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 Sec. 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
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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, 981551 (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 Sec. 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 Sec. 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 Sec. 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
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reconstructed source, as specified in Sec. 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. Invivo 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 invitro 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 costeffective 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 beyondthe 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 methanolcontaining wastewater that is determined to be affected wastewater under the Pharmaceuticals Production
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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 Sec. 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 Sec. 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 RCRApermitted 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 Sec. 63.111 of the HON. Note that this change also affects industrial furnaces used as air pollution control devices under Sec. 63.1257(a)(4), as well as wastewater treatment units under Sec. 63.1256(g)(13).

Comment: One commenter noted that the list of exempt wastewater in Sec. 63.1256(a)(3)(i) omits two of the types of wastewater that are exempted in Sec. 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 Sec. 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 Sec. 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, Sec. 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, Sec. 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 Sec. 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 Sec. 63.1256. According to Sec. 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 Sec. 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 Sec. 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 Sec. 63.1256(a)(4) as Sec. 63.1256(a)(3), and we redesignated the maintenance wastewater requirements in Sec. 63.1256(a)(3)(ii) as Sec. 63.1256(a)(4). We also added a statement to the redesignated Sec. 63.1256(a)(4) to specify that maintenance wastewater is exempt from all other provisions in subpart GGG. Finally, we revised Sec. 63.1256(a) introductory paragraph and Sec. 63.1256(a)(1) to more clearly explain what provisions are specified in Sec. 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
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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 Sec. 63.1261 of the September 21, 1998 promulgated rule. The proposed amendments to Sec. 63.1261 reference terms that are defined in proposed amendments to Sec. 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 Sec. 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 Sec. 63.1254(c), or at least one vent is routed to a control device subject to the grandfathering provisions in Sec. 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 Sec. 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
Sec. 63.1254(a)(3)(ii), and (3) all vents that are controlled in accordance with the alternative standard in Sec. 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 Sec. 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
Sec. 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 processbased emission reduction (for the sum of the nonTRE 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
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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 Sec. 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 Sec. 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 EPAapproved, 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 Sec. 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 Sec. 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 Sec. 63.1250(h)(1), (4), (5), and (6). [[Page 52594]]
63.1252(d)(6) through (d)(8). Corrected these paragraphs by replacing the incorrect references to Sec. 63.1254(a)(2) and (a)(3) with the correct references to Sec.
63.1254(a)(1)(i). Replaced incorrect reference to Sec. 63.1253(c)(1) with correct reference to Sec.
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 Sec. 63.178(c)(iii) with the complete reference to Sec. 63.178(c)(3)(iii). 63.1255(c)(2)(i) and (e)(3).. Corrected these paragraphs by replacing references to Sec. 63.178(b) with references to Sec. 63.178. The more comprehensive reference allows an owner or operator to implement the monitoring interval adjustment option in Sec. 63.178(c) for valves under Sec. 63.1255(e)(3). However, the change has essentially no impact for pumps and agitators because Sec.
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 Sec. 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 Sec. 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 Sec.
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 Sec. 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
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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 5501 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. 1044, 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 costbenefit 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 leastcostly, most costeffective, 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 leastburdensome 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 [[Page 52596]]
than 50,000; and (4) a small organization that is any notforprofit 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 processbased 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. 20600358. 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) 2602740.

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 addon control devices for storage tanks even though addon 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. 104113 (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. Sec. 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. Sec. 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 63NATIONAL 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 GGGNational 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:
Sec. 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 Sec. 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 Sec. 63.1251;
(ii) Are located at a plant site that is a major source as defined in section 112(a) of the Act; and
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(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 requir

FOR FURTHER INFORMATION CONTACT For information concerning these final amendments, contact Mr. Randy McDonald, Organic Chemicals Group, Emission Standards Division (MD13), U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, telephone number (919) 5415402, 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 021142023, (617) 9181740
Umesh Dholakia: U.S. EPA Region II, 290 Broadway Street, New York, NY 100071866, (212) 6374023
Doreen Au: U.S. EPA Region III, 1650 Arch Street, Philadelphia, PA 19103, (215) 8145471
Lee Page, U.S. EPA Region IV, 61 Forsyth Street, SW, Atlanta, GA 30303 3104, (404) 5629131
Shaun Burke, IL/IN, (312) 3535713; Joseph Cardile, MI/WI, (312) 353 2151; Erik Hardin, MN/OH, (312) 3532402; U.S. EPA Region V, 77 West Jackson Boulevard, Chicago, IL 606043507
John Jones: U.S. EPA Region VI, 1445 Ross Avenue, Suite 1200 (6ENAT), Dallas, TX 75202, (214) 6657233
Gary Schlicht: U.S. EPA Region VII, 726 Minnesota Avenue, Kansas City, KS 66101, (913) 5517097
Tami ThomasBurton: U.S. EPA Region VIII, 999 18th Street, Suite 500, Denver, CO 80202, (303) 3126581
Ken Bigos: U.S. EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105, (415) 7441240
Dan Meyer: U.S. EPA Region X, 1200 Sixth Street, Seattle, WA 98101, (206) 5534150