Overview
Title
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; NESHAP for Pharmaceuticals Production (Renewal)
Agencies
ELI5 AI
The EPA wants people to check if their rules for how medicine factories deal with bad air kinds need to change. They asked for people to share their thoughts about this for another 30 days.
Summary AI
The Environmental Protection Agency (EPA) is seeking public comments on the renewal of an information collection request (ICR) related to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Pharmaceuticals Production. This request has been submitted to the Office of Management and Budget (OMB) for review and is set to extend the ICR that is currently active until February 28, 2025. The EPA is collecting this data to ensure compliance with existing regulations for pharmaceuticals manufacturing that involves hazardous pollutants. The public has an additional 30 days to provide comments on this request.
Abstract
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Pharmaceuticals Production (EPA ICR Number 1781.10, OMB Control Number 2060-0358) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through February 28, 2025. Public comments were previously requested via the Federal Register on May 18, 2023 during a 60-day comment period. This notice allows for an additional 30 days for public comments.
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AnalysisAI
The document from the Federal Register serves as a notification by the Environmental Protection Agency (EPA) regarding an ongoing effort to renew an information collection request (ICR). This ICR pertains to the National Emission Standards for Hazardous Air Pollutants (NESHAP) specifically targeting pharmaceutical production facilities. These standards aim to regulate and ensure compliance in controlling hazardous air pollutants emitted by these manufacturing operations.
Summary of the Document
The primary focus of the document is to inform the public that the EPA is seeking additional feedback as part of the process to renew its ICR, which is scheduled to remain active until February 28, 2025. The agency extends an invitation to the public to submit their comments within 30 days, providing an opportunity for stakeholders to engage in the review process. The intent of collecting this data is to uphold compliance with NESHAP, which applies to major sources of hazardous air pollutants from pharmaceutical manufacturing operations.
Significant Issues and Concerns
One concern evident in the document is the consistency in the estimated burden of hours required from respondents, despite noticeable changes in operational and maintenance costs attributed to inflation adjustments. While operational costs have been recalibrated according to the CEPCI Equipment Cost Index to reflect 2022 dollars, the stagnant figure in respondent burden hours may necessitate further explanation to ensure transparency and understanding.
The document's use of technical language may present challenges for those without a background in regulatory or environmental policy. This complexity might hinder effective public engagement, crucial during the comment period.
Additionally, the abstract does not delve into specifics regarding the kind of information being collected or its role in confirming compliance, potentially limiting stakeholders' comprehension of the ICR's breadth and impact.
Impact on the Public
The notice has implications for the general public by providing a channel for them to voice their opinions or concerns regarding EPA's standards and their enforcement. Broadly, this transparency and opportunity for input allow citizens to participate in ensuring that environmental regulations meet public health and safety expectations.
Impact on Specific Stakeholders
For specific stakeholders, particularly pharmaceuticals manufacturing owners and operators, this document holds more direct consequences. Compliance with NESHAP ensures adherence to stringent environmental standards, possibly necessitating modifications in their current operational procedures. The estimated number of respondents, indicated to be 27, seems low, raising questions about its representativeness of the whole industry. Providing context or justification for this number might assure stakeholders that the standards reflect an accurate cross-section of the industry.
Moreover, while the document invites feedback, it lacks comprehensive guidelines about how this input will be factored into the decision-making process. This uncertainty may affect stakeholders' willingness to invest time and resources into providing substantial feedback.
Overall, while the document presents a procedural standard approach to regulatory compliance, addressing these ambiguities could enhance transparency and stakeholder engagement, ultimately strengthening environmental protection efforts.
Financial Assessment
The Federal Register document concerning the information collection activities by the Environmental Protection Agency (EPA) provides specific financial details related to the administration of the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Pharmaceuticals Production. Two key monetary aspects are highlighted within the document:
Financial Overview
The total estimated cost for administering and complying with this regulation is outlined to be $5,750,000 per year. This amount notably includes $174,000 allocated annually for capital or operation and maintenance (O&M) costs. These figures are indicative of the financial burden placed on the regulated entities, which are the owners and operators of pharmaceuticals manufacturing operations.
Adjustments and Cost Indices
The document discusses an increase in O&M costs attributable to an adjustment using the CEPCI Equipment Cost Index, which updates costs from 2007 dollars to 2022 dollars. This adjustment reflects inflation and changes in equipment costs over time, ensuring that the financial expectations remain aligned with current economic conditions.
Issues and Clarifications
One notable issue is the lack of change in the total estimated respondent burden hours, despite the adjustments in O&M costs due to inflation. This could lead to questions about how financial estimates align with operational burdens. It might need clarification to ensure stakeholders understand how these costs impact their responsibilities without an increase in their required effort or time commitment.
Additionally, the mention of the CEPCI Equipment Cost Index could benefit from an explanation or a reference. The inclusion of such context would aid stakeholders in comprehensively understanding why and how these adjustments are made, especially for those less familiar with financial indices and economic adjustments within the regulatory environment.
Implications for Stakeholders
The financial allocations referenced highlight the ongoing operational costs for compliance with the EPA's standards. For the relatively small number of respondents, totaling 27, these costs emphasize the potential financial heavy lifting required to meet regulatory expectations. Stakeholders might find it beneficial to understand this allocation, particularly how it aligns with the broader aim of maintaining air quality standards through regulated emissions.
In summary, while the document provides a concise overview of financial requirements, there remains an opportunity to refine clarity around how these costs are structured and justified in alignment with the operational burdens on stakeholders. Providing detailed insights into the exact nature and impact of these financial allocations could enhance understanding and effective engagement from the public during the comment period.
Issues
• The document indicates that there is no change in the total estimated respondent burden hours despite the adjustments in O&M costs due to inflation. This might need clarification to ensure transparency and understanding.
• The document refers to capital or operation & maintenance costs adjusted from 2007 dollars to 2022 dollars using the CEPCI Equipment Cost Index. It might be beneficial to provide a brief explanation or reference for CEPCI Equipment Cost Index for clarity.
• The language used throughout the document is technical and may not be easily understandable by all stakeholders without a background in regulatory or environmental policy, which could limit effective public participation in the comment period.
• The abstract, while summarizing the document, does not offer specific details about the type of information being collected or how it assures compliance, which might be crucial for stakeholders to fully understand the scope and implications of the ICR.
• The identified 'Estimated number of respondents' is 27, which is relatively low. It might be useful to provide context or justification for this number to ensure it is reflective of the industry size or representative sample.
• The document mentions a public comment period but lacks detailed guidelines on how public feedback will impact the ICR submission or decision-making process.