Webinar: COVID-Era Regulation of Antimicrobials and Hand Sanitizers – EPA and FDA Respond to the Pandemic

Join us for an informative overview of COVID-era issues associated with antimicrobial claims and recent EPA rules concerning “long-lasting” claims for residual efficacy of antimicrobial. 

Presented by: Shumaker Partner Joe Simpson

July 20th / Noon to 1:00 p.m. EDT

Topics include:

  • U.S. EPA’s new protocol for residual efficacy claims for antimicrobials.
  • Enhanced enforcement by U.S. EPA and FDA concerning disinfectants and hand sanitizers.
  • Expedited review of products intended to combat COVID-19.

Register here for this complimentary webinar.

Shumaker Environmental Update, April 15, 2021

Interested Parties Review of Draft Hazardous Waste Management Rules: Ohio EPA has made a package of draft amended and no-change Hazardous Waste Management Program rules available for review by Interested Parties. The package is known as the “Review 2020” package because it is made up primarily of rules that are required under state statute to be reviewed every five years. The package contains 91 rules in Chapters 3745-50 to 3745-279 of the Administrative Code, and are amended to correct typos, make word choice changes, correct punctuation, and to ensure consistency with U.S. EPA’s Resource and Recovery Conservation Act (RCRA) Subtitle C Program. The Fact Sheet is available here. Additional information regarding the rules is available here. The comment deadline is April 21, 2021.

If you have any questions regarding the draft rules, or the Hazardous Waste Management program in general, contact Michael E. Born at 614.628.4415 or via email at mborn@shumaker.com.

Public Hearing Notice – Ohio Administrative Code (OAC) Chapter 3750, State Emergency Response Commission (SERC): Director of Environmental Protection, under the authority of Chapter 3750 of the Ohio Revised Code (ORC) and in accordance with Chapter 119 the SERC, is proposing multiple rules of the OCA Chapter 3750 to the Joint Committee on Agency Rule Review (JCARR) after a review to fulfill the requirements of ORC 106.03 (5-year review). The rules address the administration and implementation of ORC Chapter 3750, Emergency Planning regulations. Amendments are being made to OAC rules 3750-1-01, 3750-10-01, 3750-20-10, 3750-20-70, 3750-20-72, 3750-20-74, 3750-25-15, 3750-30-01, 3750-30-015, 3750-30-20, 3750-30-27, and 3750-50-01 to address typos, citation references, and to add recent federal rule language to be consistent with the federal Emergency Planning and Community Right-to-Know Act (EPCRA). The Public Notice is available here. A synopsis of the rule content is available here. Additional information is available here. Ohio EPA will be holding a virtual public hearing on the proposed new rules on April 23, 2021 at 10:30 AM. The meeting will be held exclusively online, and may be accessed through Ohio EPA’s website at: http://epa.ohio.gov/virtual.

If you have questions regarding Emergency Planning regulations or DAPC rules, contact Michael E. Born at 614.628.4415 or via email at mborn@shumaker.com or Michael A. Snyder at 614.628-4469 or via email at msnyder@shumaker.com.

Public Notice: Proposed ‘No Changes’ Rulemaking Governing Secondary Maximum Contaminant Rules:  Ohio EPA, Division of Drinking and Ground Waters (DDAGW), is proposing “no change” to rules 3745-82-01, 3745-82-03, and 3745-82-04 of the OAC. DDAGW has reviewed these rules to satisfy the five-year rule review requirements of section106.03 and 106.031 of the ORCOAC Chapter 3745-82 describes and establishes monitoring requirements and definitions for secondary maximum contaminant levels. DDAGW is proposing to file the following rule with no changes. Click on each rule number to review it.

Rule Number Rule Title
 3745-82-01  Definitions
 3745-82-03  Monitoring for Compliance with Secondary Maximum Contaminant Levels
 3745-82-04  Monitoring for Compliance with the Fluoride Secondary Maximum Contaminant Level

The Public Notice is available here. The Business Impact Analysis (BIA) Form is available here. The comment deadline is April 26, 2021.

If you have questions regarding groundwater monitoring requirements, contact Cheri Budzynski at 419.321.1332 or via email at cbudzynski@shumaker.com.

Early Stakeholder Outreach – OAC Chapter 3745-79 – Small Business Technical Assistance Rules Requesting Stakeholder Input:  Ohio EPA, Division of Air Pollution Control (DAPC), is seeking stakeholder input on the rules in OAC 3745-79. The rules in OAC Chapter 3745-79 establish the small business technical assistance program. The program created by these rules and ORC 3704.18 helps small businesses understand and comply with air pollution regulations. Ohio EPA is reviewing the rules as part of its general review to fulfill the requirements of ORC 106.03 and ORC 106.031 (5-year review). Ohio EPA is not aware, at this time, of any major changes necessary to these rules. The Early Stakeholder Fact Sheet is available here. The comment deadline is May 13, 2021.

If you have questions regarding the small business technical assistance program contact, Mark E. Mercer at 419.321.1436 or via email at mmercer@shumaker.com.

Draft Available for Comment – OAC Chapter 3745-18, “Sulfur Dioxide Regulations Rules”: Ohio EPA, DAPC, has completed a review of the rules in Chapter 3745-18, pursuant to Section 106.03 and 106.031 of the ORC (five-year review), and found changes to the rules to be necessary. The rules in this chapter set limits, testing, and recordkeeping requirements for emissions of sulfur dioxide from sources in the state of Ohio. The rules are a part of Ohio’s State Implementation Plan (SIP) for the attainment and maintenance of the National Ambient Air Quality Standards (NAAQS) as required by the Clean Air Act. The Public Notice is available here. A synopsis of the changes is available here, and the Business Impact Analysis is available here. The comment deadline is May 17, 2021.

If you have any questions regarding the sulfur dioxide regulations, contact Michael A. Snyder at 614.628.4469 or via email at msnyder@shumaker.com.

Proposal of Amended Rules – OAC Chapter 3745-26, Inspection and Maintenance Program Rules: Ohio EPA, DAPC has proposed amended rules in OAC Chapter 3745-26, I/M Program Rules. The rules in this chapter contain the requirements for Ohio’s motor vehicle inspection and maintenance (I/M) program, also known as E-Check. The program currently tests cars in seven counties in Northeast Ohio (Cuyahoga, Geauga, Lake, Lorain, Medina, Summit, and Portage). These rules fulfill a requirement in the Clean Air Act and are a part of Ohio’s SIP for the attainment and maintenance of the NAAQS for ozone in the Cleveland/Akron/Lorain Metropolitan area. The changes in this rule making are minor and being made after a review to fulfill the requirements of ORC 106.03 (5-year review). The Public Notice is available here. The synopsis of the rule content is available here. Ohio EPA will be holding a virtual public hearing on the new rules on May 18, 2021, at 10:30AM. The virtual hearing may be accessed at the following website: https://attendee.gotowebinar.com/register/8393245570090551310

If you have questions regarding the motor vehicle inspection and maintenance program contact, Mark E. Mercer at 419.321.1436 or via email at mmercer@shumaker.com.

Proposal of Amended Rules – OAC Chapter 3745-104, Accidental Releases Prevention Program Rules: Ohio EPA, DAPC)has proposed amended rules in OAC Chapter 3745-104, “Accidental Releases Prevention Program” Rules to the Joint Committee on Agency Rule Review (JCARR). The rules in this chapter establish Ohio’s Accidental Release Prevention Program. These rules were promulgated after Ohio received delegation of authority from U.S. EPA in December 1999 for the program. The rules require facilities to submit a Risk Management Plan (RMP), and implement a prevention program, and an emergency response plan or program. The Public Notice is available here. A synopsis of the rule content is available here. Ohio EPA will be holding a virtual public hearing on the new rules on May 18, 2021, at 2:30 PM. The virtual hearing may be accessed at the following website: https://attendee.gotowebinar.com/register/7487899999198592270

If you have any questions regarding the accidental release program, contact Michael A. Snyder at 614.628.4469 or via email at msnyder@shumaker.com.

Environmental Update, July 2020 (Issue 16)

OHIO EPA RULEMAKINGS
AND ANNOUNCEMENTS
 
Air 

Notice of Adoption of Rules – Amendments to Ohio’s “Nitrogen Oxides – Reasonably Available Control Technology” Rules: The Director of the Ohio Environmental Protection Agency (Ohio EPA) has adopted the following amended rules of the Ohio Administrative Code (OAC):

Rule #            Title
3745-110-01 | Definitions
3745-110-02 | Applicability
3745-110-03 | RACT Requirements and/or Limitations 
                         for Emissions of NOx from Stationary
                         Sources
3745-110-04 | Compliance Deadlines
3745-110-05 | Compliance Methods

The rules in OAC Chapter 3745-110 are intended to assist Ohio in attaining and maintaining the national ambient air quality standard (NAAQS) for ozone by limiting the emissions of Nitrogen Oxides (NOx) from stationary industrial sources such as, but not limited to, boilers, combustion turbines, and internal combustion engines. NOx emissions are a pollutant that leads to the formation of ozone.

The Director’s order of adoption was issued on Monday, June 8, 2020

These amended rules became effective on Thursday, June 18, 2020. Additional information regarding the adopted rule language is available here.

If you have any questions regarding the amendments to Ohio’s “Nitrogen Oxides – Reasonably Available Control Technology” rules, contact Mike Born at mborn@shumaker.com or 614.628.4415.

Continue reading “Environmental Update, July 2020 (Issue 16)”

Environmental Update, June 2020 (Issue 15)

LAWYER SPOTLIGHT     

Joe Simpson has extensive experience in environmental law, including litigation and regulatory counseling regarding environmental matters.

He has represented Fortune 500 clients concerning compliance in Comprehensive Environmental Response Compensation and Liability Act (CERCLA or Superfund), Resource Conservation and Recovery Act (RCRA), Clean Air Act, Clean Water Act, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Toxic Substances Control Act (TSCA), and other matters. Additionally, Joe has extensive experience in environmental indemnity litigation.

In recent years, Joe has served as counsel for a major petroleum company in litigation challenging the company’s Clean Air Act permits for a multibillion dollar refinery expansion project. He also served as part of a team that successfully defended a major petroleum company in multimillion dollar litigation related to environmental representations and warranties pertaining to the sale of a chemical plant.

OHIO EPA RULEMAKINGS AND ANNOUNCEMENTS

Air 

Public Comment Request – 2015 Ozone National Ambient Air Quality Standard Emissions Inventory & Emissions Statement Program – Butler, Clermont, Cuyahoga, Geauga, Hamilton, Lake, Lorain, Medina, Portage, Summit, and Warren Counties: The Director of Ohio EPA is requesting that the United States Environmental Protection Agency (U.S. EPA) revise the current State Implementation Plan to include the 2014 NOx and VOC emissions inventory as the base year inventory for the 2015 Ozone National Air Ambient Quality Standards (NAAQS). This submittal covers the requirements for both the emissions inventory requirements and the emission statement program under the 2015 ozone NAAQS. The emission statement program was already approved under previous NAAQS and remains unchanged. Ohio EPA has prepared an inventory for the Cincinnati and Cleveland 2015 Ozone NAAQS nonattainment area, including the point, nonpoint, non-road, and on-road sectors. The base year ozone emissions inventory is an inventory of the actual reported, estimated, or calculated annual and ozone season day NOx and VOC emissions for Ohio sources. The State of Ohio will request that U.S. EPA review and approve the 2014 emission inventory and Ohio’s emission statement program for the purpose of the 2015 ozone NAAQS. A draft emissions inventory and emission statement is available here.  

Comments can be submitted to Holly Kaloz at holly.kaloz@epa.ohio.gov. The comment deadline is Monday, June 22, 2020.  

If you have any questions regarding the 2015 Ozone National Ambient Air Quality Standard Emissions Inventory & Emissions Statement Program, contact Mike Born at mborn@shumaker.com or 614.628.4415.

Water – Drinking and Groundwater

Continue reading “Environmental Update, June 2020 (Issue 15)”