[Federal Register Volume 66, Number 149 (Thursday, August 2, 2001)]
[Proposed Rules]
[Pages 40166-40168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18880]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[FRL-7020-2]
RIN 2060-AE83


National Emission Standards for Hazardous Air Pollutants for 
Pharmaceuticals Production

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: 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being withdrawn.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and Regulations'' section of this Federal Register is withdrawn, all 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.

DATES: 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.

ADDRESSES: 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

[[Page 40167]]

located 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.

FOR FURTHER INFORMATION CONTACT: 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: [email protected].

SUPPLEMENTARY INFORMATION: Comments. Comments and data may be submitted 
by electronic mail (e-mail) to: [email protected]. 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 http://www.epa.gov/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:

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                                                                                        Examples of regulated
              Category                     NAICS codes              SIC codes                  entities
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Industry...........................  325411 and 325412.....  2833 and 2834.........   Producers of
                                                                                      finished dosage forms of
                                                                                      drugs (e.g., tablets,
                                                                                      capsules, and solutions),
                                                                                      active ingredients, or
                                                                                      precursors.
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    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 Sec. 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

[[Page 40168]]

operators 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.

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.

    Dated: July 24, 2001.
Christine Todd Whitman,
Administrator.
[FR Doc. 01-18880 Filed 8-1-01; 8:45 am]
BILLING CODE 6560-50-P