# National Emission Standards for Hazardous Air Pollutants for Source Categories: Pharmaceuticals Production > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A98-23168 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** September 21, 1998 - **Citation:** 63 FR 50280 ## Text SUMMARY: This action promulgates national emission standards for hazardous air pollutants (NESHAP) to reduce air emissions of hazardous air pollutants (HAP) from existing and new facilities that manufacture pharmaceutical products. The Agency intends that this promulgated rule will have a common technology basis with a rule promulgated this date under the Clean Water Act (CWA) and published elsewhere in this issue of the Federal Register; this will allow coordinated and cost effective compliance planning by the industry. The standards implement section 112 of the Clean Air Act (CAA) as amended in 1990. The standards apply to major source facilities which produce pharmaceutical products. The major HAP emitted by facilities covered by this final rule include methylene chloride, methanol, toluene, and hydrogen chloride. Methylene chloride is considered to be a probable human carcinogen and the other pollutants can cause noncancer health effects in humans. The promulgated rule is estimated to reduce HAP emissions from existing facilities by 22,000 megagrams per year (Mg/yr) (24,000 tons per year [tons/yr]). It also reduces volatile organic compound (VOC) emissions. DATES: This regulation is effective on September 21, 1998. The incorporation by reference of certain publications listed in the regulation is approved by the Director of the Office of the Federal Register as of September 21, 1998. See the SUPPLEMENTARY INFORMATION section concerning judicial review. ADDRESSES: Docket. Docket No. A-96-03, containing supporting information used in developing the standards, is available for public inspection and copying between 8:30 a.m. and 3:30 p.m., Monday through Friday, at EPA's Air Docket Section, Waterside Mall, Room 1500, 1st Floor, 401 M Street SW., Washington, DC 20460. A reasonable fee may be charged for copying. FOR FURTHER INFORMATION CONTACT: For information concerning the final CAA standard, contact Mr. Randy McDonald at (919) 541-5402, Organic Chemicals Group, Emission Standards Division (MD-13), U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711. For further information concerning the CWA effluent limitation guidelines pretreatment standards and new source performance standards, contact Dr. Frank H. Hund, at (202) 260-7786, Engineering and Analysis Division (4303), U.S. Environmental Protection Agency, 401 M Street SW., Washington, DC 20460. For information concerning applicability and rule determinations, contact your State or local representative or the appropriate EPA regional representatives. For a listing of EPA regional contacts, see the following SUPPLEMENTARY INFORMATION section. SUPPLEMENTARY INFORMATION: An electronic version of documents from the Office of Air and Radiation (OAR) are available through EPA's OAR Technology Transfer Network Web site (TTNWeb). The TTNWeb is a collection of related Web sites containing information about many areas of air pollution science, technology, regulation, measurement, and prevention. The TTNWeb is directly accessible from the Internet via the World Wide Web at the following address, ``http://www.epa.gov/ttn''. Electronic versions of this preamble and rule are located under the OAR Policy and Guidance Information Web site, ``http://www.epa.gov/ttn/ oarpg/'', under the Federal Register Notices section. If more information on the TTNWeb is needed, contact the Systems Operator at (919) 541-5384. Regulated entities. Entities potentially regulated are those which produce pharmaceutical products and intermediates and are located at facilities that are major sources as defined in section 112 of the CAA. Regulated categories and entities include: ---------------------------------------------------------------------------------------------------------------- Category Regulated entities ---------------------------------------------------------------------------------------------------------------- Industry............................... Facilities described by the SIC codes 2833 and 2834 and NAICS codes 32541 and 325412. Producers of finaished dosage forms of drugs, for example, tablets, capsules, solutions, that contain an active ingredient generally, but not necessarily, in association with inactive ingredients. Producers of components whose intended primary use is to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals. ---------------------------------------------------------------------------------------------------------------- This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your facility, company, business, organization, etc., is regulated by this action, you should carefully examine the applicability criteria in Sec. 63.1250 of the rule. If you have questions regarding the applicability of this action to a particular entity, contact the appropriate Regional representative: Region I NESHAP (MACT) Coordinator, U.S. EPA Region I, John F. Kennedy Federal Building, One Congress Street, Boston, MA 02203-001, (617) 565-3438 Region II Umesh Dholakia, U.S. EPA Region II, 290 Broadway Street, New York, NY 10007-1866, (212) 637-4023 (Umesh), (212) 637-4065 (Yue-On) Region III Bernard Turlinski, U.S. EPA Region III, 841 Chestnut Building, Philadelphia, PA 19107, (215) 566-2150 Region IV Lee Page, U.S. EPA Region IV, Atlanta Federal Center, 61 Forsyth Street SW, Atlanta, GA 30303-3104, (404) 562-9131 Region V Bruce Varner, U.S. EPA Region V, 77 West Jackson Boulevard, Chicago, IL 60604-3507, (312) 886-6793 Region VI Robert Todd, U.S. EPA Region VI, First Interstate Bank Tower @ Fountain Place, 1445 Ross Avenue, 12th Floor, Suite 1200, Dallas, TX 75202-2733, (214) 665-2156 [[Page 50281]] Region VII Richard Tripp, U.S. EPA Region VII, Air Toxics Coordinator, 726 Minnesota Avenue, Kansas City, KS 66101, (913) 551-7566 Region VIII Ann Marie Patrie, U.S. EPA Region VIII, Air Toxics Coordinator, 999 18th Street, Suite 500, Denver, CO 80202-2466, (303) 312-6524 Region IX Nahid Zoueshtiagh, U.S. EPA Region IX, Air Division-6, 75 Hawthorne Street, San Francisco, CA 94105, (415) 744-1261 Region X Andrea Wullenweber, U.S. EPA Region X, Air Toxics Coordinator, 1200 Sixth Avenue, Seattle, WA 98101, (206) 553-8760 Judicial review. Under section 307(b)(1) of the Act, judicial review of NESHAP is available only by filing a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit within 60 days of today's publication of this final rule. Under section 307(b)(2) of the Act, the requirements that are the subject of today's notice may not be challenged later in civil or criminal proceedings brought by the EPA to enforce these requirements. The information presented in this preamble is organized as follows: I. List of Source Categories II. Background A. Summary of Considerations Made in Developing These Standards B. Regulatory Background C. Regulation of the Pharmaceutical Manufacturing Industry Under the Clean Water Act III. Authority for National Emission Standards for Hazardous Air Pollutants (NESHAP) Decision Process A. Source of Authority for NESHAP Development B. Criteria for Development of NESHAP IV. Summary of Promulgated Standards A. Source Categories to be Regulated B. Pollutants to be Regulated and Associated Environmental and Health Benefits C. Affected Sources D. Storage Tank Provisions E. Process Vent Provisions F. Wastewater Provisions G. Equipment Leaks H. Pollution Prevention Alternative I. Heat Exchange Provisions J. Emissions Averaging Provisions K. Alternative Standard L. Test Methods and Compliance Procedures M. Monitoring Requirements N. Recordkeeping and Reporting Requirements V. Summary of Environmental, Energy, Cost, and Economic Impacts A. Air Impacts B. Water and Solid Waste Impacts C. Energy Impacts D. Cost Impacts E. Economic Impacts VI. Major Comments and Changes to the Proposed Standards A. Applicability Provisions and Definitions B. Storage Tank Provisions C. Process Vent Provisions D. Wastewater Provisions E. Equipment Leak Provisions F. Pollution Prevention Alternative G. Alternative Standard H. Testing Provisions and Compliance Demonstrations I. Equations J. Monitoring Requirements K. Recordkeeping and Reporting Requirements L. Management of Change VII. Technical Amendment to 40 CFR Part 9 VIII. Administrative Requirements A. Docket B. Executive Order 12866 C. Enhancing the Intergovernmental Partnership Under Executive Order 12875 D. Paperwork Reduction Act E. Regulatory Flexibility Act F. Unfunded Mandates G. Submission to Congress and the Comptroller General Office H. National Technology Transfer and Advancement Act I. Executive Order 13045 I. List of Source Categories Section 112 of the amended Act requires that EPA evaluate and control emissions of HAP. The control of HAP is achieved through promulgation of emission standards under sections 112(d) and 112(f) and work practice and equipment standards under section 112(h) for categories of sources that emit HAP. On July 16, 1992, EPA published an initial list of major and area source categories to be regulated (57 FR 31576). Included on that list were major sources emitting HAP from pharmaceuticals production. Production methods used in the manufacture of pharmaceutical products include both batch and continuous operations, although batch operations make up a majority of the processes. The sizes of the facilities range from those that make one product at the rate of several hundred kilograms per year (kg/yr) to those that produce numerous pharmaceutical products on the scale of thousands of kilograms (megagrams [Mg]) per year. Air emissions of HAP compounds originate from breathing and withdrawal losses from storage tanks, venting of process vessels, leaks from piping and equipment used to transfer HAP compounds (equipment leaks), and volatilization of HAP from wastewater streams. Pollutants emitted from the production processes include a range of organic compounds, including VOC and several specific HAP. Among the most prevalent are methylene chloride and methanol, which account for nearly 70 percent of all HAP emissions from this industry. Detailed information describing manufacturing processes and emissions can be found in the basis and purpose document located in Docket A-96- 03, Item No. III-B-01. As of 1992, over 80 U.S. companies at 270 facilities were producing pharmaceutical products. Manufacturing operations covered by this NESHAP include chemical synthesis, formulation, fermentation, and extraction processes and are generally classified under standard industrial classification 283. An estimated 101 facilities are considered to be major sources according to the CAA criterion of having the potential to emit 10 tons/yr of any one HAP or 25 tons/yr of combined HAP, based on 1992 emissions data. Today's final standard applies to all major sources that produce pharmaceutical products. Area sources are not subject to this standard. II. Background A. Summary of Considerations Made in Developing These Standards This regulation reduces emissions of many of the HAP listed in section 112(b)(1) of the CAAA. The alternatives considered in the development of this regulation, including those alternatives selected as standards for new and existing sources, are based on process and emissions data received from the existing facilities known by the EPA to be in operation. Regulatory alternatives more stringent than the maximum achievable control technology (MACT) floor (minimum control level) were selected when they were judged to be reasonable, considering cost, nonair impacts, and energy requirements. Today's final rule gives existing affected sources 3 years from the date of promulgation to comply. This is the maximum amount of time allowed by the Act. New affected sources are required to comply with the standard upon startup. Included in today's final rule are methods for determining initial compliance as well as monitoring, recordkeeping, and reporting requirements. All of these components are necessary to ensure that affected sources comply with the standards both initially and over time. However, the [[Page 50282]] EPA has made every effort to simplify the requirements in the final rule. In addition, EPA has significantly reduced the amount of cross- referencing to other rules included in today's final standards at the request of facilities affected by these standards. In addition, this rule contains an important and innovative pollution prevention alternative for the pharmaceutical industry that provides an option to reduce HAP emissions through reductions in HAP solvent consumption as opposed to installing end-of-pipe controls. The EPA has developed a regulation that provides a pollution prevention compliance alternative to the traditional control requirements, and the EPA encourages the pharmaceutical industry to meet the CAA requirements through its use. This alternative demonstrates EPA's commitment to developing regulations that are cost effective and flexible, and that reduce monitoring, recordkeeping, and reporting burdens. Representatives from other interested EPA offices and programs, including State and regional environmental agency personnel, and representatives from industry participated in the regulatory development process as MACT partnership members. For example, Region II, acting as the lead, worked closely with the States of New York and New Jersey as well as the pharmaceutical industry in developing the pollution prevention alternative. The partnership members were given opportunities to review and comment on the regulation prior to proposal and had the opportunity to comment on the proposed standards and to provide additional information during the public comment period that followed proposal. The standards were proposed in the Federal Register on April 2, 1997 [62 FR 15754]. The preamble to the proposed standards and the basis and purpose document (Docket Item III-B-01) described the rationale for the proposed standards. Public comments were solicited at the time of proposal. To provide interested persons the opportunity for oral presentation of data, views, or arguments concerning the proposed standards, a public hearing was offered at proposal. However, the public did not request a hearing and, therefore, one was not held. The public comment period was from April 2, 1997 to July 2, 1997. More than 40 letters were received during the comment period. Commenters included industry representatives and State agencies. The comments were carefully considered, and changes were made in the proposed standards when determined by the EPA to be appropriate. A detailed discussion of these comments and responses can be found in the promulgation background information document (BID) which is located in Docket No. A- 96-03, Item V-B-01, which is referenced in the ADDRESSES section of this preamble. The promulgation BID (summary of comments and responses document) serves as the basis for the revisions that have been made to the standards between proposal and promulgation. Section VI of this preamble discusses these major changes. B. Regulatory Background Today's final rule implements section 112(d) of the Clean Air Act (CAA) amendments of 1990, which require the Administrator to regulate emissions of HAP listed in section 112(b) of the CAA. The intent of this rule is to protect the public health by requiring new and existing major sources to reduce generation of emissions by using pollution prevention strategies or to control emissions to the level achievable by the maximum achievable control technology (MACT), taking into consideration the cost of achieving such emission reductions, any nonair quality and other air quality related health and environmental impacts, and energy requirements. In 1978, EPA published a control techniques document entitled ``Control of Volatile Organic Emissions from Manufacture of Synthesized Pharmaceutical Products,'' EPA-450/2-78-029. The control technique guidelines document (CTG) contains a presumptive norm for reasonably available control technology (RACT) for the manufacturing operations covered under SIC Codes 2833 and 2834. Today's final rule does not affect the presumptive RACT guidelines, although a portion of emissions sources are covered by both today's final regulation and the CTG document. In 1994, EPA promulgated National Emission Standards for Hazardous Air Pollutants for Certain Processes Subject to the Negotiated Regulation for Equipment Leaks. Pharmaceutical processes, defined as processes that synthesize pharmaceutical intermediates or final products using carbon tetrachloride or methylene chloride as a reactant or process solvent, are subject to this rule. Today's final rule requires control of leaking components that are currently not subject to the Negotiated Regulation for Equipment Leaks, but that contain and/ or transport HAP and are associated with processes in this source category. Today's rule also allows sources subject to the Negotiated Regulation to comply with the LDAR provisions of this rule. C. Regulation of the Pharmaceutical Manufacturing Industry Under the Clean Water Act The Clean Water Act (CWA) and a recent settlement agreement (see 59 FR 25869) require EPA to develop effluent limitations guidelines and standards regulations for the pharmaceutical manufacturing industry. On May 2, 1995 at 60 FR 21592, the EPA proposed best available technology (BAT) economically achievable and new source performance standards (NSPS) regulations for 53 volatile and semivolatile organic pollutants of which 17 are HAP. The Agency also proposed pretreatment standards for existing sources (PSES) and performance standards for new sources (PSNS) for 45 volatile organic pollutants of which 16 are HAP. The technology basis for the volatile organic limitations were based on steam stripping and advanced biological treatment. The proposed NSPS and PSNS differed from BAT and PSES, respectively, in that they were based on steam stripping plus distillation. In the April 2, 1997 proposal EPA indicated that it was considering changing the BAT technology basis to advanced biological treatment only. The EPA also described three options under consideration for setting PSES and PSNS to address HAP and non-HAP wastewater pollutant discharges not controlled by the MACT standards. Under the first option compliance with the MACT standards would constitute compliance with PSES and PSNS. Option 2 involved compliance with the MACT standards plus additional PSES based on the performance data base for the 1995 proposed PSES for all volatile organic pollutants except alcohols and related pollutants, and Option 3 was the same as Option 2 except the additional pollutants included alcohols and related pollutants. On August 8, 1997, at 62 FR 42720, the EPA published a Notice of Availability (NOA) to allow public comment on the data received since the May 2, 1995 CWA proposal and to further develop and revise options for the control of volatile organic pollutant discharges presented in the April 2, 1997 MACT proposal. The EPA provided the results of an EPA sampling study designed to provide information concerning the pass- through analysis for water soluble organic pollutants such as methanol and provided a discussion thereafter of the final pass-through analysis that EPA would be performing with respect to these and other [[Page 50283]] pollutants. The EPA also presented revisions to the pretreatment options (Options 2 and 3) which were first suggested in the CWA section of the April 2, 1997 MACT proposal. Elsewhere in today's Federal Register EPA is publishing final effluent limitation guideline and standards under the Clean Water Act for the pharmaceutical manufacturing point source category. III. Authority for National Emission Standards for Hazardous Air Pollutants (NESHAP) Decision Process A. Source of Authority for NESHAP Development Section 112 of the Clean Air Act gives the EPA the authority to establish national standards to reduce air emissions from sources that emit one or more HAP. Section 112(b) contains a list of HAP to be regulated by NESHAP. Section 112(c) directs the Agency to use this pollutant list to develop and publish a list of source categories for which NESHAP will be developed; this list was published in the Federal Register on July 16, 1992 (57 FR 31576). The Agency must list all known categories and subcategories of ``major sources'' that emit one or more of the listed HAP. A major source is defined in section 112(a) as any stationary source or group of stationary sources located within a contiguous area and under common control that emits or has the potential to emit in the aggregate, considering controls, 10 tons/yr or more of any one HAP or 25 tons/yr or more of any combination of HAP. B. Criteria for Development of NESHAP The NESHAP are to be developed to control HAP emissions from both new and existing sources according to the statutory directives set out in section 112(d) of the Act. The statute requires the standards to reflect the maximum degree of reduction in emissions of HAP that is achievable for new or existing sources. This control level is referred to as the ``maximum achievable control technology'' (MACT). The selection of MACT must reflect consideration of the cost of achieving the emission reduction, any nonair quality health and environmental impacts, and energy requirements for control levels more stringent than the floor (described below). The MACT floor is the least stringent level for MACT standards. For new sources, the standards for a source category or subcategory ``shall not be less stringent than the emission control that is achieved in practice by the best controlled similar source, as determined by the Administrator'' [section 112(d)(3)]. Existing source standards should be no less stringent than the average emission limitation achieved by the best performing 12 percent of the existing sources for categories and subcategories with 30 or more sources or the average emission limitation achieved by the best performing 5 sources for categories or subcategories with fewer than 30 sources [section 112(d)(3)]. The determination of the MACT floor for existing sources under today's rule is that the average emission limitation achieved by the best performing sources is based on a measure of central tendency, such as the arithmetic mean, median, or mode. The determination of percentage reduction in the production-indexed consumption factors used in the pollution prevention alternative is based on the criteria that the alternative must achieve emissions reductions equivalent to what would have been achieved by complying with the MACT. IV. Summary of Promulgated Standards A. Source Categories to be Regulated Today's final rule regulates HAP emissions from pharmaceutical production facilities that are determined to be major sources. These standards apply to existing sources as well as new sources. The final standards for existing and new source are summarized in Table 1. BILLING CODE 6560-50-P Table 1.--Standards for New and Existing Sources -------------------------------------------------------------------------------------------------------------------------------------------------------- Applicability Emission point New or existing? ---------------------------------------------- Requirement Applicability Level Cutoff -------------------------------------------------------------------------------------------------------------------------------------------------------- Process vents...................... New.................. Processes............ >400 lb HAP/yr 98 percent control or 20 ppmv TOC and 20 ppmv uncontrolled. hydrogen halide and halogen outlet limit. Existing............. Processes............ 2,000 lb 93 percent control or 2,000 lb HAP/yr or 20 HAP/yr controlled. ppmv TOC and 20 ppmv hydrogen halide and halogen outlet limit (if there are any vents in a process not manifolded to the control device, process must still meet 93 percent control); and 98 percent* for individual vents (within a process) meeting cutoff based on flow and emissions or 20 ppmv TOC and 20 ppmv hydrogen halide and halogen outlet limit. Storage tanks...................... New and existing..... 10,000 gal 1.9 psia 90 percent control or 20 ppmv TOC and 20 ppmv and 20,000 gal 1.9 psia 95 percent control or 20 ppmv TOC and 20 ppmv vapor pressure of hydrogen halide and halogen outlet limit** liquid stored. Wastewater......................... New and existing..... >Mg/yr total HAP load 1,300 ppm 99 percent reduction of Table 2 HAP. from all POD from at POD of Table 2 PMPU. HAP. 5,200 ppmw 99 percent reduction of Table 2 HAP. at POD of total HAP 90 percent reduction of Table 3 HAP. load. 95 percent reduction of total HAP using biotreatment. >1 Mg/yr total HAP 10,000 99 percent reduction of Table 2 HAP. load from facility. ppmw at POD of total 90 percent reduction of Table 3 HAP. HAP load. 95 percent reduction of total HAP using biotreatment. New.................. >1 Mg/yr total HAP 110,000 99 percent reduction of Table 3 HAP and load from all POD ppmw at POD of Table existing source requirements. from PMPU. 3 HAP. [[Page 50284]] Equipment leaks.................... New and existing..... All components in HAP LDAR program. service. -------------------------------------------------------------------------------------------------------------------------------------------------------- *For process vents controlled to 93 percent prior to April 2, 1997, no additional control is required. **For tanks controlled to 90 percent prior to April 2, 1997, no additional control is required. BILLING CODE 6560-50-M B. Pollutants to be Regulated and Associated Environmental and Health Benefits Pharmaceutical production facilities emit an estimated 34,000 Mg/yr of organic and inorganic HAP. Organic HAP include methylene chloride, methanol, toluene, dimethylformamide, and hexane as well as other HAP. Hydrogen chloride is an inorganic HAP emitted by this industry. Today's final rule reduces HAP emissions from pharmaceutical facilities by 65 percent. Some of these pollutants are considered to be carcinogenic, and all can cause toxic health effects following exposure, including nausea, headaches, and possible reproductive effects. The EPA does recognize that the degree of adverse effects to human health can range from mild to severe. The extent and degree to which the human health effects may be experienced is dependent upon (1) the ambient concentration observed in the area (e.g., as influenced by emission rates, meteorological conditions, and terrain); (2) the frequency of and duration of exposures; (3) characteristics of exposed individuals (e.g., genetics, age, pre-existing health conditions, and lifestyle) which vary significantly with the population; and (4) pollutant specific characteristics (toxicity, half-life in the environment, bioaccumulation, and persistence). Most of the organic HAP emitted from this industry are classified as VOC. The emission controls for HAP will reduce non-HAP VOC emissions as well. Emissions of VOC have been associated with a variety of health and welfare impacts. Volatile organic compound emissions, together with nitrogen oxides, are precursors to the formation of tropospheric ozone. Exposure to ambient ozone is responsible for a series of public health impacts, such as alterations in lung capacity; eye, nose, and throat irritation; nausea; and aggravation of existing respiratory disease. The welfare impacts from exposure to ambient ozone include damage to selected commercial timber species and economic losses for commercially valuable crops such as soybeans and cotton. Hydrogen chloride is listed under section 112(r) of the CAA. The intent of section 112(r), Prevention of Accidental Releases, is to focus on chemicals that would pose a significant hazard to the community in the event of an accident, to prevent their accidental release, and to minimize consequences should a release occur. Hydrogen chloride, along with the other substances listed under section 112(r)(3), is listed because it is known to cause, or may be reasonably anticipated to cause death, injury, or serious adverse effects to human health or the environment (see 59 FR 4478, January 31, 1994). Sources that handle hydrogen chloride in greater quantities than the established threshold quantity under section 112(r)(5) are subject to the risk management program requirements under section 112(r)(7) (see 58 FR 54190, October 20, 1993). In essence, the MACT standards mandated by the CAA will ensure that all major sources of air toxic emissions achieve the level of control already being achieved by the better controlled and lower emitting sources in each category. This approach provides assurance to citizens that each major source of toxic air pollution will be required to effectively control its emissions. In addition, the emission reductions achieved by today's final standards, when combined with the reductions achieved by other MACT standards, will contribute to achieving the primary goal of the CAA, which is to ``protect and enhance the quality of the Nations's air resources so as to promote the public health and welfare and the productive capacity of its population'' (the CAA, section 101(b)(1)). C. Affected Sources Emission points identified from pharmaceuticals production include process vents, equipment leaks, storage tanks, wastewater collection and treatment systems, and heat exchange systems. The affected source subject to this subpart is any pharmaceutical manufacturing operation, as defined in Sec. 63.1251 of today's final rule, that meets the following criteria: (1) it manufactures a pharmaceutical product, as defined in Sec. 63.1251; (2) it is located at a plant site that is a major source as defined in section 112(a) of the Act; and (3) it processes, uses, or produces HAP. Based on this definition of affected source, new sources are created by reconstructing existing sources, constructing new ``greenfield'' facilities, or constructing an addition to an existing source which is a dedicated pharmaceutical manufacturing process unit (PMPU) and exceeds 10 tons/yr of an individual HAP or 25 tons/yr of combined HAP. Reconfigurations of existing equipment do not constitute ``construction'' and therefore NSM would not be triggered under this circumstance. Therefore, a new affected source subject to this subpart is any affected source for which construction or reconstruction commenced after April 2, 1997, and the standard was applicable at the time of construction or reconstruction, or any PMPU that is dedicated to manufacturing a single product that has the potential to emit 10 tons per year of any one HAP or 25 tons per year of combined HAP, for which construction commenced after April 2, 1997. The PMPU is defined according to the equipment used to make a pharmaceutical product. The PMPU also includes storage tanks that are associated with the process. D. Storage Tank Provisions Today's final standards require existing and new sources to control emissions from storage tanks having volumes greater than or equal to 38 cubic meters (m3) (10,000 gallons), and storing material with a vapor pressure of greater than or equal to 13.1 kPa (1.9 psi). The final standards require that emissions from storage tanks with capacities greater than or equal to 38 m3 (10,000 gallons) and less than 75 m3 (20,000 gallons) be reduced by 90 percent. Emissions from storage tanks greater than or equal to 75 m3 (20,000 gallons) must be reduced by 95 percent. [[Page 50285]] One of the following control systems can be applied to meet these requirements: 1. An internal floating roof with specified seals and fittings; 2. An external floating roof with specified seals and fittings; 3. An external floating roof converted to an internal floating roof with specified seals and fittings; or 4. A closed vent system with the appropriate 90 or 95 percent efficient control device. The final rule also includes an alternative standard for any storage tank vents that are routed to an add-on control device. Under the alternative standard, an owner or operator may choose to comply with a total organic compound (TOC) and hydrogen halide and halogen limit of 20 ppmv or less, measured prior to dilution and at the outlet of the control device. The alternative standard is discussed in more detail in sections IV.K and VI.G of this preamble and is included in Sec. 63.1253(d) of the final rule. Today's final rule does not provide for vapor balancing systems to be used as an alternative means of control for storage tanks. E. Process Vent Provisions The MACT standard for most existing process vents was set at the floor level of control, which was determined to be 93 percent control. The final standards require existing sources to reduce emissions from the sum of all vents within a process to 900 kg/yr (2,000 pounds per year [lb/yr]), considering control, or meet an overall process control level of 93 percent. The 2,000 lb/yr compliance option is limited to seven processes per year per facility. Additionally, a regulatory alternative beyond the floor was selected that requires 98 percent control of some large emission vents. Individual process vents (manifolded or nonmanifolded) meeting the annual emissions and flow rate criteria are required to achieve 98 percent control, independent of the overall 93 percent requirement. (Those process vents achieving 93 percent control prior to April 2, 1997 are not required to meet the 98 percent control requirement.) The MACT standard for process vents at new sources was set at the floor level of control. The MACT floor was determined from the best controlled similar source and is based on the most stringent control level achieved for both chemical synthesis and formulation type processes. Today's final standards for new sources require 98 percent control of vents in a process that has uncontrolled emissions greater than 182 kg/yr (400 lb/yr). An alternative standard for process vents was added to the final rule [see Sec. 63.1254(c)]. Under the alternative standard, an owner or operator may choose to comply with a TOC and hydrogen halide and halogen limit of 20 ppmv or less, measured prior to dilution and at the outlet of the control device. If only a portion of the process vents associated with a process comply with the alternative standard, then the remaining process vents must be controlled to the levels required by the standards (e.g., 93 percent for the sum of remaining vents and/ or 98 percent control of some individual vents for existing sources and 98 percent control of the sum of remaining vents for new sources). The process vent and storage tank standards also contain provisions for complying in essentially the same manner as is described by the alternative standard--by routing streams to control devices achieving an outlet concentration of TOC and hydrogen halide and halogen limit of 20 ppmv or less, measured prior to dilution. These provisions differ from those described under the Alternative standard only in the monitoring options available. F. Wastewater Provisions The MACT floor for wastewater at existing sources was determined to be 54 percent control of HAP emissions from wastewater. The EPA calculated HAP concentration cutoffs for wastewater streams, above which steam stripping of wastewater streams would result in a level of control as stringent as the floor. This approach is similar to the hazardous organic NESHAP (HON) and allows for the control of those wastewater streams containing the most significant amount of HAP. The final standards require existing sources to control wastewater with the following characteristics at the point of determination (POD): 1. Streams having partially soluble HAP compound concentrations of 1,300 ppmw or greater and a total PMPU HAP load of 1 Mg/yr or greater; 2. Streams having a combined total HAP concentration of 5,200 ppmw or greater and a total PMPU load of 1 Mg/yr or greater; 3. Streams having a total HAP concentration of 10,000 ppmw with a total facility HAP load of 1 Mg/yr or greater; or The final standards require that air emissions from wastewater collection systems be suppressed and that wastewater is treated. Compliance is demonstrated by one of the following methods: 1. Using an enhanced biotreatment system for soluble HAP; 2. Demonstrating removals achieving 99 percent by weight of partially soluble HAP compounds, and 90 percent by weight of soluble HAP compounds, from treatment systems; or 3. Demonstrating a removal of 95 percent by weight of total organic HAP from treatment systems. For new sources, the MACT floor for wastewater is based on a facility that currently incinerates a significant percentage of wastewater containing HAP in an incinerator combusting a mixture of wastes. The final standards require the same applicability and control requirements described above for existing sources and an increased removal of solubles (from 90 to 99 percent) for streams having a soluble HAP concentration of 110,000 ppmw at any of the load criteria (1 Mg/yr total HAP from the PMPU, or facility). A de minimis HAP concentration and flow rate exemption was added to today's final rule. Streams containing less than 5 ppmw of partially soluble and/or soluble HAP and a total yearly load of 0.05 kg/yr of partially soluble and/or soluble HAP are not considered wastewater, and thus, are exempted from the wastewater provisions in today's final rule. G. Equipment Leaks Today's final rule contains revisions to the proposed equipment leak requirements that were originally based on subpart H (of the HON rule). The final rule primarily contains changes to the standards for valves and connectors in gas/vapor service and light liquid service. The standards for valves in gas/vapor service and in light liquid service were changed as follows: the requirement to implement a quality improvement program and all references to Sec. 63.175 have been removed; an allowance for monitoring every 2 years for those processes with less than 0.25 percent leaking valves has been added; an allowance for valve subgrouping was also added; the equation used to determine the percent of leaking valves in a process was changed to eliminate the optional credit for valves removed, Vc; and the rolling average of leaking valves was revised so that it is calculated as an average of the last 3 monitoring periods for annual or biannual monitoring programs. The monitoring schedule for connectors in gas/vapor service and light liquid service was revised to allow for decreased monitoring for those components with the lowest leak rates. For leak rates less than 0.25, the monitoring frequency for connectors is [[Page 50286]] now once every 8 years. Finally, the equipment leak provisions were removed from appendix GGGA to Section 63.1255. H. Pollution Prevention Alternative Today's final standards include a pollution prevention (P2) alternative standard that meets the MACT floor for existing sources and can be implemented in lieu of meeting the requirements for existing process vents, storage tanks, wastewater streams and equipment leaks. The P2 alternative only applies to existing sources and includes two options which are shown in Table 2. Under option 1, owners or operators can satisfy the requirements for all emission source types associated with each pharmaceutical manufacturing process unit (PMPU) by demonstrating that the production-indexed consumption of HAP has decreased by at least 75 percent from a baseline set no earlier than the 1987 calendar year. The production indexed HAP consumption factor is expressed as kg HAP consumed/kg product produced. Under the second P2 option, owners or operators must demonstrate at least a 50 percent reduction in the production indexed HAP consumption factor, plus an additional amount of reduction in HAP emissions through the use of add- on controls, such that the overall reduction in HAP emissions is at least 75 percent from the baseline period. Table 2.--Alternative P2 Standard ------------------------------------------------------------------------ Option Description of P2 option ------------------------------------------------------------------------ 1............................. Demonstrate at least a 75 percent reduction in the kg consumption/kg production factor from a baseline period. 2............................. Demonstrate at least a 50 percent reduction in the kg/kg factor, plus an additional reduction from add-on control equivalent to at least a 75 percent overall reduction in the kg/kg factor from baseline. ------------------------------------------------------------------------ The following restrictions also apply to the pollution prevention standards in today's final rule. For any reduction in the production- indexed HAP consumption factor that is achieved by reducing a HAP that is also a VOC, an equivalent reduction in the production-indexed VOC consumption factor is required. For any reduction in the production- indexed HAP consumption factor that is achieved by reducing a HAP that is not a VOC, the production-indexed VOC consumption factor may not be increased. Also, the final rule allows owners or operators of PMPU's that generate HAP emissions to qualify for the pollution prevention alternative, provided that the HAP emissions generated in the PMPU are reduced to the required levels for process vents, storage tanks, wastewater streams and equipment leaks specified in Secs. 63.1252 through 63.1256 of today's final standards. The baseline production- indexed HAP and VOC consumption factors must be based on consumption and production values averaged over the time period from startup of the process until the present time (assuming the process has been in operation at least 1 full year), or the first 3 years of operation (beginning no earlier than 1987), whichever is the lesser time period. Processes that began operation after April 2, 1997 are not eligible for the P2 alternative. Today's final standards also require owners and operators complying with the P2 standard to submit a P2 Demonstration Summary as part of the Precompliance Notification Report that describes how the P2 alternative will be applied at their facilities. The minimum data requirements for the P2 Demonstration Summary are listed in Sec. 63.1257(f) of today's final rule. I. Heat Exchange Provisions Today's final standards for heat exchange systems are unchanged from proposal. Owners or operators must comply with the heat exchange provisions listed in the HON at Sec. 63.104 with two exceptions: (1) the monitoring frequency shall be no less than quarterly, and (2) owners or operators of heat exchange systems that meet current good manufacturing practice (CGMP) requirements at 21 CFR part 211 may elect to use the physical integrity of the reactor as the surrogate indicator of heat exchange system around reactors. J. Emissions Averaging Provisions The emissions averaging provisions in today's final rule are unchanged from proposal. The final rule allows emissions averaging among process vents and among storage tanks at existing sources. Restrictions on the use of emissions averaging are listed in Sec. 63.1252(d) of today's final rule and are essentially the same as those contained in the HON. The alternative standard (see following section K) is not to be included in the emissions averaging provisions and/or calculations. K. Alternative Standard For owners or operators of affected sources that treat emissions with an add-on control device, an alternative standard has been added under Secs. 63.1253(d) (storage tanks) and 63.1254(c) (process vents). To comply with today's alternative standard(s), the control device must achieve an outlet, undiluted TOC concentration, as calibrated based on methane or the predominant HAP, of 20 ppmv or less and a hydrogen halide and halogen concentration of 20 ppmv or less, as demonstrated through the test methods and procedures in Sec. 63.1257 and monitoring provisions in Sec. 63.1258. The applicability level is the control unit and all sources vented to the control unit which is considered one regulated entity. Because the applicability of this standard is focused on the control device, this scenario is considered one regulated entity with regard to the number of violations that would apply if there is an exceedance of the 20 ppmv TOC and 20 ppmv hydrogen halide and halogen outlet concentration limit(s). The remaining process vents within a process not controlled by the alternative standard must be controlled to the percent reduction required by the standards. L. Test Methods and Compliance Procedures To determine compliance with the percent reduction requirement for pharmaceutical process vents, uncontrolled and controlled emissions from all process vents within the process shall be quantified to demonstrate the appropriate overall reduction requirements (93 percent or 98 percent). For process vents controlled by devices handling less than 10 tons/yr, the owner or operator can either test or use calculational methodologies to determine the uncontrolled and controlled emission rates from individual process vents. For process vents controlled by devices handling more than 10 tons/yr, tests are required to determine the reduction efficiency of each device. Performance test provisions require testing under worst-case conditions, but the final rule provides flexibility in determining these worst-case conditions. Control devices that have previously been tested under conditions required by this standard and condensers are exempt from emissions testing. Testing is not required for devices used to control emission streams from storage or wastewater sources exclusively. However, if testing is conducted, then the same methods apply. M. Monitoring Requirements Monitoring is required in the final rule to determine whether a source is in compliance on an ongoing basis. This monitoring is done either by continuously measuring emission [[Page 50287]] reductions directly or by continuously measuring a site-specific operating parameter, the value of which is established by the owner or operator during the initial compliance determination. The operating parameter value is defined as a single point at either a minimum or maximum value established for a control device that, if achieved on a daily average or block average by itself or in combination with one or more other operating parameter values, determines that an owner or operator is complying with the applicable operating limits. These parameters are required to be monitored at 15-minute intervals throughout the operation of the control device for devices controlling greater than 1 tons/yr. For devices controlling streams totaling less than 1 ton/yr, only a site-specific periodic verification that the devices are operating as designed is required to demonstrate continuous compliance. Owners and operators must determine the most appropriate method of verification and propose this method to the Agency for approval in the precompliance report, which is due 6 months prior to the compliance date of the standard. The monitoring requirements apply to all control devices, even those used exclusively for storage tanks or wastewater sources. N. Recordkeeping and Reporting Requirements Table 1 to subpart GGG was revised to clarify the specific requirements of the final rule and the referenced requirements in the General Provisions. A summary column describing the requirements of each part of the General Provisions has been added to Table 1 and additional comments address wording issues and exceptions to the General Provisions language. V. Summary of Environmental, Energy, Cost, and Economic Impacts These NESHAP would affect pharmaceutical production facilities that are major sources in themselves, or constitute a portion of a major source. There are 270 existing facilities manufacturing pharmaceuticals, 101 of which were assumed to be major sources for the purpose of developing these standards and calculating impacts. The expected rate of growth for the pharmaceutical industry is expected to be 2.4 percent per year through 1998. A. Air Impacts Today's final standards will reduce HAP emissions from existing sources by 22,000 Mg/yr (24,000 tons/yr) from the baseline level, a reduction of 65 percent from baseline, and 75 percent from uncontrolled. These reductions also will occur if facilities elect to implement the alternative pollution prevention standard. Since many of the HAP emitted by the pharmaceutical industry are also VOC, today's final standards also will reduce VOC emissions. B. Water and Solid Waste Impacts Much of the steam stripping operations will result in recoverable material. However, the new source requirement for very rich, soluble HAP-containing wastewater is expected to generate solid waste. The EPA estimates that an average of 900 tons of solid waste per year per facility will be generated as a result of today's final standards. However, biological treatment is a possible means of compliance. C. Energy Impacts Today's final standards for the pharmaceuticals source category will require an additional energy usage of 2,400 x 10\9\ British thermal units per year (Btu/yr). D. Cost Impacts The emission reductions required by this regulation can be achieved using one or more of several different techniques. To determine costs, certain control scenarios were assumed. The scenarios used in costing were judged to be the most feasible scenarios possible for meeting the requirements of the standards from a technical and cost standpoint. The total control cost includes the capital cost to install the control device, the costs involved in operating the control device, and costs associated with monitoring the device to ensure compliance. Monitoring costs include the cost to purchase and operate monitoring devices, as well as reporting and recordkeeping costs required to demonstrate compliance. Nationwide, the total annual cost of this standard to the industry for existing and new sources is approximately $64 million and $11 million, respectively (1998 dollars). To estimate these annual costs, capital costs were annualized over 10 years (with no delay for installation). (The annual costs presented in the preamble to the effluent limitations guidelines and standards are lower than the above costs because they are based on a longer annualization period. Costs for the effluent guidelines limitations and standards are annualized over 16 years (a 1-year installation period plus a 15-year project life). As a result, annual costs for existing sources in the preamble to the effluent limitations guidelines and standards (referred to as pretax annualized costs for the MACT standards rule for all facilities) are reported at $58.4 million.) The EPA believes that monitoring, reporting, and recordkeeping costs will be substantially reduced for those facilities that choose to comply with today's final rule through either the P2 option or the alternative standard of 20 ppm TOC and 20 ppm hydrogen halides and halogens. E. Economic Impacts The economic impact analysis of this standard shows that the estimated price increase from compliance with the recommended standards for process vents, storage tanks, and wastewater is 1.1 percent. Estimated reduction in market output is 1.9 percent. No plant closures are expected from compliance with this set of alternatives. For more information, consult the economic impact report entitled ``Economic Analysis of Air Pollution Regulation Regulations: Pharmaceutical Industry, August 1996.'' VI. Major Comments and Changes to the Proposed Standards In response to comments received on the proposed standards, changes have been made to the final standards. While some of these changes are clarifications designed to make EPA's intent clearer, many of them are significant changes to the requirements of the proposed standards. A summary of the substantive comments and/or changes made since proposal are described in the following sections. Detailed responses to public comments are included in the promulgation BID: Summary of Public Comments and Responses (Docket Item No. V-B-01). Additional information on the final standards is contained in the docket for this rulemaking (see ADDRESSES section of this preamble). A. Applicability Provisions and Definitions 1. General Applicability: Definition of Pharmaceutical Product At proposal, pharmaceutical product was defined as ``any material described by the Standard Industrial Classification (SIC) Code 283, or any other fermentation, biological or natural extraction, or chemical synthesis product regulated by the Food and Drug Administration, including components (excluding excipients) of pharmaceutical formulations, or intermediates used in the production of a pharmaceutical product.'' Many commenters stated that, based on the proposed definition of pharmaceutical product, the general applicability of the standard is too broad, ambiguous, and [[Page 50288]] appears to overlap with other MACT standards that cover the chemical industry. Comments on the definition of pharmaceutical product focused on the following four areas: (1) the use of Standard Industrial Classification (SIC) codes, (2) the scope of products regulated by the FDA, (3) the meaning of the term ``intermediates,'' and (4) the exclusion of specific products/processes. Many commenters suggested that instead of referencing SIC code 283, the definition of pharmaceutical product should be narrowed to include only SIC codes 2833 and 2834 because facilities classified under these two SIC codes produce pharmaceuticals as their primary product, and were the source of information and data that formed the basis for the proposed rule. Two other commenters stated that the use of SIC codes or the new North American Industrial Classification System (NAICS) codes in defining pharmaceutical products was inappropriate because of the ambiguous nature of SIC and NAICS code applicability, and that instead of using SIC or NAICS codes, the definition should clearly describe the characteristics of the processes that are subject to the rule. One of the commenters also provided a recommended definition of pharmaceutical product based upon the definition of ``drug product'' already established by the Food and Drug Administration at 21 CFR 210.3 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs). Many commenters stated that the inclusion of the phrase, ``regulated by the Food and Drug Administration'' should be deleted from the definition of pharmaceutical products because many nondrug products such as cosmetics, food additives, plastics (food contact films) and dietary supplements, are regulated by the FDA and could be interpreted as being pharmaceutical products based on the proposed definition of pharmaceutical product. However, another commenter requested that EPA expand the definition of pharmaceutical products to include products regulated by the U.S. Department of Agriculture (USDA) as well as the FDA because the pharmaceutical industry produces animal biologics using the same processes used to produce human biologics, and therefore, HAP emitted from the production of animal biologics also should be regulated as part of the pharmaceutical NESHAP. Many commenters stated that the use of the term ``intermediates'' in the definition of pharmaceutical product was confusing and brings many unintended chemicals and processes into the pharmaceutical NESHAP; and therefore, the term should be either clarified or deleted from the definition of pharmaceutical product. One commenter stated that inclusion of the term, ``intermediate,'' in the definition of pharmaceutical product makes it unclear how far back in the manufacturing chain a regulated entity must look when determining applicability. Many commenters stated that operations that manufacture raw materials (such as acids and solvents) that are not precursors to active ingredients in pharmaceutical products should not be regulated as part of the pharmaceutical NESHAP. Several commenters stated that the rule should only apply to processes which produce materials which exclusively or primarily are used to make drug active ingredients. Another commenter stated that EPA needs to clarify that intermediates already regulated by the HON are excluded from the pharmaceutical NESHAP. Four commenters requested that EPA specifically exclude certain ``nonpharmaceutical products'' from the definition of pharmaceutical product. One commenter expressed concern that due to the inclusion of SIC code 2835 and the phrase, ``regulated by the FDA,'' in the pharmaceutical product definition, equipment used to manufacture medical devices or substances used in the manufacture of medical devices could be subject to the pharmaceutical NESHAP instead of the miscellaneous organic NESHAP (MON). Therefore, the commenter requested that ``medical devices'' be specifically excluded from the definition of pharmaceutical product. A second commenter stated that the rule should not apply to specialty chemical manufacturers who occasionally engage in tolling a pharmaceutical intermediate. The commenter further stated that tolling of pharmaceutical intermediates could be driven overseas if U.S. specialty chemical opera tions require long lead times to identify MACT requirements, develop compliance systems, and amend title V requirements. A third commenter suggested that EPA exclude contract manufacturing from the pharmaceutical rule, and allow it to be covered by the MON. The fourth commenter requested that EPA specifically exclude ``color additives and other inactive ingredients'' from the definition of pharmaceutical product because the commenter interpreted EPA's exclusion of excipients from the definition of pharmaceutical product to mean that the pharmaceutical NESHAP was only intended to cover active ingredients. The fourth commenter also provided a definition of excipients developed by the International Pharmaceutical Excipients Council. The EPA considered all of the above comments and revised the definition of pharmaceutical product based on these and other considerations. The rationale for the revised definition is presented below. The EPA agrees with the commenters that SIC codes may be ambiguous, were not developed with environmental regula tion in mind, and may not reflect individual processes within a facility, and therefore, that the use of SIC codes to define pharmaceutical product may introduce unintended ambiguity into applicability determinations. Also, EPA believes that the use of the newer NAICS codes in defining applicability would result in the same problems with ambiguity and intended use. However, based on industry survey responses, EPA recognizes that facilities primarily claiming SIC codes 2833 and 2834 and/or NAICS codes 325411 and 325412 produce medicinals and pharmaceuticals as their primary products. Therefore, for the sake of clarity and consistent with the survey responses, EPA has retained the SIC Codes and added the NAICS codes in the definition of pharmaceutical product. The EPA also agrees that the term ``regulated by FDA'' is also ambiguous. As noted by one commenter, in 21 CFR section 207.10(e), FDA exempts from registration and drug listing, ``manufacturers of harmless inactive ingredients that are excipients, coloring, flavorings, emulsifiers, lubricants, preservatives, or solvents that become components of drugs, and who otherwise would not be required to register under this part.'' The EPA agrees that some of the processes used to manufacture such substances were not intended for coverage by this rule, and that was the intent of including the phrase ``regulated by FDA'' in the definition of pharmaceutical product in the proposed rule. Based on the comments, EPA believes that a less ambiguous way to define pharmaceutical product would be to base it on definitions contained in 21 CFR 210.3 (Current Good Manufacturing Practice in Manufacturing, Processing, or Holding of Drugs; General) for drug product or active ingredient. These definitions capture formulation products as well as pharmaceutical active ingredients and their precursors. [[Page 50289]] The proposed rule also was intended to cover intermediates that are manufactured prior to the final processing steps in which a compound becomes a pharma ceutical product. However, EPA recognizes the difficulty associated with defining an intermediate, especially the point at which a chemical becomes associated with pharma ceutical manufacturing. Because the pharmaceutical industry is characterized by numerous processes that may be conducted prior to the actual synthesis and isolation of active ingredients, EPA rejects the notion that, in order to simplify applicability, only those processes yielding active ingredients should be covered by the rule. Rather, EPA agrees with the suggestion that the rule be based on the primary intended use of the materials manufactured. By defining applicability according to primary use as pharmaceutical products or as their precursors, intermediates that are further processed to become active ingredients or drug components are covered. Therefore, in order to clarify the boundaries of the coverage of such precursors or intermediates, the definition of process was changed in the final rule to clarify that the provisions of the subpart apply to materials whose ``primary use'' is as a pharmaceutical product or precursor. The ``primary use'' approach also addresses the comment regarding the exclusion of contract manufacturing from the pharmaceutical rule. Simply put, contract manufacturers will be subject to this standard during periods when they manufacture a pharmaceutical product. To simplify the determination of applicability for facilities that conduct contract manufacturing, some commenters suggested that the rule apply to processes whose primary product is a pharmaceutical active ingredient. The concept of primary product has been used in past regulations (e.g., HON, P&R IV, etc.) and was not considered in the proposed rule because there was a conscious effort to disengage production equipment from products manufactured. Because the standards are process-based, the intent of the proposal was to cover the production of pharmaceutical products, regardless of what pieces of equipment were used to manufacture them in the course of a year. Conceptually, the primary product definition makes sense for process lines that can be used to manufacture more than one product. In the pharmaceutical manufacturing industry, however, process equipment is reconfigured such that the same pieces of equipment may not always be part of the same process line. Under the current concept of primary product that appears in other rules, it would still be difficult to determine the primary product of a nondedicated process, because not all the same equipment would be associated with the ``process.'' However, by reverting back to the concept of ``primary use,'' owners and operators can clearly delineate applicability based on the intended use of materials they manufacture, and not the equipment they are manufactured in. The revised definition for pharmaceutical product in today's final rule borrows heavily from definitions contained in 21 CFR 210.3 (Current Good Manufacturing Practice in Manufacturing, Processing, or Holding of Drugs; General). The revised definition of pharmaceutical product and a new definition for primary use are shown below. Also, definitions for ``active ingredient,'' ``component,'' and ``excipient'' have been included in today's final rule. Pharmaceutical product means: (1) any material described by the standard industrial classification (SIC) code 2833 or 2834; (2) any material whose manufacturing process is described by the north american industrial classification system (NAICS) code 325411 or 325412; (3) a finished dosage form of a drug, for example, a tablet, capsule, solution, etc., that contains an active ingredient generally, but not necessarily, in association with inactive ingredients; or (4) any component whose intended primary use is to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals (the term does not include excipients, but includes drug components such as raw starting materials or precursors that undergo chemical change or processing before they become active ingredients). Primary use means the single largest use of a material. For reasons described above and in response to related comments, the applicability language in Sec. 63.1250(a) also has been changed in the final rule such that the rule only applies to those pharmaceutical manufacturing operations that meet the following criteria: (1) they manufacture a pharmaceutical product, as defined in section 63.1251, (2) they are located at a plant site that is a major source as defined in section 112(a) of the Act, and (3) they process, use, or produce HAP. The third criterion was included in response to one commenter's concern that, while the rule covers all processes at a facility which is determined to be major source, some processes at those major sources do not emit HAP. The commenter also stated that although this situation may not pose a significant compliance problem, the lack of an exclusion for these non-HAP emitting processes posed an unwarranted regulatory burden. The EPA agreed with the commenter, and modified the applicability of the rule as described above. 2. Definition of PMPU and Pharmaceutical Manufacturing Operations The EPA received several comments on the proposed definitions of PMPU and pharmaceutical manufacturing operations. At proposal, PMPU was defined as ``any processing equipment assembled to process materials and manufacture a pharmaceutical product and associated storage tanks, waste-water management units, or components such as pumps, compressors, agitators, pressure relief devices, sampling connection systems, open- ended valves or lines, valves, connectors, and instrumentation systems that are used in the manufacturing of a pharmaceutical product.'' Pharmaceutical manufacturing operations were defined to ``include PMPU's and other processes and operations as well as associated equipment such as heat exchange systems that are located at a facility for the purpose of manufacturing pharmaceuticals.'' One commenter stated that having both ``pharmaceutical manufacturing operation'' and PMPU in the proposed rule was confusing and redundant. The commenter stated that by having both terms, the rule implies that the definition of PMPU does not cover all of the equipment to be regulated by subpart GGG. The commenter further stated that the inclusion of the phrase ``associated equipment'' in the pharmaceutical manufacturing operations definition was unclear because the definition of PMPU already covers ``associated'' equipment. The commenter also stated that heat exchangers were given as an example of ``associated equipment'' under the definition of pharmaceutical manufacturing operation, but not included as an example in the definition of PMPU. For these reasons, the commenter suggested that the definition of pharmaceutical manufacturing operation be deleted entirely, and that heat exchangers be added to the list of examples of ``associated equipment'' in the PMPU definition. [[Page 50290]] Two commenters stated that wastewater management units should not be included in the definition of PMPU. One commenter stated that wastewater management units are not subject to the standard, but instead are used to comply with the standard. This commenter also pointed out that neither the HON's definition of chemical manufacturing process unit (CMPU) nor the Polymers and Resin I NESHAP definition of elastomer product process unit (EPPU) includes wastewater management units. The commenter further stated that including wastewater management units in the definition of PMPU could be interpreted to require new source MACT at an existing wastewater management unit if a new, major, dedicated PMPU is built that will contribute wastewaters to that unit. Another commenter stated that packaging operations (e.g., ``placement of dose forms, such as tablets, into containers, and assembly, closure, and labeling of these containers'') are not pharmaceutical manufacturing operations, and thus, should be explicitly excluded from the definition of pharmaceutical manufacturing operations. Many commenters stated that the definition of PMPU should be modified to make it clear that a PMPU is a group of equipment. These commenters were concerned that, as written, the definition of PMPU could be interpreted to mean that an individual piece of equipment constitutes a PMPU, and thus, the addition of a single piece of equipment to an existing dedicated process line could trigger new source MACT. Many commenters stated that a PMPU should be identified by its primary product and suggested adding language to the definition that makes it clear that PMPU's manufacture pharmaceutical products as their primary product. After consideration of the above comments on the definitions of pharmaceutical manufacturing operations and PMPU, EPA has decided to retain both terms, but with some modifications. The terms ``Pharmaceutical Manufacturing Operations'' and ``Pharmaceutical Manufacturing Process Unit (PMPU)'' were not intended in the proposed rule to refer to the same sources entirely. While the term ``Pharmaceutical Manufacturing Operations'' is the broadest term used in the rule and covers all emission sources within a given facility that are the direct or indirect result of pharmaceutical manufacturing, the term ``PMPU'' was intended to encompass each process unit within the facility and its associated equipment. Therefore, the pharmaceutical manufacturing operations encompasse all PMPU's at a given facility as well as equipment that is not included in individual PMPU's. In the proposed rule, the PMPU was used exclusively to define new source applicability in Sec. 63.1250(c). In today's final rule, PMPU's also have replaced ``processes'' in the pollution prevention standard, and therefore, PMPU's serve several functions in the final rule. The PMPU also serves as the basis of the wastewater cutoffs for the standard, at 1 Mg/yr applicability HAP load per PMPU. The EPA believes that the broader term for pharmaceutical manufacturing operations is necessary to include sources that cannot be associated with single PMPU's. By including wastewater management units in the definition of PMPU at proposal, EPA intended that all wastewater streams and residuals would be considered part of the PMPU. The EPA reviewed the definition of process and PMPU for consistency with the HON and other MACT standards. Wastewater management units are subject to the standard, but manage wastewater from several PMPU. However, wastewater generated in a PMPU is not specifically defined as part of the PMPU, but rather can be associated with it. This convention is analogous to process vent emissions; although they are not specifically identified as part of the PMPU, a PMPU may generate process vent emissions. In deciding whether the PMPU has the potential to emit 10 or 25 tons of HAP, all emissions from all sources associated with the PMPU, including process vents and wastewater, must be considered. Therefore, the definition of PMPU was modified to not specify wastewater streams, residuals, and wastewater management units, as part of the PMPU. Although EPA recognizes that rarely will one piece of equipment comprise a PMPU, the Agency disagrees with the commenters that a PMPU must always be defined as a group of equipment. The definition of PMPU in today's final rule, however, includes the term, ``process'' which is defined as a ``logical grouping of processing equipment which collectively function to produce a pharmaceutical product'' and ``may consist of one or more unit operations.'' However, a PMPU is not always associated with specific groupings of equipment associated with a given process. (See also section VI.A.3 of this preamble and Sec. 63.1252 of the final rule for a complete definition of process.) In response to suggestions that EPA define a PMPU by its primary product, the EPA has included a primary use concept in the definition of pharmaceutical product in the final rule as discussed previously in section VI.A.1, above. Based on the comments discussed above and related comments, the definitions of PMPU and pharmaceutical manufacturing operations in today's final rule are as follows: Pharmaceutical manufacturing process unit (PMPU) means the process, as defined in this subpart, and any associated storage tanks, equipment identified in Sec. 63.1252(f), and components such as pumps, compressors, agitators, pressure relief devices, sampling connection systems, open-ended valves or lines, valves, connectors, and instrumentation systems that are used in the manufacturing of a pharmaceutical product. Pharmaceutical manufacturing operations means the facility-wide collection of PMPU's and any other equipment such as heat exchanger systems or cooling towers, that are not associated with an individual PMPU, but that are located at a facility for the purpose of manufacturing pharmaceutical products and are under common control. 3. Definition of Process The EPA received a number of comments on the proposed definition of process. At proposal, process was defined as ``a logical grouping of processing equipment which collectively function to produce a pharmaceutical product or isolated intermediate. A process may consist of one or more unit operations. For the purposes of this subpart, process includes all or a combination of reaction, recovery, separation, purification, or other activity, operation, manufacture, or treatment which are used to produce a product or isolated intermediate. The physical boundaries of a process are flexible, providing a process ends with a product or isolated intermediate, or with cessation of onsite processing. Nondedicated solvent recovery and nondedicated formulation operations are considered single processes that are used to recover or formulate numerous materials and/or products.'' Many commenters requested that the definition of process be clarified to indicate that Quality Assurance and Quality Control (QA/ QC) laboratories are not considered part of the process. These commenters were concerned that, although it may be clear that QA/QC labs are not ``processing equipment'' or ``an activity or an operation used to produce a product,'' the words, ``or [[Page 50291]] other activity, operation,'' may lead to confusion as to whether QA/QC labs are part of the process. The commenters suggested that EPA explicitly exclude QA/QC labs from the definition of process because QA/QC laboratories emit insignificant quantities of HAP, and therefore, time-consuming nonapplicability demonstrations could be avoided. Several commenters recommended that EPA include storage tanks in the definition of process so that sources that choose to comply using the pollution prevention alternative are not exempted from the storage tank requirements in Sec. 63.1252(b) of the proposed rule. The commenters stated that emissions from storage tanks may be significant, and that sources should be required to comply with the storage tank standards under all circumstances. Many commenters requested that EPA modify the definition of process to clarify how the process vent provisions will apply to formulation facilities. These commenters were concerned that the use of the term ``nondedicated'' in reference to formulation facilities results in confusion as to how to apply the standard. The commenters pointed out that, unlike equipment used in pharmaceutical chemical synthesis facilities, equipment in a formulation facility are only used to formulate products, and therefore, formulation facilities are ``dedicated'' to formulation operations. However, the commenters also pointed out that the equipment at the formulation facility is used to produce many different products, and therefore, is ``nondedicated.'' For these reasons, the commenters recommended that, for formulation operations, the term, ``nondedicated,'' be applied to the equipment within the facility and not the facility itself. The commenters also requested that for formulation operations, EPA limit the definition of process to formulation activities within a contiguous area (such as a formulation building or a contiguous area within a multipurpose building in which formulation takes place). The commenters cited examples where separate formulation operations are located at the same plant site, but are physically separate, and thus would require separate emission control systems. Another commenter was concerned that use of the term ``nondedicated'' could be interpreted as including solvent recovery or formulation operations that process small quantities of pharmaceutical- related materials, but whose primary use is for a process subject to another MACT rule. The commenter recommended that this issue be resolved by (1) deleting the term ``nondedicated'' from the proposed definition of process, and (2) adding the phrase, ``whose primary use is associated with the manufacture of pharmaceutical products'' after the word ``operations'' in the last sentence of the proposed definition of process. One commenter suggested that the phrase ``or isolated intermediate'' (used throughout the definition) be deleted because ``processes produce products,'' but ``portions of processes produce intermediates.'' The commenter further explained that although the product of one process may be used as a raw material in another process, the product serving as the raw material is not typically thought of as an intermediate. The EPA has modified the definition of process in the final rule in response to the comments described above. The EPA agrees with the commenters that QA/QC laboratories are not part of the process, and the definition of process in the final rule excludes QA/QC laboratories. To clarify EPA's intention that storage tanks be included as part of the pollution prevention alternative, and in response to the comments regarding the perceived exclusion of storage tanks from the P2 alternative, today's final rule includes storage tanks in the definition of PMPU and refers to PMPU's instead of ``processes'' in the pollution prevention provisions (see also section V.A.2 of this preamble--Definition of PMPU and Pharmaceutical Manufacturing Operations, and section VI.F--Pollution Prevention Alternative). The EPA disagrees with the commenters who believe that the term, ``nondedicated,'' as applied to formulation facilities, should be applied to the equipment within the facility and not to the facility itself. As explained in section VI.A.1 of this preamble, the pharmaceutical NESHAP regulates processes, not equipment, and the concept of primary use is applied to the pharmaceutical product, not to the equipment used to manufacture the product. However, today's final rule clarifies the intent of the proposed rule with regard to formulation and solvent recovery operations: those operations occurring within a contiguous area are to be considered as single processes, regardless of the final product of that formulation or recovery operation. The EPA agrees with the suggestions provided by one commenter to delete all references to ``isolated intermediate'' and has incorporated these comments into the definition of process in the final rule. Also, the definition of pharmaceutical product in the final rule (see section VI.A.1--General Applicability: Definition of Pharmaceutical Product) states that pharmaceutical product ``includes drug components such as raw starting materials or precursors that undergo chemical change or processing before they become active ingredients.'' Therefore, drug components such as raw materials and precursors, which are themselves products of processes, are defined as products, rather than ``intermediates,'' thus eliminating the need for the concept of ``intermediates'' (see also section VI.A.6--Definition of Isolated Intermediate). For the reasons stated above, the definition of ``process'' in today's final rule is as follows: Process means all equipment which collectively function to produce a pharmaceutical product. A process may consist of one or more unit operations. For the purposes of this subpart, process includes all or a combination of reaction, recovery, separation, purification, or other activity, operation, manufacture, or treatment which are used to produce a pharmaceutical product. Cleaning operations are considered part of the process. The holding of the pharmaceutical product in tanks or other holding equipment for more than 30 consecutive days, or transfer of the pharmaceutical product to containers for shipment, marks the end of a process, and the tanks are considered part of the PMPU that produced the stored material. When material from one unit operation is used as the feedstock for the production of two or more different pharmaceutical products, the unit operation is considered the endpoint of the process that produced the material, and the unit operations into which the material is routed mark the beginning of the other processes. Nondedicated recovery devices located within a contiguous area within the affected source are considered single processes. Nondedicated formulation operations occurring within a contiguous area are considered single processes. Quality Assurance and Quality Control laboratories are not considered part of any process. The revised definition of process provided above clarifies when a process ends. The EPA selected 30 days as a reasonable period of time, beyond which, if a material has not been further processed or reacted, a process can be considered complete for the purposes of this subpart. Applicability determinations and control requirements would be more difficult without such a time frame. The definition of process is a key element of the rule because most of the [[Page 50292]] applicability and compliance determinations are based on the process, as a unit. Because of concerns that processes could be artificially divided into smaller portions of processes in order to meet the 2,000 lb/yr limit, EPA limited the number of processes per facility that can comply with the 2,000 lb/yr limit to seven per year. However, EPA also added that processes with very low emissions (less than 100 lb/yr HAP, uncontrolled) would not be counted as part of the seven process limit. These limitations and exemptions are currently under review and may be revised at a later time. 4. Definition of Process Vent The EPA received several comments on the proposed definition of process vent, primarily related to the following two issues: (1) the establishment of a de minimis level or cutoff below which controls would not be required and (2) how the rule applies to process vents that are manifolded together. At proposal, process vent was defined as ``a vent from a unit operation through which a HAP-containing gas stream is, or has the potential to be, released to the atmosphere. Examples of process vents include, but are not limited to, vents on condensers used for product recovery, bottom receivers, surge control vessels, reactors, filters, centrifuges, and process tanks. Process vents do not include vents on storage tanks regulated under Sec. 63.1252(b), vents on wastewater emission sources regulated under Sec. 63.1252(d), or pieces of equipment regulated under Sec. 63.1252(e).'' Many commenters requested that EPA modify the definition of process vent to exempt any vent that contains a gas stream with less than 50 ppmv HAP averaged over the unit operation. These commenters cited 40 CFR part 63.113(g) of the HON, which exempts vents with less than 50 ppmv from monitoring or any other provisions of sections 63.114 through 63.118. One of these commenters provided a cost analysis, using EPA's recently released biofilter cost model, for an existing fermentation operation, the emissions from which typically contain less than 50 ppmv methanol. The cost effectiveness of biofiltration for this scenario was estimated to be $27,000/Mg, with a percent control of 60 percent (i.e., from 50 ppmv to 20 ppmv, EPA's established practical limit of control), a value that the commenter stated was ``clearly unreasonable.'' The commenter further stated that for fermenter and fermenter preparation vents, a cutoff of 100 to 200 ppmv could be justified (as opposed to 50 ppmv) and requested that EPA consider such a cutoff. Two commenters stated that the proposed definition of process vent implies that every process vent is connected to a single piece of unit operations equipment, which often is not the case at multiproduct, multibatch facilities. One of the commenters suggested that the definition include a statement indicating that ``multiproduct facilities having multiple production trains may have large numbers of process vents, which could discharge directly to the atmosphere; discharge through a dedicated control equipment; or which can be manifolded from many process units into a common header leading to a common control equipment.'' The other commenter stated that compliance with the process vent standards would be more difficult and expensive if the definition of process vent included the combined or commingled vents from several pieces of unit operations equipment, rather than just one piece of equipment. This commenter also questioned if standard industrial hygiene type exhaust pickups and general room ventilation exhaust points are meant to be included in the definition of process vents. The commenter pointed out that those types of systems may exhaust through a stack, which may be interpreted as being an emission point, but noted that some states do not consider these emission points for the purposes of Title V permits. The commenter stated that, if these emission points were not considered in developing the MACT floors, they should not be included as process vents, and requested clarification from EPA. As explained in section VI.C of this preamble, the definition of process vent in today's final rule includes a de minimis cutoff for uncontrolled and undiluted vent streams of 50 ppmv HAP. Regarding multiple vents (from the same process) being manifolded together into a common header, the Agency considers the common header in this rule to be a single process vent, and has revised the definition of process vent to reflect this view. In response to one commenter's question about whether or not industrial hygiene exhausts and general room ventilation exhausts would meet the definition of process vent, these sources would not be considered process vents if they are under the 50 ppmv HAP cutoff. Based on the changes discussed above, the definition of process vent in the final rule is as follows: Process vent means a vent from a unit operation or vents from multiple unit operations within a process that are manifolded together into a common header, through which a HAP-containing gas stream is, or has the potential to be, released to the atmosphere. Examples of process vents include, but are not limited to, vents on condensers used for product recovery, bottom receivers, surge control vessels, reactors, filters, centrifuges, and process tanks. Emission streams that are undiluted and uncontrolled containing less than 50 ppmv HAP, as determined through process knowledge, test data using Methods 18 of 40 CFR part 60, appendix A, or any other test method that has been validated according to the procedures in Method 301 or appendix A of this part, are not considered process vents. Process vents do not include vents on storage tanks regulated under Sec. 63.1253, vents on wastewater emission sources regulated under Sec. 63.1256, or pieces of equipment regulated under Sec. 63.1255. 5. Definition of Process Condenser The EPA received numerous comments on the proposed definition of process condenser. These comments primarily dealt with the dual role of condensers as both process condensers and air pollution control devices, and in which category recirculating condensation systems should be class ified. At proposal, process condenser was defined as ``a condenser whose primary purpose is to recover material as an integral part of a unit operation. The condenser must support vapor-to- liquid phase change for periods of source equipment operation that are above the boiling or bubble point of substances(s). Examples of process condensers include distillation condensers, reflux condensers, process condensers in line prior to the vacuum source, and process condensers used in stripping or flashing operations.'' Many commenters took issue with the phrase ``integral part of a unit operation'' and ``process condensers in line prior to the vacuum source.'' These commenters cited examples where it could be concluded that a condenser is not integral to a process because it does not perform any necessary process function. The commenters also stated that if there were two condensers in series prior to a vacuum source, and the first condenser effected a phase change, then the second condenser should be considered an air pollution control device, even though it is located ``prior to a vacuum source.'' Three commenters suggested that the intended use be considered when determining whether a condenser is a process condenser or an air pollution control device. Two of these commenters stated that, ``if the condenser is acting as a control unit, so [[Page 50293]] that its presence is intended to prevent chemicals from reaching the uncontrolled environment; if the materials collected are led towards management and disposal systems; and if the collected materials are in no way used, reused, nor sold for fuel value, then the condenser is serving as a control unit regardless of the fact that the bubble point is met or not at the source.'' The other commenter disagreed with the condition that to be a process condenser, the condenser must support a vapor-to-liquid phase change for periods of source equipment operation that are above the boiling or bubble point of the substance(s). This commenter pointed out that under the proposed definition, the same condenser will sometimes be a process condenser and sometimes an air pollution control device, and tracking when the condenser switches from one to the other would be burdensome. Therefore, the commenter recommended that the facility which operates the condenser (and knows the process best) be allowed to determine whether it is a process condenser or an air pollution control device. Another commenter suggested that EPA distinguish between process condensers and condensers serving as air pollution control devices by including a specific temperature limit (i.e., 20 deg.C) such that condensers that lower the temperature of the exit gas stream to a colder temperature would be considered air pollution control devices instead of process condensers. Many commenters requested that EPA specifically address process condensers that belong to recirculating drying systems. Most commenters stated that condensers in recirculating drying systems should be considered pollution control devices. However, one commenter stated that recirculating condensation systems should be defined as neither process condensers nor air pollution control devices, but defined separately, with ``management systems to account for their pollution prevention effects to be worked out at a later date for the promulgated standard.'' The major concern of all of these commenters, however, was that under the proposed definition, the recirculating condensation systems would be considered process condensers, and thus, the uncontrolled emissions and resulting emissions reductions would be considerably lower than if the condenser was considered an air pollution control device. Even though these systems generate considerably lower emissions as compared to once-through systems, owners and operators could not take advantage of the high emission reductions in the process vent standard that requires 93 percent control or 2,000 lb/yr after control from the entire process. The EPA disagrees with the suggestion that the owner or operator should be allowed to determine whether a condenser is a process condenser or an air pollution control device based on ``intended use.'' Because one of the formats of the process vent standard requires that a reduction from uncontrolled emissions be applied across a process (i.e., achieve a 93 percent reduction in emissions from the process), EPA is concerned about the opportunity for crediting reductions achieved by condensing boiling streams on other sources in the process. In fact, in requesting data from industry (which was later used to set the MACT floor), the MACT partnership specifically confirmed from responders that the data reported was based on the definition of process condenser as described in the proposed rule. Therefore, EPA has retained the intent of the proposed definition, but has made clarifying changes. The definition of process condenser in the final rule is as follows: Process condenser means a condenser whose primary purpose is to recover material as an integral part of a process. The condenser must support a vapor-to-liquid phase change for periods of source equipment operation that are at or above the boiling or bubble point of substance(s) at the liquid surface. Examples of process condensers include distillation condensers, reflux condensers, and condensers used in stripping or flashing operations. In a series of condensers, all condensers up to and including the first condenser with an exit gas temperature below the boiling or bubble point of the substance(s) at the liquid surface are considered to be process condensers. All condensers in line prior to a vacuum source are included in this definition. The EPA also rejects the suggestion to use 20 deg.C as a temperature cutoff in determining whether a condenser is a process condenser or an air pollution control device. Because of the differences in the chemical and physical properties of substances used in the manufacture of pharmaceutical products, one temperature cannot be used to represent all processes; in some cases, a condenser operating at 20 deg.C could actually be an air pollution control device and not a process condenser. Finally, EPA disagrees with the requests that condensers in recirculating drying systems be considered as pollution control devices or defined separately. Emissions from the recirculating drying systems only occur during periodic depressurizations, and these uncontrolled emissions may be low enough such that the process may be under the 2,000 lb/yr cutoff. Processes with recirculating drying systems also may be able to take advantage of the pollution prevention standard. 6. Definition of Isolated Intermediate At proposal, isolated intermediate was defined as ``any intermediate that is removed from the process equipment for temporary or permanent storage or transferred to shipping containers.'' The concept of an intermediate was also included in the proposed definition of pharmaceutical product which contained a reference to ``intermediates used in the production of pharmaceutical products (see section VI.A.1 of this preamble). One commenter on the proposed rule stated that EPA should not use or define the term, ``isolated intermediate,'' in the pharmaceutical NESHAP. (The same commenter also stated that the term, ``isolated intermediate,'' should be removed from the definition of process [see also section VI.A.3--Definition of Process].) The commenter pointed out that the term is ``peculiar to the Toxic Substances Control Act (TSCA), where a long history of interpretation has been developed,'' and if EPA uses this same term in the pharmaceutical NESHAP, ``inconsistencies in interpretation will be inevitable.'' Many other commenters suggested that the definition of isolated intermediate be modified so that the physical removal of an intermediate from the process equipment is not required as a condition for meeting the definition of isolated intermediate. These commenters pointed out that, in some cases, an intermediate may remain in a storage tank or other retention equipment prior to being used in a different process step, and without ever being removed from either set of process equipment. The commenters further stated that the fact that retention tanks are used as separation lines as an alternative to storing the material in drums or separate containers ``is a matter of convenience.'' Therefore, the commenters recommended the following modified definition of isolated intermediate: Isolated intermediate means any intermediate that is stored in storage tanks or other holding equipment for later use, or that is transferred to containers for shipment or storage. After considering these and other related comments (see section VI.A.3 of this preamble), EPA has deleted the [[Page 50294]] term, ``isolated intermediate,'' from the definition of process to avoid confusion and emphasize that products are the end result of processes. Therefore, isolated intermediates are no longer defined or referred to in today's final rule. Also, the definition of process in the final rule incorporates the commenters' suggestion above regarding the fact that physical removal of the ``product'' from the process equipment should not be a required condition for meeting the definition of ``product.'' In addition, the definition of process in the final rule specifies when a process ``ends.'' 7. Research and Development Facilities Many commenters expressed support for the proposed definition of research and development facilities because it draws a clear distinction between activities related to manufacturing (which are covered under today's final pharmaceutical production NESHAP) and those related to research and development (which are not covered by today's final rule). The commenters further stated that such a clear distinction is necessary because pharmaceutical manufacturing operations and research and development activities are often located at the same site. Many commenters requested that EPA make it clear that pilot plants are not subject to the proposed pharmaceutical standards if they meet the definition of ``research and development facility.'' In determining whether an operation of facility constitutes a research and development facility, it is EPA's intention that owners and operators and implementing agencies should refer to the definition of research and development facility which appears in Section 112(c)(7) of the Clean Air Act, rather than relying on existing company designations or facility names. For example, if a pilot plant is collocated with pharmaceutical manufacturing operations that are subject to this subpart, and the pilot plant meets the criteria outlined in the definition of research and development facility, then the pilot plant would not be subject to this subpart. Two commenters were concerned that the term ``de minimis,'' as it is used in the definition of research and development facility, was not defined in the proposed rule. One of the commenters stated that, without clarification (of de minimis) the definition will lead to exhaustive and potentially contentious negotiations between sources and regulatory agencies, and may result in inequitable exemption decisions at similar facilities located in different jurisdictions. The commenter also pointed out that some States have included more specific provisions, such as limiting the number of products produced, establishing maximum daily emission rates, or requiring segregation of the R&D activities from the production areas. Although EPA recognizes the concerns of the commenters, today's final rule does not establish a de minimis level for research and development facilities. The EPA does not have sufficient data to establish a de minimis level, and therefore, such determinations will have to be made by the applicable permitting authorities. Also, EPA is in the process of collecting background information on the various segments of research and development facilities nationwide and is considering development of a NESHAP for one or more of these segments in the future. 8. Consistency With Other Rules The EPA received numerous comments regarding the potential for overlapping regulations. Commenters were strongly opposed to the idea of the same sources being subject to multiple regulations and asked EPA to clarify which regulations applied to pharmaceutical manufacturing operations. The EPA has identified several potential areas in which today's final standards, the RCRA standards (subpart AA or CC), and/or subpart I of 40 CFR part 63 could apply to the same situation. To avoid inconsistent requirements, the EPA has tried to make the regulatory language as specific as possible as to which regulation(s) the owner or operator must comply with to satisfy the requirements of all regulatory programs. For example, if an air pollution control device is subject to the pharmaceuticals production NESHAP and RCRA requirements, Sec. 63.1250(h)(2) of today's final rule states that the owner or operator may elect to comply with the monitoring, recordkeeping and reporting requirements of either rule, as long as they identify which rule's requirements they have selected in the Notification of Compliance Status report. However, if the owner/operator elects to go with RCRA requirements, there may be additional (minimal) reporting requirements. Similarly, Secs. 63.1250(h)(1), (3) and (h)(4) address overlap with other MACT standards, subpart Kb (the NSPS for organic liquid storage tanks), and subpart I (the negotiated regulation for equipment leaks). After the compliance date for today's final rule for pharmaceuticals production, an affected source subject to Subpart I is required to comply only with the provisions of today's final rule. For sources subject to other MACT standards and NSPS Kb, reporting requirements may be streamlined to the extent that the rules are consistent. B. Storage Tank Provisions The proposed and final standards for storage tanks with capacities greater than 20,000 gallons (i.e., reduce HAP emissions by at least 95 percent) represent a control level that is beyond the MACT floor. In deciding to go beyond the MACT floor, EPA determined that floating roof technology was less costly than condensers (which represented the MACT floor technology and 90 percent control) and resulted in greater emission reductions. Many commenters stated that the proposed requirements for storage tanks with capacities greater than or equal to 20,000 gallons represent an increase in stringency (beyond the MACT floor) without precedent. These commenters suggested that 90 percent control of HAP emissions was more appropriate and consistent with the storage tank provisions of similar rules (e.g., the HON and 40 CFR 60, Subpart Kb). The commenters also questioned EPA's assumption that floating roof technology could and would be used to reduce emissions from storage tanks, given the general lack of storage tanks at pharmaceutical manufacturing facilities that are fitted with floating roofs and the use of horizontal storage tanks (which cannot be fitted with floating roofs) at some facilities. In addition, commenters requested that EPA include in the final rule: (1) an exemption for storage tanks emitting less than 500 lb/yr of HAP (an alternative that was considered and then dropped during the regulatory review .process), and (2) a provision that allows vapor balancing systems as an alternative means of control. The commenters reviewed what was gained by dropping the 500 lb/yr cutoff alternative and concluded that in the top 12 percent of storage tanks, the associated emissions that would not be controlled under the 500 lb/yr cutoff alternative are 2,710 lb/yr (or 150 lb/yr/ tank). Based on an annualized cost of $142,500/yr (to control the 2,710 lb/yr), the commenters determined that the cost effectiveness of controlling the emissions from storage tanks with emissions less than 500 lb/yr would be $115,913/Mg. The commenters further stated that the EPA has authority under the law to establish de minimis provisions for exceptions from statutory directives when the benefits of regulation are significantly outweighed by the associated costs and other [[Page 50295]] burdens, and the 500 lb/yr cutoff alternative meets the criteria for establishing such a de minimis provision, especially considering the fact that the proposed storage tank provisions represent a control level above the MACT floor. Many commenters stated that the rule should specify that vapor balancing systems meet the requirements of the storage tank provisions. The commenters stated that vapor balancing systems are effective, relatively easy to use, capable of achieving control efficiencies as high as 90 to 98 percent, and are accepted under other rules (both NSPS and NESHAP), and therefore, should be accepted in the pharmaceutical NESHAP. One commenter also pointed out that, when vapor balancing is used (i.e., the storage tank vapor space is routed to the truck), the source of pollution is the vapor content of the truck; however, when the storage tank is vented to a control device, there are two sources of pollution: the HAP vapor from the truck and secondary pollutants from the control device. The same commenter recommended that the State of New Jersey requirements for vapor control (7:27-16.4 VOC Transfer Operations, Other Than Gasoline) be incorporated into the storage tank provisions. In response to the comments on the proposed storage tank provisions, today's final rule does not include provisions for vapor balancing of storage tanks. However, this issue will be addressed in the Organic Liquids distribution MACT standard. The MACT floor for storage tanks was determined to be 90 percent control of HAP from storage tanks and did not cover tank truck vapor. The EPA also considered the commenters' request for a 500 lb/yr cutoff, but rejected it because a sufficient number of small storage tanks in service at pharmaceutical manufacturing facilities are controlled, and the 500 lb/ yr cutoff represents an alternative that is less stringent than the MACT floor, and thus, is not acceptable. The control level for storage tanks with capacities greater than or equal to 20,000 gallons in the final rule is the same as proposed level (i.e., 95 percent). As explained in the Basis and Purpose Document (see Docket A-96-03, Item No. III-B-01 ), EPA chose 95 percent control (as opposed to the MACT floor) for storage tanks greater than 20,000 gallons because floating roof technology has been demonstrated to achieve 95 percent control and is considerably less expensive than other technologies. Although floating roofs currently may not be in use on storage tanks in the pharmaceutical industry, EPA is not aware of any technical obstacles to their use, except in the case of horizontal tanks. Also, owners or operators still have the option of using add-on controls instead of floating roofs. C. Process Vent Provisions The EPA received numerous comments on the proposed standards for process vents. Comments focused on the following areas: (1) establishment of a concentration-based applicability cutoff, (2) implementation of the 98 percent control requirement, (3) new source MACT for process vents, and (4) compliance periods. 1. Applicability Cutoff Many commenters suggested that EPA establish a concentration threshold below which an emission stream would not be considered a process vent, and thus would be exempt from further applicability determinations, control or monitoring requirements. The commenters recommended a de minimis concentration of 50 ppmv or 50 ppmw for process vents. After consideration of the above recommendations and comments related to the alternative standard (see section VI.G of this preamble), EPA decided to establish a de minimis cutoff for process vents equal to 50 ppmv HAP, based on uncontrolled, undiluted emissions. The de minimis cutoff is incorporated into the definition of process vent, which states that uncontrolled, undiluted emission streams containing less than 50 ppmv HAP are not considered process vents. 2. Implementation of the 98 Percent Control Requirement Today's final rule requires facilities to apply an equation in Sec. 63.1254(a)(3) to determine if emissions from the process vent must be controlled by 98 percent as opposed to 93 percent. The applicability equation uses two variables, vent flow and yearly uncontrolled HAP emissions, to calculate a flow rate. The calculated flow rate is then compared to the process vent's actual flow rate, and if the actual flow rate is less than or equal to the calculated flow rate, the process vent requires 98 percent control. A number of commenters believe that the 98 percent control applicability equation should be deleted because it will create a significant recordkeeping burden, will be practically impossible to implement, and will significantly hamper operational flexibility. The major concern noted by the commenters was that the applicability equation, though fairly straight-forward for dedicated single-product processes, is extremely difficult if not impossible to apply to multipurpose nondedicated processes. The commenters stated that, because nondedicated processes use individual pieces of equipment to make numerous products over the course of a year, the emission stream characteristics of the associated process vents will change depending on the product being manufactured, and thus, the recordkeeping requirements for a single process vent would be burdensome. The commenters also pointed out that a facility may have 200 to 300 individual process vents. Another concern raised by the commenters was that a slight variance from forecasted production could result in a process vent previously required to control emissions by 93 percent to become subject to the 98 percent control requirement, and the affected facility would not have sufficient lead time to upgrade their control equipment from 93 to 98 percent. The commenters were concerned that such uncertainties will hamper operational flexibility because facilities will be forced to impose limitations on production to ensure that they will not trigger 98 percent control. The commenters also stated that applying the applicability equation to manifolded vents would further complicate matters because more sources emitted through the same vent will result in greater variability of vent stream characteristics. The commenters also requested that if EPA retains the 98 percent control requirement for existing process vents in the final rule, that Sec. 63.1252(c)(4) in the proposed rule be revised to clearly describe how to apply the 98 percent control applicability equation. Commenters noted that using the past actual annual HAP emissions versus projected annual HAP emissions in the applicability equation is an issue because the production of many products varies from year to year, and historical and forecasted annual HAP emission estimates may be very different. The commenters also were concerned that the proposed rule did not clearly establish how to determine the process vent's actual flow rate, which will be compared to the applicability equation's calculated flow rate. Finally, the commenters suggested that EPA specify that the applicability equation applies to individual pieces of equipment in a formulation facility. The commenters were concerned with how the applicability equation would be applied to nondedicated formulation facilities. The commenters pointed out that nondedicated formulation facilities often use multiple pieces of the same equipment to perform one operation [[Page 50296]] (e.g., six tray dryers), and not all of these pieces of equipment will be used to produce every product in the formulation facility (i.e., not all trays of the dryer are always used). After considering the comments above, EPA decided to retain the 98 percent control requirement for existing process vents that meet the applicability criteria. (For those process vents already controlled to 93 percent prior to April 2, 1997, no additional control is necessary.) The applicability equation applies to individual process vents within a process; however today's final rule considers manifolded process vents within each process to constitute a single process vent. With the exception of formulation operations and recovery devices, the definition of process is based on the product manufactured, not the equipment used to manufacture it. Therefore, the determination of which vents require control to the 98 percent level for nondedicated process vents should be straightforward; namely, owners and operators need to anticipate the total uncontrolled HAP emissions per year from each vent from each process, and the average flow rate of the vent. The total uncontrolled emissions should be based on the potential number of batches per year that the facility can run for each process. Based on this projection, the owner or operator can decide whether to install or use an existing 98 percent control device or limit the number of batches to stay below the applicability threshold. Today's final rule also requires facilities to keep track of the number of batches of products they make each year to show that their number of batches is less than the number needed to trigger 98 percent. In response to the commenters' request, the average flow rate has been clarified in the final rule to mean the weighted average flow rate of the emission events contributing to the process vent. For solvent recovery or formulation operations, the definition of process in today's final rule has been clarified to include all operations within a contiguous area; therefore, for these operations, a single process may be associated with several products. Like other processes, the application of the 98 percent control applicability equation should be based on individual process vents or manifolded vents. Thus, if each piece of equipment that is located at a formulation facility, considering processes by contiguous areas, has a separate vent, then the applicability equation is applied to each vent separately; however, if the vents from each piece of equipment are manifolded together, then they are treated as one process vent and the equation is applied to the aggregated flow. As part of the rationale for retaining the 98 percent requirement, EPA notes that this level of control is imposed only on vents that have the potential to emit 25 tons/yr or more, on an uncontrolled basis. Secondly, the applicability equation is indexed on cost-effectiveness. Streams that are too dilute for cost effective control would not, per the equation, be required to be controlled. Third, process vents already controlled to levels of 93 percent or greater prior to April 2, 1997, would be grandfathered and not required to increase controls to 98 percent. The EPA believes that after these considerations are made, only very large streams that are cost effective to control to 98 percent will trigger the 98 percent control requirement. 3. New Source MACT for Process Vents At proposal, new source MACT for process vents was set at 98 percent control for process vents with uncontrolled emissions greater than or equal to 400 lb/yr. The rationale for the 400 lb/yr cutoff (uncontrolled) was that it represented the smallest controlled process considered to be a similar source. Many commenters stated that the standard for new process vents should include a 2,000 lb/yr controlled emissions compliance alternative, because it is unreasonable and unwarranted to require vents with low HAP emissions to achieve 98 percent control. The commenters agreed with EPA's conclusion that 98 percent control represents the best controls in practice for certain sources; however, the commenters believe that the applicability cutoff for new source MACT for process vents is legally flawed because the cutoff did not consider two of the four process types in the industry (fermentation and extraction). The commenters also stated that the process on which the 400 lb/yr cutoff is based is not representative of the industry's processes because the process emits primarily one HAP (methanol) and is controlled by a dedicated scrubber and appears to be only a portion of a process based on the EPA's definition of process in the proposed rule. Citing other rules that set new source MACT as the average level of control achieved by sources using new source MACT control technology, the commenters performed an analysis of the MACT floor data base and determined that the average level of controlled emissions from the best-performing 12 plants was approximately 1,400 lb/yr. The commenters excluded two processes from their analysis that had uncontrolled emissions greater than 1 million lb/yr because these processes are much larger than the typical pharmaceutical manufacturing process and would skew the data. According to the commenters, if these two (larger) processes are included in the analysis, the average level of controlled emissions from the best-performing 12 plants would equal 6,400 lb/yr. The EPA has reviewed the data used to set the MACT floor for process vents at new sources. Based on this review, the EPA has concluded that the data support the level of the proposed standard for new sources. The EPA based the 98 percent control requirement on the 26 processes (under the proposed definition) at 7 plants in the data base that achieve or exceed this control level. These processes include dedicated and nondedicated formulation, chemical synthesis, and fermentation processes. The EPA has concluded that these processes are representative of the control challenges faced by the industry despite the fact that the data do not include an extraction process. The EPA has further concluded that the 98 percent control level achieved at the best controlled processes is applicable to all four process types. The EPA does not believe that the variation in exhaust gas characteristics among the four types of processes in the industry is significant enough to warrant individual evaluation of achievable control levels. In any case, extraction processes are typically solvent-intensive, resulting in the highest average HAP concentration of the four types of processes. High HAP concentrations are conducive to high percent control levels. The commenters suggested that the EPA adopt a 2,000 lb/yr actual emissions compliance alternative to account for variability within the industry. The commenters based this alternative on the average level of controlled [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A98-23168. Public record. Not legal advice.