40 CFR Part 63, Subpart GGG - National Emission Standards for Pharmaceuticals Production

The States of Iowa, Kansas, Missouri, and Nebraska and the local agencies of Lincoln-Lancaster County, Nebraska, and the city of Omaha, Nebraska, have submitted updated regulations for delegation of EPA authority for implementation and enforcement of NSPS, NESHAP, and MACT standards. The submissions cover new EPA standards and, in some instances, revisions to standards previously delegated. EPA's review of the pertinent regulations shows that they contain adequate and effective procedures for the implementation and enforcement of these Federal standards. This action informs the public of delegations to the above-mentioned agencies. All sources subject to the requirements of EPA regulations are also subject to the equivalent requirements of the above-mentioned state or local agencies. For the current, most up-to-date, status of delegations to the above-mentioned agencies, please refer to the web pages in the “What does this action do?” section of this document.

The U.S. Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Surface Coating of Wood Building Products to address the results of the residual risk and technology review (RTR) that the EPA is required to conduct under the Clean Air Act (CAA). We found risks due to emissions of air toxics to be acceptable from this source category and determined that the current NESHAP provides an ample margin of safety to protect public health. We identified no new cost-effective controls under the technology review to achieve further emissions reductions. The EPA is proposing: To add an alternative compliance demonstration equation; to amend provisions addressing periods of startup, shutdown and malfunction (SSM); to amend provisions regarding electronic reporting; and to make technical and editorial changes. The EPA is proposing these amendments to improve the effectiveness of the NESHAP. This action also proposes a new EPA test method to measure isocyanate compounds in certain surface coatings.

On March 14, 2018, the Environmental Protection Agency (EPA) proposed a rule titled, “National Emission Standards for Hazardous Air Pollutants: Leather Finishing Operations Residual Risk and Technology Review.” The EPA is reopening the comment period on the proposed rule that closed on April 30, 2018. The EPA is taking this action because the supporting document—Analysis of Demographic Factors for Populations Living Near Leather Finishing Operations—was inadvertently not included in the docket for this proposed rule. As this analysis is now available to the public, the EPA has reopened the comment period for an additional 30 days.

The Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Friction Materials Manufacturing Facilities source category. The proposed amendments address the results of the residual risk and technology reviews (RTRs) conducted as required under the Clean Air Act (CAA). The proposed amendments also address the startup, shutdown, and malfunction (SSM) provisions of the rule and update the reporting and recordkeeping requirements.

This action proposes amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) Refinery MACT 1 and Refinery MACT 2 regulations to clarify the requirements of these rules and to make technical corrections and minor revisions to requirements for work practice standards, recordkeeping and reporting. This action also proposes technical corrections for the New Source Performance Standards (NSPS) for Petroleum Refineries.

The Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants for Wet-Formed Fiberglass Mat Production to address the results of the residual risk and technology review (RTR) that the EPA is required to conduct in accordance with section 112 of the Clean Air Act (CAA). We found risks due to emissions of air toxics to be acceptable from this source category, determined that the current standards provide an ample margin of safety to protect public health, and identified no new cost-effective controls under the technology review to achieve further emissions reductions. Therefore, we are proposing no revisions to the numerical emission limits based on these analyses. However, the EPA is proposing to revise provisions pertaining to emissions during periods of startup, shutdown, and malfunction (SSM); add requirements for electronic submittal of performance test results; revise certain monitoring, recordkeeping, and reporting requirements; and make other miscellaneous technical and editorial changes. While the proposed amendments would not result in reductions in emissions of hazardous air pollutants (HAP), if finalized, they would result in improved compliance and implementation of the rule.

The Environmental Protection Agency (EPA) is proposing to grant the New Hampshire Department of Environmental Services (NH DES) the authority to implement and enforce the amended Asbestos Management and Control Rule in place of the National Emission Standard for Asbestos (Asbestos NESHAP) as it applies to certain asbestos-related activities. Upon approval, NH DES's amended rule would apply to all sources that otherwise would be regulated by the Asbestos NESHAP with the exception of inactive waste disposal sites that ceased operation on or before July 9, 1981. These inactive disposal sites are already regulated by State rules that were approved by EPA on January 11, 2013. This proposed approval would make NH DES's amended Asbestos Management and Control Rule federally enforceable.

The Environmental Protection Agency (EPA) is publishing editorial and technical revisions to the EPA's Method 301 “Field Validation of Pollutant Measurement Methods from Various Waste Media” to correct and update the method. In addition, the EPA is clarifying the regulatory applicability of Method 301 as well as its suitability for use with other regulations. The revisions include ruggedness testing for validation of test methods intended for application at multiple sources, determination of the limit of detection for all method validations, incorporating procedures for determining the limit of detection, revising the sampling requirements for the method comparison procedure, adding storage and sampling procedures for sorbent sampling systems, and clarifying acceptable statistical results for candidate test methods. We are also clarifying the applicability of Method 301 to our regulations and adding equations to clarify calculation of the correction factor, standard deviation, estimated variance of a validated test method, standard deviation of differences, and t-statistic for all validation approaches. We have also made minor changes in response to public comments. Changes made to the Method 301 field validation protocol under this action apply only to methods submitted to the EPA for approval after the effective date of this final rule.

The Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Leather Finishing Operations to address the results of the residual risk and technology review (RTR) that the EPA is required to conduct in accordance with section 112 of the Clean Air Act (CAA). We found risks due to emissions of air toxics to be acceptable from this source category and determined that the current NESHAP provides an ample margin of safety to protect public health. We identified no new cost-effective controls under the technology review to achieve further emissions reductions. Therefore, we are proposing no revisions to the numerical emission limits based on these analyses. However, the EPA is proposing amendments to regulatory provisions pertaining to emissions during periods of startup, shutdown, and malfunction (SSM); amendments to add electronic reporting; and amendments to clarify certain rule requirements and provisions. While the proposed amendments would not result in reductions in emissions of hazardous air pollutants (HAP), this action, if finalized, would result in improved compliance and implementation of the rule.

The Environmental Protection Agency (EPA) is notifying the public that it has issued the guidance memorandum titled “Reclassification of Major Sources as Area Sources Under Section 112 of the Clean Air Act”. The EPA is also withdrawing the memorandum titled “Potential to Emit for MACT Standards—Guidance on Timing Issues.”

This action finalizes amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Off-Site Waste and Recovery Operations (OSWRO). The final amendments address continuous monitoring on pressure relief devices (PRDs) on containers. This issue was raised in a petition for reconsideration of the 2015 amendments to the OSWRO NESHAP, which were based on the residual risk and technology review (RTR). Among other things, the 2015 amendments established additional monitoring requirements for all PRDs, including PRDs on containers. For PRDs on containers, these monitoring requirements were in addition to the inspection and monitoring requirements for containers and their closure devices already required by the OSWRO NESHAP. This final action removes the additional monitoring requirements for PRDs on containers that resulted from the 2015 amendments because we have determined that they are not necessary. This action does not substantially change the level of environmental protection provided under the OSWRO NESHAP, but reduces burden to this industry compared to the current rule by $28 million in capital costs related to compliance, and $4.2 million per year in total annualized costs under a 7 percent interest rate. Over 15 years at a 7-percent discount rate, this constitutes an estimated reduction of $39 million in the present value, or $4.3 million per year in equivalent annualized cost savings.

This action proposes corrections and updates to regulations for source testing of emissions. The proposed rule includes corrections to testing provisions that contain inaccuracies, updates to outdated procedures, and approved alternative procedures that provide testers enhanced flexibility. The revisions will improve the quality of data but will not impose new substantive requirements on source owners or operators.

This action completes the final residual risk and technology reviews (RTR) that the Environmental Protection Agency (EPA) conducted for the Wool Fiberglass Manufacturing source category regulated under the national emission standards for hazardous air pollutants (NESHAP). In this action, the EPA is readopting the existing emission limits for formaldehyde, establishing emission limits for methanol, and a work practice standard for phenol emissions from bonded rotary spin (RS) lines at wool fiberglass manufacturing facilities. In addition, the EPA is revising the emission standards promulgated on July 29, 2015, for flame attenuation (FA) lines at wool fiberglass manufacturing facilities by creating three subcategories of FA lines and establishing emission limits for formaldehyde and methanol emissions, and either emission limits or work practice standards for phenol emissions for each subcategory of FA lines.

On September 21, 2017, the Environmental Protection Agency (EPA) proposed a rule titled, “National Emission Standards for Hazardous Air Pollutants From the Portland Cement Manufacturing Industry Residual Risk and Technology Review.” The EPA is extending the comment period on the proposed rule that was scheduled to close on November 6, 2017, by 15 days until November 21, 2017. The EPA is making this change based on one request for additional time to prepare comments on this proposed rule.

This action finalizes the residual risk and technology review (RTR) conducted for the Publicly Owned Treatment Works (POTW) source category regulated under national emission standards for hazardous air pollutants (NESHAP). In addition, we are taking final action addressing revised names and definitions of the subcategories, revisions to the applicability criteria, revised regulatory provisions pertaining to emissions during periods of startup, shutdown, and malfunction (SSM), initial notification requirements for existing Group 1 and Group 2 POTW, revisions to the requirements for new Group 1 POTW, requirements for electronic reporting, and other miscellaneous edits and technical corrections. While we do not anticipate any emission reductions as a result of these revisions, the changes should provide clarity for sources determining applicability and ensuring compliance.

Because the Environmental Protection Agency (EPA) received adverse comment, we are withdrawing the direct final rule for the National Emission Standards for Hazardous Air Pollutants for Wool Fiberglass Manufacturing; Flame Attenuation Lines, published on July 27, 2017.

This action finalizes the residual risk and technology review (RTR) conducted for the Manufacturing of Nutritional Yeast source category regulated under national emission standards for hazardous air pollutants (NESHAP). In addition, we are finalizing other amendments, including revisions to the form of the volatile organic compounds (VOC) standards for fermenters, removal of the option to monitor brew ethanol, inclusion of ongoing relative accuracy test audit (RATA), and revisions to other monitoring, reporting, and recordkeeping requirements.

This action finalizes the residual risk and technology review (RTR) conducted for the chemical recovery combustion sources at kraft, soda, sulfite, and stand-alone semichemical pulp mills regulated under the national emission standards for hazardous air pollutants (NESHAP). We are finalizing our proposed determination that risks from the source category are acceptable and that the standards provide an ample margin of safety to protect public health. We are also finalizing amendments to the NESHAP based on developments in practices, processes, and control technologies identified as part of the technology review. These final amendments include revisions to the opacity monitoring provisions and the addition of requirements to maintain proper operation of the electrostatic precipitator (ESP) automatic voltage control (AVC). Additional amendments are also being finalized including the requirement to conduct 5-year periodic emissions testing, and submit electronic reports; revisions to provisions addressing periods of startup, shutdown, and malfunction (SSM); and technical and editorial changes. These amendments are made under the authority of the Clean Air Act (CAA) and will improve the effectiveness of the rule.

This action finalizes amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Phosphoric Acid Manufacturing and Phosphate Fertilizer Production source categories. These final amendments are in response to two petitions for reconsideration filed by industry stakeholders on the rule revisions to the NESHAP for the Phosphoric Acid Manufacturing and Phosphate Fertilizer Production source categories that were promulgated on August 19, 2015. We are revising the compliance date by which affected sources must include emissions from oxidation reactors when determining compliance with the total fluoride emission limits for superphosphoric acid (SPA) process lines. In addition, we are revising the compliance date for the monitoring requirements for low-energy absorbers. We are also clarifying one option and adding a new option, to the monitoring requirements for low-energy absorbers.

The Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) From the Portland Cement Manufacturing Industry to address the results of the residual risk and technology review (RTR) the EPA is required to conduct in accordance with section 112 of the Clean Air Act (CAA). We found risks due to emissions of air toxics to be acceptable from this source category with an ample margin of safety, and we identified no new cost-effective controls under the technology review to achieve further emissions reductions. Therefore, we are proposing no revisions to the numerical emission limits based on these analyses. However, the EPA is proposing amendments to correct and clarify rule requirements and provisions. While the proposed amendments would not result in reductions in emissions of hazardous air pollutants (HAP), this action, if finalized, would result in improved monitoring, compliance, and implementation of the rule.

In this action, the Environmental Protection Agency (EPA) is proposing amendments to previous proposals to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Wool Fiberglass Manufacturing source category. In the July 29, 2015, final rulemaking, the EPA deferred action on previously proposed formaldehyde, methanol and phenol emission limits from rotary spin (RS) lines at wool fiberglass manufacturing facilities. In this action, the EPA is proposing to readopt the existing emission limits for formaldehyde, to establish emission limits for methanol, and to establish a work practice standard for phenol emissions from bonded RS lines at wool fiberglass manufacturing facilities. In addition, the EPA is proposing amendments to the emission limits promulgated on July 29, 2015, for formaldehyde, methanol, and phenol from flame attenuation (FA) lines at wool fiberglass manufacturing facilities. The EPA is only taking comments on the specific proposed requirements and revisions set forth in this proposed rulemaking, which are based on information contained in this proposal. The EPA is not taking comment on any aspect of previous rulemakings, including the November 25, 2011, April 15, 2013, and November 13, 2014, proposals.

On October 8, 2014, the Environmental Protection Agency (EPA) finalized amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Manufacture of Amino/Phenolic Resins (APR). Subsequently, the EPA received three petitions for reconsideration of the final rule. The EPA is reconsidering and requesting public comment on issues related to the maximum achievable control technology (MACT) standards for continuous process vents (CPVs) at existing affected sources. The EPA is proposing to revise the MACT standard for back-end CPVs at existing affected sources based on hazardous air pollutant (HAP) emissions test data for back-end CPVs at existing sources for this source category submitted by petitioners. The EPA is also soliciting comments regarding the need to revise the standard for front-end CPVs at existing sources, and to extend the compliance date for the proposed revised emission limit for back-end CPVs at existing sources. Additionally, the EPA is proposing requirements for storage vessels at new and existing sources during periods when an emission control system used to control vents on fixed roof tanks is undergoing planned routine maintenance. The EPA is seeking comments only on the four issues specifically addressed in this notice: proposed revised back-end CPV MACT standards for existing sources, whether the EPA should modify the front-end CPV MACT standards for existing sources, whether the EPA should extend the compliance date for the proposed revised back-end CPV MACT standards for existing sources, and the proposed work practice standards for storage vessels during planned routine maintenance of emission control systems. In this rulemaking, the EPA is not reopening or requesting comment on any other aspects of the 2014 final amendments to the NESHAP for the Manufacture of APR, including other issues raised in petitions for reconsideration of the 2014 rule. The EPA estimates this proposal, if finalized as proposed, would reduce compliance costs to this industry by $2.1 million per year, compared to a revised cost estimate of the MACT standard as amended in 2014.

This action proposes amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Off-Site Waste and Recovery Operations (OSWRO). The proposed amendments address an issue related to monitoring pressure relief devices (PRDs) on containers. This issue was raised in a petition for reconsideration of the amendments to the OSWRO NESHAP finalized in 2015 based on the residual risk and technology review (RTR). Among other things, the 2015 amendments established additional monitoring requirements for all PRDs, including PRDs on containers. For PRDs on containers, these monitoring requirements were in addition to the inspection and monitoring requirements for containers and their closure devices, which include PRDs that were already required by the OSWRO NESHAP. This proposed action would remove the additional monitoring requirements for PRDs on containers that resulted from the 2015 amendments because we have determined that they are not necessary. This action, if finalized as proposed, would not substantially change the level of environmental protection provided under the OSWRO NESHAP. The proposed amendments would reduce capital costs related to compliance to this industry by $28 million compared to the current rule. Total annualized costs, at an interest rate of 7 percent, would be reduced by $4.2 million per year. These costs are associated with a present value of $39 million dollars, discounted at 7 percent over 15 years.

The Environmental Protection Agency (EPA) is amending the electronic reporting requirements for the National Emission Standards for Hazardous Air Pollutants: Coal- and Oil-Fired Electric Utility Steam Generating Units (also known as the Mercury and Air Toxics Standards (MATS)) to allow for the temporary submission, through June 30, 2018, of certain reports using the portable document file (PDF) format and to correct inadvertent errors. With this action owners or operators of Electric Utility Steam Generating Units (EGUs) will be able to continue to use temporarily a single electronic reporting system for MATS data submissions, to rely on correct language for mercury (Hg) relative accuracy test audit (RATA) requirements, and to rely on the correct acceptance criterion for ongoing quality assurance test requirements for Hg RATAs. This extension will allow the EPA the necessary time to develop, implement, and test the code necessary so that all MATS reports required to be submitted electronically can be submitted using the Emissions Collection and Monitoring Plan System (ECMPS) Client Tool.

On December 27, 2016, the Environmental Protection Agency (EPA) proposed a rule titled, “National Emission Standards for Hazardous Air Pollutants (NESHAP): Publicly Owned Treatment Works (POTW).” The EPA is extending the comment period on the proposed rule that was scheduled to close on February 27, 2017, by 30 days until March 29, 2017. The EPA is making this change based on one request for additional time to prepare comments on this proposed rule.

This action sets forth the Environmental Protection Agency's (EPA's) final decision on the issues for which it announced reconsideration on July 12, 2016, that pertain to certain aspects of the June 30, 2015, final amendments for the Ferroalloys Production source category regulated under national emission standards for hazardous air pollutants (NESHAP). The EPA is amending the rule to allow existing facilities with positive pressure baghouses to perform visible emissions monitoring twice daily as an alternative to installing and operating bag leak detection systems (BLDS) to ensure the baghouses are operating properly. In addition, this final action explains that EPA is maintaining the requirement that facilities must use a digital camera opacity technique (DCOT) method to demonstrate compliance with opacity limits. However, this final action revises the rule such that it references the recently updated version of the DCOT method. In this action, the EPA also explains that no changes are being made regarding the rule provision that requires quarterly polycyclic aromatic hydrocarbons (PAH) emission testing for furnaces producing ferromanganese (FeMn) with an opportunity for facilities to request decreased compliance test frequency from their permitting authority after the first year. Furthermore, in this action, the EPA is denying the request for reconsideration of the PAH emission limits for both FeMn and silicomanganese (SiMn) production furnaces.

On December 28, 2016, the Environmental Protection Agency (EPA) published a notice to announce its proposed amendments to the National Emission Standards for Hazardous Air Pollutants for the Manufacturing of Nutritional Yeast source category. The notice also requested public comment on the proposed amendments. The EPA is announcing that a public hearing will be held. In addition, the EPA is extending the public comment period.

The Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Chemical Recovery Combustion Sources at Kraft, Soda, Sulfite, and Stand-Alone Semichemical Pulp Mills to address the results of the residual risk and technology review (RTR) that the EPA is required to conduct under the Clean Air Act (CAA). These proposed amendments include revisions to the opacity monitoring provisions; addition of electrostatic precipitator (ESP) parameter monitoring provisions; a requirement for 5-year periodic emissions testing; revisions to provisions addressing periods of startup, shutdown, and malfunction (SSM); and technical and editorial changes. The EPA is proposing these amendments to improve the effectiveness of the rule.

The Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Manufacturing of Nutritional Yeast source category. The proposed amendments address the results of the residual risk and technology reviews (RTRs) conducted as required under the Clean Air Act (CAA) as well as other actions deemed appropriate during the review of these standards. The proposed amendments include revising the form of the fermenter volatile organic compounds (VOC) emission limits, changing the testing and monitoring requirements, and updating the reporting and recordkeeping requirements.

The Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Publicly Owned Treatment Works (POTW) to address the results of the residual risk and technology review (RTR) conducted under the Clean Air Act (CAA). As a result of our review, we are proposing to include pretreatment requirements to limit emissions from collection systems and the POTW treatment plant; requirements for existing, new, or reconstructed industrial (Group 1) POTW to comply with both the requirements in this rule and those in the applicable NESHAP for which they act as control; and hazardous air pollutants (HAP) emission limits for existing, non-industrial (Group 2) POTW. In addition, the EPA is proposing to revise the applicability criteria, revise the names and definitions of the industrial (Group 1) and non-industrial (Group 2) subcategories, revise regulatory provisions pertaining to emissions during periods of startup, shutdown, and malfunction, add requirements for electronic reporting, and make other miscellaneous edits and technical corrections.

This action proposes amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Phosphoric Acid Manufacturing and Phosphate Fertilizer Production source categories. The proposed amendments are in response to two petitions for reconsideration filed by industry stakeholders on the rule revisions to NESHAP for the Phosphoric Acid Manufacturing and Phosphate Fertilizer Production source categories that were promulgated on August 19, 2015 (80 FR 50386) (hereafter the “August 2015 Final Rule”). We are proposing to revise the compliance date by which affected sources must include emissions from oxidation reactors when determining compliance with the total fluoride (TF) emission limits for superphosphoric acid (SPA) process lines. We are also proposing to add a new option, and clarify an existing option, to the monitoring requirements for low-energy absorbers. In addition, we are proposing to revise the compliance date for the monitoring requirements for low-energy absorbers.

In this action, the Environmental Protection Agency (EPA) proposes editorial and technical revisions to the EPA's Method 301 “Field Validation of Pollutant Measurement Methods from Various Waste Media” in order to correct and update the method. In addition, the EPA is clarifying the applicability of Method 301 as well as its utility to other regulatory provisions. The proposed revisions include ruggedness testing for validation of test methods for application at multiple sources, determination of limit of detection for all method validations, incorporating procedures for determining the limit of detection, revising the sampling requirements for the comparison procedure, adding storage and sampling procedures for sorbent sampling systems, and clarifying acceptable statistical results for candidate test methods. We also propose to clarify the applicability of Method 301 to our regulations and to add equations to clarify calculation of the correction factor, standard deviation, estimated variance of a validated test method, standard deviation of differences, and t-statistic for all validation approaches. Changes made to the Method 301 field validation protocol under this proposed action would apply only to methods submitted to the EPA for approval after the effective date of this action.