also concerns the replacement of protected water supplies that are adversely affected by underground coal mining operations. Both of these issues are addressed in section 720(a) of SMCRA. We are approving Alabama's amendment because it is either no less stringent than SMCRA or is not inconsistent with SMCRA. Please refer to III. Director's Findings.

2. Commenters also believe that the proposed amendment does not give an unfair advantage to Alabama coal mining companies or impose an unfair burden on Alabama landowners. They state that the amendment “fairly balances the legal interests of surface landowners with Alabama's and the Nation's need for coal as an essential source of energy.” This balance, the commenters point out, is exactly what SMCRA was designed to provide.

Response: In order to approve amendments to State program statutes, we must ensure that the amendments are consistent with and no less stringent than SMCRA or are not inconsistent with it. We believe that Alabama's amendment meets these criteria and we are approving it. Please refer to III. Director's Findings.

3. One commenter asserts that if the proposed amendment is not approved, the underground mining industry in Alabama will shut down. He writes, “[d]eath of an industry was not the purpose of the carefully crafted federal and state programs now in place.”

Response: We agree that the demise of the underground mining industry in Alabama or any other State was not the purpose of the federal and state programs. Indeed, section 102(k) of SMCRA encourages the full use of coal resources through the development and application of underground extraction technologies. Therefore, we carefully review state statute amendments in light of SMCRA, including section 102(k), to ensure that they are consistent with and are no less stringent than SMCRA or are not inconsistent with it.

4. Several commenters allege that before the enactment of SMCRA and Alabama's counterpart to SMCRA, Alabama common law provided that coal mine operators could not subside the land unless they had the express permission of the surface owners. They state that the enactment of section 516 of SMCRA and the Alabama counterpart at section 9-16-91 of ASMCRA changed the applicability of Alabama's common law. They contend that the Federal and State Acts now allow coal mine operators to subside the land without the express consent of the surface owners, and provide specific remedies for correcting any damages that might result from such subsidence. The existing common law provision, they explain, is therefore inconsistent with SMCRA and the Alabama counterpart to SMCRA. The commenters further explain that section 505(a) of SMCRA states that SMCRA supercedes any state law that is inconsistent with its provisions. Therefore, the commenters maintain that Alabama's common law is superceded by SMCRA and Alabama's counterpart to SMCRA. The current proposed changes to Alabama's program merely “eliminates the application of inconsistent and contrary State law” which SMCRA specifically prohibits in the first place.

Response: Please refer to our response at IV. Summary and Disposition of Comments Public Comments A. Comments Pertaining to the Impact of SMCRA on Alabama Common Law.

5. Some commenters point out that the proposed amendment does not seek to lessen the federal requirements. They maintain that it “does not alter in any way a surface owner's right, or a coal company's obligation, to ‘repair or compensation’ for damages caused by subsidence.”

Response: We agree that Alabama's proposed revisions and additions at section 9-16-91(e) of ASMCRA do not affect a surface owner's right or a coal company's obligation to repair or compensation for damages caused by subsidence. Please refer to III. Director's Findings A. through C. Neither does section 9-16-91(f) of ASMCRA that pertains to the remedies for subsidence damage affect a surface owner's right or a coal company's obligation to repair or compensation for damages caused by subsidence in light of Alabama's statement in its letter dated May 3, 2000, that it will take appropriate enforcement action against an operator who fails to fully repair or compensate for subsidence damage to protected structures or who fails to fully replace water for subsidence damage to protected water supplies. Please refer to III. Director's Findings D.

6. Finally, many commenters argue that the amendment merely clarifies what is implicit in both the state and federal regulatory schemes—that the remedies for damages caused by subsidence outlined in section 9-16-91 of ASMCRA are the “only” remedies available to surface owners. One commenter wrote, “The amendment simply makes clear that the ‘repair or compensation’ remedy available to surface owners for subsidence related damages is generally exclusive.” The amendment clarifies that a surface owner cannot seek punitive damages in state court for subsidence related damage if the mining company is in substantial compliance with its mining permit. The remedy for the surface owner is the repair or compensation provisions of SMCRA.

Response: Nothing in SMCRA or the implementing Federal regulations explicitly or implicitly limits the remedies available to surface landowners for damages to protected structures and water supplies caused by subsidence to only those listed at sections 516 and 720 of SMCRA and the Federal regulations at 30 CFR 817.121(c). SMCRA provides minimum standards for repair and compensation of subsidence related damage to protected structures and for replacement of protected water supplies. States must, at the very least, adopt these minimum standards. Any remedies available under State law which exceed the minimum requirements set forth in SMCRA are not changed by SMCRA. However, a State may change or limit only those available remedies that exceed those found in SMCRA without violating SMCRA. As discussed in III. Director's Findings, Alabama's program provides these minimum standards.

We received comments from fourteen individuals, two attorneys representing surface landowners, and representatives from five organizations (the Alabama Farmers Federation, WildLaw, the Alabama Environmental Council, Friends of Hurricane Creek, and the Citizen's Coal Council). These individuals and groups oppose Alabama's amendment and assert that we should disapprove it because it is inconsistent with and less stringent than SMCRA and the existing Alabama program. The comments are discussed below.

1. Many commenters contend that the amendment is unconstitutional because it: (1) Deprives property owners of their property without due process; (2) is an ex post facto law; (3) does not distinguish between the two types of surface rights ownership in Alabama: surface rights that require surface support and surface rights where mineral release is a statement on the deed; (4) gives coal companies the right of eminent domain; (5) gives coal companies the private right of condemnation; (6) prevents property owners from suing; (7) prevents any relief from the violation of their surface rights; (8) is an unconstitutional interference with contracts; and (9) is an unconstitutional redrafting of the common law.

Response: We found that we can approve the amendment. Please refer to III. Director's Findings. Also, in approving or disapproving any amendment, we can only consider whether the amendment satisfies the applicable program and amendment approval criteria of 30 CFR 732.15 and 732.17(h)(10). The constitutionality of changes to State law cannot be determined by OSM, but must be addressed by the institutions of the State with the authority to determine such issues.

2. One commenter asserts that if unlimited power of destruction is given to the coal companies, then it must also be given to any other big company that wants it. There will be no end to it. He writes, “Act 99-593 could be the most devastating act ever introduced and passed through legislature, and if approved, would no doubt be the greatest threat to landownership ever recorded in history.”

Response: In section 102 of SMCRA, two of the purposes of SMCRA are to assure that: (1) The rights of surface landowners and other persons with a legal interest in the land or its related appurtenances are fully protected from the adverse effects of coal mining operations and (2) the coal supply essential to the Nation's energy requirements and its economic and social well-being is provided and strike a balance between protection of the environment and agricultural productivity and the Nation's need for coal as an essential source of energy. Therefore, we carefully review state statute amendments in light of SMCRA to ensure that they are consistent with and are no less stringent than SMCRA or are not inconsistent with SMCRA. Please refer to III. Director's Findings.

3. Commenters also contend that the amendment would exempt coal companies from having to pay penalties and compensatory damages for subsidence on land, or prevent compensation in the full amount of the diminution in value resulting from subsidence. One commenter states that the amendment allows coal companies to set their own standards as to what constitutes repair to a house or structure.

Response: We disagree that the amendment prevents compensation in the full amount of the diminution in value resulting from subsidence or allows coal companies to set their own standards as to what constitutes repair to a house or structure. As stated in III. Director's Findings, Alabama's proposed revisions to sections 9-16-91(e)(1), (e)(3), (e)(4), and (f) of ASMCRA which pertain to the repair and compensation for material damage to protected structures and water supplies caused by subsidence and subsidence damage agreements are no less stringent than or are not inconsistent with SMCRA. To the extent that the amendment affects Alabama law concerning penalties for subsidence on land, other than repair, compensation, or replacement required by SMCRA sections 515(b)(2), 516(b)(1), and 720(a), such penalties are beyond the scope of SMCRA. Also, please refer to IV. Summary and Disposition of Comments Public Comments B.5. and B.6.

4. Another commenter expressed a concern about the lack of balance in this law. He writes, “Under normal punitive damage laws, it is normal that if you take from one group, you give something to the other group. This law does not allow for that.”

Response: Please refer to our response at IV. Summary and Disposition of Comments Public Comments C.2. and C.3.

5. One commenter asserts that the amendment is inconsistent with the basic premise of SMCRA, which is to regulate. He writes, “The changes proposed by the Act do nothing to regulate or to control [the coal] industry. Instead, the Act takes one activity of the industry—which is not currently controlled by the regulatory authority because of the interpretation and enforcement of SMCRA—and removes all other restraint on that activity. The sole purpose of this change is to give underground coal operators the right to lawfully subside property without purchasing that right from the surface owner. It turns a regulatory act into an enabling act.”

Response: Although one of the premises of SMCRA involves regulating coal mining operations, other premises exist. Section 102(b) of SMCRA involves fully protecting the rights of surface landowners and other persons with a legal interest in the land or its related appurtenances from the adverse effects of coal mining operations. It is our responsibility when reviewing and approving amendments to State program statutes to make sure that the amendments are no less stringent than or are not inconsistent with SMCRA. We found that Alabama's proposed amendments in sections 9-16-91(e) and (f) of ASMCRA that pertain to the repair and compensation for material damage to protected structures and water supplies and subsidence damage agreements meet this requirement. Please refer to III. Director's Findings.

6. One commenter argues that the amendment is inconsistent with the Energy Policy Act of 1992 which added US Code section 1309(a) to SMCRA. The Energy Policy Act created federal substantive rights that extend beyond the protections afforded by inconsistent or less protective state laws. Accordingly, “[s]ection 1309(a) rights are remedial—not preventative—and were intended to serve as additional rights—not replacement rights.” The commenter argues that the proposed amendment attempts to interpret section 1309(a) of SMCRA to preempt all rights and remedies a surface owner has that are not expressly provided by SMCRA. Clearly, this is inconsistent with the purposes of SMCRA as amended by the Energy Policy Act.

Response: The purpose of section 720(a), which was added to SMCRA by the Energy Policy Act, is to establish minimum standards for the repair of or compensation for material damage to protected structures and water supplies caused by subsidence. Remedies under State law which exceed these standards are unaffected by SMCRA. As stated in III. Director's Findings D.1., Alabama provides the minimum standards for repair or compensation. Therefore, we are approving this provision of Alabama's amendment.

In response to questions concerning the impact of SMCRA on State laws, please refer to IV. Summary and Disposition of Comments Public Comments A.

7. One commenter also asserts that the amendment is inconsistent with the fundamental principle that SMCRA is a minimum standard that cannot preempt more stringent State laws. He argues that the only real protection a surface landowner in Alabama has from subsidence is found outside of SMCRA under the Alabama common law. This common law, which is more stringent than SMCRA, allows a surface owner an absolute right to support and full recovery of damages for subsidence. The commenter argues that since section 505(a) of SMCRA prohibits the Federal Act from superceding any more stringent State law, Alabama's counterpart to SMCRA cannot supercede any more stringent State law. Therefore, the proposed amendment, which would supercede Alabama common law, makes Alabama's Act less stringent than SMCRA.

Response: We have addressed the impact of SMCRA on State laws in IV. Summary and Disposition of Comments Public Comments A. Comments Pertaining to the Impact of SMCRA on Alabama Common Law. The changes to State law contained in section 9-16-91 of ASMCRA and enacted by the Alabama legislature do not conflict with the requirements of SMCRA. In approving or disapproving any amendment, we can only consider whether the amendment satisfies the applicable program and amendment approval criteria of 30 CFR 732.15 and 732.17(h)(10). We found that Alabama's proposed amendments in sections 9-16-91(e) and (f) of ASMCRA that pertain to the repair and compensation for material damage to protected structures and water supplies and subsidence damage agreements meet this requirement. Please refer to III. Director's Findings.

8. Two commenters contend that the intention of SMCRA, demonstrated at 30 U.S.C. 1255, 1270(e) and (f), 1271(d), and Public Law 102-486, Title XXV, § 2504(a)(2), was to leave in place all common, property, contract, and tort laws.

Response: Please refer to our response at IV. Summary and Disposition of Comments Public Comments A. Comments Pertaining to the Impact of SMCRA on Alabama Common Law for a discussion of the impact of SMCRA on State law.

9. Commenters contend that the amendment gives the Alabama regulatory authority the right to adjudicate property disputes, which is specifically prohibited in both federal and state law. One commenter writes, “If the changes are approved, the [regulatory authority] will have the power to renegotiate deeds that are eighty years old in favor of the mineral owner merely by the grant of a permit to the operator.” Since ASMC does not engage in any determination of whether an applicant has a right to subside in considering whether or not to grant a mining permit, it will allow the operator to decide unilaterally that the surface owner is not entitled to support of the surface. In effect, ASMC will have the jurisdiction to adjudicate title disputes without a hearing, without input from the surface owner, and will strip that surface owner of his right to be heard and strip his right to a jury.

Response: We disagree that this amendment gives the Alabama regulatory authority the right to adjudicate property disputes by the mere issuance of a mining permit. Nothing in the amendment addresses adjudication of property disputes. Further, the issuance of a permit does not automatically settle property disputes. Such disputes can be settled only in accordance with the appropriate State law. Please refer to our response at IV. Summary and Disposition of Comments Public Comments A. Comments Pertaining to the Impact of SMCRA on Alabama Common Law for a discussion of the impact of SMCRA on State laws.

10. One commenter suggests that if the proposed changes are accepted to any degree, it should be made clear that the changes apply only to those who have already waived their surface support right and not to those who have not waived it.

Response: Again, property rights issues are not addressed in SMCRA. Property rights are the topic of Alabama law. Please refer to our response at IV. Summary and Disposition of Comments Public Comments A. Comments Pertaining to the Impact of SMCRA on Alabama Common Law for a discussion of the impact of SMCRA on State laws.

11. Opponents contend that the proposed amendment is inconsistent with sections 101, 102, and 520(e) of SMCRA.

Response: We did not find that the above referenced sections of SMCRA were affected by changes to section 9-16-91 of ASMCRA. Therefore, we did not find that Alabama's amendment was inconsistent with or less stringent than any of the above referenced sections. Please refer to III. Director's Findings.

1. Section 9-16-91(e)(1). We received comments from three people on this section of Alabama's amendment. The first commenter stated that the provision in this section is fully consistent with the Energy Policy Act of 1992. Another commenter asserted that subparagraph (e)(1) merely makes modest amendments to language in the paragraph and does not make any substantive changes. Because the provision was previously approved by OSM as no less stringent than SMCRA, it should be approved in this instance. However, a third commenter questioned why Alabama is making changes in the language that was substantively identical to the language at the Federal counterpart if there are no changes to the substance of this provision.

Response: As stated in III. Director's Findings A., Alabama's revision at section 9-16-91(e)(1) involves minor wording changes to a previously approved statute, that do not change its meaning. Therefore, we are approving the revision because it is no less stringent than the Federal statute at section 720(a)(1) of SMCRA.

2. Section 9-16-91(e)(3). We received comments from two people on this section of Alabama's amendment. The first commenter stated that the provision extends a state legislative mandate to the existing requirement at section 880-X-10D-.58 of Alabama's surface mining regulations. Similarly, the second commenter contended that subparagraph (e)(3) is a necessary addition to the State program to make it compliant with the Federal regulation at 30 CFR 817.121(c)(1).

Response: As stated in III. Director's Findings B., we do not have a counterpart Federal provision in SMCRA for Alabama's section 9-16-91(e)(3) of ASMCRA. However, the provision is consistent with certain requirements of section 516(b)(1) of SMCRA and the language is substantively identical to the Federal regulations at 30 CFR 817.121(c). We are approving the addition of this provision to Alabama's statutes because it is consistent with our Federal regulations and statutes and will not make the Alabama statutes less stringent than the Federal statutes.

3. Section 9-16-91(e)(4). We received comments from two people on this section of Alabama's amendment. The first commenter stated that this new section makes no change to existing State program requirements. The second commenter contended that new subparagraph (e)(4), as required and consistent with 30 CFR 732.15(d), merely clarifies and established ASMC's authority to enforce the subsidence control requirements in section 9-16-91 of ASMCRA.

Response: As stated in III. Director's Findings C., we do not have a counterpart Federal statute in SMCRA for Alabama's statute addition at section 9-16-91(e)(4) of ASMCRA. However, Alabama's intent by adding this provision is to make it clear that it has the power to enforce the provision of section 9-16-91 of ASMCRA. We are approving this statute because it is not inconsistent with our Federal regulations or statutes and will not make the Alabama statutes less stringent than the Federal statutes.

4. Section 9-16-91(f). a. Supporting Comments. (1) Commenters contend that this particular provision represents an expression of the state legislative will in regards to the rights of the potentially aggrieved persons to seek and obtain particular remedies through the state civil justice system. Since the provision is in the nature of a civil damage limitation statute and has no direct bearing on the regulation of coal mining operations, review or approval by the Department of Interior should not be required in order for it to become law.

Response: We disagree with the assertion that Alabama's amendment does not require review or approval by the Department of the Interior. The provisions at 30 CFR 732.17(g) require States to submit any changes to their laws or regulations concerning their approved surface mining programs to the Director of OSM (Director) for review and approval. Further, no changes in a State's law or regulations concerning surface mining can take effect until such time as the Director approves them. Section 9-16-91(f) of ASMCRA is a revision to Alabama's Surface Mining Act. The revisions contained in section 9-16-91 of ASMCRA involve substantive changes to Alabama's surface mining regulatory program and, therefore, require our review and approval. We agree that certain aspects of the statute involve matters that are not covered by SMCRA. As discussed in III. Director's Findings D. we have approved changes to section 9-16-91(f) of ASMCRA because they are consistent with or do not conflict with provisions contained in SMCRA. While we have approved the changes, we made no judgment on changes that do not relate to or conflict with SMCRA.

(2) Commenters also assert that this provision does not impose any additional burdens or responsibilities on the State Regulatory Authority and does not undermine the requirements of the state and federal statutes that coal operators fully compensate or repair subsidence related damage to protected structures or water supplies. Since section 9-16-91 of ASMCRA does not limit, proscribe, eliminate, amend or otherwise alter performance standards or subsidence remedies established by SMCRA, it meets the requirements of 30 CFR 732.15(a) and (c), and is consistent with or no less stringent than SMCRA.

Response: We agree that Alabama's proposed revisions and additions at section 9-16-91(e) and (f) of ASMCRA do not affect a coal company's obligation to repair or compensate for damages caused by subsidence. Please refer to III. Director's Findings.

(3) Many commenters argue that because SMCRA does not explicitly provide any right to recover punitive damages as compensation for subsidence effects, it implicitly limits a surface owner's right to full compensation or repair for subsidence damage and nothing more. One commenter writes, “[n]either SMCRA nor the regulations thereunder provide that operators of underground coal mines shall ‘repair or compensate’ and pay such additional damages as a jury may assess for punishment or otherwise.” Thus, section 9-16-91(f) merely makes specific what was implied by SMCRA.

Response: Nothing in SMCRA or the implementing Federal regulations explicitly or implicitly limits the remedies available to surface landowners for damages to protected structures and water supplies caused by subsidence to only those listed at sections 516 and 720 of SMCRA and the Federal regulations at 30 CFR 817.121(c). SMCRA provides minimum standards for repair and compensation of subsidence related damage to protected structures and for replacement of protected water supplies. States must, at the very least, adopt these minimum standards. Any remedies available under State law which exceed the minimum requirements set forth in SMCRA are not changed by SMCRA. However, a State may change or limit only those available remedies that exceed those found in SMCRA without violating SMCRA. As discussed in III. Director's Findings, Alabama's program provides these minimum standards.

(4) Many commenters state that Alabama's common law is different from SMCRA because it requires a coal mine operator to get the express permission of the surface owner before subsiding the land. Supporters contend that SMCRA does not require this. One commenter points to a 1997 proposed rule published by OSM (62 FR 4864) as proof that SMCRA and the implementing regulations do not require coal mine operators to obtain the consent of surface owners to subside the land. The existing common law provision, therefore, is inconsistent with SMCRA and the Alabama counterpart. Section 505(a) of SMCRA states that SMCRA supercedes any state law that is inconsistent with its provisions. Therefore, the common law is superceded by SMCRA and Alabama's counterpart. The addition of this section just makes it clear that the common law is superceded.

Response: Please refer to our response to the comment at IV. Summary and Disposition of Comments Public Comments A. Comments Pertaining to the Impact of SMCRA on Alabama Common Law.

(5) One commenter states that a surface owner in Alabama should not be allowed to recover punitive damages for subsidence damage because Congress specifically encourages longwall mining.

Response: SMCRA does not specifically encourage longwall mining, but at section 102(k) “encourages the full utilization of coal resources through the development and application of underground extraction technologies.” Further, section 520(e) of SMCRA does not restrict the right that any person (or class of persons) may have under any State statute or common law to seek enforcement of any of the provisions of SMCRA and its implementing regulations or to seek any other relief available under State law. The limitation of additional damages as related to certain types of mining is a matter outside the scope of SMCRA.

(6) Finally, commenters contend that current Alabama common law is more stringent than SMCRA because it allows for the recovery of punitive damages. This is inconsistent with Alabama's surface mining law that states that its rules and regulations cannot be more stringent than the federal surface mining law.

Response: In approving or disapproving any amendment, we can only consider whether the amendment satisfies the applicable program and amendment approval criteria of 30 CFR 732.15 and 732.17(h)(10). The stringency of an amendment compared to other State laws is not relevant to this amendment. Therefore, we cannot consider it in our decision making.

b. Opposing Comments. (1) Opponents question the constitutionality of this provision. One commenter states that “[b]y restricting punitive damages in the fashion proposed, the landowners” constitutional rights are violated.” Another commenter states that this section “will not withstand constitutional challenges, either under Alabama's constitution or the federal constitution, because it is an unlawful taking of property, favors one class of citizens over another, and violates the landowner's right to a jury trial through its limitations on damages.”

Response: In approving or disapproving any amendment, we can only consider whether the amendment satisfies the applicable program and amendment approval criteria of 30 CFR 732.15 and 732.17(h)(10). The constitutionality of an amendment is something that must be addressed by the institutions in the State with the authority to determine such issues.

(2) Several commenters argue that because SMCRA does not explicitly limit a surface owner's right to full compensation or repair for subsidence damage and nothing more, it implicitly allows surface owners to seek punitive damages as compensation for subsidence effects. Section 9-16-91(f) of ASMCRA narrows a surface owner's common law and remedial rights in direct contravention of this implicit congressional intent.

Response: Nothing in SMCRA or the implementing Federal regulations explicitly or implicitly limits the remedies available to surface landowners for damages to protected structures and water supplies caused by subsidence to only those listed at sections 516 and 720 of SMCRA and the Federal regulations at 30 CFR 817.121(c). Section 520(e) of SMCRA does not restrict the right that any person (or class of persons) may have under any State statute or common law to seek enforcement of any of the provisions of SMCRA and its implementing regulations or to seek any other relief under State law. The changes to State law in section 9-16-91 of ASMCRA as enacted by the Alabama legislature and as clarified by us and Alabama do not conflict with the requirements found in SMCRA. Please refer to III. Director's Findings.

(3) Several commenters also point out that SMCRA exists to regulate the mining industry, yet this provision does nothing to add to that regulation. Instead, it provides civil justice reform to allow the industry to violate surface owners' rights with impunity. Opponents contend that civil justice reform does not belong in a regulatory Act. One commenter writes, “[l]et SMCRA regulate mining industry and let the surface owner's damages be governed by the substantive law of property, contracts, tort and damages.” Another commenter stated that he was disturbed by the attempt to use SMCRA as a vehicle for tort reform in Alabama.

Response: In approving or disapproving any amendment, we can only consider whether the amendment satisfies the applicable program and amendment approval criteria of 30 CFR 732.15 and 732.17(h)(10). Section 720 of SMCRA provides minimum standards that underground coal operators must adhere to regarding the repair and compensation for subsidence damage to protected structures and replacement of water for subsidence damage to protected water supplies. In part, section 9-16-91(f) of ASMCRA pertains to the remedies for subsidence damage and subsidence damage agreements and does not conflict with SMCRA. We are approving these provisions because they are no less stringent than the corresponding provisions in SMCRA. Please refer to III. Director's Findings D.

(4) Some commenters acknowledge that this provision may not affect the day-to-day operation of ASMC, but believe it will have a great impact on ASMC's ability to control the mining industry because it removes all deterrents on subsidence. One commenter writes, “The purpose of punitive damages is not to compensate for the injury suffered, but rather to punish the defendant for his conduct and to deter the defendant and others from engaging in the same conduct. If a coal mining company engages in activities that would subject it to punitive damages, then it deserves to be punished just like every other industry operating within Alabama. What will come of landowners rights if the only potential deterrent is removed?” Another commenter states that this provision allows underground mining companies to intentionally take the domestic water supplies from the landowners and force the landowners into long and costly legal battles with little adverse economic consequences. A third commenter points out that this provision eliminates a mining company's liability for damage to personal property, damage to physical injury, or wrongful death or emotional distress.

Response: For damage caused by subsidence, section 720 of SMCRA only requires coal companies to compensate or repair for material damage to protected structures and to replace for damage to protected water supplies. As stated in III. Director's Findings, Alabama's program provides these remedies. Any additional remedies including punitive damages are beyond the scope of SMCRA. However, section 520(e) of SMCRA allows any person (or class of persons) to seek enforcement of any of the provisions of SMCRA or any other relief that he or she may have under State statute or common law. Any remedies under State law which exceed the minimum requirements set forth in SMCRA are not changed by SMCRA. However, a State may change or limit only those remedies that exceed those found in SMCRA without violating SMCRA.

(5) Other commenters believe that while the provision will not inhibit the remedial requirements to repair or compensate for damages to structures, it will undermine the purpose of SMCRA—to fully protect the rights of surface landowners. One commenter writes, “This approach of limiting remedies for actual damage suffered simply does not provide adequate protection for surface property owners.”

Response: Please refer to our response to comment number four (4) of this section.

(6) Some commenters state that this provision is especially unfair to those landowners that have the absolute right to support of their surface in its natural state. One commenter contends that section 9-16-91(f) does not provide adequate protection for those persons whose property has been damaged by underground mining operations and have not waived their rights to the support of their surface interests through appropriate contractual provisions. Another commenter writes, “statutory remedies provided under a legislative act should not necessarily be the exclusive method used in determining the amount of recoverable damages in cases where the surface owner has not waived his or her right of support and where his property is, in fact, permanently and severely damaged.”

Response: For damage caused by subsidence, section 720 of SMCRA only requires coal companies to compensate or repair for material damage to protected structures and to replace for damage to protected water supplies. As stated in III. Director's Findings, Alabama's program provides these remedies. Any additional remedies including punitive damages are beyond the scope of SMCRA. However, section 520(e) of SMCRA allows any person (or class of persons) to seek enforcement of any of the provisions of SMCRA or any other relief that he or she may have under State statute or common law. Any remedies under State law which exceed the minimum requirements set forth in SMCRA are not changed by SMCRA. However, a State may change or limit only those remedies that exceed those found in SMCRA without violating SMCRA. In addition, sections 507(b)(9) and 510(b)(6)(C) of SMCRA clearly provide that nothing in SMCRA shall be construed to authorize the regulatory authority to adjudicate property rights or title disputes. Instead, matters concerning these issues are to be determined in accordance with State law. Changes in property rights or title disputes must be addressed by the institutions in the State with responsibilities for resolving such issues. Also, please refer to IV. Summary and Disposition of Comments Public Comments A. Comments Pertaining to the Impact of SMCRA on Alabama Common Law.

(7) One commenter asserts that actual cost of repair of an existing structure does not always reflect the actual loss of value that the structure may have suffered as a result of undermining. He writes, “The language of the Act in this provision would apparently lead to the especially bizarre result that no recovery at all would be available in situations where damage is particularly severe.” Further, the commenter points out that the value of land typically includes not only the current use of the land, but also any potential future use. This provision would not allow these values to be taken into account when determining the loss in value of property as a result of subsidence. The commenter concludes that this provision is “grossly unfair to the surface landowner and amounts to a serious deprivation of important property rights that have been traditionally and are otherwise presently protected by Alabama law.”

Response: For damage caused by subsidence, section 720 of SMCRA only requires coal companies to compensate or repair for material damage to protected structures and to replace for damage to protected water supplies. As stated in III. Director's Findings, Alabama's program provides these remedies. Any additional remedies including punitive damages are beyond the scope of SMCRA. However, section 520(e) of SMCRA allows any person (or class of persons) to seek enforcement of any of the provisions of SMCRA or any other relief that he or she may have under State statute or common law. Any remedies under State law which exceed the minimum requirements set forth in SMCRA are not changed by SMCRA. However, a State may change or limit only those remedies that exceed those found in SMCRA without violating SMCRA.

(8) One commenter states that the limitation of punitive damages is not inappropriate as a general manner. However, in cases where fraud or misrepresentation has served as the basis for the permit, the ability of a surface owner to seek and obtain punitive damages should not be limited. The commenter believes that Alabama needs to clarify the language in this section to make it clear that punitive damages are limited only in cases where lawful activities are being undertaken.

Response: We believe that Alabama's amendment makes it clear that the provisions at section 9-16-91(f) only apply in cases where lawful activities are being undertaken. If the operator is found to have engaged in intentional, willful, or wanton conduct that is not in substantial compliance with a permit, the ability to seek additional damages is preserved. Please refer to III. Director's Findings D.1.

Based on the above findings, we are approving the amendments to the Alabama program.

To implement this decision, we are amending the Federal regulations at 30 CFR part 901, which codify decisions concerning the Alabama program. We are making this final rule effective immediately to expedite the State program amendment process and to encourage Alabama to bring its program into conformity with the Federal standards without undue delay. SMCRA requires consistency of State and Federal standards.

This rule is exempted from review by the Office of Management and Budget under Executive Order 12866.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart federal regulation.

This rule does not have federalism implications. SMCRA delineates the roles of the federal and state governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that state laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that state programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that, to the extent allowed by law, this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of state regulatory programs and program amendments since each program is drafted and promulgated by a specific state, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed state regulatory programs and program amendments submitted by the states must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing federal regulations and whether the other requirements of 30 CFR parts 730, 731, and 732 have been met.

Section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that a decision on a proposed state regulatory program provision does not constitute a major federal action within the meaning of section 102(2)(C) of the National Environmental Policy Act (NEPA) (42 U.S.C. 4332(2)(C)). A determination has been made that such decisions are categorically excluded from the NEPA process (516 DM 8.4.A).

This rule does not contain information collection requirements that require approval by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior has determined 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. ). The state submittal which is the subject of this rule is based upon counterpart federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. Accordingly, this rule will ensure that existing requirements previously promulgated by OSM will be implemented by the state. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart federal regulation.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Does not have an annual effect on the economy of $100 million.

b. Will not cause a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions.

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.

This determination is based upon the fact that the state submittal which is the subject of this rule is based upon counterpart federal regulations for which an analysis was prepared and a determination made that the federal regulation was not considered a major rule.

This rule will not impose a cost of $100 million or more in any given year on any governmental entity or the private sector.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(8), the Coast Guard finds that good cause exists for not publishing an NPRM. Good cause exists for not publishing an NPRM due to the date the Application for Approval of Marine Event was received, there was insufficient time to draft and publish an NPRM. Further, it is a local event with minimal impact on the waterway, vessels may still transit through New York Harbor during the event, the zone is only in affect for 1 1/2 hours and vessels can be given permission to transit the zone except for about 45 minutes during this time. Any delay encountered in this regulation's effective date would be contrary to public interest since immediate action is needed to close the waterway and protect the maritime public from the hazards associated with this fireworks display.

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 . This is due to the following reasons: it is a local event with minimal impact on the waterway, vessels may still transit through New York Harbor during the event, the zone is only in affect for 1 1/2 hours and vessels can be given permission to transit the zone except for about 45 minutes during this time. Vessel traffic will still be able to transit through Anchorage Channel as it is unaffected by this zone. Vessels will still be able to anchor in Federal Anchorage No. 20-B, to the north, and 20-C, to the south. Additionally, vessels will not be precluded from mooring at or getting underway from commercial or recreational piers in the vicinity of the zone.

The Coast Guard has received an application to hold a fireworks program on the waters of New York Harbor. This regulation establishes a safety zone in all waters of New York Harbor within a 180-yard radius of the fireworks barge in approximate position 40°41′40.3″N, 074°02′33.5″W (NAD 1983), about 235 yards south of Ellis Island. The safety zone is in effect from 8 p.m. (e.s.t.) until 9:30 p.m. (e.s.t.) on Wednesday, June 28, 2000. There is no rain date for this event. The safety zone prevents vessels from transiting a portion of New York Harbor and is needed to protect boaters from the hazards associated with fireworks launched from a barge in the area. Recreational and commercial vessel traffic will still be able to transit through Anchorage Channel as it is unaffected by this zone. Additionally, vessels will still be able to anchor in Federal Anchorage No. 20-B, to the north, and 20-C, to the south. This safety zone precludes the waterway users from entering only the safety zone itself. Public notifications will be made prior to the event via the Local Notice to Mariners.

This final rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. It has not been reviewed by the Office of Management and Budget under that Order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979). The Coast Guard expects the economic impact of this final rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. This finding is based on the minimal time that vessels will be restricted from the zone, that vessels may still transit through New York Harbor during the event, that vessels may still anchor in Federal Anchorage No. 20-B, to the north, and 20-C, to the south, that vessels will not be precluded from mooring at or getting underway from commercial or recreational piers in the vicinity of the zone, and advance notifications which will be made.

The size of this safety zone was determined using National Fire Protection Association and New York City Fire Department standards for 6′′ mortars fired from a barge combined with the Coast Guard's knowledge of tide and current conditions in the area.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), the Coast Guard considered whether this final rule will have a significant economic impact on a substantial number of small entities. “Small entities” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

For reasons discussed in the Regulatory Evaluation above, the Coast Guard certifies under section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) that this final rule will not have a significant economic impact on a substantial number of small entities.

This final rule does not provide for a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Coast Guard has analyzed this final rule under the principles and criteria contained in Executive Order 13132 and has determined that this final rule does not have implications for federalism under that Order.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) [Pub. L. 104-4, 109 Stat. 48] requires Federal agencies to assess the effects of certain regulatory actions on State, local, and tribal governments, and the private sector. UMRA requires a written statement of economic and regulatory alternatives for rules that contain Federal mandates. A Federal mandate is a new or additional enforceable duty imposed on any State, local, or tribal government, or the private sector. If any Federal mandate causes those entities to spend, in the aggregate, $100 million or more in any one year, the UMRA analysis is required. This final rule does not impose Federal mandates on any State, local, or tribal governments, or the private sector.

The Coast Guard considered the environmental impact of this final rule and concluded that under figure 2-1, paragraph 34(g), of Commandant Instruction M16475.1C, this final rule is categorically excluded from further environmental documentation. This rule fits paragraph 34(g) as it establishes a safety zone. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES .

On April 26, 2000, we published a notice of proposed rulemaking (NPRM) entitled Safety Zone: Coast Guard Activities New York Annual Fireworks Displays in the Federal Register (65 FR 24436). We received no letters commenting on the proposed rule. No public hearing was requested, and none was held.

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 . This is due to the following reasons: They are locally supported, annual events with minimal impact on the waterways, the zones are only in affect for 1 1/2 hours and vessels can be given permission to transit the zones except for about 45 minutes during this time, the public was additionally notified of the NPRM via the First Coast Guard District Local Notice to Mariners Number 019, dated May 9, 2000. Additionally, vessel traffic can transit around the safety zones with the exception of the locations in Sandy Hook Bay and Rondout Creek, vessels will not be precluded from getting underway, or mooring at, any piers or marinas currently located in the vicinity of the safety zones with the exception of the locations in Sandy Hook Bay and Rondout Creek. The sponsors of the displays held in Highlands, NJ and Kingston, NY reported they have not received any objections from the public for these annual displays dating back to 1997. The display in Highlands, NJ has been held in the same location for 5 years and the display in Kingston, NY has been held in the same location for 10 years.

The Coast Guard is establishing five permanent safety zones that will be activated for fireworks displays occurring at the same location and time on an annual basis. The five locations are Highlands, New Jersey in Sandy Hook Bay; Kingston, New York on Rondout Creek; Glen Cove, New York on Hempstead Harbor; Elizabeth, New Jersey on the Arthur Kill; and Yonkers, New York on the Hudson River. Establishing permanent safety zones by notice and comment rulemaking gives the public the opportunity to comment on the zones, provides better notice than promulgating temporary rules annually, and decreases the amount of annual paperwork required for these events. The Coast Guard has received no prior notice of any impact caused by the previous events.

The sizes of these safety zones were determined using National Fire Protection Association and New York City Fire Department standards for 5-12 inch mortars fired from a barge or shore, combined with the Coast Guard's knowledge of tide and current conditions in these areas. The five safety zones are:

The Highlands Chamber of Commerce and Seastreak America sponsor this annual fireworks display. The safety zone in Sandy Hook Bay includes all waters of Sandy Hook Bay and the Shrewsbury River Channel within a 150-yard radius of the fireworks barge in approximate position 40°24′34″ N 073°59′45″ W (NAD 1983), about 140 yards south of Shrewsbury River Channel Lighted Buoy 9 (LLNR 35775). The regulation is effective annually from 8 p.m. (e.s.t.) to 11 p.m. (e.s.t.) on the Saturday before Father's Day. The safety zone closes a portion of southern Sandy Hook Bay and the Shrewsbury River Channel and will prevent marine traffic from transiting a portion of these two areas. It is needed to protect boaters from the hazards associated with fireworks launched from a barge in the area.

The city of Kingston, New York sponsors this annual fireworks display. The safety zone in Rondout Creek includes all waters of Rondout Creek between the Kingston-Port Ewen Bridge (mile 1.1) and the Kingston-US 9 Bridge (mile 1.3). The fireworks are fired from shore at the Kingston Municipal Docks. The regulation is effective annually from 8 p.m. (e.s.t.) to 11 p.m. (e.s.t.) on the last Sunday in June. The safety zone closes a portion of Rondout Creek and prevents marine traffic from transiting the area. It is needed to protect boaters from the hazards associated with fireworks launched from shore in the area.

The city of Glen Cove sponsors this annual fireworks display. The safety zone in Hempstead Harbor includes all waters of Hempstead Harbor within a 360-yard radius of the fireworks barge in approximate position 40°51′58″ N 073°39′34″ W (NAD 1983), about 500 yards northeast of Glen Cove Breakwater Light 5 (LLNR 27065). The regulation is effective annually from 8 p.m. (e.s.t.) to 11 p.m. (e.s.t.) on July 1st, 2nd, 3rd, 4th, and 5th. The safety zone prevents vessels from transiting a portion of Hempstead Harbor, and is needed to protect boaters from the hazards associated with fireworks launched from a barge in the area. Marine traffic will still be able to transit through the western 1,075 yards of the 1,435-yard wide Hempstead Harbor during the event. Additionally, vessels are not precluded from getting underway from public or private facilities at Glen Cove or Red Spring Point, NY, in the vicinity of this event.

The safety zone west of Yonkers includes all waters of the Hudson River within a 360-yard radius of the fireworks barge in approximate position 40°56′14.5″ N 073°54′33″ W (NAD 1983), about 475 yards northwest of Yonkers Municipal Pier, New York. The regulation is effective annually from 8 p.m. (e.s.t.) to 11 p.m. (e.s.t.) on July 4th and the third Saturday of September. If either event is canceled due to inclement weather, then this event will be held on July 5th and the third Sunday of September. The safety zone prevents vessels from transiting a portion of the Hudson River and is needed to protect boaters from the hazards associated with fireworks launched from a barge in the area. Marine traffic will still be able to transit through the western 715 yards and eastern 115 yards of the 1550 yard-wide Hudson River during the event. Additionally, vessels will not be precluded from mooring at or getting underway from any piers in the vicinity of the safety zone.

The city of Elizabeth sponsors this annual fireworks display. The safety zone on the Arthur Kill includes all waters of the Arthur Kill within a 150-yard radius of the fireworks land shoot in Elizabeth, New Jersey, in approximate position 40°38′50″ N 074°10′58″ W (NAD 1983), about 675 yards west of Arthur Kill Channel Buoy 20 (LLNR 36780). The regulation is effective annually from 8 p.m. (e.s.t.) to 11 p.m. (e.s.t.) on July 4th. If the event is canceled due to inclement weather, then this event will be held on July 5th. The safety zone prevents vessels from transiting a portion of the Arthur Kill, and is needed to protect boaters from the hazards associated with fireworks launched from shore in the area. Marine traffic will still be able to transit through the southern 90 yards of the Arthur Kill opposite the display site in Elizabeth, New Jersey during the event. Additionally, vessels will not be precluded from mooring at or getting underway from any piers in the vicinity of the safety zone.

The effective period for each proposed safety zone is from 8 p.m. (e.s.t.) to 11 p.m. (e.s.t.) However, vessels may enter, remain in, or transit through these safety zones during this time frame if authorized by the Captain of the Port New York, or designated Coast Guard patrol personnel on scene, as provided for in 33 CFR 165.23. Generally, blanket permission to enter, remain in, or transit through these safety zones will be given except for the 45-minute period that a Coast Guard patrol vessel is present.

The Coast Guard received no letters commenting on the proposed rulemaking. No changes were made to this rulemaking.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 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 Transportation (DOT) (44 FR 11040, February 26, 1979).

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary.

This finding is based on the minimal time that vessels will be restricted from the zones, and all of the zones are in areas where the Coast Guard expects insignificant adverse impact on all mariners from the zones' activation. The sponsors of the displays held in Highlands, NJ and Kingston, NY reported they have not received any objections from the public for these annual displays dating back to 1997. The display in Highlands, NJ has been held in the same location for 5 years and the display in Kingston, NY has been held in the same location for 10 years. The Coast Guard has not received any negative comments on these annual displays. Marine traffic will only be precluded from transiting around these safety zones in southern Sandy Hook Bay and Rondout Creek. There is sufficient open water for expected marine traffic to transit around the other three safety zones. There are no commercial maritime facilities that will be affected by these regulated areas. Vessels may also still transit through Sandy Hook Bay, Hempstead Harbor, the Arthur Kill, and the Hudson River during these events. Vessels will not be precluded from getting underway, or mooring at, any piers or marinas currently located in the vicinity of the safety zones with the exception of the locations in Sandy Hook Bay and Rondout Creek. Additionally, marine traffic can plan their transits through Rondout Creek, Sandy Hook Bay, and the Shrewsbury River Channel around the time the Kingston, New York and Highlands, New Jersey safety zones are in effect. The marine community will have advance notice of these two events as they are annual events with local community support. Advance notifications will also be made to the local maritime community by the Local Notice to Mariners, marine information broadcasts, and facsimile broadcasts, if needed.

The size of these safety zones were determined using National Fire Protection Association and New York City Fire Department standards for 5-12 inch mortars fired from a barge or shore, combined with the Coast Guard's knowledge of tide and current conditions in these areas.

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

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

This rule will affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit or anchor in a portion of Sandy Hook Bay, Rondout Creek, Hempstead Harbor, the Arthur Kill, and the Hudson River during the times these zones are activated.

These safety zones will not have a significant economic impact on a substantial number of small entities for the following reasons: Vessel traffic can transit around the safety zones with the exception of the locations in Sandy Hook Bay and Rondout Creek. Vessels will not be precluded from getting underway, or mooring at, any piers or marinas currently located in the vicinity of the safety zones with the exception of the locations in Sandy Hook Bay and Rondout Creek. The sponsors of the displays held in Highlands, NJ and Kingston, NY reported they have not received any objections from the public for these displays dating back to 1997. The display in Highlands, NJ has been held in the same location for 5 years and in Kingston, NY for 10 years. There are no commercial marine facilities that will be affected by any of these regulated areas. These are all annual events with local community support and vessels will normally be precluded from entering any of the zones for only a 45-minute period on an annual basis. Additionally, the Coast Guard has not received any negative reports from small entities affected by these displays.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. However, we received no requests for assistance from small entities.

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 Agricultural 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 1-800-REG-FAIR (1-888-734-3247).

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

We have analyzed this rule under Executive Order 13132 and have determined that this rule does not have implications for federalism under that Order.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government's having first provided the funds to pay those unfunded mandate costs. This rule will not impose an unfunded mandate.

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 concern an environmental risk to health or risk to safety that may disproportionately affect children.

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

Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.

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

The Clean Air Act (Act), as amended in 1977, required States to adopt emission controls reflective of reasonably available control technology (RACT) for sources of VOC emissions in ozone nonattainment areas. Subsequently, EPA issued three sets of control technique guidelines (CTGs) documents, establishing a “presumptive norm” for RACT for various categories of VOC sources. The three sets of CTGs were (1) Group I—issued before January 1978 (15 CTGs); (2) Group II—issued in 1978 (9 CTGs); and (3) Group III—issued in the early 1980's (5 CTGs). Those sources not covered by a CTG were called non-CTG sources. EPA determined that an area's State Implementation Plan (SIP) approved attainment date established which RACT rules the State needed to adopt and implement and for which areas. In those areas where the State sought from EPA an extension of the attainment date under section 172(a)(2) of the Act to as late as December 31, 1987, the Act as amended in 1977 required RACT for all CTG sources and for all major VOC non-CTG sources. The 1977 amendments to the Act defined as major any VOC non-CTG source with a potential to emit 100 tons per year or more of VOC emissions. Indiana sought and received such an extension from EPA for Lake and Porter Counties.

Congress amended the Act in 1990. The 1990 amendments to the Act reduced the size definition of major source to 25 tons per year or more of VOC emissions for sources located in severe ozone nonattainment areas. Section 182(b)(2) of the Act, as amended, requires States to adopt RACT rules for all areas designated nonattainment for ozone and classified as moderate or above. There are three parts to the section 182(b)(2) RACT requirement: (1) RACT for sources covered by an existing CTG—i.e., a CTG issued prior to the enactment of the amended Act of 1990; (2) RACT for sources covered by a post-enactment CTG; and (3) all major sources not covered by a CTG. These section 182(b)(2) RACT requirements are referred to as the RACT “catch-up” requirements.

Section 183 of the amended Act requires EPA to issue CTGs for 13 source categories by November 15, 1993. EPA published a CTG by this date for the following source categories—Synthetic Organic Chemical Manufacturing Industry (SOCMI) Reactors and Distillation, aerospace manufacturing coating operation, shipbuilding and ship repair coating operations, and wood furniture coating operation; however, EPA has not completed the CTGs for the remaining source categories. The amended Act requires States to submit rules for sources covered by a post-enactment CTG in accordance with a schedule specified in a CTG document.

The EPA created a CTG document as appendix E to the General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990 . (57 FR 18070, 18077, April 28, 1992). In appendix E, EPA interpreted the Act to allow a State to submit a non-CTG rule by November 15, 1992, or to defer submittal of a RACT rule for sources that the State anticipated would be covered by a post-enactment CTG, based on the list of CTGs EPA expected to issue to meet the requirement in section 183. Appendix E states that if EPA fails to issue a CTG by November 15, 1993 (which it did for 11 source categories), the responsibility shifts to the State to submit a non-CTG RACT rule for those sources by November 15, 1994. In accordance with section 182(b)(2), implementation of that RACT rule should occur by May 31, 1995.

The EPA does not require States to develop plans or regulations to control emissions from sources which are not located in the planning area. In order to determine whether this might be the case, the State may examine its emissions inventory before initiating the planning and regulation development process. If the State finds no subject sources, then the State may prepare and submit to EPA, a negative declaration stating there are no sources in the planning area which would be subject to the required rule, rather than a control plan for sources in a particular category. In addition to reviewing its emissions inventory, Indiana reviewed its permit files for sources with a potential to emit 25 tons or more of VOC annually located in Lake and Porter Counties.

The State negative declarations addressed two CTG categories: Control of Volatile Organic Compound Emissions from Industrial Wastewater (EPA Document Number: EPA-453/D-93-056) and Control of Volatile Organic Emissions from Coating Operations at Aerospace Manufacturing and Rework Facilities (EPA Document Number: EPA-453/R-97-004, December 1997). The State's negative declarations also includes two source categories addressed by the Alternative Control Document:  1 Surface Coating of Automotive/ Transportation and Business Machine Plastic Parts (EPA 4531R-94-017, February 1994 including page 4-3a as revised April 4, 1994). The State negative declarations also addressed five non-CTG source categories because the State must control VOC emissions from all sources with a potential to emit 25 tons or more of VOC annually located in Lake and Porter Counties. Indiana searched its inventory and determined that no sources with a potential to emit 25 tons or more of VOC per year were located in Lake and Porter Counties in the following five non-CTG source categories: industrial clean up solvents, offset lithography operations, and SOCMI batch processes, reactors and distillation units.

No, new major sources locating in a nonattainment area are subject to the more stringent emission control requirements of New Source Review under part D of the Clean Air Act.

EPA has examined the State's negative declarations regarding the lack of need for regulations controlling emissions from the source categories identified above and located in Lake and Porter Counties. EPA also examined the supporting evidence provided by the State. Based on these examinations, EPA agrees there are currently no major sources in the nine categories for which the State submitted negative declarations located in the Lake and Porter Counties severe ozone nonattainment area. As a result, EPA approves Indiana's negative declarations for these sources.

EPA is publishing this action without prior proposal because EPA views this as a noncontroversial revision and anticipates no adverse comments. However, in a separate document in this Federal Register publication, EPA is proposing to approve the State Plan should adverse written comments be filed. This action will be effective without further notice unless EPA receives relevant adverse written comment by July 10, 2000. Should EPA receive such comments, it will publish a final rule informing the public that this action will not take effect. Any parties interested in commenting on this action should do so at this time. If no such comments are received, the public is advised that this action will be effective on August 7, 2000.

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

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

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

Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.”

Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

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

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

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

This rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities. Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

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

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

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). This rule will be effective August 7, 2000 unless EPA receives adverse written comments by July 10, 2000.

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 7, 2000. 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 section 307(b)(2).)

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

The Clean Air Act (Act), as amended in 1977, required States to adopt emission controls reflective of reasonably available control technology (RACT) for sources of VOC emissions in ozone nonattainment areas. Subsequently, EPA issued three sets of control technique guidelines (CTGs) documents, establishing a “presumptive norm” for RACT for various categories of VOC sources. The three sets of CTGs were (1) Group I—issued before January 1978 (15 CTGs); (2) Group II—issued in 1978 (9 CTGs); and (3) Group III—issued in the early 1980's (5 CTGs). Those sources not covered by a CTG were called non-CTG sources. EPA determined that an area's State Implementation Plan (SIP) approved attainment date established which RACT rules the State needed to adopt and implement and for which areas. In those areas where the State sought an extension of the attainment date under section 172(a)(2) to as late as December 31, 1987, RACT was required for all CTG sources and for all major (100 tons per year or more of VOC emissions under the 1977 Act) non-CTG sources. Indiana sought and received such an extension from EPA for Clark and Floyd Counties.

When Congress amended the Act in 1999, it included section 182(b)(2) which required States to adopt RACT rules for all areas designated nonattainment for ozone and classified as moderate or above. There are three parts to the section 182(b)(2) RACT requirement: (1) RACT for sources covered by an existing CTG— i.e., a CTG issued prior to the enactment of the amended Act of 1990; (2) RACT for sources covered by a post-enactment CTG; and (3) all major sources not covered by a CTG. These section 182(b)(2) RACT requirements are referred to as the RACT “catch-up” requirements.

Section 183 of the 1990 Amendments required EPA to issue CTGs for 13 source categories by November 15, 1993. EPA published a CTG by this date for the following source categories: Synthetic Organic Chemical Manufacturing Industry (SOCMI) Reactors and Distillation, aerospace manufacturing coating operation, shipbuilding and ship repair coating operations, and wood furniture coating operation; however, EPA has not completed the CTGs for the remaining source categories. The amended Act requires States to submit rules for sources covered by a post-enactment CTG in accordance with a schedule specified in a CTG document.

The EPA created a CTG document as appendix E to the General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990. (57 FR 18070, 18077, April 28, 1992). In appendix E, EPA interpreted the Act to allow a State to submit a non-CTG rule by November 15, 1992, or to defer submittal of a RACT rule for sources that the State anticipated would be covered by a post-enactment CTG, based on the list of CTGs EPA expected to issue to meet the requirement in section 183. Appendix E states that if EPA fails to issue a CTG by November 15, 1993 (which it did for 11 source categories), the responsibility shifts to the State to submit a non-CTG RACT rule for those sources by November 15, 1994. In accordance with section 182(b)(2), implementation of that RACT rule should occur by May 31, 1995.

The EPA does not require States to develop plans or regulations to control emissions from major sources which are not located in the planning area. In order to determine whether this might be the case, the State may examine its emissions inventory before initiating the planning and development process. If the State finds no subject sources, then it may prepare and submit to EPA, a negative declaration stating there are no sources in the planning area which would be subject to the required rule, rather than a control plan for sources in a particular category. In addition to reviewing its emissions inventory, Indiana reviewed its permit files for sources with a potential to emit 100 tons or more of VOC annually located in Clark and Floyd Counties.

The State negative declarations addressed two CTG categories: Control of Volatile Organic Compound Emissions from Industrial Wastewater (EPA Document Number: EPA-453/D-93-056) and Control of Volatile Organic Emissions from Coating Operations at Aerospace Manufacturing and Rework Facilities (EPA Document Number: EPA-453/R-97-004, December, 1997). The State's negative declarations also includes two source categories addressed by the Alternative Control Document  1 : Surface Coating of Automotive/Transportation and Business Machine Plastic Parts (EPA 4531R-94-017, February 1994 including page 4-3a as revised April 4, 1994). The State negative declarations also addressed five non-CTG source categories because the State must control VOC emissions from all sources with a potential to emit 100 tons or more of VOC annually located in Clark and Floyd Counties. Indiana searched its inventory and determined that no sources with a potential to emit 100 tons or more of VOC per year were located in Clark and Floyd Counties in the following five non-CTG source categories: industrial clean up solvents, offset lithography operations, and SOCMI batch processes, reactors and distillation units.

No, new major sources locating in a nonattainment area are subject to the more stringent emission control requirements of New source Review under part D of the Act.

EPA has examined the State's negative declarations regarding the lack of need for regulations controlling emissions from these source categories from sources located in Clark and Floyd Counties. EPA also examined the supporting evidence provided by the State. As a result, EPA approves Indiana's negative declarations for these sources.

EPA is publishing this action without prior proposal because EPA views this as a noncontroversial revision and anticipates no adverse comments. However, in a separate document in this Federal Register publication, EPA is proposing to approve the State Plan should adverse written comments be filed. This action will be effective without further notice unless EPA receives relevant adverse written comment by July 10, 2000. Should EPA receive such comments, it will publish a final rule informing the public that this action will not take effect. Any parties interested in commenting on this action should do so at this time. If no such comments are received, the public is advised that this action will be effective on August 7, 2000.

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

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

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

Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.”

Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

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

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

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

This rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities. Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

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

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

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). This rule will be effective August 7, 2000 unless EPA receives adverse written comments by July 10, 2000.

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 7, 2000. 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 section 307(b)(2).)

Throughout this document, “we,” “us” and “our” refer to EPA.

Table 1 lists the rule we are approving with the date that it was adopted by the local air agency and submitted by the California Air Resources Board (CARB).

On May 19, 2000, EPA determined that this rule submittal met the completeness criteria in 40 CFR part 51, appendix V, which must be met before formal EPA review.

We published a limited approval and limited disapproval of Rule 330 and incorporated the rule into the SIP on December 3, 1998. The SBCAPCD adopted this version of Rule 330 on April 21, 1995. SBCAPCD has not submitted to EPA any versions of Rule 330 prior to the January 20, 2000 version we are acting on today.

SBCAPCD's January 20, 2000 amendments to Rule 330 included these significant changes to its 1995 adopted version:

Generally, SIP rules must be enforceable (see section 110(a) of the Act), must require Reasonably Available Control Technology (RACT) for major sources in nonattainment areas (see section 182(a)(2)(A)), and must not relax existing requirements (see sections 110(l) and 193). The SBCAPCD regulates an ozone nonattainment area (see 40 CFR part 81), so Rule 330 must fulfill RACT.

Guidance and policy documents that we used to define specific enforceability and RACT requirements include the materials listed below.

1. Portions of the proposed post-1987 ozone and carbon monoxide policy that concern RACT, 52 FR 45044, November 24, 1987.

2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations; Clarification to Appendix D of November 24, 1987 Federal Register document,” (Blue Book), notice of availability published in the May 25, 1988 Federal Register .

3. “Control of Volatile Organic Emissions from Existing Stationary Sources Volume VI: Surface Coating of Miscellaneous Metal Parts and Products,” USEPA, June 1978, EPA-450/2-78-015.

We believe this rule is consistent with the relevant policy and guidance regarding enforceability, RACT, and SIP relaxations. On December 3, 1998, EPA gave a limited approval and limited disapproval of Rule 330 identifying several deficiencies within the rule that required correction. The deficiencies identified within EPA's limited disapproval have been either corrected or addressed adequately by the SBCAPCD's January 20, 2000 amendments to Rule 330.

EPA's approval action will incorporate the revised Rule 330 into the federally approved SIP. Our approval action will stop the sanctions process and Federal Implementation Plan clock, which were started on December 3, 1998 when EPA published its limited disapproval action in the Federal Register (see 63 FR 66758.) EPA's TSD provides more information concerning our evaluation.

Our TSD does not describe additional rule revisions recommended for the next time the local agency modifies the rule.

As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted Rule 330 because we believe it fulfills all relevant requirements. We do not think anyone will object to this action, so we are finalizing the approval without proposing it in advance. However, in the Proposed Rules section of this Federal Register , we are simultaneously proposing approval of the same submitted Rule 330. If we receive adverse comments by July 10, 2000, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, this direct final approval will be effective without further notice on August 7, 2000. This final approval will incorporate SBCAPCD Rule 330 into the federally enforceable SIP.

VOCs help produce ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions. Table 2 lists some of the national milestones leading to the submittal of this local agency VOC rule.

Under Executive Order 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. This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. 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 pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). For the same reason, this rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP 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 SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP 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. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), 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. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the 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. 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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 7, 2000. 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 section 307(b)(2).)

This Supplementary Information section is organized as follows:

EPA is approving a revision to Wisconsin's SIP to relax VOC control requirements for Uniroyal.

In the early 1980s Wisconsin adopted Reasonably Available Control Technology (RACT) regulations for the entire state. We approved these regulations and incorporated them into Wisconsin's SIP for ozone. Uniroyal manufactures vinyl coated fabrics and, under these rules, is subject to a limit of 3.8 pounds of VOC per gallon of coating, excluding water, for coatings used on vinyl coating lines.

Our approval of alternate control requirements for Uniroyal exempts the company from the 3.8 pounds of VOC per gallon of coating limit for its vinyl coating lines and requires the following:

1. At least 95% of all vinyl yardage requiring topcoats must be coated with waterborne topcoats on a monthly basis or if the 95% requirement is not met, an incinerator must control emissions to the level that would have been attained had the 95% requirement been met.

2. No more than 65,630 pounds of VOC may be released into the ambient air per month.

3. No more than 5,435 pounds of VOC may be released into the ambient air per day.

4. Specific records and monitoring data must be kept and compliance testing must be performed.

Uniroyal is located in Dane County which is designated as attainment for ozone. The county is, and has been monitoring attainment of both the 1-hour and 8-hour ozone standards. Since 1987, Uniroyal has been operating under a State-approved variance which allows emissions equivalent to the emissions allowed under the SIP revision that we are approving with this action. Consequently, our approval of the alternate control requirements for Uniroyal should not interfere with attainment or continued maintenance of the ozone standard.

Based on the rationale set forth above and in EPA's Technical Support Document, we are approving a revision to the VOC control requirements for Uniroyal Engineered Products. Our approval of this revision makes federally enforceable the State's February 7, 2000, Consent Order AM-99-900, which establishes alternate control requirements for Uniroyal.

We are publishing this action without prior proposal, because we view this as a noncontroversial revision and anticipate no adverse comments. However, in a separate document in this Federal Register publication, we are proposing to approve the State variance should adverse written comments be filed.

This action will be effective August 7, 2000 without further notice unless relevant adverse comments are received by July 10, 2000. If we receive such comments, we will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. We will then address all public comments received in a subsequent final rule based on the proposed action. We will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. If we do not receive comments, this action will be effective August 7, 2000.

Nothing in this action should be construed as permitting or allowing or establishing a precedent for any future implementation plan. Each request for revision to the SIP shall be considered separately in light of specific technical, economic, and environmental factors and in relation to relevant statutory and regulatory requirements.

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

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

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

Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.”

Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

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

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

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

This rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities. Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co. v. U.S. EPA , 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

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

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

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. Section 804, however, exempts from section 801 the following types of rules: rules of particular applicability; rules relating to agency management or personnel; and rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding this action under section 801 because this is a rule of particular applicability.

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 7, 2000. 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.

On October 6, 1997 Arizona submitted a request to redesignate the CO Tucson Air Planning Area (TAPA) nonattainment area to attainment for the NAAQS and for approval of a maintenance plan. EPA found that the TAPA met all the redesignation requirements specified in section 107(d)(3)(E) of the Clean Air Act (CAA) and also that the TAPA was eligible to use the Limited Maintenance Plan (LMP) option provided for in EPA guidance. 1 EPA therefore proposed approval of the request and the maintenance plan on July 22, 1998 (see 63 FR 39258) and provided for a 30-day public comment period.

For a full discussion of EPA's evaluation of the TAPA redesignation request and the maintenance plan, the reader is referred to the original EPA proposal (63 FR 39258, July 22, 1998) and to the Technical Support Document (TSD) accompanying that proposal notice which may be found in the docket on file at the addresses noted above.

EPA received one set of comments during the 30-day comment period provided under the original proposal. Those comments came from the Arizona Center for Law in the Public Interest (ACLPI) in a letter dated August 21, 1998. To respond to the public comments, EPA requested supplementary information from the Pima Association of Governments (PAG) relating to CO emissions projections for the area for the 10-year maintenance period extending through 2010. EPA received the information in a letter from PAG dated June 18, 1999. EPA is responding to ACLPI's comments in section II below. On December 17, 1999 (see 64 FR 70660) EPA reproposed to approve the TAPA redesignation request in order to provide the public with the opportunity to comment on the additional information provided by PAG and on additional issues that had arisen since the original proposal. EPA received no public comments during the 30-day public comment period provided under the reproposal.

EPA has considered all of the comments received from ACLPI on the original proposal and is providing the following responses.

Comment: ACLPI expressed concern that one of the CAA's requirements for redesignation, namely that the improvement in air quality is due to permanent and enforceable reductions, would not be met by the TAPA following redesignation because several Arizona statutes, including the state's auto emission inspection and maintenance program, the oxygenated fuels program and other control measures defined Tucson as “Area B”, a carbon monoxide nonattainment area. ACLPI expressed concern that the area, following redesignation, would no longer be subject to these control measures and said that under the circumstances EPA cannot conclude that the emission reductions from these programs are permanent and enforceable.

Response: The Arizona legislature has acted to amend various Arizona Statutes to expand the definition of Area B to include CO maintenance areas. On May 18, 1999 Arizona Governor Hull signed into law House Bill 2189 which amended Arizona statutes 41-796.01, 41-2121, 49-401.01, 49-402, 49-404, 49-454, 49-541 and 49-571 to ensure continued implementation of committed SIP control measures in maintenance areas.

All of these statutory amendments have been submitted as SIP revisions and EPA in this notice is approving those SIP revisions. On the basis of these statutory amendments, EPA believes that this comment has been adequately addressed.

Comment: ACLPI questioned whether the assumption in the LMP option that an area beginning the maintenance period at or below 85% of exceedance levels will continue to meet the standard for another ten years is applicable to the TAPA, given the growth that is projected for the area.

ACLPI also questioned the LMP guidance waiver of the CAA's requirement for a 10 year maintenance demonstration and also the fact that under a LMP an emissions budget may be treated as essentially not constraining for the length of the maintenance period. ACLPI made the following arguments:

• With regard to the LMP's waiver of the maintenance demonstration, the mere fact that air quality and CO emissions are at or below 85% of exceedance levels does not assure that they will not increase to above exceedance levels in less than 10 years.

• The fact that under the LMP there is no emissions budget test for conformity purposes flagrantly violates EPA's own conformity rules which explicitly apply the emission budget test to all maintenance areas. There is no exception for areas that are at or below 85% of exceedance levels and EPA cannot amend or repeal rules with a guidance document.

• There is no factual or scientific basis for presuming that a motor vehicle emissions budget will not be constraining in a limited maintenance area. The potential for emissions growth has nothing to do with existing CO levels, but is driven by factors such as growth in vehicle miles traveled (VMT), increases in vehicle trips and increased congestion. In the Tucson area, VMT is almost doubling every 20 years, and congestion is expected to significantly worsen. Continued application of conformity rules is vital to ensuring that transportation plans, programs and projects, and federal activities, are consistent with maintenance of CO standards.

Response: The additional information provided by PAG included projections extending to 2010 and 2020 for CO mobile source emissions, vehicle miles traveled (VMT) and population growth, as well as information on ambient air CO concentrations for the years 1990 through 1998. That information is contained in Tables 1 and 2 below. The full text of the PAG letter and details on the sources used for these projections are in the TSD accompanying the reproposal notice, which may be found in the docket for this document.

EPA has reviewed the additional information provided by PAG and, based on that data, has come to the following conclusions:

• Although there are projected increases in population and vehicle miles traveled (VMT), the data indicates that CO emissions will drop from 444.8 tons per day in 1990 to 367.2 in 2010, rising again to a projected 428.7 tons per day in 2020 which is still below 1990 levels. In summary, despite the projected growth in population and VMT, CO mobile source emissions in the TAPA will continue to decrease. The decrease in projected CO emissions can be attributed to existing control measures and the impacts of other programs that were not included in the Mobile model used by PAG in preparing these projections including the Pima Travel Reduction, Rideshare and Traffic Signal Coordination programs. In addition it may be anticipated that national mobile source control programs that will take effect in the future will play a role in reducing CO emissions from mobile sources.

• According to data contained in Table 2, the design value for the Tucson area for 1993-1995 was 6.0 or 67% of the NAAQs standard for CO. The design value is the second highest eight-hour concentration observed at any site in the area. The data also indicated that the design value for the years 1996 through 1998 dropped to 5.1 or 57% of CO NAAQS. EPA believes that these design values provide an ample margin of safety and time to take action in the event of a possible violation of the CO NAAQS in the future.

• EPA reviewed the projected CO mobile source emissions, VMT and population values and the corresponding design values for the years 1990 through 1999 and concluded that it would be reasonable to assume that the future relationship of these four elements would be comparable through 2010.

• The control measures contained in the TAPA maintenance plan are currently mandated by federal and state statutes and are permanent and enforceable. They include the Federal Motor Vehicle Control program, the State Inspection and Maintenance program and the State Oxyfuels program. The Arizona legislature has amended the statutes that had defined Tucson as a nonattainment area to ensure continued implementation of SIP control measures following redesignation to attainment. In addition, the Arizona legislature has amended the statutes pertaining to the State's Vehicle Emission and Inspection Program (VEIP) to assure continuation of the program through December 31, 2008. With regard to the VEIP sunset date of 2008, which is two years short of the ten-year maintenance period, in a letter to EPA dated August 23, 1998, the Arizona Department of Environmental Quality (ADEQ) states that Arizona Revised Statutes 41-2955 limits to ten years the existence of a program before it undergoes a sunset review and therefore the VEIP has been extended for the maximum time allowed under this statute, i.e. , ten years. The letter supplies a recent history of legislative changes to the VEIP, concluding that “The VEIP has consistently received support for necessary program updates from the Legislature.” EPA therefore believes that on the basis of this legislative history, it is reasonable to assume that the program will be extended when it expires in 2008. The full text of the letter from ADEQ is attached to the TSD accompanying the reproposal.

• The maintenance plan for the TAPA contains a pre-violation action level trigger which would set in motion a process designed to forestall a future violation of the CO NAAQS. Under the plan, a pre-violation action level would be reached when two verified 8-hour average concentrations in excess of 85% of the CO NAAQS occurred at any one monitor site in any CO season. When this criterion is reached, it would trigger field studies and technical evaluations and recommendations for implementation of contingency measures.

• With regard to the ACLPI's comments that: (1) The LMP policy flagrantly violates EPA's own conformity rules which explicitly apply the emission budget test to all maintenance areas; and (2) that the rule does not provide an exception for areas that are at or below 85% of exceedance levels, EPA's conformity policy has clearly provided for opportunities for a SIP to demonstrate that no budget is needed (see Transportation Conformity Rule, 61 FR 36118, July 9, 1996, paragraph B, finalized on August 15, 1997, 62 FR 43780). This section addresses this question and mentions limited maintenance plans specifically. The policy states that areas must meet budgets that the SIP identifies, but if the SIP adequately justifies that no budget is necessary, then no regional emissions test is necessary.

Comment: ACLPI contends that under section 175(A)(a) of the CAA a maintenance plan must “provide for” and “ensure” maintenance for at least 10 years. ACLPI said that EPA's LMP is based on mere speculation and neither provides for, nor ensures, maintenance for ten years and is therefore contrary to the CAA.

Response: The LMP guidance provides the rationale for the policy. It states that “EPA believes it is justifiable and appropriate to apply a different set of maintenance plan requirements to nonclassifiable CO nonattainment areas whose monitored air quality is equal to or less than 85% of exceedance levels of the CO NAAQs. The EPA does not believe that the full maintenance plan requirements need be applied to these areas because they have achieved air quality levels well below the standard without the application of control measures required by the Act for moderate and serious nonattainment areas. Also, these areas do not have either a recent history of monitored violations of the CO NAAQS or a long prior history of monitored air quality problems. EPA believes that the continued applicability of prevention of significant deterioration (PSD) requirements, any control measures already in the SIP, and Federal measures (such as the Federal motor vehicle control program) should provide adequate assurance of maintenance for these areas.”

EPA therefore believes that the LMP guidance considered the requirements of 175(A)(a) of the CAA, and interpreted those requirements in a manner consistent with the Act.

Comment: ACLPI expressed concern over the lack of clear commitments to address actual violations of the CO standards. According to ACLPI, the plan notes that state law gives ADEQ the option of reducing fuel volatility levels and raising fuel oxygen content, but there is no clear commitment from the state to take either of these steps if a violation occurs. The plan also lists various potential control measures that might be adopted to address future CO violations, but does not commit to any of them.

ACLPI asked EPA to seek clarification from the state and PAG that they are committed to adopt whatever additional controls are necessary to correct an actual violation, and to implement such controls by the start of the next CO season after the violation occurs. ACLPI claimed that without such clarification the plan will not satisfy the requirements of section 175A(d) to assure that any CO violation will be promptly corrected.

Response: As requested, EPA sought clarification from PAG as to whether they are committed to adopt whatever additional controls are necessary to correct an actual violation of the CO NAAQS, and to implement such controls by the start of the next CO season after the violation occurs. The following is a summary of the points made in the PAG response, dated November 19, 1998. The full text is contained in the TSD accompanying the reproposal notice.

• The TAPA CO LMP was designed to set evaluation triggers at a point where any violation of the CO NAAQS could be anticipated at least 5 years ahead of time. This would give enough time to fully evaluate the risk of violation and the best control measures to address any projected violations of the standard.

• The TAPA CO LMP provides that in the event of an exceedance (which must always precede a violation) the evaluation and implementation process described in the Plan will be triggered. The most likely control measure for immediate response is high oxygen requirement in the oxyfuels program that can be implemented no later than the following CO season.

• The TAPA plan provides that if the PAG finding indicates a probable violation of the CO NAAQS within 5 years, the recommended control measures to fully mitigate the projected violation must be initiated by the start of the next CO season after the violation occurs. EPA believes that the clarification of this issue provided by PAG is an adequate response to the ACLPI comment.

In summary, EPA considered the population growth and CO emissions projections provided by the PAG and the summary of the area's design values over the past few years and believes that the data, in conjunction with the pre-violation action triggers and the contingency measures provided for in the TAPA maintenance plan, provide reasonable assurance that the area will not violate the CO NAAQS during the maintenance period. EPA is therefore taking final action to approve the redesignation of the TAPA to attainment for the CO NAAQS and for approval of the maintenance plan on the grounds that the area meets the requirements for redesignation specified under the Clean Air Act, and that the TAPA is qualified to utilize the LMP option.

In this action EPA is approving the following SIP revisions relating to changes that were made in various Arizona statutes:

Amendments to A.R.S. 41-2083, 41-2122 and 41-2125 relating to the State's oxyfuels program in the Tucson area both as SIP revisions and as control measures in the maintenance plan to be implemented in the event of a probable or actual violation of the CO NAAQS in the TAPA. The SIP revision for these statutory amendments were submitted to EPA as part of the TAPA maintenance plan on October 6, 1997 and were found complete by operation of law on April 6, 1998.

Amendments to A.R.S. 49-401 and 49-406 which expand the authority of State and local certified metropolitan planning organizations to develop plans and to implement and enforce control measures for attainment as well as maintenance areas as required by section 110(a)(2)(E) of the CAA. Previous to those statutory amendments, those statutes referred only to nonattainment areas. These amendments were signed into law on May 29, 1998. They were submitted as a SIP revision on August 20, 1998 and were found complete by operation of law on February 20, 1999.

Amendments to A.R.S. 41-796.01, 41-2121, 49-401.01, 49-402, 49-404, 49-454, 49-541 and 49-571 revised the definition of the TAPA nonattainment area” to reflect continued application of all pertinent control measures in the TAPA following redesignation to attainment. Prior to these amendments, these statutes referred to the TAPA as Area B, a “carbon monoxide nonattainment area”. These amendments were signed into law on May 18, 1999. SIP revisions containing these statutory amendments were submitted to EPA on September 1, 1999 and were found to be complete on October 20, 1999.

Amendments to A.R.S. 41-3009.01, 49-541.01, 49-542, 49-545, 49-557, 49-573, 41-803, and 41-401.01 which were signed into law on May 18, 1999 relate to the continued implementation of the State's Vehicle Emissions Inspection Program (VEIP) through December 31, 2008. The SIP revisions containing these statutory amendments were submitted to EPA on September 1, 1999 and were found to be complete on October 20, 1999.

EPA is approving the Emissions Inventory for the base year 1994 contained in the LMP as meeting the requirements of section 172(c)(3) of the CAA.

EPA is approving the TAPA CO maintenance plan because it meets the requirements set forth in section 175A of the CAA and the requirements of the LMP option contained in EPA guidance of October 6, 1995.

EPA is taking final action to remove the Agency's disapprovals (56 FR 5459, February 11, 1991) of the attainment demonstration and contingency measures that were contained in the 1988 Arizona CO SIP revision for Pima County. Those disapprovals were based on the finding of the Ninth Circuit Court of Appeals on March 1, 1990 in Delaney vs. EPA , 898 F.2d 687, that the Arizona CO plans for Maricopa and Pima Counties did not fully comply with the Clean Air Act as amended in 1977, and with EPA guidance issued pursuant to that law. (See 46 FR 7182, January 21, 1981). In vacating EPA's 1988 approval of the Arizona plans, the court determined that they did not contain sufficient control measures to attain the CO ambient air quality standard as soon as possible. The Court did not say that the measures submitted by the State were unworthy of approval for their effect in strengthening the SIP.

EPA is taking final action to remove the attainment demonstration disapproval because the TAPA has not had an exceedance of the CO NAAQS from 1988 to the present, and, therefore, the original reason for the disapproval, namely that the plan did not contain sufficient control measures to attain the CO ambient air quality standard as soon as possible, is no longer applicable.

EPA is also taking final action to remove the disapproval of the 1988 CO plan contingency measures. That disapproval was based on non-compliance with the EPA guidance of January 21, 1981. (46 FR 7182, January 21, 1981) That guidance has since been superseded by new guidance, specifically the section on the contingency provisions for not-classified CO nonattainment areas contained in the General Preamble (See 57 FR 13535, April 16, 1992). The contingency provisions contained in the TAPA Limited Maintenance Plan are in compliance with the guidance provided both in the General Preamble and in the Limited Maintenance Plan Policy Guidance.

Finally, EPA is approving Arizona's request for the redesignation to attainment of the CO NAAQS for the Tucson Air Planning Area.

Under Executive Order 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. This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. 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 pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). For the same reason, this rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP 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 SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP 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. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), 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. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the 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. 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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 7, 2000. 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 section 307(b)(2).)

This section provides additional information by addressing the following questions:

The CAA Amendments of 1990 required all States to develop operating permit programs that met certain Federal criteria. In implementing the operating permit programs, the States require certain sources of air pollution to obtain permits that contain all applicable requirements under the CAA. The focus of the operating permit program is to improve enforcement by issuing each source a permit that consolidates all of the applicable CAA requirements into a Federally enforceable document. By consolidating all of the applicable requirements for a facility, the source, the public, and the permitting authorities can more easily determine what CAA requirements apply and how compliance with those requirements is determined.

Sources required to obtain an operating permit under this program include: “major” sources of air pollution and certain other sources specified in the CAA or in EPA's implementing regulations. For example, all sources regulated under the acid rain program, regardless of size, must obtain operating permits. Examples of major sources include those that have the potential to emit 100 tons per year or more of volatile organic compounds, carbon monoxide, lead, sulfur dioxide, nitrogen oxides, or particulate matter (PM 10 ); those that emit 10 tons per year of any single hazardous air pollutant (specifically listed under the CAA); or those that emit 25 tons per year or more of a combination of hazardous air pollutants (HAPs). In areas that are not meeting the National Ambient Air Quality Standards for ozone, carbon monoxide, or particulate matter, major sources are defined by the gravity of the nonattainment classification. For example, in ozone nonattainment areas classified as serious, such as the metropolitan Atlanta area in Georgia, major sources include those with the potential of emitting 50 tons per year or more of volatile organic compounds or nitrogen oxides.

Where an operating permit program substantially, but not fully, met the criteria outlined in the implementing regulations codified at 40 Code of Federal Regulations (CFR) part 70, EPA granted interim approval contingent on the State revising its program to correct the deficiencies. Because Georgia's operating permit program substantially, but not fully, met the requirements of part 70, EPA granted interim approval to the program in a rulemaking published on November 22, 1995 (60 FR 57836). The interim approval notice stipulated three conditions that had to be met in order for Georgia's program to receive full approval. Georgia submitted revisions to its interimly approved operating permit program on March 10, 1997, February 11, 1998, September 30, 1999, November 15, 1999, and January 11, 2000. This document describes the changes that have been made in Georgia's operating permit program.

One condition for full approval of Georgia's operating permit program was a rule revision to require that operating permits contain terms and conditions allowing for the trading of emissions changes within the facility. These emissions trades are solely for the purpose of complying with a Federally-enforceable emissions cap in accordance with 40 CFR 70.4(b)(12)(iii). Moreover, the permittee must provide written notification to EPA at least seven (7) days in advance of any change to the permit, and the written notification must state when the change will occur and describe the changes in emissions that will result and how these increases and decreases in emissions will comply with the terms and conditions of the permit. Georgia took action in December 1997 to include these requirements in Rule 391-3-1-.03(10)(d)1.(ii) and submitted the final State-effective rule changes to EPA on February 11, 1998.

Another condition for full approval of Georgia's operating permit program was a rule revision to ensure that the permit shield provision in 40 CFR 70.6(f) would apply to any changes in emissions resulting from emissions trading within a facility solely for the purpose of complying with a Federally-enforceable emissions cap. The revised Rule 391-3-.03(10)(d)1.(ii) containing this provision was submitted to EPA on February 11, 1998.

The third, and final, condition for full approval of Georgia's operating permit program was correction of the deficient insignificant activities provisions in the State's rules. One deficiency concerned the exemption of insignificant activities from permit requirements. While the State has considerable discretion regarding the degree of monitoring, recordkeeping and reporting required for insignificant activities, these units cannot be categorically exempted from title V permitting requirements. Moreover, Georgia's rules did not make the distinction between activities which could be omitted from permit applications and those that were considered to be insignificant but were still required to be included in the application.

In response to this interim approval issue, the State revised its approach to insignificant activities by adding Rule 391-3-1-.03(10)(g), which identifies specific insignificant activities that must be included in the permit application. Moreover, rule revisions were made to eliminate the exemption from permitting requirements for insignificant activities. The final State-effective rule changes were submitted to EPA on February 11, 1998.

Georgia made additional program changes after the interim approval became effective on December 22, 1995. The State revised its title V permit application form to address the title VI requirements for stratospheric ozone and to incorporate the flexibility described in the EPA's July 10, 1995 guidance memorandum entitle “White Paper for Streamlined Development of Part 70 Permit Applications” (White Paper). The revised form was submitted to EPA on March 10, 1997 and is available for review on Georgia's Web site at www.dnr.state.ga.us/dnr/environ . The revised form incorporated the following aspects of the White Paper:

(1) The White Paper allowed industry to submit checklists, rather than emission descriptions, for insignificant activities based on size or production rate. As a result, Georgia included several different categories of insignificant activities in checklist format in section 4.10 of the permit application form. Georgia also removed the requirement for detailed information regarding air pollution control devices, since this information is requested in the preconstruction permit application.

(2) The White Paper allowed for group treatment of emissions units subject to the broadly applicable requirements that are often found in State Implementation Plans (SIPs). The State, therefore, created section 4.20 of the application form to group emissions units and activities that were subject to the following four State rules that are generic SIP requirements: Rule 391-3-1-.02(2)(b) entitled “Visible Emissions,” Rule 391-3-1-.02(2)(d) entitled “Fuel-burning Equipment,” Rule 391-3-1-.02(2)(e) entitled “Particulate Emissions from Manufacturing Process,” and Rule 391-3-1-.02(2)(n) entitled “Fugitive Dust.”

(3) The White Paper allowed for the generic treatment of short-term activities, so the State developed section 4.40 to address those activities that occur infrequently or for short durations.

(4) The White Paper identified a number of trivial activities that could be excluded from permit applications, so Georgia included a similar list in the instructions for its permit application form.

(5) The White Paper allows industry to provide descriptions, rather than estimates, for emissions not regulated at the source, unless such estimates were needed for other purposes such as calculating permit fees. As a result, the State developed sections 2.10 and 2.20 of its permit application form to only require estimates of facility-wide potential and anticipated actual emissions in tons per year. All significant facility emissions are still required to be listed by pollutant in section 7.10.

(6) The white Paper provided that where an emissions unit is subject to a specific standard, the emissions data could be reported in the units of that standard. Georgia revised its permit application form accordingly.

(7) In order to reduce the size and cost of preparing title V permit applications, the White Paper allowed for the submittal of sample calculations to illustrate the methodology used. As a result, the State revised its permit application form to require the submittal of sample calculations to support the emissions summary information contained in section 7.10

The other programmatic change made by Georgia involves the mechanism for determining the annual title V fee amount. The State's operating permit program received interim approval based on use of the “presumptive minimum” described in 40 CFR 70.9(b)(2)(i), but Georgia has been using a mechanism based on 40 CFR 70.9(b)(1) since September 1997. This mechanism involves establishing a fee schedule that results in the collection and retention of revenues sufficient to cover the costs of the operating permit program. To accomplish this, the State develops a biennial budget projection of title V program costs and adjusts the fee amount accordingly. Georgia described its revised mechanism for assessing fees in a letter to EPA dated January 11, 2000. The State submitted a fee program update on September 30, 1999 demonstrating that its operating permit program is adequately funded by operating permit fees.

The State of Georgia has fulfilled the conditions of the interim approval granted on November 22, 1995, so EPA is taking final action to fully approve the State's operating permit program. EPA is also taking action to approve other program changes made by the State since the interim approval was granted.

EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial amendment 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 grant final full approval should adverse comments be filed. This action will be effective August 7, 2000 unless the Agency receives adverse comments by July 10, 2000.

If EPA receives such comments, then EPA will withdraw the final rule and inform the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. 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 7, 2000 and no further action will be taken on the proposed rule.

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

As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), 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. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the 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. 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.) .

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

This rule is not subject to Executive Order 13045 because it is not an economically significant regulatory action as defined in Executive Order 12866, and it does not involve decisions intended to mitigate environmental health or safety risks.

Under Executive Order 13084, Consultation and Coordination with Indian Tribal Governments, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.”

Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

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

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

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

This rule will not have a significant impact on a substantial number of small entities because part 70 approvals under section 502 of the Act do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because this approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of a flexibility analysis would constitute Federal inquiry into the economic reasonableness of State action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co., v. U.S. EPA , 427 U.S. 246, 255-266 (1976); 42 U.S.C. 7410(a)(2).

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

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 7, 2000. 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 section 307(b)(2).)

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

In reviewing operating permit programs, 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 VCS, SPA has no authority to disapprove an operating permit program for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews an operating permit program, to use VCS in place of an operating permit program that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of NTTAA do not apply.

This section provides additional information by addressing the following questions:

The CAA Amendments of 1990 required all states to develop operating permit programs that met certain Federal criteria. In implementing the operating permit programs, the states require certain sources of air pollution to obtain permits that contain all applicable requirements under the CAA. The focus of the operating permit program is to improve enforcement by issuing each source a permit that consolidates all of the applicable CAA requirements into a Federally enforceable document. By consolidating all of the applicable requirements for a facility, the source, the public, and the permitting authorities can more easily determine what CAA requirements apply and how compliance with those requirements is determined.

Sources required to obtain an operating permit under this program include “major” sources of air pollution and certain other sources specified in the CAA or in EPA's implementing regulations. For example, all sources regulated under the acid rain program, regardless of size, must obtain operating permits. Examples of major sources include those that have the potential to emit 100 tons per year or more of volatile organic compounds, carbon monoxide, lead, sulfur dioxide, nitrogen oxides, or particulate matter (PM 10 ); those that emit 10 tons per year of any single hazardous air pollutant (specifically listed under the CAA); or those that emit 25 tons per year or more of a combination of hazardous air pollutants (HAPs). In areas that are not meeting the National Ambient Air Quality Standards for ozone, carbon monoxide, or particulate matter, major sources are defined by the gravity of the nonattainment classification. For example, in ozone nonattainment areas classified as serious, major sources include those with the potential of emitting 50 tons per year or more of volatile organic compounds or nitrogen oxides.

Nashville-Davidson County made two changes to its approved title V program since EPA granted full approval on February 14, 1996 (see 61 FR 5705). This document describes the changes.

Nashville-Davidson County revised its title V permit application form to address the Title VI requirements for protection of the stratospheric ozone layer. The County's application form now contains Form APC V.34 for information regarding air conditioning units that use chlorofluorocarbons, hydrochlorofluorocarbons, or other ozone depleting substances. The new form was submitted to EPA on December 10, 1996 and is available for review on the Internet at http://healthweb.nashville.org/pollution_downloads.html.

The other programmatic change made by Nashville-Davidson County involves the mechanism for determining the annual title V fee amount. The County's operating permit program received full approval based on use of the “presumptive minimum” described in 40 CFR 70.9(b)(2)(i). But, since the spring of 1997, the County has been using a mechanism based on 40 CFR 70.9(b)(1) which involves establishing a fee schedule that results in the collection and retention of revenues sufficient to cover the costs of the operating permit program. To accomplish this each year, the County prepares a projection of the title V expenses for the coming year based on the actual title V expenses during the previous year. The anticipated expenses are then compared with the revenue that would be generated based on section 10.56.080, “Permit and Annual Emission Fees,” of Chapter 10.56, “Air Pollution Control,” of the Metropolitan Code of Laws. If the fee schedule contained in section 10.56.080 would result in a surplus, then the County adopts a lesser fee schedule utilizing the variance procedures in section 10.56.130. The County described this policy in a letter to EPA dated December 6, 1999. The County also submitted a fee program update on August 27, 1999 demonstrating that its part 70 program is adequately funded by operating permit fee revenue.

The Metropolitan Government of Nashville-Davidson County made two changes to its approved title V program after it received full approval on February 14, 1996 and EPA is taking action by this notice to approve the changes. EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial amendment 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 grant final full approval should adverse comments be filed. This action will be effective August 7, 2000 unless the Agency receives adverse comments by July 10, 2000.

If EPA receives such comments, then EPA will withdraw the final rule and inform the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. 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 7, 2000 and no further action will be taken on the proposed rule.

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

As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), 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. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the 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. 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. ).

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

This rule is not subject to Executive Order 13045 because it is not an economically significant regulatory action as defined in Executive Order 12866, and it does not involve decisions intended to mitigate environmental health or safety risks.

Under Executive Order 13084, Consultation and Coordination with Indian Tribal Governments, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.”

Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

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

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

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

This rule will not have a significant impact on a substantial number of small entities because part 70 approvals under section 502 of the Act do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because this approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of a flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

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

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 7, 2000. 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 section 307(b)(2).)

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

In reviewing operating permit programs, 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 VCS, EPA has no authority to disapprove an operating permit program for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews an operating permit program, to use VCS in place of an operating permit program that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of NTTAA do not apply.

The rule, “Organobromine Production Wastes; Identification and Listing of Hazardous Waste; Land Disposal Restrictions; Listing of CERCLA Hazardous Substances, Reportable Quantities,” was issued in the Federal Register at 63 FR 24596 (May 4, 1998). The rule vacating the listing determination for organobromine production wastes was issued in the Federal Register at 65 FR 14472 (March 17, 2000). The rule, “Hazardous Waste Management System; Identification and Listing of Hazardous Waste; Petroleum Refining Process Wastes; Land Disposal Restrictions for Newly Identified Wastesa; and CERCLA Hazardous Substance Designation and Reportable Quantities,” was issued the Federal Register at 63 FR 42110 (August 6, 1998). EPA will keep the official records for these actions in paper form. The official records are the paper records maintained at the address in the ADDRESSES section.

On March 17, 2000 EPA published a final rule announcing the vacature of regulatory provisions governing the identification of certain wastes listed as hazardous. In that final rule, EPA amended its regulations to conform with an order issued by the United States Court of Appeals for the District of Columbia Circuit (D.C. Cir.) in Great Lakes Chemical Corporation v. EPA (No. 98-1312). That court order vacated Agency regulations listing certain organobromine wastes as hazardous wastes under the Resource Conservation and Recovery Act (RCRA). The hazardous waste listing determinations that were vacated by the court and deleted from the regulations in the March 17, 2000 final rule included the wastes listed as K140 and U408. The effect of vacating the hazardous waste listing determination for these wastes was to clarify that these two wastestreams are not subject to the hazardous waste management and treatment standards under RCRA, as well as not subject to emergency notification requirements for releases of hazardous substances to the environment.

On August 6, 1998, EPA amended the regulations for hazardous waste management under RCRA to list as hazardous four wastes generated by the petroleum refining industry. The effect of the final rule was to subject the four wastes to stringent management and treatment standards under RCRA and to emergency notification requirements for releases of hazardous substances to the environment. As part of this final regulation, the Agency also amended the existing listing description for hazardous waste code F037 in 40 CFR 261.31. The intent of the amendment was to clarify that residuals generated from processing or recycling oil-bearing hazardous secondary materials (which are excluded from the definition of solid waste due to the newly promulgated exclusion at 40 CFR 261.4(a)(12)(i)) that are not returned to refinery operations and would otherwise meet a listing under subpart D of 40 CFR part 261, were to be designated as F037 listed wastes when disposed of or intended for disposal. However, the amending language included in the August 6, 1998 FR document included a typographical error that made the intent of the amendment unclear.

In the March 17, 2000 final rule vacating the hazardous waste listings for K140 and U408, EPA inadvertently removed and reserved paragraph (f) of 40 CFR 148.18. The Agency should have removed and reserved paragraph (h) of 40 CFR 148.18. Paragraph (h) of 40 CFR 148.18 is the provision prohibiting the underground injection of K140 and U408. Today, EPA is correcting this error by reinstating paragraph (f) and removing and reserving paragraph (h) of 40 CFR 148.18.

In addition, in the March 17, 2000 final rule, EPA neglected to delete the reference to U408 in appendix VII of 40 CFR part 268. Today, EPA is deleting the reference to U408 in appendix VII to 40 CFR part 268.

In the August 6, 1998 final rule, a typographical error appeared in the amended listing description for hazardous waste code F037. Today, EPA is revising the listing description for hazardous waste code F037 in 40 CFR 261.31(a) to reflect the Agency's original intent of the amendment, as described in the preamble to the August 6, 1998 final rule.

The Administrative Procedure Act generally requires agencies to provide prior notice and opportunity for public comment before issuing a final rule (5 U.S.C. 553(b)). Rules are exempt from this requirement if the issuing agency finds for good cause that notice and comment are unnecessary (5 U.S.C. 553(b)(3)(B)).

EPA has determined that providing prior notice and opportunity for comment on today's notice that corrects regulations amending the RCRA hazardous waste management requirements to comply with the court decision vacating the hazardous waste listing determinations for waste codes K140 and U408, is not necessary. The regulations are no longer legally in effect by order of the federal court of appeals. Thus, amending the hazardous waste regulations has no legal impact and only states the current legal status of the rules.

For the same reasons stated above, EPA believes there is good cause for making the amending regulations immediately effective. (See 5 U.S.C. 553(d))

Today's amendments to the RCRA hazardous waste management regulations only correct errors in Federal Register documents issued on March 17, 2000 and August 6, 1998. These corrections have no regulatory impact, and do not impose annual costs of $100 million or more. Therefore, this action is not a “significant” regulatory action, as defined by Executive Order 12866, and is not subject to review by the Office of Management and Budget. In addition, the amending regulations promulgated today will have no effect on small entities. This is evidenced by the fact that today's rule only corrects errors in the CFR. There is no impact on public or private entities, or on state, local, and tribal governments. Because the rule will not have a “significant” economic impact on small entities, a regulatory flexibility analysis is not required. Also, this final rule is not subject to the Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. Today's rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3510 et seq. ).

Today's action will have no impact upon state, local, and tribal governments, or on the private sector. The amending regulations promulgated today reflect current law, there will be no legal impact on public or private entities. Therefore, today's rule is not subject to the provisions of sections 202, 204 or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

For the same reasons stated above, this rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

This rule does not involve technical standards; thus, the requirements of section 12(c) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), 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. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the 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.

Today's final rule will have no effect upon minority and/or low-income populations. Therefore, today's rule is not subject to Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations.”

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

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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under “FOR FURTHER INFORMATION CONTACT.”

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person . The Agency has established an official record for this action under docket control number OPP-301004. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

EPA, on its own initiative, in accordance with sections 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for the combined residues of the insecticide imidacloprid, in or on stone fruit at 1.0 part per million (ppm) and the processed commodity prunes at 3.5 ppm. These tolerances will expire and are revoked on December 31, 2001. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations.

Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18-related tolerances to set binding precedents for the application of section 408 and the new safety standard to other tolerances and exemptions.

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) 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) 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. . . .”

Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

There are two situations that have arisen, resulting in the present emergency condition. First, currently there are no reliable insecticides to control the green peach aphid (GPA) on peaches and nectarines because of insecticide resistance. Second, aphids are a vector for Plum Pox Virus (PPV), a disease that damages the fruits of sensitive cultivars of stone fruits. The mechanism by which aphids transmit PPV is called non- persistent transmission. Once an aphid probes into infected plant tissue and acquires the virus, the virus can only remain infectious and be transmitted for a short period of time (minutes). Each aphid must feed directly on an infected plant, acquire sufficient virus, and then fly immediately to the next plant in order to effect a transmission.

PPV was discovered for the first time in the United States in 18 stone fruit orchards in Adams County, Pennsylvania in the fall of 1999. Indications are that PPV has been in Pennsylvania for several years, and it is possible that undetected infections of PPV exist in peach and nectarine orchards in New Jersey, New York, and West Virginia. EPA has authorized under FIFRA section 18 the use of imidacloprid on stone fruit for control of aphids in New Jersey, New York, Pennsylvania and West Virginia. After having reviewed the submissions, EPA concurs that emergency conditions exist for these states.

As part of its assessment of these emergency exemptions, EPA assessed the potential risks presented by residues of imidacloprid in or on stone fruit. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerances under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on each emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6). Although these tolerances will expire and are revoked on December 31, 2001, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on stone fruit after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether imidacloprid meets EPA's registration requirements for use on stone fruit or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of imidacloprid by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any State other than New Jersey, New York, Pennsylvania, and West Virginia to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for imidacloprid, contact the Agency's Registration Division at the address provided under “FOR FURTHER INFORMATION CONTACT.”

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 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), 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 imidacloprid and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a time-limited tolerance for combined residues of imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all expressed as parent in or on stone fruit at 1.0 ppm and prunes 3.5 ppm. EPA's assessment of the dietary exposures and risks associated with establishing these tolerances follows.

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 this unit.

Only acute and chronic dietary endpoints were defined. The 10x FQPA factor was reduced to 3x for acute and chronic exposure, and applies to all population subgroups.

1. Acute toxicity . The acute reference dose (RfD) is 0.42 milligram/kilogram body weight/day (mg/kg bwt/day) based on a lowest observed adverse effect level (LOAEL) of 42 mg/kg bwt/day based on decreased motor activity in female rats. An additional 3x FQPA factor was incorporated for all population subgroups to account for neurotoxicity, structure-activity concerns and lack of a no observed adverse effect level (NOAEL). The acute population adjusted dose (aPAD), which is the reference dose (RfD/3) was calculated to be 0.14 mg/kg bwt/day. Acceptable acute dietary exposure (food plus water) of 100% or less of the aPAD is required for all population subgroups.

2. Short- and intermediate-term toxicity . Dermal and inhalation short- and intermediate-term risk assessments are not required for imidacloprid as dermal and inhalation exposure endpoints were not identified due to the demonstrated absence of toxicity; however, because imidacloprid is registered for use on turf, home gardens and pets, EPA has identified potential short-term oral exposures to children for these uses.

A short-term oral endpoint was not identified for imidacloprid. According to current EPA policy, if an oral endpoint is needed for short-term risk assessment (for incorporation of food, water, or oral hand-to-mouth type exposures into an aggregate risk assessment), the acute oral endpoint (LOAEL = 42 mg/kg bwt/day) will be used to incorporate the oral component into aggregate risk.

3. Chronic toxicity . EPA has established the RfD for imidacloprid at 0.057 milligrams/kilograms/day (mg/kg/day). This RfD is based on increased number of thyroid lesions at the LOAEL of 16.9/24.9 mg/kg bwt/day (males and females, respectively). An additional 3x FQPA factor was used for all population subgroups. The chronic population adjusted dose (cPAD), which is the RfD/3, was calculated to be 0.019 mg/kg bwt/day. Acceptable chronic dietary exposure (food plus water) of 100% or less of the cPAD is required for all population subgroups.

4. Carcinogenicity . Imidacloprid has been classified by the Agency as a Group E chemical, no evidence of carcinogenicity for humans, thus, a cancer risk assessment is not required.

1. From food and feed uses . Tolerances, some time-limited, are currently established (40 CFR 180.472) for the combined residues of the insecticide imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all expressed as parent, in or on a variety of raw agricultural and animal commodities at levels ranging from 0.02 ppm in eggs to 15 ppm in raisins, waste. Risk assessments were conducted by EPA to assess dietary exposures and risks from imidacloprid as follows:

i. Acute exposure and risk . 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 1-day or single exposure. In conducting the acute dietary (food) risk assessment, EPA used the Theoretical Maximum Residue Contribution (TMRC) which assumes tolerance level residues and 100% crop-treated (Tier 1). The analysis evaluates individual food consumption as reported by respondents in the USDA Continuing Surveys of Food Intake by Individuals conducted in 1989 through 1992. The model accumulates exposure to the chemical for each commodity and expresses risk as a function of dietary exposure. Resulting exposure values (at the 95th percentile) and percentage of aPAD utilized ranged from 23% for the U.S. population to 45% for children 1-6 years old.

ii. Chronic exposure and risk . In conducting the chronic dietary (food only) risk assessment, EPA used: Tolerance level residues for imidacloprid and percent crop- treated (PCT) information for some of these crops.

The analysis evaluates individual food consumption as reported by respondents in the USDA Continuing Surveys of Food Intake by Individuals conducted in 1989 through 1992. The percentages of cPAD consumed for the general population and subgroups of interest ranged from 11% for nursing infants < 1 year old to 51% for children 1-6 years old.

Section 408(b)(2)(F) 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.

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 PCT as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency used PCT information as follows.

The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. EPA uses a weighted average PCT for chronic dietary exposure estimates. This weighted average PCT 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 PCT 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 PCT over a lifetime. For acute dietary exposure estimates, EPA uses an estimated maximum PCT. The exposure estimates resulting from this approach reasonably represent the highest levels to which an individual could be exposed and are unlikely to underestimate an individual's acute dietary exposure. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimated. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulation 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. From drinking water . There is no established Maximum Contaminant Level for residues of imidacloprid in drinking water. No health advisory levels for imidacloprid in drinking water have been established.

Imidacloprid is persistent, water soluble, and fairly mobile. Thus, residues of imidacloprid may be transported to both surface and ground waters. As a condition of registration, the Agency is requiring the submission of the results of two prospective ground water monitoring studies. Results from these studies are not yet available.

i. Acute exposure and risk . Estimated concentrations of imidacloprid in surface and ground water used for the acute exposure analysis were 4.1 and 1.1 micrograms per liter ( m g/L) (parts per billion (ppb)), respectively. These estimated concentrations of imidacloprid in surface and ground water were based upon an application rate of 0.5 lbs active ingredient/acre/year (ai/acre/year).

For purposes of risk assessment, the estimated maximum concentration for imidacloprid in surface and ground waters (which is 4.1 m g/L) should be used for comparison to the back-calculated human health drinking water levels of concern (DWLOCs) for the acute endpoint. The DWLOCs ranged from 800 m g/L for children 1-6 years old to 3,900 m g/L for the U.S. population. These figures are well above the drinking water estimate concentration (DWEC) of 4.1 m g/L.

ii. Chronic exposure and risk . Estimated concentrations of imidacloprid in surface and ground water for chronic exposure analysis were 0.1 and 1.1 m g/L (ppb), respectively. These estimated concentrations of imidacloprid in surface and ground water were based upon an application rate of 0.5 lbs ai/acre/year.

For purposes of chronic risk assessment, the estimated maximum concentration for imidacloprid in ground waters (which is 1.1 m g/L) should be used for comparison to the back-calculated human health DWLOCs for the chronic (non-cancer) endpoint. The DWLOCs ranged from 90 m g/L for children 1-6 years old to 490 m g/L for the U.S. population. These figures are well above the DWEC of 1.1 m g/L.

3. From non-dietary exposure . Imidacloprid is currently registered for use on the following residential non-food sites: ornamentals (e.g., flowering and foliage plants, ground covers, turf, lawns) tobacco, golf courses, walkways, recreational areas, household or domestic dwellings (indoor/outdoor), and cats/dogs.

i. Acute exposure and risk . Occupational/residential exposure risk assessments (namely, short-term dermal, intermediate-term dermal, long-term dermal, and inhalation) are not required owing to the demonstrated absence of dermal and inhalation toxicity.

ii. Chronic exposure and risk . Occupational/residential exposure risk assessments (namely, short-term dermal, intermediate-term dermal, long-term dermal, and inhalation) are not required owing to the demonstrated absence of dermal and inhalation toxicity.

iii. Short- and intermediate-term exposure and risk . Short- and intermediate-term oral exposure are not expected for adult population subgroups. However, since imidacloprid is registered for use on turf, home gardens and pets, EPA has identified potential short-term oral exposures to children for these uses. Thus, a residential short-term risk assessment via the oral route is required. See Unit IV.E.4. for a full discussion of this exposure and risk.

4. Cumulative exposure to substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) 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 or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, 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 more 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 final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. Acute risk . EPA has determined that the acute exposure to imidacloprid from food will utilize 23% of the aPAD (95th percentile) for the most highly exposed population subgroup (U.S. population—all seasons). Despite the potential for exposure to imidacloprid in drinking water, the Agency does not expect the aggregate exposure to exceed 100% of the aPAD. The DWLOC calculated for the U.S. population was 3,900 m g/L, which is well above the DWEC of 4.1 m g/L.

2. Chronic risk . In conducting the chronic dietary (food only) risk assessment, EPA used: Tolerance level residues for imidacloprid, and PCT information for some of these crops. The analysis evaluates individual food consumption as reported by respondents in the USDA Continuing Surveys of Food Intake by Individuals conducted in 1989 through 1992. The percentage of cPAD consumed for the U.S. population was 24%. The major identifiable subgroup with the highest aggregate exposure is discussed below. EPA generally has no concern for exposures below 100% of the cPAD because the cPAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Despite the potential for exposure to imidacloprid in drinking water, the Agency does not expect the aggregate exposure to exceed 100% of the cPAD. The DWLOC calculated for the U.S. population was well above the DWEC of 1.1 m g/L.

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

Dermal and inhalation short- and intermediate-term risk assessments are not required for imidacloprid, as dermal and inhalation exposure endpoints were not identified due to the demonstrated absence of toxicity. Short- and intermediate-term oral exposure are not expected for adult population subgroups. A discussion of short- and intermediate- term oral exposure and risk for children 1-6 can be found in Unit IV.E.4.

4. Aggregate cancer risk for U.S. population . Imidacloprid has been classified as a Group E chemical, no evidence of carcinogenicity for humans, thus, a cancer risk assessment is not required.

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

1. Safety factor for infants and children —i. In general . In assessing the potential for additional sensitivity of infants and children to residues of imidacloprid, EPA considered data from developmental toxicity studies in the rat and rabbit and a 2-generation reproduction study in the rat. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from maternal pesticide exposure during gestation. Reproduction studies provide information relating to effects from exposure to the pesticide on the reproductive capability of mating animals and data on systemic toxicity.

FFDCA section 408 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 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 margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. EPA believes that reliable data support using the standard MOE and uncertainty factor (usually 100 for combined interspecies and intraspecies variability) and not the additional tenfold MOE/uncertainty factor when EPA has a complete data base under existing guidelines and when the severity of the effect in infants or children or the potency or unusual toxic properties of a compound do not raise concerns regarding the adequacy of the standard MOE/safety factor.

ii. Developmental toxicity studies . In a developmental toxicity study with Sprague- Dawley rats, groups of pregnant animals (25/group) received oral administration of imidacloprid (94.2%) at 0, 10, 30, or 100 mg/kg bwt/day during gestation days 6 through 16. Maternal toxicity was manifested as decreased body weight gain at all dose levels and reduced food consumption at 100 mg/kg bwt/day. No treatment-related effects were seen in any of the reproductive parameters (i.e., Cesarean section evaluation). At 100 mg/kg bwt/day, developmental toxicity manifested as wavy ribs (fetus = 7/149 in treated vs. 2/158 in controls and litters, 4/25 vs. 1/25). For maternal toxicity, the LOAEL was 10 mg/kg bwt/day lowest dose tested (LDT) based on decreased body weight gain; a NOAEL was not established. For developmental toxicity, the NOAEL was 30 mg/kg bwt/day and the LOAEL was 100 mg/kg bwt/day based on increased wavy ribs.

In a developmental toxicity study with Chinchilla rabbits, groups of 16 pregnant does were given oral doses of imidacloprid (94.2%) at 0, 8, 24 or 72 mg/kg bwt/day during gestation days 6 through 18. For maternal toxicity, the NOAEL was 24 mg/kg bwt/day and the LOAEL was 72 mg/kg bwt/day based on mortality, decreased body weight gain, increased resorptions, and increased abortions. For developmental toxicity, the NOAEL was 24 mg/kg bwt/day and the LOAEL was 72 mg/kg bwt/day based on decreased fetal body weight, increased resorptions, and increased skeletal abnormalities.

iii. Reproductive toxicity study . In a 2-generation reproductive toxicity study, imidacloprid (95.3%) was administered to Wistar/Han rats at dietary levels of 0, 100, 250, or 700 ppm (0, 7.3, 18.3, or 52.0 mg/kg bwt/day for males and 0, 8.0, 20.5, or 57.4 mg/kg bwt/day for females). For parental/systemic/reproductive toxicity, the NOAEL was 250 ppm (18.3 mg/kg bwt/day) and the LOAEL was 750 ppm (52 mg/kg bwt/day), based on decreases in body weight in both sexes in both generations. Based on these factors, the Agency determined that the review be revised to indicate the parental/systemic/reproductive NOAEL and LOAEL to be 250 and 700 ppm, respectively, based upon the body weight decrements observed in both sexes in both generations.

iv. Prenatal and postnatal sensitivity . The developmental toxicity data demonstrated no increased sensitivity of rats or rabbits to in utero exposure to imidacloprid. In addition, the multi-generation reproductive toxicity study data did not identify any increased sensitivity of rats to in utero or postnatal exposure. Parental NOAELs were lower or equivalent to developmental or offspring NOAELs.

v. Conclusion . There is a need for a developmental neurotoxicity study for assessment of potential alterations of functional development. However, the Agency has determined that this data gap does not preclude the establishment/continuance of tolerances. The 10x safety factor to account for enhanced sensitivity of infants and children (as required by FQPA) was reduced to 3x and the factor applies to all population subgroups.

2. Acute risk . Using the conservative TMRC exposure assumptions described above, and taking into account the completeness and reliability of the toxicity data, EPA has estimated the acute exposure to imidacloprid from food for the most highly exposed population subgroup (children 1-6 years old) will utilize 45% of the aPAD. It was determined that an acceptable acute dietary exposure (food plus water) of 100% or less of the aPAD is needed to protect the safety of all population subgroups. Despite the potential for exposure to imidacloprid in drinking water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD for children 1-6 years old. The maximum concentration of imidacloprid in surface and ground water for acute exposure is very small (4.1 m g/L) compared to the DWEC of 800 m g/L.

3. Chronic risk . Using the exposure assumptions described in this unit, EPA has concluded that aggregate exposure to imidacloprid from food will utilize 51% of the RfD for infants and children. EPA generally has no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Despite the potential for exposure to imidacloprid in drinking water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD for children 1-6 years old. The maximum concentration of imidacloprid in surface and ground water for acute exposure is very small (1.1 m g/L) compared to the DWEC of 90 m g/L.

4. Short- and intermediate-term risk . As noted earlier in this document, dermal and inhalation short- and intermediate-term risk assessments are not required for imidacloprid as dermal and inhalation exposure endpoints were not identified due to the demonstrated absence of toxicity. Short- and intermediate-term oral exposure are not expected for adult population subgroups. However, since imidacloprid is registered for use on turf, home gardens and pets, EPA has identified potential short-term oral exposures to children for these uses.

A short-term oral endpoint was not identified for imidacloprid. According to current EPA policy, if an oral endpoint is needed for short-term risk assessment (for incorporation of food, water, or oral hand-to-mouth type exposures into an aggregate risk assessment), the acute oral endpoint (LOAEL = 42 mg/kg bwt/day) will be used to incorporate the oral component into aggregate risk.

The margin of exposure for chronic dietary exposure (food only) and residential exposure (hand-to-mouth from turf, garden, and pet uses) for children ages 1-6 was calculated to be 300. The safe level for imidacloprid is 300.

Potential short-term exposure from drinking water is at a level below the Agency's level of concern with the DWLOC (2 m g/L) being greater than the DWEC of 1.1 m g/L.

The Agency, concludes the short-term aggregate risk to the highest exposed population subgroup (children 1-6 years old) from home garden, turf, and pet uses of imidacloprid does not exceed EPA's level of concern.

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

The nature of imidacloprid residues in plants and in animals is adequately understood. The residue of concern is imidacloprid and its metabolites containing the 6- chloropyridinyl moiety, all expressed as parent, as specified in 40 CFR 180.472.

Adequate enforcement methodology is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

Crop field trials on peaches have been submitted, and the highest residues of imidacloprid were found to be 0.77 ppm. For the purposes of this section 18, the Agency will translate the peach residue data to all stone fruit and tolerances will be set at 1.0 ppm.

The only processed commodity associated with stone fruit is prunes, as plums can be processed into prunes. Since no processing study was submitted, a default factor of 3.4 was used, and therefore, the tolerance on prunes will be set at 3.5 ppm.

There are no Codex, Canadian, or Mexican Maximum Residue Limits for imidacloprid on sweet corn. Thus, harmonization is not an issue for these time-limited tolerances.

The rotational crop restrictions follow the original section 3 labels. In addition, there is little concern over rotational crops for this section 18 as stone fruit are rarely rotated to other crops.

Therefore, the tolerances are established for the combined residues of imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all expressed as parent, in or on stone fruit at 1.0 ppm and prunes at 3.5 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 of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 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 control number OPP-301004 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 7, 2000.

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 (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. 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 (202) 260-4865.

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.

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.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.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.2. Mail your copies, identified by the docket control number OPP-301004, 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. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. 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 file format 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 time-limited tolerances under FFDCA section 408. 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). 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 prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require 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 FIFRA section 18 petition under FFDCA section 408, such as the tolerances 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 FFDCA section 408(n)(4).

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).

Therefore, 40 CFR chapter I is amended as follows:

This is a synopsis of the Commission's Report and Order, MM Docket No. 99-321, adopted May 17, 2000, and released May 26, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center (Room CY-A257), 445 Twelfth Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Service, Inc., 1231 20th Street, NW., Washington, DC 20036, (202) 857-3800.

This is a synopsis of the Commission's Report and Order, MM Docket No. 99-246, adopted May 17, 2000, and released May 26, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center (Room CY-A257), 445 Twelfth Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Service, Inc., 1231 20th Street, NW., Washington, DC 20036, (202) 857-3800.

This is a synopsis of the Commission's Report and Order, MM Docket No. 98-151, adopted May 17, 2000, and released May 26, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Center (Room 239), 445 12th Street, SW, Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Services, Inc., (202) 857-3800, 1231 20th Street, NW, Washington, DC 20036.

This is a synopsis of the Commission's Report and Order adopted April 4, 2000, and released April 21, 2000. The complete text of this Report and Order is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street, S.W., Washington, D.C., and also may be purchased from the Commission's copy contractor, International Transcription Service, (202) 857-3800, 1231 20th Street, NW., Washington, DC 20036. The text can be obtained over the internet by going to the FCC web site, www.fcc.gov, and following the link entitled “FCC Adopts Comparative Standards for Noncommercial Educational Broadcast Stations, 4/27/00, under the “headlines” section.

1. The Commission issued a Notice of Proposed Rule Making in this proceeding in 1995 [60 FR 15275 March 23, 1995] proposing to change the process used to select noncommercial educational applicants, because the existing process was cumbersome and no longer making meaningful distinctions among applicants. Subsequently, Congress addressed related issues in the Balanced Budget Act of 1997, and the Commission issued a Further Notice of Proposed Rule Making [63 FR 58358 October 30, 1998], seeking additional comments. After considering the comments received, the Commission now adopts new simpler filing procedures and selection methods for applications seeking to construct new noncommercial educational (NCE) FM, FM translator, and television stations and to make major changes to such existing stations.

2. Applications for new and major changes to NCE stations will be filed only within “filing windows” to be announced by the Commission. The Commission will study applications filed during the window for mutual exclusivity. This replaces a system in which applications were accepted at any time, and “cut-off” lists were issued to invite competing applications.

3. If mutually applications are received within a filing window, and for existing mutually exclusive applications that have already been “cut off,” the Commission will first determine as a threshold issue, whether any application should be granted or dismissed on the basis of fair distribution of service pursuant to 47 U.S.C. 307(b) (FM stations proposing service to different communities) or on the basis of translator fill-in service as compared to non-fill-in service. If mutually exclusive applicants remain after these threshold issues, the Commission will proceed to a point system.

4. Points will be awarded as follows: (a) 3 points to an established local entity (a government applying for a station within its area of jurisdiction or any applicant that for at least the two years prior to application has had one of the following within 25 miles of the reference coordinates for the community of license: its headquarters, its campus, or the primary residences of 75% of its board members); (b) 1 to 2 points to the applicant with the best technical proposal (covering the largest area and population) depending on comparison to the next best technical proposal; and either (c) 2 points to applicants with local diversity of ownership (no overlap of attributable station principal community contours); or (d) 2 points to an applicant that does not claim local diversity of ownership points, if it is a state-wide network serving 50 accredited full-time elementary/ secondary schools or 5 accredited full-time college/university campuses. Points are determined by the applicant's qualifications at the time of application, provided that the applicant must still qualify for those points at the time of point analysis. In determining points, the interests of attributable parties such as parent organizations, officers, board members, and parties with significant financial influence that also will supply substantial programming to the station will be considered.

5. To break ties, the Commission will select the applicant with the fewest authorizations (existing stations and construction permits). If that standard fails to break the tie, the Commission will select the applicant with the fewest pending applications. If these tie breakers do not result in selection of a prevailing applicant, the Commission will implement mandatory time sharing for full service applicants. For FM translator applicants only, the final tie breaker will select the first applicant to file, similar to existing translator-only rules. The Commission will permit settlements at any time under current settlement rules, which limit reimbursement to an applicant's reasonable and prudent expenses.

6. The new procedures will apply to applications already on file and applications filed in the future. The Commission will issue a Public Notice in the future providing existing applicants with information about how to supplement their applications to claim the points for which they qualify. Existing applicants may file settlements at any time.

7. Until a successful applicant selected through a point system has completed four years of on-air operations, it will be permitted to assign or transfer control of the station's license only to a party eligible to receive the same number of points, and for consideration not to exceed reasonable and prudent expenses application and construction expenses.

8. The Commission will not use the point system for channels that are available commercially (non-reserved channels), even if one or more noncommercial organizations apply for the channel. Such applications will be resolved by auction. In reaching this conclusion, the Commission conducted an in-depth analysis of conflicting directives in the enabling statute, and Commission policies concerning allocation and use of the reserved and non-reserved channels.

As required by the Regulatory Flexibility Act (“RFA”), 5 U.S.C. 603, an Initial Regulatory Flexibility Analysis (“IRFA”) was incorporated in the Further Notice of Proposed Rulemaking for the docket in this proceeding. The Commission sought written public comments on the proposals set forth in the Notice, including comment on the IRFA. The Commission's Final Regulatory Flexibility Analysis (“FRFA”) in this Report and Order (“Order”) conforms to the RFA, as amended by the Contract With America Advancement Act of 1996, Public Law 104-121, 110 Stat. 847 (1996).

The Commission previously determined that traditional hearings, the method used to select among competing applicants for new noncommercial educational broadcast construction permits, were time consuming and burdensome, and that the criteria used in those hearings were vague and difficult to apply. This Order amends the Commission's rules to establish a simpler, clearer, and more streamlined process for selecting among competing noncommercial educational applicants. Specifically, it (1) establishes a point system, a type of simplified paper hearing on channels reserved for NCE use; (2) clarifies that auctions will apply on non-reserved broadcast channels; and (3) provides additional circumstances in which an NCE entity can have a non-reserved channel allocated as reserved.

No comments were received specifically in response to the IRFA in MM Docket No. 95-31. However, one commenter, in expressing support for the use of lotteries, an option not selected, stated that it thought lotteries would have a positive effect on small businesses.

Under the RFA, small entities may include small organizations, small businesses, and small governmental jurisdictions. 5 U.S.C. S 601(6). The RFA, 5 U.S.C. 601(3), generally defines the term “small business” as having the same meaning as the term “small business concern” under the Small Business Act, 15 U.S.C. 632. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (“SBA”). Pursuant to 5 U.S.C. 601(3), the statutory definition of a small business applies “unless an agency after consultation with the Office of Advocacy of the SBA and after opportunity for public comment, establishes one or more definitions of such term that are appropriate to the activities of the agency and publishes such definition(s) in the Federal Register . 1 We received no comment in response to either IRFA on how to define radio and television broadcast “small businesses.” Therefore, we will continue to utilize SBA's definitions for the purpose of this FRFA.

The rules adopted in this Order will apply to television and radio stations licensed to operate on channels reserved as “noncommercial educational.” With respect to television stations, the Small Business Administration defines a television broadcasting station that has no more than $10.5 million in annual receipts as a small business. Television broadcasting stations consist of establishments primarily engaged in broadcasting visual programs by television to the public, except cable and other pay television services. Television stations that the Federal Communications Commission (FCC) would consider commercial, as well as those that the FCC would consider noncommercial educational, are included in this industry. Also included are other establishments primarily engaged in television broadcasting and which produce taped television program materials. Separate establishments primarily engaged in producing taped television program materials are classified under another SIC number.

For 1992 the total number of television stations that produced less than $10.0 million in revenue was 1,155 of the 1,509 television stations then operating, both commercial and noncommercial, or 77 percent. As of July 31, 1999, of the 1,599 total television stations, 370 are noncommercial educational. Thus, we estimate that the proposed rules will potentially affect 285 (77 percent of 370) noncommercial educational television stations that are small businesses. These existing stations would only be affected if they file an application for major modification of their existing facilities, and if another applicant files a mutually exclusive application. These estimates may overstate the number of small entities since the revenue figures on which they are based do not include or aggregate revenues from non-television affiliated companies. On the other hand they may understate the number of small entities, because we believe that a larger percentage of noncommercial educational stations are small businesses than the percentage applicable to the television industry as a whole. We recognize that the proposed rules may also affect minority and women owned stations, some of which may be small entities. In 1997, minorities owned and controlled 38 (3.2%) of 1,193 commercial television stations in the United States. Comparable figures are not available for noncommercial stations. According to the U.S. Bureau of the Census, in 1987 women owned and controlled 27 (1.9%) of 1,342 commercial and noncommercial television stations in the United States. The proposal would also affect pending and future mutually exclusive applications for noncommercial television stations. As of August 1999, there are currently 67 pending applications for 22 channels reserved for noncommercial educational television usage.

The rule changes would also affect noncommercial educational radio stations. The SBA defines a radio broadcasting station that has no more than $5 million in annual receipts as a small business. A radio broadcasting station is an establishment primarily engaged in broadcasting aural programs by radio to the public. Radio stations that the Federal Communications Commission (FCC) would consider commercial, as well as those that the FCC would consider noncommercial educational, are included in this industry. Also included are entities which primarily are engaged in radio broadcasting and which produce radio program materials. However, radio stations which are separate establishments and are primarily engaged in producing radio program material are classified under another SIC number. The 1992 Census indicates that 96 percent of radio station establishments produced less than $5 million in revenue in 1992. Official Commission records indicate that 11,334 individual radio stations were operating in 1992. As of July 31, 1999, official Commission records indicate that 12,582 radio stations are currently operating. Of the current radio station total, 2,055 stations are noncommercial educational. Thus, we estimate that 1,923 (96%) of these noncommercial educational stations are small businesses, possibly more because we believe that a greater percentage of noncommercial educational stations are small businesses than of the radio industry overall. These existing stations would only be affected by the proposal if they choose to file applications for major modification of facilities and if their applications are mutually exclusive with the application of another noncommercial entity. Applicants for new NCE radio stations would also potentially be affected. As of August 1999 there were 371 pending mutually exclusive groups of 1,102 applications, for new noncommercial FM radio stations. We also note that this proposal will affect future applications. With respect to minority ownership of radio stations, no information is available for noncommercial stations, but it is available for commercial stations. In 1997, minorities owned 284 (2.8%) of 10,282 commercial radio stations.

The measures adopted in the Order are anticipated to reduce the overall administrative burden of the Commission's application processes on applicants and the Commission. Use of a point system will eliminate the expense of preparing for and appearing at lengthy traditional hearings. Applicants should also receive decisions faster, because the Commission will make numerical calculations instead of preparing detailed hearing decisions. These savings should more than offset the time that would be required for applicants to gather and submit documentation supporting the points claimed. No additional professional services are required by applicants filing under these revised rules. Further, the cost of compliance will not vary between large and small entities.

This Order sets forth the Commission's new streamlined procedures for selecting among competing noncommercial educational applicants. All significant alternatives presented in the comments were considered. Small entities participating in auctions for non-reserved channels may be eligible for a new entrant auction credit. Small entities may be eligible for points in the point system based on diversity of ownership, established local entity, and in a tie breaker for number of existing authorizations and applications.

The Commission will send a copy of the Reexamination of the Comparative Standards for Noncommercial Educational Applicants, including this FRFA, in a report to be sent to Congress pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996. See 5 U.S.C. 801(a)(1)(A). In addition, the Commission will send a copy of this Order, including this FRFA, to the Chief Counsel for Advocacy of the Small Business Administration. Further, the Commission's Office of Public Affairs, Reference Operations Division, shall send a copy of this Order, including FRFA, to the Chief Counsel for Advocacy of the Small Business Administration.

1. On its own motion, the Commission reconsidered the conditions under which it would lift the voluntarily-imposed stay of the horizontal ownership rules, 47 CFR 76.503. These rules were adopted and stayed in part on October 8, 1999 at 64 FR 67198 (Dec 1, 1999).

2. Subsequently, the Commission ordered that its horizontal ownership rules be stayed until the U.S. Court of Appeals for the D.C Circuit issued a decision upholding the constitutionality of section 613(f)(1)(A) of the Communications Act of 1934, as amended, 47 U.S.C. 533(f)(1)(A). The Commission also ordered that parties not in compliance with the rules on the date the U.S. Court of Appeals for the D.C. Circuit issued such decision must come into compliance within 180 days of the court decision. This order was published in the Federal Register (65 FR 12135, March 8, 2000).

3. On May 19, 2000, the U.S. Court of Appeals for the D.C. Circuit issued its decision, upholding the constitutionality of section 613(f)(1)(A) of the Act, as amended 47 U.S.C. 533(f)(1)(A).

The purpose of this regulation is to implement the portion of the National Defense Authorization Act for 1999, Public Law 105-261, that amended chapter 55 of title 10, United States Code, and chapter 89 of title 5, United States Code, to establish a demonstration project under which certain Medicare and other eligible DoD beneficiaries can enroll in health benefit plans offered under the FEHB Program. The legislation was signed into law on October 17, 1998. The demonstration project will run for a period of three years from January 1, 2000, through December 31, 2002. DoD, with OPM concurrence, has selected eight geographic areas to serve as demonstration project areas. The legislation requires that between 6 and 10 geographic areas be selected. No more than 66,000 individuals can participate in the demonstration project at any one time. Beneficiaries who are provided coverage under the demonstration project will not be eligible to receive care at a military medical treatment facility or to enroll in a health care plan under DoD's TRICARE program. Individuals who disenroll or cancel enrollment from the demonstration project are not eligible to reenroll in the demonstration project. OPM will establish separate risk pools for developing demonstration project enrollee premium rates. The government contribution for demonstration enrollees will be paid by DoD and cannot exceed the maximum percentage or dollar amount that the government would have contributed had the enrollee been enrolled as a regular FEHB enrollee in the same health benefits plan and at the same level of benefits.

The legislation requires OPM and DoD to jointly produce and submit two reports to Congress designed to assess the viability of expanding access to the FEHB Program to certain Medicare and other eligible DoD beneficiaries permanently. The first report is due by April 1, 2001; the second is due by December 31, 2002. The reports will focus on enrollee participation levels, impact on Medicare Part B enrollment, premium rates and costs as compared to those for regular FEHB enrollees, impact on accessibility of care in military treatment facilities, impact on medical readiness and training in military treatment facilities, impact on the cost, accessibility, and availability of prescription drugs for DoD beneficiaries, and recommendations on eligibility and enrollment.

OPM has determined it is necessary to specify certain differences from existing FEHB Program regulations because of the unique features of the demonstration project. This regulation amends chapter 16 of title 48, Code of Federal Regulations (CFR) to enumerate these differences.

When developing premium rates for demonstration project community-rated carriers, OPM will not use similarly sized subscriber group (SSSG) rating methodologies to determine the reasonableness of the carrier's demonstration project premium rates. We are not using SSSG's because we have learned from our consultations with community-rated carriers that there are no similar employer sponsored groups with which to compare. Instead we are benchmarking premiums against adjusted community rates if available, Medigap offerings, or other similar products to determine reasonableness. We believe that these data will result in competitively developed premium rates.

We have determined the most cost effective and administratively efficient way for the federal government to track expenditures is to allow experience-rated carriers participating in the demonstration project to draw funds from their existing FEHB Letter of Credit (LOC) account to pay demonstration project benefits costs in the same manner as they do for benefits costs incurred by regular FEHB members.

All carriers must account separately for health benefits charges paid using demonstration project funds and regular FEHB funds. Direct administrative costs attributable solely to the demonstration project will be fully chargeable to the demonstration project. Indirect administrative costs associated with the demonstration project will be allocated to the demonstration project based on the percentage obtained by dividing the dollar amount of claims processed under the demonstration project by the dollar amount of total claims processed for FEHB Program activity. This percentage will also be used to determine the amount of an experience-rated carrier's service charge that will be allocated to the demonstration project.

Because of the way premiums are collected from enrollees and annuitants and the way the government distributes them to carriers, there will be a period between the effective date of demonstration project enrollees' coverage and the first deposit of premium into experience-rated carriers' LOC accounts. DoD enrollments will become effective on January 1, 2000, and the first demonstration project premiums will be withheld from annuities on February 1, 2000. The enrollees' and government's share of the premiums are due to OPM from DoD on the first day of each month thereafter through the conclusion of the demonstration project. However, since enrollees will be entitled to coverage for at least a month before the first premium payment, there won't be an opportunity for carriers to build a sufficient cash flow to cover the costs of the demonstration project group during this period. We are addressing this problem by allowing experience-rated carriers to draw on their existing LOC accounts in the same manner as for regular FEHB claims.

Since this is a start-up program with no specific experience, we determined that experience-rated and community-rated carrier risk must be mitigated in order to keep premiums as low as possible. Carriers will report on demonstration project revenues, health benefits charges, and administrative expenses as directed by OPM. Experience-rated carriers will be required to perform a final reconciliation of revenue and costs for the demonstration group at the end of the demonstration project. If a community-rated carrier wants to make a claim on the Employees Health Benefits Fund, it will be required to perform annual reconciliations for the duration of the demonstration project. OPM will reimburse carrier costs in excess of the premiums first from the carrier's demonstration project Contingency Reserve and then from the Employees Health Benefits Fund Administrative Reserve. After the final accounting, OPM will place any surplus demonstration project premiums in the regular Contingency Reserves of all carriers continuing in the FEHB Program for the contract year following the year in which the demonstration project ends. Credit will be in proportion to the amount of subscription charges paid and accrued to each carrier's plan for the last year of the demonstration project. Should the program be extended beyond the three year demonstration project period, we will regulate to address any necessary changes to these provisions.

We also have made other miscellaneous changes to chapter 16 of title 48, CFR.

On July 6, 1999, OPM published an interim regulation in the Federal Register (64 FR 36271). OPM subsequently received comments from three organizations—one trade association representing FEHB fee-for-service/PPO plans, one fee-for-service/PPO health benefit carrier, and one employee union. One organization that commented on the proposed rule stated that OPM's proposed formula for allocating indirect administrative costs to the demonstration project is overly prescriptive and conflicts with Section 31.203 of the Federal Acquisition Regulations. The commenter indicates that the FAR allows contractors to allocate indirect administrative expenses using any sound method in accordance with generally accepted accounting principles. This entitles carriers to select among various methods of allocation. While it would seem reasonable to allow carriers to select among various methods for allocating administrative expenses to the demonstration project, OPM is required by the authorizing legislation, Public Law 105-261, to perform an analysis of the demonstration project's rates and costs. In order to perform this analysis, OPM must set a standard for comparison. Consequently, OPM is requiring that only one method be used to determine allocable indirect costs so that these costs can be credibly compared among carriers. We will continue to use claims as the basis for allocation of indirect administrative costs associated with the demonstration project.

One commenter believes that in order to fulfill its obligation to DoD retirees, the Department of Defense should pay DoD retirees' entire premium and reimburse them fully for any out-of-pocket charges they incur during the demonstration project. OPM and DoD do not have the legislative authority to fully pay the premiums and out-of-pocket costs for DoD beneficiaries and their family members. The National Defense Authorization Act for 1999 requires that the government contribution toward DoD beneficiaries be no more than the maximum the government contributes toward the premiums of regular federal employees. The commenter also believes that sufficient utilization and claims experience exists on the DoD demonstration project group for OPM to set premium rates based on the experience of the group without having to base the rates on those of similarly sized subscriber groups. While utilization and claims data does exist on the demonstration project group, not all of the carriers in the FEHB Program are experience-rated, so not all of them rely solely on this information to set rates. A community-rated carrier under the regular FEHB Program is required to use the same rating methodology to develop its FEHB Program rates as it does for other groups of a similar size. The regulation eliminates the requirement that a carrier must use the same methodology as it uses for similar sized employers so that the carrier can develop its rates using Medigap or other Medicare supplemental rating methodologies.

One commenter questions how separate accounting for benefits and administrative costs will be accomplished and verified in the absence of requiring application of the government's Cost Accounting Standards. The commenter believes that to uphold the integrity of the FEHB Program and to gain a true assessment of the success or failure of the demonstration project, OPM should require the application of relevant Cost Accounting Standards to charges made by FEHB participating carriers. OPM cannot require carriers to account for operations using the Cost Accounting Standards because the National Defense Authorization Act, 2000 exempts FEHB carriers from the standards for fiscal year 2000.

The commenter believes that it is inappropriate to use regular FEHB reserves to pay any costs in excess of premiums for the DoD group since a portion of the funds that comprise the Administrative Reserve are deducted from regular FEHB enrollee premiums. The commenter asserts that regular FEHB enrollees should not subsidize the DoD group. The National Defense Authorization Act for 1999 authorizes OPM to use the Employees Health Benefits Fund, which includes the FEHB Administrative Reserve, to pay costs the office incurs for activities associated with implementing the demonstration project. OPM believes that availability of the Administrative Reserve to mitigate risk is essential to maintain reasonable premiums given the short duration of the demonstration project, and the potential that a carrier could enroll a small number of enrollees. OPM believes that use of the Administrative Reserve is the most reliable and desirable manner in which to effectuate the intentions of Congress with regard to the demonstration project.

One commenter asserts that use of the Administrative Reserve to offset carrier losses, and requirements for carriers to pay surpluses to the Administrative Reserve, violates the FEHB Act and the demonstration project legislation. OPM believes that it has the legal authority to use the Administrative Reserve to mitigate carrier losses incurred as a result of the demonstration project. Therefore, OPM is retaining this aspect of the regulation in its final form.

The demonstration project constitutes a mandate to study the feasibility of providing coverage modeled after the FEHB Program to Medicare and other eligible military retirees and their families. This study will result in two reports to Congress that will influence the decision of Congress as to whether to expand the demonstration project to the entire population of eligible military retirees on a permanent basis.

The demonstration project is not a program of insurance in the same sense that the FEHB Program is a program of insurance. Although the carriers participating in the study are FEHB Program insurance carriers, and although the enrollees participating will be covered for their health insurance needs, the project is, in principle and in operation, a study rather than a continuing insurance program. Indeed, the statutory limitations imposed upon the project—limitations on number of enrollees and the duration of the project—are antithetical to a continuing program of insurance, but are appropriate to a study. OPM's mitigation of risk of losses during the study is analogous to self-insuring for purposes of mitigating risk, and allows the demonstration project to simulate normal conditions to overcome the artificial constraints of an uncertain number of enrollees and the short duration of the project.

OPM recognizes that the unknown participation rate and the short-term nature of the project generate an upward pressure on the premium rates for demonstration project enrollees. This is because in a typical, sustainable program of insurance, the risk pool is sufficiently large so that insurance risk is spread with some confidence across the pool while maintaining appropriate premium rates. In contrast, under the demonstration project, some plans may attract only a small number of beneficiaries, creating a small risk pool. In addition, the indefinite duration of a typical, ongoing program allows a carrier to anticipate the experience of the risk pool and provides the opportunity to recoup unexpected losses over the long term by making appropriate adjustments to future premium rates based upon past experience with the insured group. However, where the period over which a carrier is expected to cover the risk pool is limited, there is a substantial likelihood that there will be insufficient opportunity to offset losses in subsequent years. Thus, OPM recognizes that the risk inherent in covering the demonstration project population requires mitigation if the project is to succeed.

FEHB Program carriers can expect to attract a small demonstration project enrollment, may not have reserves sufficient to cover claims in excess of premium income, and may have reinsurance arrangements that preclude the use of their FEHB Program reserves to pay demonstration project claims. Although other strategies for implementing the demonstration project are available, OPM has determined that the strategy set forth in these regulations is the most appropriate for all FEHB Program carriers.

We believe that the commenter has made a valid point with respect to the portion of the interim regulation that required carriers to return surplus premium to the Administrative Reserve upon completion of the demonstration project. OPM initially required the return of any surplus to the Administrative Reserve (1) as the corresponding alternative to the Administrative Reserve bearing the mitigation of loss; and (2) for equitable purposes, to enable all carriers in the FEHB Program to ultimately enjoy any gains as well as bear any losses. OPM reasoned that this alternative was preferable to allowing a windfall resulting from higher than required premiums to go to any one carrier. However, as an alternative approach, OPM agrees that it is appropriate to treat the surplus as any other surplus reserve that a carrier maintains upon termination of its participation in the FEHB Program. Therefore, OPM is changing the final regulation to require demonstration project surpluses to be distributed to the Contingency Reserves of all carriers continuing in the FEHB Program in the year after the demonstration project ends, in proportion to the subscription charges paid and accrued for the carrier for the last year of the demonstration project.

A commenter indicated its view that OPM failed to follow required notice and comment procedures by failing to provide an opportunity for comment on the interim regulations. As we stated in the preamble to the interim regulations, carriers needed the information that was contained in the interim regulations in order to have sufficient time to develop reserve accounts and premiums for enrollments to be effective for contract year 2000. OPM has now followed all of the required procedures in adopting these final regulations. The final regulations are being issued after taking into consideration the carrier's comments together with other comments, in order for appropriate preparations to be made for contract year 2001. This commenter also indicated that because OPM does not advance any rationale for waiving notice and comment on 48 CFR 1652.216-71, Accounting and Allowable Cost, the rule making should be rendered invalid. OPM has simply rewritten this section of the FEHBAR in plain language, and has made no substantive changes to the regulation. The Administrative Procedures Act waives the advance notice and comment requirement when a change is not substantive. The commenter states that the date of the Audit Guide currently in effect is July 24, 1998, and that this date should be stated in the regulation. We did not list the specific date of the Audit Guide in the regulation because we want to be able to use the most recent version of the Audit Guide in effect at any given time. The commenter indicates that the regulation makes an erroneous statement that the Audit Guide should be used to resolve all audit findings, while the commenter believes that corrective action plans should apply only to audits of IPAs and should not be extended to OPM audit findings. We have revised the regulation accordingly. The commenter indicated that the word “actual” needs to be deleted from the phrase “ actual, reasonable, allowable, and allocable” because the FAR makes certain imputed costs, such as facilities capital cost of money, allowable. The Armed Services Board of Contract Appeals has ruled that the cost of capital is an actual cost. Therefore, no changes were made to the regulation based on this comment. The commenter also stated that OPM had included a new requirement in paragraph (b)(1)(i) of 1652.216-71 by asking the carrier to justify that costs chargeable to the contract are reasonable and necessary. While we have reworded the paragraph in plain language, the requirement is not new. Carriers have always been required to show proper justification that costs are actual, necessary, and reasonable. The previous language in paragraph (b)(1)(i) stated that “The allowable costs chargeable to the contract for a contract period shall be the actual, necessary, and reasonable amounts incurred with proper justification and accounting support * * *.” We are simply clarifying the requirement by stating it in the active voice. The carrier correctly notes that this requirement differs from a related FAR requirement.

Because we became aware during the rate negotiation process that some participating carriers did not understand that the risk mitigation provisions applied to all carriers, the regulation was clarified to indicate that community-rated carrier risk will be mitigated using the Employees Health Benefits Fund Administrative Reserve.

Section 7701(c) of title 31, United States Code, requires each contractor doing business with a government agency to furnish its Taxpayer Identification Number (TIN) to that agency [see FAR 4.902]. Accordingly, we have added a new clause FEHBAR 1652.204-73, Taxpayer Identification Number, to FEHBAR Subpart 1652.2 and the FEHBP Clause Matrix at Subpart 1652.3. We have also made reference changes and updated the Matrix to conform to changes in the Federal Acquisition Regulation (FAR) since the Matrix was last revised.

In addition to the above definitions, in 1652.216-70(b), we have clarified that the term “State” as used in 5 U.S.C. 8909(f) includes a U.S. territory or possession.

I certify that this regulation will not have a significant economic impact on a substantial number of small entities because the regulation will only affect health insurance carriers under the Federal Employees Health Benefits Program.

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

For the reasons set forth in the preamble, OPM is amending chapter 16 of title 48, CFR as follows: