# National Emission Standards for Hazardous Air Pollutants for Pharmaceuticals Production > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A00-21195 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** August 29, 2000 - **Citation:** 65 FR 52588 ## Text ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63 [FRL-6855-1] RIN 2060-AJ17 National Emission Standards for Hazardous Air Pollutants for Pharmaceuticals Production AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule; amendments. SUMMARY: On September 21, 1998 (63 FR 50280), EPA promulgated national emission standards for hazardous air pollutants (NESHAP) for Pharmaceuticals Production. On November 17 and 20, 1998, petitions for reconsideration and review of the September 1998 rule were filed in the U.S. Court of Appeals for the District of Columbia Circuit. The petitioners raised over 12 technical issues and concerns with the rule. Additional issues were raised by intervenors on the side of the petitioners. On April 10, 2000, EPA proposed amendments to the Pharmaceuticals Production NESHAP to address the issues raised by the petitioners. This document takes final action on those proposed amendments. EFFECTIVE DATE: August 29, 2000. ADDRESSES: Docket No. A-96-03 contains supporting information used in developing the NESHAP. The docket is located at the U. S. Environmental Protection Agency, 401 M Street, SW, Washington, DC 20460 in Room M-1500, and may be inspected from 8:30 a.m. to 5:30 p.m., Monday through Friday, excluding legal holidays. FOR FURTHER INFORMATION CONTACT: For information concerning these final amendments, contact Mr. Randy McDonald, Organic Chemicals Group, Emission Standards Division (MD-13), U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, telephone number (919) 541-5402, electronic mail address mcdonald.randy@epa.gov. For information concerning applicability and rule determinations, contact your State or local representative or the appropriate EPA Regional Office representative. Following is a listing of EPA Regional contacts. EPA Regional Office Contacts Director, Office of Environmental Stewardship, Attn: Air Compliance Clerk: U.S. EPA Region I, 1 Congress Street, Suite 1100 (SEA), Boston, MA 02114-2023, (617) 918-1740 Umesh Dholakia: U.S. EPA Region II, 290 Broadway Street, New York, NY 10007-1866, (212) 637-4023 Doreen Au: U.S. EPA Region III, 1650 Arch Street, Philadelphia, PA 19103, (215) 814-5471 Lee Page, U.S. EPA Region IV, 61 Forsyth Street, SW, Atlanta, GA 30303-3104, (404) 562-9131 Shaun Burke, IL/IN, (312) 353-5713; Joseph Cardile, MI/WI, (312) 353-2151; Erik Hardin, MN/OH, (312) 353-2402; U.S. EPA Region V, 77 West Jackson Boulevard, Chicago, IL 60604-3507 John Jones: U.S. EPA Region VI, 1445 Ross Avenue, Suite 1200 (6EN-AT), Dallas, TX 75202, (214) 665-7233 Gary Schlicht: U.S. EPA Region VII, 726 Minnesota Avenue, Kansas City, KS 66101, (913) 551-7097 Tami Thomas-Burton: U.S. EPA Region VIII, 999 18th Street, Suite 500, Denver, CO 80202, (303) 312-6581 Ken Bigos: U.S. EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105, (415) 744-1240 Dan Meyer: U.S. EPA Region X, 1200 Sixth Street, Seattle, WA 98101, (206) 553-4150 SUPPLEMENTARY INFORMATION: Docket. The docket is an organized and complete file of all the information considered by the EPA in the development of this rulemaking. The docket is a dynamic file because material is added throughout the rulemaking process. The docketing system is intended to allow members of the public and industries involved to readily identify and locate documents so that they can effectively participate in the rulemaking process. Along with the proposed and promulgated standards and their preambles, the contents of the docket will serve as the record in the case of judicial review. (See section 307(d)(7)(A) of the Clean Air Act (CAA).) The regulatory text and other materials related to this rulemaking are available for review in the docket or copies may be mailed on request from the Air Docket by calling (202) 260-7548. A reasonable fee may be charged for copying docket materials. Worldwide Web (WWW). In addition to being available in the docket, an electronic copy of this final rule will be available on the WWW through the Technology Transfer Network (TTN). Following signature, a copy of the rule will be posted on the TTN's policy and guidance page for newly proposed or promulgated rules http://www.epa.gov/ttn/oarpg. The TTN provides information and technology exchange in various areas of air pollution control. If more information regarding the TTN is needed, call the TTN HELP line at (919) 541-5384. Regulated Entities. The regulated category and entities affected by this action include: Category NAICS codes SIC codes Examples of regulated entities Industry 325411 and 325412 2833 and 2834 • Producers of finished dosage forms of drugs ( e.g. , tablets, capsules, and solutions), active ingredients, or precursors. Typically 325199 Typically 2869 • Producers of material whose primary use is as an active ingredient or precursor. This table is not intended to be exhaustive, but rather provides a guide for readers likely to be interested in the revisions to the regulation affected by this action. To determine whether your facility, company, business, organization, etc., is regulated by this action, you should carefully examine all of the applicability criteria in § 63.1250 of the promulgated rule, as well as in the amendments to the applicability sections contained in this action. If you have questions regarding the applicability of these amendments to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section. Outline. The information presented in this preamble is organized as follows: I. What is the history of the Pharmaceuticals Production NESHAP? II. What types of public comments were received on the April 10, 2000 proposal? III. What major issues were raised in the public comments and what changes were made for the final amendments? A. Applicability B. Compliance Dates C. Process Vent Requirements D. Wastewater Requirements E. Recordkeeping F. Delegation of Authority G. Clarification of Statements in the Proposal Preamble H. Technical Correction to Monitoring Requirements for Hydrogen Halides and Halogens I. Minor Corrections IV. What are the administrative requirements for these final amendments? A. Executive Order 12866, Regulatory Planning and Review B. Executive Order 13132, Federalism C. Executive Order 13084, Consultation and Coordination with Indian Tribal Governments D. Executive Order 13045, Protection of Children for Environmental Health Risks and Safety Risks E. Unfunded Mandates Reform Act of 1995 F. Regulatory Flexibility Act (RFA), as Amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq. G. Paperwork Reduction Act H. National Technology Transfer and Advancement Act I. Congressional Review Act I. What Is the History of the Pharmaceuticals Production NESHAP? On September 21, 1998, we promulgated NESHAP for Pharmaceuticals Production as subpart GGG in 40 CFR part 63. On November 17 and 20, 1998, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed petitions for reconsideration and review of the promulgated Pharmaceuticals Production NESHAP in the U.S. Court of Appeals for the District of Columbia Circuit, PhRMA v. EPA, 98-1551 (D.C. Cir.). Issues raised by the petitioners included applicability of the rule, definition of a process, the 98 percent reduction requirement for certain process vents, the alternative standard, and recordkeeping requirements. The intervenors raised additional issues regarding the applicability of the rule to specialty chemical manufacturers and the clarity of the rule, especially with respect to the leak detection and repair (LDAR) provisions. On December 21, 1999, the parties filed a motion to lodge a settlement agreement with the court. The settlement agreement established a schedule by which EPA would propose revisions to the NESHAP and the preamble language agreed to by the parties. The settlement agreement provided that EPA would sign proposed rule amendments no later than 60 days after execution of the settlement. The settlement agreement also provided that EPA would sign final rule amendments no later than 180 days after the date on which the proposed amendments were signed. On February 22, 2000, the parties filed a motion to lodge a stipulation to modify the settlement agreement. The parties agreed to change the date by which EPA must sign the proposed rule amendments from 60 to 90 days after the execution of the settlement agreement (March 20, 2000). The date by which EPA must sign the final amendments was not changed (August 21, 2000). On April 10, 2000 (65 FR 19152), we proposed amendments to address the issues raised by PhRMA and the intervenors of the promulgated Pharmaceuticals Production NESHAP which include corrections and clarifications to ensure that the rule will be implemented as intended. In this action, we are promulgating the amendments proposed on April 10, 2000. II. What Types of Public Comments Were Received on the April 10, 2000 Proposal? We received seven public comment letters on the April 10, 2000 proposed amendments. Six of the comment letters were from industry representatives, and one was from a university representative. The comments addressed the compliance dates, applicability, requirements for hydrogenation vents and wastewater, recordkeeping burden, and the delegation of authority. The commenters also identified errors and incomplete discussions in the preamble to the proposed amendments, minor inconsistencies between the proposed amendments and the settlement agreement, and miscellaneous typographical errors. Some commenters expressed support for the proposed changes. We considered these comments and, where appropriate, made changes to the proposed amendments. This preamble summarizes significant issues raised and the changes to the proposed amendments. Our response to all comments can be found in National Emission Standards for Hazardous Air Pollutants for Pharmaceuticals Production: Summary of Public Comments and Responses on Proposed Amendments. This document may be found in the docket. III. What Major Issues Were Raised in the Public Comments and What Changes Were Made for the Final Amendments? A. Applicability Comment: One commenter interprets the proposed changes to § 63.1250(b) to mean that a source that implements process changes that meet the new definition of the term “reconstruction” may be subject to new source requirements under the amended rule, whereas they would have been subject to less stringent existing source requirements under the original rule. However, after reading the discussion in the preamble to the proposed amendments regarding compliance dates for new and reconstructed sources that would apply in the event the final amendments are more stringent than the original NESHAP, the commenter is unsure when such sources must comply with the new source requirements (or how long they may continue to comply with existing source requirements). The statement that such sources must “continue to comply with the NESHAP until October 21, 2002” was particularly confusing because it was not clear which requirements apply after the amendments are promulgated or whether the source must comply with existing source requirements after October 21, 2002 until it meets reconstruction. Response: The proposed change to § 63.1250(b) would require compliance with the new source requirements for dedicated pharmaceutical manufacturing process units (PMPU) that have the potential to emit hazardous air pollutants (HAP) emissions above specified thresholds and for which reconstruction commenced after October 21, 1999. The commenter is correct that such a reconstructed PMPU would have been subject to existing source requirements under the September 21, 1998 promulgated rule. As a result, it is possible that the PMPU would be subject to more stringent requirements under the amended rule than under the September 21, 1998 promulgated rule. The date when the PMPU must be in compliance with the requirements for new sources depends on the date that reconstruction commenced, as specified in § 63.1250(f) (4) or (5). If you commenced reconstruction between October 21, 1999 and April 10, 2000, you must comply with the requirements for new sources beginning on October 21, 2002. If you commenced reconstruction after April 10, 2000 and before August 29, 2000, you must comply with the requirements for new sources beginning on the date 1 year after the effective date of the final amendments. In both cases, if you startup the reconstructed PMPU before the date when it must be in compliance with the new source requirements, you must, at a minimum, comply with the requirements for existing sources in the September 21, 1998 promulgated rule between startup and that date. If reconstruction commences after August 29, 2000, you must comply with the existing source requirements specified in today's amendments until you shutdown to commence reconstruction, and you must comply with the new source requirements upon startup of the reconstructed source, as specified in § 63.1250(f)(2). Comment: One commenter is uncertain whether their process to produce an imaging agent classified under SIC code 2835 would be subject to the NESHAP. This commenter was confused by the revised definitions of the terms “pharmaceutical product,” “precursor,” and “component,” as well as the corresponding discussion in the preamble to the proposed amendments. As an alternative, this commenter believes we should consider using the applicability language in 40 CFR 439.0 of the Pharmaceutical Manufacturing Point Source Category because the commenter considers that wording to be more definitive. Response: The definition of pharmaceutical product includes any material whose manufacturing process is described by NAICS code 325411 or 325412. In-vivo diagnostic substances described by SIC code 2835 are also covered by NAICS 325412. If your imaging agent is one of these substances, it is a pharmaceutical product, and the process to produce it is subject to subpart GGG. If that imaging agent is produced at a facility whose primary manufacturing operations are described by SIC code 2833 or 2834, the processes used to produce precursors to the imaging agent would also be subject to subpart GGG. Conversely, if the imaging agent is an in-vitro diagnostic substance, it is excluded from the definition of active ingredient. Thus it is not a pharmaceutical product, and its production process is not subject to subpart GGG. We disagree with the commenter's suggestion to use the same applicability language as in 40 CFR 439.0. The NESHAP and effluent limitation guidelines are developed under different statutes with different mandates; the applicability does not need to be identical. B. Compliance Dates Comment: Two commenters oppose the proposed delay in the compliance dates. One of the commenters believes the delay is unnecessary because cost-effective control technologies are available. The other commenter opposes the delay because we did not promulgate the NESHAP until 10 months after the scheduled promulgation date, the NESHAP specifies the maximum compliance time allowed by the CAA even though many control measures could be implemented in a much shorter time, and the commenter believes the proposed changes weaken the control requirements. One of the commenters also disagrees with our assertion that the authority to revise emission standards under section 112(d) of the CAA also includes the authority to set new compliance dates. The commenter says the CAA does not provide the authority to delay the general applicability of the promulgated standard beyond 3 years from promulgation; it only allows compliance with the amendments, if more stringent than the original rule, to be extended to 3 years after promulgation of the amendments. The commenter further states that it is clear that we have not revised the NESHAP in accordance with section 112(d) of the CAA because there is no indication that we reevaluated the maximum achievable control technology (MACT) floor or beyond-the-floor options. Response: As we explained in the preamble to the proposed amendments, we believe the scope of the changes are sufficiently far-reaching and complex that the amended rule would effectively be a new rule. We proposed a compliance date 3 years after the date the settlement agreement was signed and available. This time period was selected to be consistent with the time period that we considered to be reasonable for achieving compliance with the September 21, 1998 promulgated rule. We continue to believe this is reasonable. C. Process Vent Requirements Comment: Section 63.1254(a)(3)(ii)(C) of the proposed amendments would require 95 percent control for the sum of all process vents within some processes that contain hydrogenation steps. One commenter stated that the proposed requirement will be unattainable for some processes even if all nonhydrogenation vents are completely controlled. The commenter believes the required reduction should be 93 percent as for other existing processes. However, to fully address the safety issue of hydrogenation vents, the commenter also requested that we consider exempting all emissions from the hydrogenation step from the point hydrogen is added until after the excess hydrogen is purged from the reactor. Response: The commenter's reference is to the provision that would allow processes containing hydrogenation vents to achieve at least 95 percent reduction overall, rather than comply with the 98 percent requirement for the Total Resource Effectiveness (TRE) streams and either the 93 percent reduction or mass limit for other streams. The provision was added to address concerns that controlling some hydrogenation vents could be unsafe; the 95 percent requirement is applied to the process and allows (in exchange for lessening of the requirement to control TRE vents to 98 percent) an overall emission reduction that is greater than the MACT floor. Contrary to the commenter's assertion, other existing processes are required to achieve 93 percent control on vents other than TRE vents, and 98 percent on TRE vents, not just an overall 93 percent as stated. Therefore, the level of the standard is actually higher than 93 percent for processes containing TRE vents. This added provision is intended to allow greater flexibility in selecting streams for control, while preserving the emissions reductions associated with the standard. Additionally, the provision was suggested by the industry trade association, which suggests that this level of control (95 percent) is achievable in the industry. D. Wastewater Requirements Comment: One commenter disagrees with the proposed change in the annual load used to determine an affected wastewater stream from 1 Megagrams per year (Mg/yr) to 0.25 Mg/yr. The commenter notes that our rationale for changing the load threshold was that we changed the definition of process. However, according to the commenter, there is no definitive correlation between the terms “process” and “point of determination.” Furthermore, because we did not propose changes to the definition of “point of determination” or to the referenced terms “storage tank” and “last recovery device,” the commenter believes the load threshold should remain at 1 Mg/yr. Response: We disagree with the commenter. For processes with wastewater discharges that either do not go through recovery devices or the recovery devices are dedicated to particular discharges, the change in the definition of the term “process” will result in less HAP discharged per process. In addition, storage tanks that are assigned to one process under the original definition of the term “process” may not all be assigned to a single process under the revised definition. Therefore, we continue to believe that it is reasonable to reduce the load threshold for a PMPU. Comment: One commenter requested that we remove methanol from the list of soluble HAP. The commenter is concerned that without this change, publicly owned treatment works (POTW) will no longer accept methanol-containing wastewater that is determined to be affected wastewater under the Pharmaceuticals Production NESHAP because the POTW do not want to become affected sources under the NESHAP for POTW. As evidence to support removing methanol from the list, the commenter refers to the preamble for the Pharmaceutical Manufacturing Point Source Category in which we recognize that methanol is adequately treated at POTW. The commenter also pointed out that the American Forest and Paper Association filed a petition requesting EPA to remove methanol from the list of HAP contained in section 112(b)(1) of the CAA, and that some of the data in that petition address the treatability of methanol in POTW. Response: Under the NESHAP, every wastewater stream that meets the applicable concentration cutoff must be managed and treated in a manner consistent with MACT; this requirement applies to streams treated either onsite or offsite. Another point to remember is that the basis for the wastewater treatment requirements was steam stripping. Biological treatment that meets specific conditions is allowed as an alternative. Comment: In § 63.1256(g)(13)(ii), which exempts owners and operators from the wastewater provisions in subpart GGG if they treat wastewater in boilers and process heaters that are permitted under the Resource Conservation and Recovery Act (RCRA), one commenter requested that we change the phrase “boilers and process heaters” to “boilers and industrial furnaces.” The commenter pointed out that 40 CFR 260.10 does not define process heaters, and that the existing language could be construed to mean that the exemptions in § 63.1256(g)(13)(ii) do not apply to energy recovery devices classified as industrial furnaces ( i.e., cement kilns, lime kilns, and blast furnaces). Response: We did not intend to exclude industrial furnaces from the list of RCRA-permitted devices that are exempt from the wastewater provisions. We intended to apply exemptions in the same manner as in the Hazardous Organic NESHAP (HON), which addressed this issue by including industrial furnaces in the definition of the term “boiler.” The reasons for including industrial furnaces within the definition of the term “boiler” as opposed to defining a separate term are presented in the preamble to proposed amendments for the HON (61 FR 43705). Therefore, the final amendments include a definition for the term “boiler” that is identical to the definition in § 63.111 of the HON. Note that this change also affects industrial furnaces used as air pollution control devices under § 63.1257(a)(4), as well as wastewater treatment units under § 63.1256(g)(13). Comment: One commenter noted that the list of exempt wastewater in § 63.1256(a)(3)(i) omits two of the types of wastewater that are exempted in § 63.132(f) of the HON: equipment leaks and activities included in maintenance and startup, shutdown, and malfunction plans. The commenter requested that we add these two exemptions to the list in § 63.1256(a)(3)(i) so that pharmaceutical plants are not required to manage small, infrequent, and/or random leaks and discharges of wastewater in accordance with the provisions of § 63.1256. In subsequent discussions, the commenter cited an example of such small discharges as the small amount of water that drains from a hose when it is disconnected from one unit so that it can be moved and reconnected to another unit. Even though the hose is purged before being disconnected, some water remains. Response: After considering the comments, we decided to provide exemptions for equipment leaks and for drips from disconnected hoses. The exemption for equipment leaks is consistent with the HON, which provides the basis for most of the wastewater provisions in subpart GGG. Specifically, § 63.132(f) exempts equipment leaks with HAP concentrations greater than 10,000 parts per million by weight (ppmw) from the management and treatment requirements for Group 1 wastewater. Equipment leaks with lower concentrations are also effectively exempted in the HON because they are unlikely to exceed the Group 1 wastewater flow rate threshold of 10 liters per minute (lpm). The drips from a disconnected hose are unintentional discharges that occur despite reasonable efforts to purge the hose before disconnecting it. We believe these drips can be considered spills, which are exempt from the wastewater provisions. However, to clarify this point, we have provided a specific exemption for drips from procedures such as disconnecting hoses after clearing lines. We decided not to add an exemption for wastewater that is discharged as a result of activities included in maintenance wastewater plans. Under the proposed amendments, § 63.1256(a)(3)(ii) exempts maintenance wastewater from the definition of wastewater, which means it is not subject to the wastewater provisions other than the requirements in § 63.1256(a)(3)(ii). Adding another exemption for wastewater generated as a result of activities covered by the maintenance wastewater plan would be redundant. We also decided not to add an exemption for wastewater that is discharged as a result of activities included in startup, shutdown, and malfunction plans. Section 63.1250(g) specifies that each provision in subpart GGG (except the emission limitations) applies during startups, shutdowns, and malfunctions. This provision effectively exempts wastewater generated during startups, shutdowns, and malfunctions from the management and treatment requirements in § 63.1256. According to § 63.1250(g), the only requirement for such wastewater is that the owner or operator must identify and implement procedures to prevent or minimize emissions during startups, shutdowns, and malfunctions; and the procedures must be documented in a written plan. Therefore, we believe adding an exemption in § 63.1256(a)(3) is unnecessary because existing provisions already accomplish the goal of such an exemption. After considering the comments and the exemption provisions in general, we decided that the requirements would be clearer if we rearranged a few statements. Therefore, in the final amendments, we have moved the list of exemptions from § 63.1256(a)(3)(i) to the definition of the term “wastewater stream.” We also added equipment leaks and drips from procedures such as disconnecting hoses to the list. We then redesignated the multiphase discharge requirements in § 63.1256(a)(4) as § 63.1256(a)(3), and we redesignated the maintenance wastewater requirements in § 63.1256(a)(3)(ii) as § 63.1256(a)(4). We also added a statement to the redesignated § 63.1256(a)(4) to specify that maintenance wastewater is exempt from all other provisions in subpart GGG. Finally, we revised § 63.1256(a) introductory paragraph and § 63.1256(a)(1) to more clearly explain what provisions are specified in § 63.1256(a)(1) through (5). We believe these changes clarify the wastewater provisions without changing the intent. E. Recordkeeping Comment: One commenter believes the recordkeeping and reporting burden is excessive and suggests that we continue to work with the Food and Drug Administration to increase flexibility, perhaps by using the concepts of “Master Process” or “Batch Records.” The commenter acknowledges that the concept of a “standard batch” helps to alleviate this burden but cites our Agency Information Collection Request notice (65 FR 17258, March 31, 2000), which estimates the average recordkeeping and reporting burden to be 694 hours per source per year, as evidence that more relief is needed. Response: The recordkeeping and reporting requirements in the proposed amendments are needed to demonstrate compliance. These requirements received considerable scrutiny during the settlement negotiations. As the commenter noted, we introduced the concept of a “standard batch” as one way to minimize the burden. Another way to minimize the burden is to implement the alternative standard; the reduction in the burden associated with this compliance option is not reflected in the estimate in the Agency Information Collection Request. F. Delegation of Authority Comment: Several commenters oppose the proposed change to the delegation of authority language because it was not part of the settlement agreement, and we did not explain why the change is needed. One commenter also expressed concern that the proposed change could have a significant adverse impact on sources by requiring a second layer of regulatory agency approval of alternatives to monitoring or recordkeeping provisions in cases where a State rule and the Pharmaceuticals Production NESHAP apply to the same source. The commenter noted that getting approval from both the State and EPA would result in a substantial burden on the source without providing any additional environmental benefit. Response: After considering the comments, we have decided not to amend the delegation of authority provisions in § 63.1261 of the September 21, 1998 promulgated rule. The proposed amendments to § 63.1261 reference terms that are defined in proposed amendments to § 63.90 of 40 CFR part 63, subpart E (64 FR 1880, January 12, 1999). The regulations in subpart E implement section 112(l) of the CAA and specify the procedures and criteria for approving State, local, territorial, and tribal rules, programs, or other requirements that would substitute for NESHAP. The proposed amendments to subpart E are intended to clarify these procedures and criteria, including the authorities which we will and will not delegate. Because the proposed amendments to subpart E may not be promulgated before the amendments to subpart GGG, we must remove the references to them from subpart GGG. We anticipate, however, that after amendments to subpart E are promulgated, we will also amend subpart GGG (and all other NESHAP) to be consistent. G. Clarification of Statements in the Proposal Preamble Several commenters expressed concern that the discussions of some issues in the preamble to the proposed amendments could cause confusion because the discussions were either incomplete or inconsistent with the proposed regulatory language. The following paragraphs discuss each concern. 1. Annual Mass Emission Limit for Process Vents Section II.G of the preamble to the proposed amendments explains the proposed changes in the 900 kilograms per year (kg/yr) annual mass limit compliance option for process vents. For example, one of the proposed changes in this compliance option was to allow it to be used for all of the other vents in a process where at least one vent meets the requirements for control to 98 percent under § 63.1254(a)(3)(i). Comment: One commenter believes the proposal preamble may cause confusion because it does not also say that you may comply with the 900 kg/yr annual mass limit for all of the other vents in a process where at least one vent complies with the alternative standard in § 63.1254(c), or at least one vent is routed to a control device subject to the grandfathering provisions in § 63.1254(a)(3)(ii). Response: The commenter is correct that the proposed amendments extend the 900 kg/yr annual mass limit compliance option to more situations than the one described in the proposal preamble. Section 63.1254(a)(2)(iii) in the final amendments, which is identical to the language in the proposed amendments, specifies three types of vents that you may exclude when determining compliance with the 900 kg/yr annual mass limit: (1) All vents that must be controlled to 98 percent in accordance with § 63.1254(a)(3)(i), (2) all vents that otherwise would be subject to the 98 percent control requirement if they were not controlled by a grandfathered control device according to § 63.1254(a)(3)(ii), and (3) all vents that are controlled in accordance with the alternative standard in § 63.1254(c). 2. Emission Reduction for Processes With Both TRE and Hydrogenation Vents Section II.H of the proposal preamble includes a discussion of the emission limitations for vents in processes that include at least one TRE vent and at least one hydrogenation vent that we proposed adding in § 63.1254(a)(3)(ii)(C). Comment: One commenter believes the explanation of the proposed emission limitation is confusing because it does not clearly describe the two distinct parts to the proposed provision in § 63.1254(a)(3)(ii)(C). According to the commenter, the first part applies to processes that meet specified control criteria on or before April 2, 1997, and these processes must maintain the level of control achieved on the date of the proposed amendments ( i.e., April 10, 2000). The commenter also noted that the second part applies to any other process where the annual mass limit or process-based emission reduction (for the sum of the non-TRE vents) cannot be met because the hydrogenation vent(s) cannot be safely controlled, and the HAP emissions from the sum of all vents in these processes must be reduced by at least 95 percent. Response: We agree with the commenter that the proposal preamble did not fully explain the two parts of the proposed provisions for processes with hydrogenation vents. The commenter's assessment of the second part of this provision is correct, but the first part needs additional discussion. Processes that had a TRE vent on or before April 2, 1997 and for which the HAP emissions from the sum of all process vents were controlled to between 93 and 98 percent by weight must continue to be controlled to the level achieved on or before April 2, 1997 (not on or before April 10, 2000). 3. Recordkeeping Requirements for Process Vents Section II.O of the proposal preamble describes several proposed changes to the recordkeeping requirements, including a discussion of the proposed concept of a “standard batch.” Comment: One commenter believes the discussion is confusing because it does not clearly state that the requirement to check whether standard batch conditions have been exceeded applies only to two types of processes: (1) Processes subject to the 900 kg/yr annual mass emission limit and (2) processes subject to a percent reduction requirement where at least one vent in the process is controlled to less than the percent reduction required for the process as a whole. The commenter is concerned that the proposal preamble could be interpreted to mean the check is required for all processes. Response: The commenter is correct. You may define a standard batch for any process. However, the requirement to document whether each batch meets all of the conditions of the standard batch applies only in the two cases identified by the commenter. Because changes in operating conditions may cause changes in emission levels, this documentation (along with the requirement to recalculate uncontrolled and controlled emissions for each nonstandard batch) is the procedure used to demonstrate ongoing compliance in these two situations. The documentation is not needed in other situations where other types of monitoring are sufficient to demonstrate ongoing compliance ( e.g., a continuous emissions monitoring system (CEMS) for demonstrating compliance with the alternative standard) or the changes in emission levels do not affect ongoing compliance ( e.g., when all vents in a process are routed to the same control device). The documentation requirements are specified in § 63.1259(b)(5) in both the proposed and final amendments. 4. Compliance With Subpart PPP Section II.C of the proposal preamble discussed the proposed addition of a § 63.1250(h)(6) to address overlap situations between subparts GGG and PPP. Comment: One commenter pointed out that the second reference to subpart GGG that says, “* * * you would still be required to comply with all other requirements in subpart GGG * * *” is incorrect and should say, “* * * you would also be required to comply with all other requirements in subpart PPP for the corresponding PMPU * * *” Response: The commenter is correct. If you demonstrate compliance with subpart GGG by controlling process vents in accordance with the requirements in subpart PPP, you must also comply with all of the other requirements in subpart PPP for the corresponding PMPU. H. Technical Correction to Monitoring Requirements for Hydrogen Halides and Halogens Comment: One commenter raised an issue that involves the alternative standard. Under the alternative standard in the promulgated NESHAP, the owner or operator must use CEMS to demonstrate ongoing compliance with the total organic compound (TOC) and total hydrogen halide and halogen outlet concentration limits. The commenter states that CEMS should not be required to demonstrate compliance with the hydrogen halide and halogen limits because we have not required CEMS to demonstrate compliance with hydrochloric acid (HCl) and chlorine limits in past rules ( e.g., the hazardous waste combustion, municipal waste combustion, and hospital/medical/infectious waste incineration), and there are no EPA-approved, commercially available methods to monitor these pollutants in gas streams continuously. As an alternative, the commenter recommends that we require parametric monitoring like that already required to demonstrate compliance with the other outlet concentration limits in the rule. Response: We agree with the commenter that clarification of the hydrogen halide and halogen monitoring requirements under the alternative standard is needed. As a result, we have made technical amendments to the standard for alternative procedures for monitoring hydrogen halides and halogens emitted under two scenarios: (1) When these pollutants are generated in combustion devices that are used to control halogenated vent streams, and (2) when these pollutants are emitted directly from the process. One of the primary sources of hydrogen halide and halogen emissions is combustion devices that are used to control halogenated vent streams. In these situations, most of the chlorine is converted to HCl in the incinerator. Therefore, we believe that monitoring for HCl would serve as an acceptable surrogate for all of the hydrogen halides and halogens in the emission stream. We provided three options for monitoring to demonstrate compliance with the outlet concentration limit for hydrogen halides and halogens under the alternative standard for these emission streams. The first option is to continuously monitor for HCl using an instrument based on Fourier Transform infrared (FTIR) spectroscopy that meets Performance Specification 15 in appendix B of 40 CFR part 60. Because HCl is readily controlled in a properly operated scrubber, the second option requires the owner or operator to conduct an initial demonstration that the scrubber reduces HCl by 95 percent, set scrubber operating parameters during the initial compliance determination, and demonstrate ongoing compliance by continuously monitoring the operating parameters. In the event an owner or operator wishes to monitor for HCl using a CEMS for which we have not promulgated a performance specification, we are also including a third option that requires the owner or operator to prepare a monitoring plan and submit it for approval in accordance with the procedures specified in § 63.8. If you emit hydrogen halides and halogens directly from the process, the requirement to use CEMS to measure the total hydrogen halide and halogen concentration is unchanged from the September 21, 1998 promulgated rule. However, because we have not promulgated performance specifications for halogen monitors, we have amended the rule to require that the owner or operator prepare a monitoring plan and submit it for approval in accordance with § 63.8. I. Minor Technical Corrections We are making several changes throughout subpart GGG to correct referencing and typographical errors, to improve consistency in terminology, and to make the amendments consistent with the settlement agreement. Two of the commenters identified many of the needed corrections; we identified several others. All of the corrections are described in Table 1. Table 1.—Minor Technical Corrections to Subpart GGG Section of subpart GGG Description of correction 63.1250(f)(5)(i) Changed the referenced date from April 2, 1997 to April 10, 2000. The intended date was the date of publication of the proposed amendments, not the date of publication of the proposed rule, because a source that commences construction or reconstruction after April 10, 2000 must, upon startup before August 29, 2000, comply with the proposed amendments. 63.1250(h)(1)(i) Corrected a typographical error in this paragraph. The word “of” was replaced with “or” in the first sentence so that the sentence reads as follows: “* * * elect to comply with either the provisions of this subpart or the provisions of another subpart * * *”. 63.1250(h)(2) and (3) Replaced the word “consistency” with “compliance” in the headings of both sections to be consistent with the language used in the headings in § 63.1250(h)(1), (4), (5), and (6). 63.1252(d)(6) through (d)(8) Corrected these paragraphs by replacing the incorrect references to § 63.1254(a)(2) and (a)(3) with the correct references to § 63.1254(a)(1)(i). Replaced incorrect reference to § 63.1253(c)(1) with correct reference to § 63.1253(c)(1)(i). Replaced the word “requirements” with “criteria”. 63.1255(b)(4)(iv)(B) Corrected this paragraph by replacing incomplete reference to § 63.178(c)(iii) with the complete reference to § 63.178(c)(3)(iii). 63.1255(c)(2)(i) and (e)(3) Corrected these paragraphs by replacing references to § 63.178(b) with references to § 63.178. The more comprehensive reference allows an owner or operator to implement the monitoring interval adjustment option in § 63.178(c) for valves under § 63.1255(e)(3). However, the change has essentially no impact for pumps and agitators because § 63.1255(b)(4)(iv)(B) specifies that the monitoring interval adjustment for pumps and agitators is to be quarterly, which is the same monitoring frequency that is specified in § 63.1255(c)(2)(i). This is the intended result. In effect, because the HON requires monthly monitoring, the adjustment is already built in to § 63.1255(c)(2)(i). We do not believe that an additional adjustment is warranted. 63.1255(e)(5)(iii) Corrected typographical errors in the definitions of two of the terms that follow Equation 4. The uppercase “I” for the variable that counts the number of subgroups has been replaced with the correct lowercase “i”. 63.1255(f)(1)(iii) Corrected this paragraph by replacing the incorrect reference to paragraph (b)(3)(iii)(B) with the correct reference to paragraph (b)(4)(iii)(B). 63.1255(f)(4)(iv) Corrected this paragraph by replacing the incorrect reference to paragraph (b)(3)(i) with the correct reference to paragraph (b)(4)(i). 63.1255(h)(3)(ii) Corrected this paragraph by replacing the incorrect reference to paragraph (b)(3)(iv) with the correct reference to paragraph (b)(4)(iv). 63.1256(a)(1)(i)(B) Revised this paragraph to specify that the wastewater stream is an affected wastewater stream if the concentration of partially soluble and/or soluble HAP is “greater than” 5,200 ppmw, whereas the original language specified a concentration “of” 5,200 ppmw. This change makes the terminology in this paragraph consistent with the terminology in § 63.1256(a)(1)(i)(A), (C), and (D). 63.1257(d)(2)(i)(C)( 4 )( ii ) Corrected this paragraph by replacing the incorrect reference to paragraph (d)(2)(iii) with the correct reference to paragraph (d)(3)(iii). 63.1258(b)(5)(ii) Added a sentence to the end of this paragraph that was part of the settlement agreement but was inadvertently left out of the proposed amendments. The sentence reads as follows: “If the owner or operator corrects for supplemental gases as specified in § 63.1257(a)(3)(ii) for noncombustion control devices, the flow must be evaluated as specified in paragraph (b)(5)(ii)(C) of this section.” IV. What Are the Administrative Requirements for These Final Amendments? A. Executive Order 12866, Regulatory Planning and Review Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA must determine whether the regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review and the requirements of the Executive Order. The Executive Order defines “significant regulatory action” as one that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Pursuant to the terms of Executive Order 12866, it has been determined that these amendments do not constitute a “significant regulatory action” because they do not add any new control requirements. Consequently, this action was not submitted to OMB for review under Executive Order 12866. B. Executive Order 13132, Federalism Executive Order 13132 (64 FR 43255, August 10, 1999) requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. The EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation. If EPA complies by consulting, Executive Order 13132 requires EPA to provide to OMB, in a separately identified section of the preamble to the rule, a federalism summary impact statement (FSIS). The FSIS must include a description of the extent of EPA's prior consultation with State and local officials, a summary of the nature of their concerns and EPA's position supporting the need to issue the regulation, and a statement of the extent to which the concerns of State and local officials have been met. Also, when EPA transmits a draft final rule with federalism implications to OMB for review pursuant to Executive Order 12866, EPA must include a certification from the Agency's Federalism Official stating that EPA has met the requirements of Executive Order 13132 in a meaningful and timely manner. Today's amendments will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because State and local governments do not own or operate any sources that would be subject to these amendments. Thus, the requirements of section 6 of the Executive Order do not apply to today's action. C. Executive Order 13084, Consultation and Coordination With Indian Tribal Governments Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to OMB, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.” Today's amendments to subpart GGG do not significantly or uniquely affect the communities of Indian tribal governments. No tribal governments own or operate sources subject to these amendments. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to today's action. D. Executive Order 13045, Protection of Children From Environmental Health Risks and Safety Risks Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, EPA must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by EPA. The EPA interprets Executive Order 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. Today's amendments are not subject to Executive Order 13045 because they are based on technology performance, not health or safety risks. Furthermore, this rule has been determined not to be “economically significant” as defined under Executive Order 12866. E. Unfunded Mandates Reform Act of 1995 Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. L. 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with Federal mandates that may result in expenditures by State, local, and tribal governments, in aggregate, or by the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least-costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least-costly, most cost effective, or least-burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. The EPA has determined that today's amendments do not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, or tribal governments, in the aggregate, or the private sector in any 1 year. The maximum total annual cost of the Pharmaceuticals Production NESHAP for any year has been estimated to be approximately $64 million (63 FR 50287, September 21, 1998), and today's amendments do not add new requirements that would increase this cost. Thus, today's amendments are not subject to the requirements of sections 202 and 205 of the UMRA. In addition, EPA has determined that these amendments contain no regulatory requirements that might significantly or uniquely affect small governments because they contain no requirements that apply to such governments or impose obligations upon them. Therefore, today's amendments are not subject to the requirements of section 203 of the UMRA. F. Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq. The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today's amendments on small entities, a small entity is defined as: (1) A small business in SIC code 2833 or 2834 that has as many as 750 employees; (2) a small business in SIC code 2869 that has as many as 1,000 employees; (3) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (4) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. After considering the economic impacts of today's amendments on small entities, we have concluded that this action will not have a significant economic impact on a substantial number of small entities. The EPA has determined that none of the small entities will experience a significant impact because the amendments impose no additional regulatory requirements on owners or operators of affected sources. Although today's amendments will not have a significant economic impact, EPA nonetheless has tried to reduce the impact of the amendments on small entities. Many of the amendments define optional means of compliance. For example, vapor balancing was added as an optional means of compliance for storage tanks, a facilitywide limit on the mass of process vent emissions replaces the limit on the number of processes that may comply with the process-based emission limit, additional compliance alternatives are included for process vents that meet the criteria for 98 percent control, and optional parameter monitoring is included as an alternative to correcting to 3 percent oxygen when supplemental gas is introduced to a dense gas system or a system controlled with combustion devices and the owner or operator complies with the alternative standard. The proposed amendments also include simplified recordkeeping requirements when the owner or operator documents conditions that define a standard batch, and the process is operated within that range of conditions. G. Paperwork Reduction Act The OMB has approved the information collection requirements contained in the 1998 NESHAP under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , and has assigned OMB control No. 2060-0358. An Information Collection Request (ICR) document has been prepared by EPA (ICR No. 1781.01), and a copy may be obtained from Sandy Farmer by mail at U.S. Environmental Protection Agency, Office of Environmental Information, Collection Strategies Division (2822), 1200 Pennsylvania Avenue, NW, Washington DC 20460, by email at farmer.sandy@epa.gov, or by calling (202) 260-2740. Today's amendments will have no net impact on the information collection burden estimates made previously. An oversight has been corrected by adding recordkeeping and reporting requirements for storage tanks equipped with floating roofs. The promulgated rule only included recordkeeping and reporting requirements for add-on control devices for storage tanks even though add-on control devices and floating roofs were considered in the cost impacts and burden estimates. Also, the amendments clarify the intent of several provisions in the 1998 NESHAP and correct inadvertent omissions and minor drafting errors in the 1998 NESHAP. Consequently, the ICR has not been revised. H. National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act (NTTAA), Pub. L. 104-113 (March 7, 1996), directs all Federal agencies to use voluntary consensus standards instead of government-unique standards in their regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., material specifications, test methods, sampling and analytical procedures, and business practices) that are developed or adopted by one or more voluntary consensus bodies. Examples of organizations generally regarded as voluntary consensus standards bodies include the American Society for Testing and Materials (ASTM), the National Fire Protection Association (NFPA), and the Society of Automotive Engineers (SAE). The NTTAA requires Federal agencies like EPA to provide Congress, through OMB, with explanations when an agency does not use available and applicable voluntary consensus standards. During the rulemaking, EPA searched for voluntary consensus standards that might be applicable. The search identified no applicable voluntary consensus standards. Accordingly, the NTTAA requirement to use applicable voluntary consensus standards does not apply to today's amendments. I. The Congressional Review Act The Congressional Review Act, 5 U.S.C. § 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. § 804(2). This rule will be effective August 29, 2000. List of Subjects in 40 CFR Part 63 Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Intergovernmental relations, Reporting and recordkeeping requirements. Dated: August 15, 2000. Carol M. Browner, Administrator. For the reasons set out in the preamble, part 63 of title 40, chapter I of the Code of Federal Regulations is amended as follows: PART 63—NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES 1. The authority citation for part 63 continues to read as follows: Authority: 42 U.S.C. 7401, et seq. Subpart GGG—National Emission Standards for Pharmaceuticals Production 2. Section 63.1250 is amended by: a. Revising paragraph (a), b. Revising paragraph (b), c. Revising paragraph (c), d. Revising paragraph (f); e. Revising paragraph (h)(1); f. Revising paragraph (h)(2) heading; g. Revising paragraph (h)(3) heading; h. Revising paragraphs (h) (4) and (5); and i. Adding paragraph (h)(6). The revisions and additions read as follows: § 63.1250 Applicability. (a) Definition of affected source. (1) The affected source subject to this subpart consists of the pharmaceutical manufacturing operations as defined in § 63.1251. Except as specified in paragraph (d) of this section, the provisions of this subpart apply to pharmaceutical manufacturing operations that meet the criteria specified in paragraphs (a)(1) (i) through (iii) of this section: (i) Manufacture a pharmaceutical product as defined in § 63.1251; (ii) Are located at a plant site that is a major source as defined in section 112(a) of the Act; and (iii) Process, use, or produce HAP. (2) Determination of the applicability of this subpart shall be reported as part of an operating permit application or as otherwise specified by the permitting authority. (b) New source applicability. A new affected source subject to this subpart and to which the requirements for new sources apply is: An 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 a pharmaceutical manufacturing process unit (PMPU) 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 or reconstruction commenced after October 21, 1999. (c) General Provisions. Table 1 of this subpart specifies and clarifies the provisions of subpart A of this part that apply to an owner or operator of an affected source subject to this subpart. The provisions of subpart A specified in Table 1 are the only provisions of subpart A that apply to an affected source subject to this subpart. (f) Compliance dates. The compliance dates for affected sources are as follows: (1) An owner or operator of an existing affected source must comply with the provisions of this subpart no later than October 21, 2002. (2) An owner or operator of a new or reconstructed affected source must comply with the provisions of this subpart on August 29, 2000 or upon startup, whichever is later. (3) Notwithstanding the requirements of paragraph (f)(2) of this section, a new source which commences construction or reconstruction after April 2, 1997 and before September 21, 1998 shall not be required to comply with this subpart until September 21, 2001 if: (i) The requirements of this subpart are more stringent than the requirements of this subpart in effect before August 29, 2000 and contained in the 40 CFR, part (63.1200-end), edition revised as of July 1, 2000; and (ii) The owner or operator complies with the requirements published on April 2, 1997 (62 FR 15754) during the period until September 21, 2001. (4) Notwithstanding the requirements of paragraph (f)(2) of this section, a new source which commences construction or reconstruction after September 21, 1998 and before April 10, 2000 shall not be required to comply with this subpart until October 21, 2002 if: (i) The requirements of this subpart are more stringent than the requirements of this subpart in effect before August 29, 2000; and (ii) The owner or operator complies with the requirements of this subpart in effect before August 29, 2000 during the period between startup and October 21, 2002. (5) Notwithstanding the requirements of paragraph (f)(2) of this section, a new source which commences construction or reconstruction after April 10, 2000 and before August 29, 2000 shall not be required to comply with this subpart until August 29, 2001 if: (i) The requirements of this subpart are more stringent than the requirements published on April 10, 2000 (65 FR 19152); and (ii) The owner or operator complies with the requirements of this subpart in effect before August 29, 2000 during the period between startup and August 29, 2001. (6) Pursuant to section 112(i)(3)(B) of the Act, an owner or operator may request an extension allowing the existing source up to 1 additional year to comply with section 112(d) standards. (i) For purposes of this subpart, a request for an extension shall be submitted no later than 120 days prior to the compliance dates specified in paragraphs (f) (1) through (5) of this section, except as provided in paragraph (f)(6)(ii) of this section. The dates specified in § 63.6(i) for submittal of requests for extensions shall not apply to sources subject to this subpart. (ii) An owner or operator may submit a compliance extension request after the date specified in paragraph (f)(6)(i) of this section provided the need for the compliance extension arose after that date and before the otherwise applicable compliance date, and the need arose due to circumstances beyond reasonable control of the owner or operator. This request shall include the data described in § 63.6(i)(6)(i) (A), (B), (C), and (D). (h) * * * (1) Compliance with other MACT standards. (i) After the compliance dates specified in this section, an affected source subject to the provisions of this subpart that is also subject to the provisions of any other subpart of this part 63 may elect to comply with either the provisions of this subpart or the provisions of another applicable subpart governing the maintenance of records and reporting to EPA. The affected source shall identify in the Notification of Compliance Status report required by § 63.1260(f) under which authority such records will be maintained. (ii) After the compliance dates specified in paragraph (f) of this section, at an offsite reloading or cleaning facility subject to § 63.1253(f), compliance with the emission standards and associated initial compliance, monitoring, recordkeeping, and reporting provisions of any other subpart of this part 63 constitutes compliance with the provisions of § 63.1253(f)(7) (ii) or (iii). The owner or operator of the affected storage tank shall identify in the Notification of Compliance Status report required by § 63.1260(f) the subpart of this part 63 with which the owner or operator of the offsite reloading or cleaning facility complies. (2) Compliance with 40 CFR parts 264 and 265, subparts AA, BB, and/or CC. * * * (3) Compliance with 40 CFR 60.112(b). * * * (4) Compliance with subpart I of this part. After the compliance dates specified in this section, an affected source with equipment subject to subpart I of this part may elect to comply with either the provisions of § 63.1255 or the provisions of subpart H of this part for all such equipment. The owner or operator shall identify in the Notification of Compliance Status report required by § 63.1260(f) the provisions with which the owner elects to comply. (5) Compliance with other regulations for wastewater. After the compliance dates specified in this section, the owner or operator of an affected wastewater stream that is also subject to provisions in 40 CFR parts 260 through 272 may elect to determine whether this subpart or 40 CFR parts 260 through 272 contain the more stringent control requirements ( e.g., design, operation, and inspection requirements for waste management units; numerical treatment standards; etc.) and the more stringent testing, monitoring, recordkeeping, and reporting. Compliance with provisions of 40 CFR parts 260 through 272 that are determined to be more stringent than the requirements of this subpart constitutes compliance with this subpart. For example, provisions of 40 CFR parts 260 through 272 for treatment units that meet the conditions specified in § 63.1256(g)(13) constitute compliance with this subpart. In the Notification of Compliance Status report required by § 63.1260(f), the owner or operator shall identify the more stringent provisions of 40 CFR parts 260 through 272 with which the owner or operator will comply. The owner or operator shall also identify in the Notification of Compliance Status report required by § 63.1260(f) the information and procedures used to make any stringency determinations. If the owner or operator does not elect to determine the more stringent requirements, the owner or operator must comply with both the provisions of 40 CFR parts 260 through 272 and the provisions of this subpart. (6) Compliance with subpart PPP of this part. After the compliance dates specified in this section, an affected source with equipment in a pharmaceutical manufacturing process unit that is also part of an affected source under subpart PPP of this part may elect to demonstrate compliance with § 63.1254 by controlling all process vents in accordance with § 63.1425 (b), (c)(1), (c)(3), (d), and/or (f). Alternatively, the owner or operator may elect to determine which process vents must be controlled to comply with the percent reduction requirements of § 63.1254 and control only those vents in accordance with § 63.1425 (b), (c)(1), (c)(3), (d), and/or (f). For any pharmaceutical manufacturing process unit controlled in accordance with the requirements of § 63.1425, the owner or operator must also comply with all other requirements in subpart PPP of this part. In the Notification of Compliance Status report required by § 63.1260(f), the owner or operator shall identify which pharmaceutical manufacturing process units are meeting the control requirements for process vents and all other requirements of subpart PPP of this part, and the owner or operator shall describe the calculations and other information used to identify which process vents must be controlled to comply with the percent reduction requirements of § 63.1254, if applicable. 3. Section 63.1251 is amended by: a. Revising the definitions for Active ingredient, Annual average concentration, Construction, Consumption, Excipient, Large control device, Pharmaceutical manufacturing operations, Pharmaceutical product, Primary use, Process, Process tank, Repaired, Shutdown, Small control device, Startup, Storage tank, Vapor-mounted seal, and Wastewater stream; b. Removing the definition of Component; c. Revising paragraphs (3) and (8) in the definition for Operating scenario; and d. Adding definitions in alphabetical order for Boiler, Combustion device burner, Dense gas system, Isolated intermediate, Maintenance wastewater, Precursor, Reconstruction, Standard batch, Supplemental gases, and System flowrate. The revisions and additions read as follows: § 63.1251 Definitions. Active ingredient means any material that is intended 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. This term does not include food, food additives (except vitamins and other materials described by SIC code 2833 or 2834), color additives, cosmetics, in-vitro diagnostic substances, x-ray film, test indicator devices, and medical devices such as implants, artificial joints, surgical bandages, and stitching material. Annual average concentration, as used in the wastewater provisions in § 63.1256, means the total mass of partially soluble and/or soluble HAP compounds in a wastewater stream during the calendar year divided by the total mass of the wastewater stream discharged during the same calendar year, as determined according to the procedures specified in § 63.1257(e)(1) (i) and (ii). Boiler means any enclosed combustion device that extracts useful energy in the form of steam and is not an incinerator. Boiler also means any industrial furnace as defined in 40 CFR 260.10. Combustion device burner means a device designed to mix and ignite fuel and air to provide a flame to heat and oxidize waste organic vapors in a combustion device. Construction means the onsite fabrication, erection, or installation of an affected source or a PMPU. Addition of new equipment to a PMPU subject to existing source standards does not constitute construction, but it may constitute reconstruction of the affected source or PMPU if it satisfies the definition of reconstruction in this section. Consumption means the quantity of all HAP raw materials entering a process in excess of the theoretical amount used as reactant, assuming 100 percent stoichiometric conversion. The raw materials include reactants, solvents, and any other additives. If a HAP is generated in the process as well as added as a raw material, consumption includes the quantity generated in the process. Dense gas system means a conveyance system operated to limit oxygen levels below 12 percent. Excipient means any substance other than the active drug or product which has been appropriately evaluated for safety and is included in a drug delivery system to either aid the processing of the drug delivery system during its manufacture; protect, support, or enhance stability, bioavailablity, or patient acceptability; assist in product identification; or enhance any other attribute of the overall safety and effectiveness of the drug delivery system during storage or use. Isolated intermediate means a product of a process. An isolated intermediate is usually a product of a chemical synthesis, fermentation, or biological extraction process; several different isolated intermediates may be produced in the manufacture of a finished dosage form of a drug. Precursors, active ingredients, or finished dosage forms are considered isolated intermediates. An isolated intermediate is stored before subsequent processing. Storage occurs at any time the intermediate is placed in equipment used solely for storage, such as drums, totes, day tanks, and storage tanks. The storage of an isolated intermediate marks the end of a process. Large control device means a control device that controls total HAP emissions of greater than or equal to 10 tons/yr, before control. Maintenance wastewater means wastewater generated by the draining of process fluid from components in the pharmaceutical manufacturing process unit into an individual drain system in preparation for or during maintenance activities. Maintenance wastewater can be generated during planned and unplanned shutdowns and during periods not associated with a shutdown. Examples of activities that can generate maintenance wastewater include descaling of heat exchanger tubing bundles, cleaning of distillation column traps, draining of pumps into an individual drain system, and draining of portions of the pharmaceutical manufacturing process unit for repair. Wastewater from cleaning operations is not considered maintenance wastewater. Operating scenario, * * * (3) The applicable control requirements of this subpart, including the level of required control, and for vents, the level of control for each vent; (8) For reporting purposes, a change to any of these elements not previously reported, except for paragraph (5) of this definition, shall constitute a new operating scenario. Pharmaceutical manufacturing operations means the facilitywide collection of PMPU and any other equipment such as heat exchanger systems, wastewater and waste management units, 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. Pharmaceutical product means any of the following materials, excluding any material that is a nonreactive solvent, excipient, binder, or filler, or any material that is produced in a chemical manufacturing process unit that is subject to the requirements of subparts F and G of this part 63: (1) Any material described by the standard industrial classification (SIC) code 2833 or 2834; or (2) Any material whose manufacturing process is described by North American Industrial Classification System (NAICS) code 325411 or 325412; or (3) A finished dosage form of a drug, for example, a tablet, capsule, solution, etc.; or (4) Any active ingredient or precursor that is produced at a facility whose primary manufacturing operations are described by SIC code 2833 or 2834; or (5) At a facility whose primary operations are not described by SIC code 2833 or 2834, any material whose primary use is as an active ingredient or precursor. Precursor means a material that is manufactured to undergo further chemical change or processing to ultimately manufacture an active ingredient or finished dosage form of a drug. This term does not include commodity chemicals produced by the synthetic organic chemical manufacturing industry. Primary use means 50 percent or more of a material is used for a particular purpose. Process means all equipment which collectively function to produce a pharmaceutical product or isolated intermediate (which is also a pharmaceutical product). A process may consist of one or more unit operations. For the purposes of this subpart, process includes any, all, or a combination of reaction, recovery, separation, purification, or other activity, operation, manufacture, or treatment which are used to produce a pharmaceutical product or isolated intermediate. Cleaning operations conducted are considered part of the process. Nondedicated solvent recovery operations located within a contiguous area within the affected source are considered single processes. A storage tank that is used to accumulate used solvent from multiple batches of a single process for purposes of solvent recovery does not represent the end of the process. Nondedicated formulation operations occurring within a contiguous area are considered a single process that is used to formulate numerous materials and/or products. Quality assurance and quality control laboratories are not considered part of any process. Ancillary activities are not considered a process or part of any process. Ancillary activities include boilers and incinerators (not used to comply with the provisions of § 63.1253, § 63.1254, or § 63.1256(h)), chillers and refrigeration systems, and other equipment and activities that are not directly involved ( i.e., they operate within a closed system and materials are not combined with process fluids) in the processing of raw materials or the manufacturing of a pharmaceutical product. Process tank means a tank that is used to collect material discharged from a feedstock storage tank or unit operation and to transfer this material to another unit operation within the process or to a product storage tank. Surge control vessels and bottoms receivers that fit these conditions are considered process tanks. Product storage tanks are considered process tanks and are part of the PMPU that produce the stored material. For the purposes of this subpart, vents from process tanks are considered process vents. Reconstruction, as used in § 63.1250(b), shall have the meaning given in § 63.2, except that “affected or previously unaffected stationary source” shall mean either “affected facility” or “PMPU.” As used in § 63.1254(a)(3)(ii)(A)( 3 ), reconstruction shall have the meaning given in § 63.2, except that “source” shall mean “control device.” Repaired means that equipment: (1) Is adjusted, or otherwise altered, to eliminate a leak as defined in the applicable paragraphs of § 63.1255, and; (2) Is, unless otherwise specified in applicable provisions of § 63.1255, monitored as specified in § 63.180(b) and (c) as appropriate, to verify that emissions from the equipment are below the applicable leak definition. Shutdown means the cessation of operation of a continuous process for any purpose. Shutdown also means the cessation of a batch process or any related individual piece of equipment required or used to comply with this subpart as a result of a malfunction or for replacement of equipment, repair, or any other purpose not excluded from this definition. Shutdown also applies to emptying and degassing storage vessels. Shutdown does not apply to cessation of a batch process at the end of a campaign, for routine maintenance, for rinsing or washing of equipment between batches, or other routine operations. Small control device means a control device that controls total HAP emissions of less than 10 tons/yr, before control. Standard batch means a batch process operated within a range of operating conditions that are documented in an operating scenario. Emissions from a standard batch are based on the operating conditions that result in highest emissions. The standard batch defines the uncontrolled and controlled emissions for each emission episode defined under the operating scenario. Startup means the setting in operation of a continuous process unit for any purpose; the first time a new or reconstructed batch process unit begins production; for new equipment added, including equipment used to comply with this subpart, the first time the equipment is put into operation; or, for the introduction of a new product/process, the first time the product or process is run in equipment. For batch process units, startup does not apply to the first time the equipment is put into operation at the start of a campaign to produce a product that has been produced in the past, after a shutdown for maintenance, or when the equipment is put into operation as part of a batch within a campaign. As used in § 63.1255, startup means the setting in operation of a piece of equipment or a control device that is subject to this subpart. Storage tank means a tank or other vessel that is used to store organic liquids that contain one or more HAP as raw material feedstocks. Storage tank also means a tank or other vessel in a tank farm that receives and accumulates used solvent from multiple batches of a process or processes for purposes of solvent recovery. The following are not considered storage tanks for the purposes of this subpart: (1) Vessels permanently attached to motor vehicles such as trucks, railcars, barges, or ships; (2) Pressure vessels designed to operate in excess of 204.9 kilopascals and without emissions to the atmosphere; (3) Vessels storing organic liquids that contain HAP only as impurities; (4) Wastewater storage tanks; and (5) Process tanks (including product tanks and isolated intermediate tanks). Supplemental gases are any gaseous streams that are not defined as process vents, or closed-vent systems from wastewater management and treatment units, storage tanks, or equipment components and that contain less than 50 ppmv TOC, as determined through process knowledge, that are introduced into vent streams or manifolds. Air required to operate combustion device burner(s) is not considered supplemental gas. System flowrate means the flowrate of gas entering the control device. Vapor-mounted seal means a continuous seal that completely covers the annular space between the wall of the storage tank or waste management unit and the edge of the floating roof and is mounted such that there is a vapor space between the stored liquid and the bottom of the seal. Wastewater stream means water that is discarded from a PMPU through a single POD, that contains an annual average concentration of partially soluble and/or soluble HAP compounds of at least 5 parts per million by weight and a load of at least 0.05 kg/yr. The following are not considered wastewater streams for the purposes of this subpart: (1) Stormwater from segregated sewers; (2) Water from fire-fighting and deluge systems, including testing of such systems; (3) Spills; (4) Water from safety showers; (5) Samples of a size not greater than reasonably necessary for the method of analysis that is used; (6) Equipment leaks; (7) Wastewater drips from procedures such as disconnecting hoses after clearing lines; and (8) Noncontact cooling water. 4. Section 63.1252 is amended by: a. Revising the introductory paragraph; b. Revising paragraph (d)(2); c. Revising the first sentence in paragraph (d)(5); d. Revising paragraph (d)(6) through (d)(8); e. Revising paragraph (e) introductory text; f. Revising the second sentence in paragraph (e)(1); and g. Adding paragraph (e)(4). The revisions and additions read as follows: § 63.1252 Standards: General. Each owner or operator of any affected source subject to the provisions of this subpart shall control HAP emissions to the level specified in this section on and after the compliance dates specified in § 63.1250(f). Initial compliance with the emission limits is demonstrated in accordance with the provisions of § 63.1257, and continuous compliance is demonstrated in accordance with the provisions of § 63.1258. (d) * * * (2) Only emission sources subject to the requirements of § 63.1253(b)(1) or (c)(1)(i) or § 63.1254(a)(1)(i) may be included in any averaging group. (5) Emission points controlled to comply with a State or Federal rule other than this subpart may not be credited in an emission averaging group, unless the level of control has been increased after November 15, 1990 above what is required by the other State or Federal rule. * * * (6) Not more than 20 processes subject to § 63.1254(a)(1)(i), and 20 storage tanks subject to § 63.1253(b)(1) or (c)(1)(i) at an affected source may be included in an emissions averaging group. (7) Compliance with the emission standards in § 63.1253 shall be satisfied when the annual percent reduction efficiency is greater than or equal to 90 percent for those tanks meeting the criteria of § 63.1253(a)(1) and 95 percent for those tanks meeting the criteria of § 63.1253(a)(2), as demonstrated using the test methods and compliance procedures specified in § 63.1257(g). (8) Compliance with the emission standards in § 63.1254(a)(1)(i) shall be satisfied when the annual percent reduction efficiency is greater than or equal to 93 percent, as demonstrated using the test methods and compliance procedures specified in § 63.1257(h). (e) Pollution prevention alternative. Except as provided in paragraph (e)(1) of this section, an owner or operator may choose to meet the pollution prevention alternative requirement specified in either paragraph (e)(2) or (3) of this section for any PMPU or for any situation described in paragraph (e)(4) of this section, in lieu of the requirements specified in §§ 63.1253, 63.1254, 63.1255, and 63.1256. Compliance with paragraphs (e)(2) and (3) of this section shall be demonstrated through the procedures in § 63.1257(f). Any PMPU for which the owner or operator seeks to comply by using the pollution prevention alternative shall begin with the same starting material(s) and end with the same product(s). The owner or operator may not comply with the pollution prevention alternative by eliminating any steps of a process by transferring the step offsite (to another manufacturing location). (1) * * * The hydrogen halides that are generated as a result of combustion control of emissions must be controlled according to the requirements of paragraph (g)(1) of this section. (4) The owner or operator may comply with the requirements in either paragraph (e)(2) or (3) of this section for a series of processes, including situations where multiple processes are merged, subject to the following conditions: (i) The baseline period shall be a single year beginning no earlier than the 1992 calendar year. (ii) The term “PMPU” shall have the meaning provided in § 63.1251 except that the baseline and modified PMPU may include multiple processes ( i.e. , precursors, active ingredients, and final dosage form) if the owner or operator demonstrates to the satisfaction of the Administrator that the multiple processes were merged after the baseline period into an existing process or processes. (iii) Nondedicated formulation and solvent recovery processes may not be merged with any other processes. 5. Section 63.1253 is amended by: a. Revising paragraph (a); b. Revising paragraph (d); and c. Adding paragraph (f). The revisions and additions read as follows: § 63.1253 Standards: Storage tanks. (a) Except as provided in paragraphs (d), (e), and (f) of this section, the owner or operator of a storage tank meeting the criteria of paragraph (a)(1) of this section is subject to the requirements of paragraph (b) of this section. Except as provided in paragraphs (d), (e), and (f) of this section, the owner or operator of a storage tank meeting the criteria of paragraph (a)(2) of this section is subject to the requirements of paragraph (c) of this section. Compliance with the provisions of paragraphs (b) and (c) of this section is demonstrated using the initial compliance procedures in § 63.1257(c) and the monitoring requirements in § 63.1258. (1) A storage tank with a design capacity greater than or equal to 38 m 3 but less than 75 m 3 storing a liquid for which the maximum true vapor pressure of total HAP is greater than or equal to 13.1 kPa. (2) A storage tank with a design capacity greater than or equal to 75 m 3 storing a liquid for which the maximum true vapor pressure of total HAP is greater than or equal to 13.1 kPa. (d) As an alternative standard, the owner or operator of an existing or new affected source may comply with the storage tank standards by routing storage tank vents to a combustion control device achieving an outlet TOC concentration, as calibrated on methane or the predominant HAP, of 20 ppmv or less, and an outlet concentration of hydrogen halides and halogens of 20 ppmv or less. If the owner or operator is routing emissions to a noncombustion control device, it must achieve an outlet TOC concentration, as calibrated on methane or the predominant HAP, of 50 ppmv or less, and an outlet concentration of hydrogen halides and halogens of 50 ppmv or less. Compliance with the outlet concentrations shall be determined by the initial compliance procedures of § 63.1257(c)(4) and the continuous emission monitoring requirements of § 63.1258(b)(5). (f) Vapor balancing alternative. As an alternative to the requirements in paragraphs (b) and (c) of this section, the owner or operator of an existing or new affected source may implement vapor balancing in accordance with paragraphs (f)(1) through (7) of this section. (1) The vapor balancing system must be designed and operated to route organic HAP vapors displaced from loading of the storage tank to the railcar or tank truck from which the storage tank is filled. (2) Tank trucks and railcars must have a current certification in accordance with the U.S. Department of Transportation (DOT) pressure test requirements of 49 CFR part 180 for tank trucks and 49 CFR 173.31 for railcars. (3) Hazardous air pollutants must only be unloaded from tank trucks or railcars when vapor collection systems are connected to the storage tank's vapor collection system. (4) No pressure relief device on the storage tank, or on the railcar, or tank truck shall open during loading or as a result of diurnal temperature changes (breathing losses). (5) Pressure relief devices on affected storage tanks must be set to no less than 2.5 psig at all times to prevent breathing losses. The owner or operator shall record the setting as specified in § 63.1259(b)(12) and comply with the requirements for each pressure relief valve in paragraphs (f)(5)(i) through (iii) of this section: (i) The pressure relief valve shall be monitored quarterly using the method described in § 63.180(b). (ii) An instrument reading of 500 ppmv or greater defines a leak. (iii) When a leak is detected, it shall be repaired as soon as practicable, but no later than 5 days after it is detected, and the owner or operator shall comply with the recordkeeping requirements of § 63.1255(g)(4)(i) through (iv). (6) Railcars or tank trucks that deliver HAP to an affected storage tank must be reloaded or cleaned at a facility that utilizes one of the control techniques in paragraph (f)(6)(i) through (ii) of this section: (i) The railcar or tank truck must be connected to a closed-vent system with a control device that reduces inlet emissions of HAP by 90 percent by weight or greater; or (ii) A vapor balancing system designed and operated to collect organic HAP vapor displaced from the tank truck or railcar during reloading must be used to route the collected HAP vapor to the storage tank from which the liquid being transferred originated. (7) The owner or operator of the facility where the railcar or tank truck is reloaded or cleaned must comply with the requirements in paragraph (f)(7)(i) through (iii) of this section: (i) Submit to the owner or operator of the affected storage tank and to the Administrator a written certification that the reloading or cleaning facility will meet the requirements of this section. The certifying entity may revoke the written certification by sending a written statement to the owner or operator of the affected storage tank giving at least 90 days notice that the certifying entity is rescinding acceptance of responsibility for compliance with the requirements of this paragraph (b)(7)(i). (ii) If complying with paragraph (f)(6)(i) of this section, demonstrate initial compliance in accordance with § 63.1257(c), demonstrate continuous compliance in accordance with § 63.1258, keep records as specified in § 63.1259, and prepare reports as specified in § 63.1260. (iii) If complying with paragraph (f)(6)(ii) of this section, keep records of: (A) The equipment to be used and the procedures to be followed when reloading the railcar or tank truck and displacing vapors to the storage tank from which the liquid originates, and (B) Each time the vapor balancing system is used to comply with paragraph (f)(6)(ii) of this section. 6. Section 63.1254 is revised to read as follows: § 63.1254 Standards: Process vents. (a) Existing sources. For each process, the owner or operator of an existing affected source must comply with the requirements in paragraphs (a)(1) and (3) of this section or paragraphs (a)(2) and (3) of this section. Initial compliance with the required emission limits or reductions in paragraphs (a)(1) through (3) of this section is demonstrated in accordance with the initial compliance procedures described in § 63.1257(d), and continuous compliance is demonstrated in accordance with the monitoring requirements described in § 63.1258. (1) Process-based emission reduction requirement. (i) Uncontrolled HAP emissions from the sum of all process vents within a process that are not subject to the requirements of paragraph (a)(3) of this section shall be reduced by 93 percent or greater by weight, or as specified in paragraph (a)(1)(ii) of this section. Notification of changes in the compliance method shall be reported according to the procedures in § 63.1260(h). (ii) Any one or more vents within a process may be controlled in accordance with any of the procedures in paragraphs (a)(1)(ii)(A) through (D) of this section. All other vents within the process must be controlled as specified in paragraph (a)(1)(i) of this section. (A) To outlet concentrations less than or equal to 20 ppmv as TOC and less than or equal to 20 ppmv as hydrogen halides and halogens; (B) By a flare that meets the requirements of § 63.11(b); (C) By a control device specified in § 63.1257(a)(4); or (D) In accordance with the alternative standard specified in paragraph (c) of this section. (2) Process-based annual mass limit. (i) Actual HAP emissions from the sum of all process vents within a process must not exceed 900 kilograms (kg) in any 365-day period. (ii) Actual HAP emissions from the sum of all process vents within processes complying with paragraph (a)(2)(i) of this section are limited to a maximum of 1,800 kg in any 365-day period. (iii) Emissions from vents that are subject to the requirements of paragraph (a)(3) of this section and emissions from vents that are controlled in accordance with the procedures in paragraph (c) of this section may be excluded from the sums calculated in paragraphs (a)(2)(i) and (ii) of this section. (iv) The owner or operator may switch from compliance with paragraph (a)(2) of this section to compliance with paragraph (a)(1) of this section only after at least 1 year of operation in compliance with paragraph (a)(2) of this section. Notification of such a change in the compliance method shall be reported according to the procedures in § 63.1260(h). (3) Individual vent emission reduction requirements. (i) Except as provided in paragraph (a)(3)(ii) of this section, uncontrolled HAP emissions from a process vent must be reduced by 98 percent or in accordance with any of the procedures in paragraphs (a)(1)(ii)(A) through (D) of this section if the uncontrolled HAP emissions from the vent exceed 25 tons per year, and the flow-weighted average flowrate (FRa) calculated using Equation 1 of this subpart is less than or equal to the flowrate index (FRI) calculated using Equation 2 of this subpart. ER29AU00.000 ER29AU00.001 Where: FR a = flow-weighted average flowrate for the vent, scfm. D i = duration of each emission event, min. FR i = flowrate of each emission event, scfm. n = number of emission events. FRI = flowrate index, scfm. HL = annual uncontrolled HAP emissions, lb/yr, as defined in § 63.1251. (ii) Grandfathering provisions. As an alternative to the requirements in paragraph (a)(3)(i) of this section, the owner or operator may comply with the provisions in paragraph (a)(3)(ii)(A), (B), or (C) of this section, if applicable. (A) Control device operation. If the owner or operator can demonstrate that a process vent is controlled by a control device meeting the criteria specified in paragraph (a)(3)(ii)(A)( 1 ) of this section, then the control device is required to be operated according to paragraphs (a)(3)(ii)(A)( 2 ), ( 3 ), and ( 4 ) of this section: ( 1 ) The control device was installed on any process vent that met the conditions of paragraph (a)(3)(i) of this section on or before April 2, 1997, and was operated to reduce uncontrolled emissions of total HAP by greater than or equal to 93 percent by weight, but less than 98 percent by weight; ( 2 ) The device must be operated to reduce inlet emissions of total HAP by 93 percent or by the percent reduction specified for that control device in any preconstruction permit issued pursuant to regulations approved or promulgated through rulemaking under title I (including parts C or D) of the Clean Air Act, whichever is greater; ( 3 ) The device must be replaced or upgraded to achieve at least 98 percent reduction of HAP or meet any of the conditions specified in paragraphs (a)(1)(ii)(A) through (D) of this section upon reconstruction or replacement. ( 4 ) The device must be replaced or upgraded to achieve at least 98 percent reduction of HAP or meet any of the conditions specified in paragraphs (a)(1)(ii)(A) through (D) of this section by April 2, 2007, or 15 years after issuance of the preconstruction permit, whichever is later. (B) Process operations. If a process meets all of the conditions specified in paragraphs (a)(3)(ii)(B)( 1 ) through ( 3 ) of this section, the required level of control for the process is the level that was achieved on or before April 2, 1997. This level of control is demonstrated using the same procedures that are used to demonstrate compliance with paragraph (a)(1) of this section. ( 1 ) At least one vent in the process met the conditions of paragraph (a)(3)(i) of this section on or before April 2, 1997; and ( 2 ) The overall control for the process on or before April 2, 1997 was greater than or equal to 93 percent by weight, but less than 98 percent by weight; and ( 3 ) The production-indexed HAP consumption factor for the 12-month period in which the process was operated prior to the compliance date is less than one-half of the 3-year average baseline value established no earlier than the 1987 through 1989 calendar years. (C) Hydrogenation vents. Processes meeting the conditions of paragraphs (a)(3)(ii)(C)( 1 ) through ( 3 ) of this section are required to be operated to maintain the level of control achieved on or before April 2, 1997. For all other processes meeting the conditions of paragraph (a)(3)(ii)(C)( 3 ) of this section, uncontrolled HAP emissions from the sum of all process vents within the process must be reduced by 95 percent or greater by weight. ( 1 ) Processes containing a process vent that met the conditions of paragraph (a)(3)(i) of this section on or before April 2, 1997; and ( 2 ) Processes that are controlled to greater than or equal to 93 percent by weight, but less than 98 percent by weight; and ( 3 ) Processes with a hydrogenation vent that, in conjunction with all other process vents from the process that do not meet the conditions of paragraph (a)(3)(i) of this section, cannot meet the requirements of paragraph (a)(1) or (2) of this section. (b) New sources . (1) Except as provided in paragraph (b)(2) of this section, uncontrolled HAP emissions from the sum of all process vents within a process at a new affected source shall be reduced by 98 percent or greater by weight or controlled in accordance with any of requirements of paragraphs (a)(1)(ii)(A) through (D) of this section. Initial compliance with the required emission limit or reduction is demonstrated in accordance with the initial compliance procedures in § 63.1257(d), and continuous compliance is demonstrated in accordance with the monitoring requirements described in § 63.1258. (2) Annual mass limit. The actual HAP emissions from the sum of all process vents for which the owner or operator is not complying with paragraph (b)(1) of this section are limited to 900 kg in any 365-day period. (c) Alternative standard. As an alternative standard, the owner or operator of an existing or new affected source may comply with the process vent standards by routing vents from a process to a combustion control device achieving an outlet TOC concentration, as calibrated on methane or the predominant HAP, of 20 ppmv or less, and an outlet concentration of hydrogen halides and halogens of 20 ppmv or less. If the owner or operator is routing emissions to a noncombustion control device, it must achieve an outlet TOC concentration, as calibrated on methane or the predominant HAP, of 50 ppmv or less, and an outlet concentration of hydrogen halides and halogens of 50 ppmv or less. Any process vents within a process that are not routed to this control device must be controlled in accordance with the provisions of paragraph (a) or (b) of this section, as applicable. Initial compliance with the outlet concentrations is demonstrated in accordance with the initial compliance procedures described in § 63.1257(d)(1)(iv), and continuous compliance is demonstrated in accordance with the emission monitoring requirements described in § 63.1258(b)(5). 7. Section 63.1255 is amended by: a. Revising paragraph (a)(1); b. Revising paragraph (a)(7); c. Revising paragraphs (a)(10)(ii) and (iii); d. Adding paragraphs (a)(11) and (12); e. Revising paragraph (b); f. Revising paragraph (c)(2)(i); g. Revising “paragraph (b)(1)(v)” to read “paragraph (b)(4)(i)” in paragraph (c)(3)(i); h. Revising the definitions of the terms “P L ” and “P T ” following Equation 3 in paragraph (c)(4)(iv); i. Removing the definition of the term “PS” following Equation 3 in paragraph (c)(4)(iv) and adding the definition of the term “P S ” following Equation 3 in paragraph (c)(4)(iv); j. Revising “paragraph (b)(1)(vi)” to read “paragraph (b)(4)(ii)” in paragraph (c)(5)(i)(B); k. Revising paragraphs (c)(5)(vi)(B) and (C); l. Revising paragraphs (c)(6) and (7); m. Revising paragraph (c)(9); n. Revising paragraphs (d)(1)(ii); o. Revising paragraph (e)(3) introductory text; p. Revising the definitions of the terms “%V Li ” and V i ” following Equation 4 in paragraph (e)(5)(iii); q. Revising the definition of the term “%V L ” following Equation 5 in paragraph (e)(6)(ii); r. Revising “paragraph (b)(1)(v)” to read “paragraph (b)(4)(i)” in paragraph (e)(7)(i); s. Adding paragraphs (e)(7)(iii)(A) through (C); t. Revising the second sentence in paragraph (e)(9); u. Revising paragraph (f); v. Revising paragraph (g)(2) introductory text; w. Revising paragraph (g)(2)(i)(A); x. Removing paragraph (g)(2)(v), redesignating paragraphs (g)(2)(vi) through (ix) as paragraphs (g)(2)(v) through (viii), and revising redesignated paragraphs (g)(2)(vi) and (viii); y. Revising the first sentence in paragraph (g)(3); z. Revising paragraph (g)(4) introductory text aa. Revising paragraph (g)(4)(iv) bb. Revising paragraph (g)(4)(v)(A) cc. Revising “§ 63.174(c)” to read “§ 63.174(c)(1)(i) and (c)(2)(ii)” in the first sentence in paragraph (g)(4)(vii)(B) dd. Revising “§§ 63.178(c)(3)(ii) and (c)(3)(iii)” to read “§ 63.178(c)(3)(ii) and (iii)” in the first sentence in paragraph (g)(4)(viii) ee. Revising the first sentence in paragraph (g)(5) introductory text ff. Removing paragraph (g)(5)(ii), redesignating paragraphs (g)(5)(iii) through (vi) as paragraphs (g)(5)(ii) through (v), and revising “appendix” to read “section” in the second sentence of redesignated paragraph (g)(5)(ii) gg. Revising paragraph (g)(6) heading hh. Revising the first sentence in paragraph (g)(7) introductory text ii. Revising “paragraph (b)(1)(vi)” to read “paragraph (b)(4)(ii)” in paragraph (g)(7)(i)(D) jj. Revising paragraph (h)(2) heading kk. Revising paragraph (h)(2)(i)(B) ll. Revising “paragraph (b)(1)(ix)” to read “paragraph (b)(4)(iv)” in paragraph (h)(2)(ii) mm. Revising “paragraph (b)(1)(vi)” to read “paragraph (b)(4)(ii)” in paragraph (h)(2)(iii)(B) nn. Revising paragraph (h)(2)(iv) oo. Revising “§ 63.1250(e)” to read “§ 63.1250(f)” in the second sentence in paragraph (h)(3)(i) pp. Revising paragraph (h)(3)(ii) introductory text qq. Revising paragraphs (h)(3)(ii)(C) and (D); and rr. Revising paragraph (h)(3)(iv); The revisions and additions read as follows: § 63.1255 Standards: Equipment leaks. (a) * * * (1) The provisions of this section apply to pumps, compressors, agitators, pressure relief devices, sampling connection systems, open-ended valves or lines, valves, connectors, instrumentation systems, control devices, and closed-vent systems required by this section that are intended to operate in organic hazardous air pollutant service 300 hours or more during the calendar year within a source subject to the provisions of this subpart. (7) Equipment to which this section applies shall be identified such that it can be distinguished readily from equipment that is not subject to this section. Identification of the equipment does not require physical tagging of the equipment. For example, the equipment may be identified on a plant site plan, in log entries, or by designation of process boundaries by some form of weatherproof identification. If changes are made to the affected source subject to the leak detection requirements, equipment identification for each type of component shall be updated, if needed, within 90 calendar days or by the next Periodic Report following the end of the monitoring period for that component, whichever is later. (10) * * * (ii) The identification on a valve in light liquid or gas/vapor service may be removed after it has been monitored as specified in paragraph (e)(7)(iii) of this section, and no leak has been detected during the follow-up monitoring. (iii) The identification on equipment, except on a valve in light liquid or gas/vapor service, may be removed after it has been repaired. (11) Except as provided in paragraph (a)(11)(i) of this section, all terms in this subpart that define a period of time for completion of required tasks ( e.g., weekly, monthly, quarterly, annual) refer to the standard calendar periods unless specified otherwise in the section or paragraph that imposes the requirement. (i) If the initial compliance date does not coincide with the beginning of the standard calendar period, an owner or operator may elect to utilize a period beginning on the compliance date, or may elect to comply in accordance with the provisions of paragraph (a)(11)(ii) or (iii) of this section. (ii) Time periods specified in this subpart for completion of required tasks may be changed by mutual agreement between the owner or operator and the Administrator, as specified in subpart A of this part. For each time period that is changed by agreement, the revised period shall remain in effect until it is changed. A new request is not necessary for each recurring period. (iii) Except as provided in paragraph (a)(11)(i) or (ii) of this section, where the period specified for compliance is a standard calendar period, if the initial compliance date does not coincide with the beginning of the calendar period, compliance shall be required according to the schedule specified in paragraph (a)(11)(iii)(A) or (B) of this section, as appropriate. (A) Compliance shall be required before the end of the standard calendar period within which the initial compliance date occurs if there remain at least 3 days for tasks that must be performed weekly, at least 2 weeks for tasks that must be performed monthly, at least 1 month for tasks that must be performed each quarter, or at least 3 months for tasks that must be performed annually; or (B) In all other cases, compliance shall be required before the end of the first full standard calendar period after the period within which the initial compliance date occurs. (iv) In all instances where a provision of this subpart requires completion of a task during each of multiple successive periods, an owner or operator may perform the required task at any time during each period, provided the task is conducted at a reasonable interval after completion of the task during the previous period. (12) In all cases where the provisions of this subpart require an owner or operator to repair leaks by a specified time after the leak is detected, it is a violation of this section to fail to take action to repair the leaks within the specified time. If action is taken to repair the leaks within the specified time, failure of that action to successfully repair the leak is not a violation of this section. However, if the repairs are unsuccessful, a leak is detected and the owner or operator shall take further action as required by applicable provisions of this section. (b) References . (1) The owner or operator of a source subject to this section shall comply with the provisions of subpart H of this part, as specified in paragraphs (b)(2) through (4) of this section. The term “process unit” as used in subpart H of this part shall be considered to be defined the same as “group of processes” for sources subject to this subpart GGG. The term “fuel gas system,” as used in subpart H of this part, shall not apply for the purposes of this subpart GGG. (2) Sections 63.160, 63.161, 63.162, 63.163, 63.167, 63.168, 63.170, 63.173, 63.175, 63.176, 63.181, and 63.182 shall not apply for the purposes of this subpart GGG. The owner or operator shall comply with the provisions specified in paragraphs (b)(2)(i) through (viii) of this section. (i) Sections 63.160 and 63.162 shall not apply; instead, the owner or operator shall comply with paragraph (a) of this section; (ii) Section 63.161 shall not apply; instead, the owner or operator shall comply with § 63.1251; (iii) Sections 63.163 and 63.173 shall not apply; instead, the owner or operator shall comply with paragraph (c) of this section; (iv) Section 63.167 shall not apply; instead, the owner or operator shall comply with paragraph (d) of this section; (v) Section 63.168 shall not apply; instead, the owner or operator shall comply with paragraph (e) of this section; (vi) Section 63.170 shall not apply; instead, the owner or operator shall comply with § 63.1254; (vii) Section 63.181 shall not apply; instead, the owner or operator shall comply with paragraph (g) of this section; and (viii) Section 63.182 shall not apply; instead, the owner or operator shall comply with paragraph (h) of this section. (3) The owner or operator shall comply with §§ 63.164, 63.165, 63.166, 63.169, 63.177, and 63.179 in their entirety, except that when these sections reference other sections of subpart H of this part, the references shall mean the sections specified in paragraphs (b)(2) and (4) of this section. Section 63.164 applies to compressors. Section 63.165 applies to pressure relief devices in gas/vapor service. Section 63.166 applies to sampling connection systems. Section 63.169 applies to pumps, valves, connectors, and agitators in heavy liquid service; instrumentation systems; and pressure relief devices in liquid service. Section 63.177 applies to general alternative means of emission limitation. Section 63.179 applies to alternative means of emission limitation for enclosed-vented process units. (4) The owner or operator shall comply with §§ 63.171, 63.172, 63.174, 63.178, and 63.180, except as specified in paragraphs (b)(4)(i) through (vi) of this section. (i) Section 63.171 shall apply, except § 63.171(a) shall not apply. Instead, delay of repair of equipment for which leaks have been detected is allowed if one of the conditions in paragraphs (b)(4)(i)(A) through (B) exists: (A) The repair is technically infeasible without a process shutdown. Repair of this equipment shall occur by the end of the next scheduled process shutdown. (B) The owner or operator determines that repair personnel would be exposed to an immediate danger if attempting to repair without a process shutdown. Repair of this equipment shall occur by the end of the next scheduled process shutdown. (ii) Section 63.172 shall apply for closed-vent systems used to comply with this section, and for control devices used to comply with this section only, except: (A) Section 63.172(k) and (l) shall not apply. The owner or operator shall instead comply with paragraph (f) of this section. (B) Owners or operators may, instead of complying with the provisions of § 63.172(f), design a closed-vent system to operate at a pressure below atmospheric pressure. The system shall be equipped with at least one pressure gage or other pressure measurement device that can be read from a readily accessible location to verify that negative pressure is being maintained in the closed-vent system when the associated control device is operating. (iii) Section 63.174 shall apply except: (A) Section 63.174(f), (g), and (h) shall not apply. Instead of § 63.174(f), (g), and (h), the owner or operator shall comply with paragraph (f) of this section. Section 63.174(b)(3) shall not apply. Instead of § 63.174(b)(3), the owner or operator shall comply with paragraphs (b)(3)(iii)(B) through (F) of this section. (B) If the percent leaking connectors in a group of processes was greater than or equal to 0.5 percent during the initial monitoring period, monitoring shall be performed once per year until the percent leaking connectors is less than 0.5 percent. (C) If the percent leaking connectors in the group of processes was less than 0.5 percent, but equal to or greater than 0.25 percent, during the initial or last required monitoring period, the owner or operator may elect to monitor once every 4 years. An owner or operator may comply with the requirements of this paragraph by monitoring at least 40 percent of the connectors in the first 2 years and the remainder of the connectors within the next 2 years. The percent leaking connectors will be calculated for the total of all required monitoring performed during the 4-year period. (D) Except as provided in paragraph (b)(4)(iii)(B) of this section, if leaking connectors comprise at least 0.5 percent but less than 1.0 percent of the connectors during the last monitoring period, the owner or operator shall monitor at least once every 2 years for the next monitoring period. At the end of that 2-year monitoring period, the owner or operator shall monitor once per year if the percent leaking connectors is greater than or equal to 0.5 percent; if the percent leaking connectors is less than 0.5 percent, the owner or operator shall monitor in accordance with paragraph (b)(4)(iii)(C) or (F) of this section, as appropriate. (E) If an owner or operator determines that 1 percent or greater of the connectors in a group of processes are leaking, the owner or operator shall monitor the connectors once per year. The owner or operator may elect to use the provisions of paragraph (b)(4)(iii)(C), (D), or (F) of this section, as appropriate, after a monitoring period in which less than 1 percent of the connectors are determined to be leaking. (F) The owner or operator may elect to perform monitoring once every 8 years if the percent leaking connectors in the group of processes was less than 0.25 percent during the initial or last required monitoring period. An owner or operator shall monitor at least 50 percent of the connectors in the first 4 years and the remainder of the connectors within the next 4 years. If the percent leaking connectors in the first 4 years is equal to or greater than 0.35 percent, the monitoring program shall revert at that time to the appropriate monitoring frequency specified in paragraph (b)(4)(iii)(C), (D), or (E) of this section. (iv) Section 63.178 shall apply except: (A) Section 63.178(b), requirements for pressure testing, may be applied to all processes (not just batch processes) and to supply lines between storage and processing areas. (B) For pumps, the phrase “at the frequencies specified in Table 1 of this subpart” in § 63.178(c)(3)(iii) shall mean “quarterly” for the purposes of this subpart. (v) Section 63.180 shall apply except § 63.180(b)(4)(ii)(A) through (C) shall not apply. Instead, calibration gases shall be a mixture of methane and air at a concentration of approximately, but less than, 10,000 parts per million methane for agitators; 2,000 parts per million for pumps; and 500 parts per million for all other equipment, except as provided in § 63.180(b)(4)(iii). (vi) When §§ 63.171, 63.172, 63.174, 63.178, and 63.180 reference other sections in subpart H of this part, the references shall mean those sections specified in paragraphs (b)(2) and (b)(4)(i) through (v) of this section, as applicable. (c) * * * (2)(i) Monitoring . Each pump and agitator subject to this section shall be monitored quarterly to detect leaks by the method specified in § 63.180(b) except as provided in §§ 63.177, 63.178, paragraph (f) of this section, and paragraphs (c)(5) through (9) of this section. (4) * * * (iv) * * * P L = number of pumps found leaking as determined through periodic monitoring as required in paragraphs (c)(2)(i) and (ii) of this section. P T = total pumps in organic HAP service, including those meeting the criteria in paragraphs (c)(5) and (6) of this section. P S = number of pumps in a continuous process leaking within 1 quarter of startup during the current monitoring period. (5) * * * (vi) * * * (B) If indications of liquids dripping from the pump/agitator seal exceed the criteria established in paragraph (c)(5)(vi)(A) of this section, or if, based on the criteria established in paragraph (c)(5)(vi)(A) of this section, the sensor indicates failure of the seal system, the barrier flu [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%3A00-21195. Public record. Not legal advice.