Skip to Content

Proposed Rule

National Emission Standards for Hazardous Air Pollutants for Pharmaceuticals Production

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Environmental Protection Agency (EPA).


Proposed rule.


The EPA is proposing to amend the national emission standards for hazardous air pollutants (NESHAP) for pharmaceuticals production. This action proposes to correct referencing errors, add test methods for analyzing wastewater, define triethylamine as a soluble hazardous air pollutant (HAP) instead of a partially soluble HAP, add an outlet concentration limit for storage tank emissions, clarify the monitoring frequency requirements for connectors, and add planned routine maintenance provisions for centralized combustion control devices.

In the “Rules and Regulations” section of this Federal Register, we are making these corrections in a direct final rule, without prior proposal, because we view these revisions as noncontroversial, and we anticipate no adverse comments. We have explained our reasons for these corrections in the preamble to the direct final rule.

If we receive no adverse comments, we will take no further action on this proposed rule. If an adverse comment applies to an amendment, paragraph, or section, and that provision may be addressed separately from the remainder of the rule, 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 We will publish a timely withdrawal in the Federal Register indicating which provisions are being withdrawn. If part or all of the direct final rule in the “Rules and Regulations” section of this Federal Register is withdrawn, all public comments pertaining to those provisions will be addressed in a subsequent final rule based on this proposed rule. We will not institute a second comment period on that subsequent final rule. Any parties interested in commenting must do so at this time.


Comments. Written comments must be received by September 4, 2001, unless a hearing is requested by August 13, 2001. If a hearing is requested, written comments must be received by September 17, 2001.

Public Hearing. If anyone contacts the EPA requesting to speak at a public hearing by August 13, 2001, a public hearing will be held on August 16, 2001.


Comments. By U.S. Postal Service, send comments (in duplicate, if possible) to: Air and Radiation Docket and Information Center (6102), Attention Docket Number A-96-03, U.S. EPA, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. In person or by courier, deliver comments (in duplicate if possible) to: Air and Radiation Docket and Information Center (6102), Attention Docket Number A-96-03, U.S. EPA, 401 M Street, SW., Washington DC 20460. The EPA requests that a separate copy of each public comment be sent to the contact person listed below (see FOR FURTHER INFORMATION CONTACT). Comments may also be submitted electronically by following the instructions provided in SUPPLEMENTARY INFORMATION.

Public Hearing. If a public hearing is held, it will be held at the EPA's Office of Administration Auditorium, Research Triangle Park, North Carolina at 10:30 a.m.

Docket. Docket No. A-96-03 contains supporting information used in developing the NESHAP. The docket is Start Printed Page 40167located at the U.S. EPA, 401 M Street, SW., Washington, DC 20460 in Room M-1500, Waterside Mall (ground floor), and may be inspected from 8 a.m. to 5:30 p.m., Monday through Friday, excluding legal holidays.

Start Further Info


Mr. Randy McDonald, Organic Chemicals Group, Emission Standards Division (MD-13), U.S. EPA, Research Triangle Park, North Carolina 27711, telephone number (919) 541-5402, electronic mail address:

End Further Info End Preamble Start Supplemental Information


Comments. Comments and data may be submitted by electronic mail (e-mail) to: Electronic comments must be submitted as an ASCII file to avoid the use of special characters and encryption problems and will also be accepted on disks in WordPerfect version 5.1, 6.1, or Corel 8 file format. All comments and data submitted in electronic form must note the docket number A-96-03. No confidential business information (CBI) should be submitted by e-mail. Electronic comments may be filed online at many Federal Depository Libraries.

Commenters wishing to submit proprietary information for consideration must clearly distinguish such information from other comments and clearly label it as CBI. Send submissions containing such proprietary information directly to the following address, and not to the public docket, to ensure that proprietary information is not inadvertently placed in the docket: Attention: Mr. Randy McDonald, c/o OAQPS Document Control Officer (Room 740B), U.S. EPA, 411 W. Chapel Hill Street, Durham, NC 27701. The EPA will disclose information identified as CBI only to the extent allowed by the procedures set forth in 40 CFR part 2. If no claim of confidentiality accompanies a submission when it is received by EPA, the information may be made available to the public without further notice to the commenter.

Public Hearing. Persons interested in presenting oral testimony or inquiring as to whether a hearing is to be held should contact Ms. Maria Noell, U.S. EPA, MD-13, Research Triangle Park, NC 27711, telephone (919) 541-5607, at least 2 days in advance of the public hearing. Persons interested in attending the public hearing must also call Ms. Maria Noell to verify the time, date, and location of the hearing. The public hearing will provide interested parties the opportunity to present data, views, or arguments concerning these proposed amendments.

Docket. The docket is an organized and complete file of all the information considered by the EPA in the development of this rulemaking. The docket is a dynamic file because material is added throughout the rulemaking process. The docketing system is intended to allow members of the public and industries involved to readily identify and locate documents so that they can effectively participate in the rulemaking process. Along with the proposed and promulgated standards and their preambles, the contents of the docket will serve as the record in the case of judicial review. (See section 307(d)(7)(A) of the Clean Air Act (CAA).) The regulatory text and other materials related to this rulemaking are available for review in the docket or copies may be mailed on request from the Air Docket by calling (202) 260-7548. A reasonable fee may be charged for copying docket materials.

Worldwide Web (WWW). In addition to being available in the docket, an electronic copy of this proposed rule will also be available through the WWW. Following signature, a copy of this action will be posted on the EPA's Technology Transfer Network (TTN) policy and guidance page for newly proposed or promulgated rules​ttn/​oarpg. The TTN at EPA's web site provides information and technology exchange in various areas of air pollution control. If more information regarding the TTN is needed, call the TTN HELP line at (919) 541-5384.

Regulated Entities. The regulated category and entities affected by this action include:

CategoryNAICS codesSIC codesExamples of regulated entities
Industry325411 and 3254122833 and 2834• Producers of finished dosage forms of drugs (e.g., tablets, capsules, and solutions), active ingredients, or precursors.

This table is not intended to be exhaustive, but rather provides a guide for readers likely to be interested in the revisions to the rule affected by this action. To determine whether your facility, company, business, organization, etc., is regulated by this action, you should carefully examine all of the applicability criteria in § 63.1250 of the rule. If you have questions regarding the applicability of these proposed amendments to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

What Are the Administrative Requirements for This Action?

Regulatory Flexibility Act (RFA), as Amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq.

The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute 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 organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of this proposed rule on small entities, a small entity is defined as: (1) A small business in the North American Industrial Classification System (NAICS) code 325411 or 325412 that has as many as 750 employees; (2) a small business in NAICS code 325199 that has as many as 1,000 employees; (3) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (4) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of this proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. The EPA has determined that none of the small entities will experience a significant impact because the amendments impose no additional regulatory requirements on owners or Start Printed Page 40168operators of affected sources. Many of the amendments provide additional compliance options, and other amendments clarify requirements and correct minor drafting errors.

For information regarding other administrative requirements for this action, please see the direct final rule action that is located in the “Rules and Regulations” section of this Federal Register publication.

Start List of Subjects

List of Subjects in 40 CFR Parts 9 and 63

  • Environmental protection
  • Administrative practice and procedure
  • Air pollution control
  • Hazardous substances
  • Intergovernmental relations
  • Reporting and recordkeeping requirements
End List of Subjects Start Signature

Dated: July 24, 2001.

Christine Todd Whitman,


End Signature End Supplemental Information

[FR Doc. 01-18880 Filed 8-1-01; 8:45 am]