May 13, 2005 – Federal Register Recent Federal Regulation Documents

This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance pregabalin [(S)-3-(aminomethyl)-5-methylhexanoic acid], including its salts, and all products containing pregabalin into Schedule V of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Acting Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and on an evaluation of the relevant data by DEA. If finalized, this action will impose the regulatory controls and criminal sanctions applicable to Schedule V non-narcotics on those who handle pregabalin and products containing pregabalin.

The Food and Drug Administration (FDA) is proposing to amend the regulation authorizing a health claim on noncariogenic carbohydrate sweeteners and dental caries, i.e., tooth decay, to include sucralose, a nonnutritive sweetener. Similar to the sweeteners currently authorized to make a health claim, sucralose is used as a sugar substitute that is minimally fermented, relative to sugar, by oral microorganisms and thus does not contribute to production of organic acids by plaque bacteria as do the fermentable sugars for which it is a substitute. FDA is taking this action in response to a health claim petition filed by McNeil Nutritionals. The agency previously concluded that there was significant scientific agreement for the relationship between slowly fermented carbohydrate sugar substitutes, specifically certain sugar alcohols, and the nonpromotion of dental caries. Based on the totality of publicly available scientific evidence, FDA now has determined that the nonnutritive sweetener sucralose, like the sugar alcohols, is not fermented by oral bacteria to an extent sufficient to lower dental plaque pH to levels that would contribute to the erosion of dental enamel. Therefore, FDA has concluded that sucralose does not promote dental caries, and it is proposing to amend the regulation authorizing a health claim relating certain noncariogenic sweeteners and nonpromotion of dental caries to include sucralose as a substance eligible for the claim.

EPA is proposing to extend the global laboratory and analytical use exemption for production and import of class I ozone depleting substances from December 31, 2005, to December 31, 2007, consistent with recent actions by the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer. The exemption allows persons in the United States to produce and import controlled substances for laboratory and analytical uses that have not been already identified by EPA as nonessential. EPA also is proposing to clarify the applicability of the laboratory and analytical use exemption to production and import of methyl bromide after the January 1, 2005, phaseout date.

We are approving, with certain exceptions, a proposed amendment to the Pennsylvania program under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Pennsylvania proposed to revise its Surface Mining Conservation and Reclamation Act (PASMCRA) and implementing regulations at 25 Pa Code Chapters 86-90 with regard to various issues including bonding, remining and reclamation, postmining discharges, and water supply protection/replacement. Pennsylvania revised its program to provide additional safeguards and clarify ambiguities.

The Pension Benefit Guaranty Corporation's regulations on Benefits Payable in Terminated Single-Employer Plans and Allocation of Assets in Single-Employer Plans prescribe interest assumptions for valuing and paying benefits under terminating single-employer plans. This final rule amends the regulations to adopt interest assumptions for plans with valuation dates in May 2005. Interest assumptions are also published on the PBGC's Web site (https://www.pbgc.gov).

DEA is amending its regulations to allow, where State laws permit, for retail pharmacy installation of automated dispensing systems at long term care facilities. Automated dispensing systems would allow dispensing of single dosage units and mitigate the problem of excess stocks and disposal.

The Coast Guard proposes establishing a temporary safety zone for the Town of Marblehead Fourth of July Fireworks. This safety zone is necessary to protect the life and property of the maritime public from the potential hazards associated with a fireworks display. The safety zone would temporarily prohibit entry into or movement within this portion of Marblehead Harbor during the closure period.

The Coast Guard proposes to establish a temporary safety zone for the City of Lynn Fourth of July Celebration. The safety zone is necessary to protect the life and property of the maritime public from the potential hazards posed by a fireworks display. The safety zone will prohibit entry into or movement within this portion of Nahant Bay during its effective period.

On December 11, 2003, EPA promulgated national emission standards for hazardous air pollutants (NESHAP) for miscellaneous coating manufacturing. This action proposes amending the NESHAP by providing additional compliance options and clarifications. Specifically, this action proposes an option to demonstrate compliance with a percent reduction emission limit by measuring total organic compounds (TOC), an option to demonstrate compliance with the weight percent hazardous air pollutant (HAP) limit in coatings products based on formulation data, and a change to the process vessel standards to allow the cover or lid on a process vessel to be opened for material additions and sampling. Other proposed amendments are clarifications of the requirements for cleaning operations, the compliance date for equipment that is added to an existing source, the conditions under which you must determine whether an emission stream is a halogenated vent stream, and the terminology used to describe the emission limits for process vessels. This action also proposes a revised definition of Group 2 transfer operations to clarify that all product loading operations are part of the miscellaneous coating manufacturing affected source and, thus, are not subject to the organic liquid distribution (OLD) NESHAP. In the Rules and Regulations section of this Federal Register, we are taking direct final action on the proposed amendments because we view the amendments as noncontroversial and anticipate no adverse comments. We have explained our reasons for the amendments in the preamble to the direct final rule. If we receive no adverse comments, we will take no further action on the proposed amendments. If we receive adverse comments, we will withdraw only those provisions on which we received adverse comments. We will publish a timely withdrawal in the Federal Register indicating which provisions will become effective and which provisions are being withdrawn. If part or all of the direct final rule in the Rules and Regulations section of today's Federal Register is withdrawn, all comments pertaining to the withdrawn provisions will be addressed in a subsequent final rule based on the proposed amendments. We will not institute a second comment period before taking the subsequent final action. Any parties interested in commenting must do so at this time.

The Environmental Protection Agency (EPA) is holding a public meeting to discuss the development of regulations for aircraft public water systems. To support the rulemaking process, EPA will undertake a collaborative stakeholder process with representatives from industry, government, public interest groups, and the general public.

On September 21, 1998, EPA promulgated national emission standards for pharmaceuticals production (40 CFR part 63, subpart GGG). This action proposes to amend the national emission standards for pharmaceuticals production to include provisions for planned routine maintenance of wastewater tanks and alternative monitoring for condensers and scrubbers. The proposed amendments also reference general standards for containers. In the Rules and Regulations section of this Federal Register, we are taking direct final action on the proposed amendments because we view the amendments as noncontroversial and anticipate no adverse comments. We have explained our reasons for the amendments in the preamble to the direct final rule. If we receive no adverse comments, we will take no further action on the proposed amendments. If we receive adverse comments, we will withdraw those provisions on which we received adverse comments. We will publish a timely withdrawal in the Federal Register indicating which provisions will become effective and which provisions are being withdrawn. If part or all of the direct final rule in the Rules and Regulations section of today's Federal Register is withdrawn, all comments pertaining to those provisions will be addressed in a subsequent final rule based on the proposed amendments. We will not institute a second comment period on the subsequent final action. Any parties interested in commenting must do so at this time.

EPA is disapproving a State Implementation Plan (SIP) revision submitted by the State of Maryland, and is issuing a protective finding for that plan pursuant to EPA's transportation conformity rule. The intended effect of this action is to disapprove Maryland's attainment plan for the Metropolitan Washington, DC severe 1-hour ozone nonattainment area (the Washington area) and to issue a protective finding which allows the motor vehicle emissions budgets identified in that plan to be used in future conformity determinations. This action allows transportation planning activities, including conformity analyses and determinations, to continue normally until such time as highway sanctions would be imposed pursuant to the Clean Air Act (the CAA or the Act) and EPA's order of sanctions rule.

The Department of Agriculture is revising Subpart B of Title 36, Code of Federal Regulations, Protection of Inventoried Roadless Areas, by adopting a new rule that establishes a petitioning process that will provide Governors an opportunity to seek establishment of or adjustment to management requirements for National Forest System inventoried roadless areas within their States. The opportunity for submitting State petitions is available for 18 months following the effective date of this final rule. Under this final rule, submission of a petition is strictly voluntary, and management requirements for inventoried roadless areas would be guided by individual land management plans until and unless these management requirements are changed through a State-specific rulemaking. Elsewhere in this part of today's Federal Register, the Department is announcing the establishment of a national advisory committee in accordance with the Federal Advisory Committee Act (5 U.S.C. App. II) to assist the Secretary with the implementation of this rule. The preamble of this rule includes a discussion of the public comments received on the proposed rule published July 16, 2004 (69 FR 42636) and the Department's responses to the comments.