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

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.

The Environmental Protection Agency (EPA) is finalizing revisions to better define the requirements associated with conducting Method 303 training courses. Method 303 is an air pollution test method used to determine the presence of visible emissions (VE) from coke ovens. This action adds language that clarifies the criteria used by the EPA to determine the competency of Method 303 training providers, but does not change the requirements for conducting the test method. These revisions will help entities interested in conducting the required training courses by clearly defining the requirements necessary to do so.

On October 18, 2016, the Environmental Protection Agency (EPA) published a document to announce its reconsideration of and request for public comment on five issues in the final National Emission Standards for Hazardous Air Pollutant Emissions: Petroleum Refinery Sector that was published on December 1, 2015. Petitioners claim that the public was not afforded an adequate opportunity to comment on these five issues. Additionally, the EPA proposed amendments to the final rule to clarify a compliance issue raised by stakeholders subject to the final rule and to correct a referencing error. The EPA is announcing that a public hearing will be held and extending the public comment period.

On September 29, 2016, the Environmental Protection Agency (EPA) proposed a rule titled, “Mercury and Air Toxics Standards (MATS) Completion of Electronic Reporting Requirements.” The EPA is extending the comment period on the proposed rule that was scheduled to close on October 31, 2016, by 15 days until November 15, 2016. The EPA is making this change based on three requests for additional time to prepare comments on this proposed rule.

On December 1, 2015, the Environmental Protection Agency (EPA) finalized amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) Refinery Maximum Achievable Control Technology (MACT) 1 and Refinery MACT 2 regulations and the New Source Performance Standards (NSPS) for petroleum refineries. Subsequently, the EPA received three petitions for reconsideration of the final rules. The EPA is announcing reconsideration and request for public comment on five issues raised in the petitions for reconsideration where petitioners claim that the public was not afforded an opportunity to comment. Additionally, the EPA is proposing amendments to the final rule to clarify a compliance issue raised by stakeholders subject to the final rule and to correct a referencing error. The EPA is seeking comment only on the five identified petition issues and on the proposed compliance issue clarification and referencing error amendments. The EPA will not respond to comments addressing any other issues or any other provisions of the final rule.

The Environmental Protection Agency (EPA) is proposing to amend 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)). This proposed rule would revise and streamline the electronic data reporting requirements of MATS (both for owners or operators of electric utility steam generating units (EGUs) who use performance stack testing and EGU owners or operators who use continuous monitoring to demonstrate compliance) and would increase data transparency. EGU owners or operators would use one familiar electronic reporting system, instead of two separate systems, reducing their burden. In addition, the public and regulatory authorities would have enhanced access to MATS data. Finally, no new continuous monitoring requirements are proposed by this action. Overall, this proposed rule would serve to ease burden, increase MATS data flow and usage, make it easier for inspectors and auditors to assess compliance, and encourage wider use of continuous emissions monitoring systems (CEMS) for MATS compliance.

This action sets forth the Environmental Protection Agency's (EPA's) final decision on the issues for which it announced reconsideration on January 21, 2015, that pertain to certain aspects of the February 1, 2013, final amendments to the “National Emission Standards for Hazardous Air Pollutants for Area Sources: Industrial, Commercial, and Institutional Boilers” (Area Source Boilers Rule). The EPA is retaining the subcategory and separate requirements for limited-use boilers, consistent with the February 2013 final rule. In addition, the EPA is amending three reconsidered provisions regarding: The alternative particulate matter (PM) standard for new oil-fired boilers; performance testing for PM for certain boilers based on their initial compliance test; and fuel sampling for mercury (Hg) for certain coal-fired boilers based on their initial compliance demonstration, consistent with the alternative provisions for which comment was solicited in the January 2015 proposal. The EPA is making minor changes to the proposed definitions of startup and shutdown based on comments received. This final action also addresses a limited number of technical corrections and clarifications on the rule, including removal of the affirmative defense for malfunction in light of a court decision on the issue. These corrections will clarify and improve the implementation of the February 2013 final Area Source Boilers Rule. In this action, the EPA is also denying the requests for reconsideration with respect to the issues raised in the petitions for reconsideration of the final Area Source Boilers Rule for which reconsideration was not granted.

This action promulgates technical and editorial corrections and revisions to regulations related to source testing of emissions. We have made corrections and updates to testing provisions, and added newly approved alternatives to existing testing regulations. These revisions will improve the quality of data and provide flexibility in the use of approved alternative procedures. The revisions do not impose any new substantive requirements on source owners or operators.

This action amends the National Emissions Standards for Hazardous Air Pollutants (NESHAP) for Petroleum Refineries in three respects. First, this action adjusts the compliance date for regulatory requirements that apply at maintenance vents during periods of startup, shutdown, maintenance or inspection for sources constructed or reconstructed on or before June 30, 2014. Second, this action amends the compliance dates for the regulatory requirements that apply during startup, shutdown, or hot standby for fluid catalytic cracking units (FCCU) and startup and shutdown for sulfur recovery units (SRU) constructed or reconstructed on or before June 30, 2014. Finally, this action finalizes technical corrections and clarifications to the NESHAP and the New Source Performance Standards (NSPS) for Petroleum Refineries. These amendments are being finalized in response to new information submitted after these regulatory requirements were promulgated as part of the residual risk and technology review (RTR) rulemaking, which was published on December 1, 2015. This action will have an insignificant effect on emissions reductions and costs.

On June 30, 2015, the Environmental Protection Agency (EPA) published the residual risk and technology review (RTR) final rule, establishing national emission standards for hazardous air pollutants (NESHAP) for the Ferroalloys Production source category. Subsequently, the EPA received two petitions for reconsideration of certain aspects of the final rule. The EPA is announcing reconsideration of and requesting public comment on three issues raised in the petitions for reconsideration, as detailed in the SUPPLEMENTARY INFORMATION section of this action. The three issues the EPA is reconsidering and seeking public comment on are the following: the polycyclic aromatic hydrocarbons (PAH) compliance testing frequency for furnaces that produce ferromanganese (FeMn); the use of the digital camera opacity technique (DCOT) for determining compliance with the shop building opacity standards; and the use of bag leak detection systems (BLDS) on positive pressure baghouses. The EPA is seeking comment only on these three issues and will not respond to comments addressing other issues or other provisions of the final rule. The EPA is not proposing any changes to the NESHAP in this document.

On May 13, 2016, the Environmental Protection Agency (EPA) proposed a rule titled, “National Emission Standards for Hazardous Air Pollutants (NESHAP): Site Remediation.” The EPA is extending the comment period on the proposed rule that was scheduled to close on June 27, 2016, by thirty days. The EPA has received letters from trade organizations and calls from business organizations requesting additional time to review and comment on the proposed rule revisions.

The Environmental Protection Agency (EPA) is providing notice that it has responded to a petition for reconsideration of a final rule published in the Federal Register on March 18, 2015. The rule promulgated amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP): Off-Site Waste and Recovery Operations (OSWRO) based on our residual risk and technology review (RTR) conducted for the OSWRO source category. The agency previously granted reconsideration of one issue raised in the petition. The Administrator denied the second issue raised in the petition in letters to the petitioners dated May 5, 2016.

This action proposes to amend the National Emission Standards for Hazardous Air Pollutants (NESHAP): Site Remediation (Site Remediation Rule) by removing exemptions from the rule for site remediation activities performed under authority of the Comprehensive Environmental Response and Compensation Liability Act (CERCLA) and for site remediation activities performed under a Resource Conservation and Recovery Act (RCRA) corrective action or other required RCRA order. The Environmental Protection Agency (EPA) is also proposing to remove the applicability requirement that site remediations be co-located with at least one other stationary source regulated by another NESHAP. The EPA is seeking comment on these issues, but is not requesting comment on any other issues or provisions of the final Site Remediation Rule at this time.

This action responds to the U.S. Supreme Court decision in Michigan v. EPA, 135 S. Ct. 2699 (2015), and explains how the Environmental Protection Agency (EPA) has taken cost into account in evaluating whether it is appropriate and necessary to regulate coal- and oil-fired electric utility steam generating units (EGUs) under section 112 of the Clean Air Act (CAA). The EPA requested comment on all aspects of its approach to considering cost through a proposed supplemental finding and on a companion Legal Memorandum available in the rulemaking docket. After consideration of public comments, the EPA, in this final supplemental finding, concludes that a consideration of cost does not cause us to change our determination that regulation of hazardous air pollutant (HAP) emissions from coal- and oil-fired EGUs is appropriate and necessary and that EGUs are, therefore, properly included on the CAA section 112(c) list of sources that must be regulated under CAA section 112(d).

Because the Environmental Protection Agency (EPA) received adverse comment, we are withdrawing the direct final rule for Clarification of Requirements for Method 303 Certification Training, published on February 25, 2016.

This action finalizes the technical corrections that the Environmental Protection Agency (EPA) proposed on February 17, 2015, to correct and clarify certain text of the EPA's regulations regarding “National Emission Standards for Hazardous Air Pollutants from Coal- and Oil-fired Electric Utility Steam Generating Units and Standards of Performance for Fossil-Fuel-Fired Electric Utility, Industrial-Commercial-Institutional, and Small Industrial-Commercial-Institutional Steam Generating Units”. We are also taking final action to remove the rule provision establishing an affirmative defense for malfunction.

This action proposes amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) Refinery MACT 1 and Refinery MACT 2 regulations and the New Source Performance Standards (NSPS) for petroleum refineries, which were published on December 1, 2015. In that action, as a result of a risk and technology review, the Environmental Protection Agency (EPA) finalized amendments to Refinery MACT 1 and Refinery MACT 2. In this action, the EPA is proposing to amend the compliance date in Refinery MACT 1 for maintenance vent standards that apply during periods of startup, shutdown, maintenance or inspection for sources constructed or reconstructed on or before June 30, 2014. In this action, the EPA is also proposing to revise the compliance dates in Refinery MACT 2 for the standards that apply during startup, shutdown, or hot standby for fluid catalytic cracking units (FCCU) and startup and shutdown for sulfur recovery units (SRU) constructed or reconstructed on or before June 30, 2014. These proposed revisions do not affect requirements that apply during normal operations. Finally, the EPA is proposing technical corrections and clarifications to the NESHAP and the NSPS for petroleum refineries. This action will have an insignificant effect on emissions reductions and costs.

On November 27, 2015, the Environmental Protection Agency (EPA) requested information related to hazardous air pollutant emissions from sources in the oil and natural gas production and natural gas transmission and storage segments of the oil and natural gas sector. The deadline to respond to our request was January 26, 2016. In response to requests from several stakeholders, the EPA is extending the period to respond to our request for information to March 11, 2016.

This action finalizes the residual risk and technology review (RTR) and the rule review the Environmental Protection Agency (EPA) conducted for Aerospace Manufacturing and Rework Facilities under the national emissions standards for hazardous air pollutants (NESHAP). In this action, we are finalizing several amendments to the NESHAP based on the review of these standards. These final amendments add limitations to reduce organic and inorganic emissions of hazardous air pollutants (HAP) from specialty coating application operations; remove exemptions for periods of startup, shutdown and malfunction (SSM) so that affected units will be subject to the emission standards at all times; and revise provisions to address recordkeeping and reporting requirements applicable to periods of SSM. These final amendments include a requirement to report performance testing through the EPA's Compliance and Emissions Data Reporting Interface (CEDRI). This action also makes clarifications to the applicability, definitions, and compliance demonstration provisions, and other technical corrections. The EPA estimates that implementation of this rule will reduce annual HAP emissions by 58 tons.

The Environmental Protection Agency (EPA) published a final rule in the Federal Register on October 26, 2015, titled NESHAP for Brick and Structural Clay Products Manufacturing; and NESHAP for Clay Ceramics Manufacturing. These amendments make two technical corrections to the published regulation.

This action requests information related to hazardous air pollutant (HAP) emissions from sources in the oil and natural gas production and natural gas transmission and storage segments of the oil and natural gas sector. In 2012, the Environmental Protection Agency (EPA) revised the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Oil and Natural Gas Production Facilities and the Natural Gas Transmission and Storage Facilities major source categories. This action requests additional data and information that was not available at that time. In particular, we are requesting data on storage vessels without potential flash emissions (PFE) and data on HAP emissions from regulated small glycol dehydrators. With regard to the small glycol dehydrators we are particularly interested in data regarding any emissions of HAP other than benzene, toluene, ethylbenzene, and xylene (BTEX), information on available control options for any such HAP and information regarding a potential compliance demonstration issue with respect to the 2012 standards for small glycol dehydration units, as they apply to units with very low emissions.

This action sets forth the Environmental Protection Agency's (EPA's) final decision on the issues for which it granted reconsideration on January 21, 2015, that pertain to certain aspects of the January 31, 2013, final amendments to the “National Emission Standards for Hazardous Air Pollutants for Major Sources: Industrial, Commercial, and Institutional Boilers and Process Heaters” (Boiler MACT). The EPA is retaining a minimum carbon monoxide (CO) limit of 130 parts per million (ppm) and the particulate matter (PM) continuous parameter monitoring system (CPMS) requirements, consistent with the January 2013 final rule. The EPA is making minor changes to the proposed definitions of startup and shutdown and work practices during these periods, based on public comments received. Among other things, this final action addresses a number of technical corrections and clarifications of the rule. These corrections will clarify and improve the implementation of the January 2013 final Boiler MACT, but do not have any effect on the environmental, energy, or economic impacts associated with the proposed action. This action also includes our final decision to deny the requests for reconsideration with respect to all issues raised in the petitions for reconsideration of the final Boiler MACT for which we did not grant reconsideration.

The Environmental Protection Agency (EPA) is finalizing national emission standards for hazardous air pollutants (NESHAP) for Brick and Structural Clay Products (BSCP) Manufacturing and NESHAP for Clay Ceramics Manufacturing. All major sources in these categories must meet maximum achievable control technology (MACT) standards for mercury (Hg), non-mercury (non-Hg) metal hazardous air pollutants (HAP) (or particulate matter (PM) surrogate) and dioxins/furans (Clay Ceramics only); health-based standards for acid gas HAP; and work practice standards, where applicable. The final rule, which has been informed by input from industry (including small businesses), environmental groups, and other stakeholders, protects air quality and promotes public health by reducing emissions of HAP listed in section 112 of the Clean Air Act (CAA).

This action finalizes the residual risk and technology review (RTR) conducted for the Primary Aluminum Production source category regulated under national emission standards for hazardous air pollutants (NESHAP). In addition, we are taking final action regarding new and revised emission standards for various hazardous air pollutants (HAP) emitted by this source category based on the RTR, newly obtained emissions test data, and comments we received in response to the 2011 proposal and 2014 supplemental proposal. These final amendments include technology-based standards and work practice standards reflecting performance of maximum achievable control technology (MACT), and related monitoring, reporting, and testing requirements, for several previously unregulated HAP from various emissions sources. Furthermore, based on our risk review, we are finalizing new and revised emission standards for certain HAP emissions from potlines using the Soderberg technology to address risk. We are also adding a requirement for electronic reporting of compliance data, eliminating the exemptions for periods of startup, shutdown, and malfunctions (SSM), and not adopting the affirmative defense provisions proposed in 2011, consistent with a recent court decision vacating the affirmative defense provisions. This action will provide improved environmental protection regarding potential emissions of HAP emissions from primary aluminum reduction facilities.

The Environmental Protection Agency (EPA) is extending the comment period for the proposed rule titled, “Revisions to Test Methods, Performance Specifications, and Testing Regulations for Air Emission Sources,” that was published in the Federal Register on September 8, 2015. The 60-day comment period in the proposed rule is scheduled to end on November 9, 2015. The extended comment period will close on December 9, 2015. The EPA recently added a technical justification to the docket for the revision in the proposed rule regarding Subpart JJJJ of Part 60 (Standards of Performance for Stationary Spark Ignition Internal Combustion Engines). We also added background information to support our reasoning for soliciting comment about Method 7E stratification. Therefore, the EPA is extending the comment period to allow the public additional time to submit comments and supporting information on these and other aspects of the proposed rule.

The Environmental Protection Agency (EPA) is announcing a public hearing for the proposed rule titled, “Revisions to Test Methods, Performance Specifications, and Testing Regulations for Air Emission Sources,” that was published in the Federal Register on September 8, 2015. The hearing will be held in Research Triangle Park, North Carolina. The EPA is proposing technical and editorial corrections and revisions to regulations related to source testing of emissions. The EPA is proposing to make corrections and updates to testing provisions that contain inaccuracies and outdated procedures, and to provide alternatives to existing testing regulations. The revisions will improve the quality of data and provide testers flexibility to use recently-approved alternative procedures. Many of the changes were suggested by testers and other end-users and will not impose new substantive requirements on source owners or operators.

This action finalizes the residual risk and technology review (RTR), and the rule review, we conducted for the Secondary Aluminum Production source category regulated under national emission standards for hazardous air pollutants (NESHAP). In this action, we are finalizing several amendments to the NESHAP based on the rule review. These final amendments include a requirement to report performance testing through the Electronic Reporting Tool (ERT); provisions allowing owners and operators to change furnace classifications; requirements to account for unmeasured emissions during compliance testing for group 1 furnaces that do not have add-on control devices; alternative compliance options for the operating and monitoring requirements for sweat furnaces; compliance provisions for hydrogen fluoride; provisions addressing emissions during periods of startup, shutdown, and malfunction (SSM); and other corrections and clarifications to the applicability, definitions, operating, monitoring and performance testing requirements. These amendments will improve the monitoring, compliance and implementation of the rule.