Summer 2024 GAWDA Committee Corner

The GAWDA Government Affairs Committee met in-person during the GAWDA Spring Management Conference in San Antonio and will meet in-person again during the Annual Convention in Phoenix. The Government Affairs Committee continues to work on its primary priorities:

The Food and Drug Administration issued a long-awaited final rule on medical gases on June 18, 2024. The new requirements go into effect on December 18, 2025, except for annual reports. The final rule includes regulatory changes for product labeling, Current Good Manufacturing Practices, product certification, and post-marketing safety reporting. The rule is mostly favorable for industry. Some remaining areas of concern include:

Requirements for a supervisor on fill logs;

• Pictograms on cylinders;
• Annual reports;
• New Drug Application number on COAs; and
• Label specimens on fill logs.

CGA’s Medical Gas Committee will provide additional advice on how to handle these issues. It is unlikely that a petition for reconsideration to the FDA will be necessary. Through Tom Badstubner, GAWDA has already provided general compliance information to members on the new final rule and will provide additional and more specific information for members in the coming months.

The Florida Department of Business and Professional Regulation has a number of unclear requirements for distributors of medical gases and their customers including registration and documentation of transactions. The fines for noncompliance in Florida are substantially higher than in all other states. Tom Badstubner and a working group of GAWDA members held a videoconference meeting with the DBPR Commissioner Walter Copeland to clarify what is actually required under the regulations and how to comply. The group submitted a follow up letter to the DBPR Commissioner to set out the issues and points that were agreed upon during the meeting. Mr. Copeland subsequently left the Department, and the task force is now following up with Michael Metz, one of the DBRP medical gas inspectors. But it appears that the Florida inspections are now more reasonable, and the issues might have been dealt with internally.

There is a dire shortage of Standard Reference Materials (SRMs) currently provided by the National Institute of Standards and Technology (NIST). Suppliers of gas standards use these SRMs to comply with the Clean Air Act and other air quality regulations. Due to inadequate staffing levels, the Gas Metrology Group at the NIST cannot keep up with the demand for these reference materials. In fact, 79% of the required gas standards are currently out of stock, and the only other sources to acquire reference materials are overseas. GAWDA members have drafted letters requesting congressional assistance and are coordinating a campaign to educate members of Congress on the need for these SRM calibration gases to support compliance with their EPA air discharge permits.

 The Pipeline and Hazardous Materials Safety Administration of DOT has indicated it would consider applications for special permits to use electronic shipping papers instead of paper documents to accompany hazmat shipments by highway transportation. A number of GAWDA members are interested in participating as parties to such a special permit once it is granted by the agency. A member company has been identified to serve as the initial applicant. A task force meeting has been scheduled to develop an application and discuss the scope of the request.

The Federal Trade Commission adopted a final rule to ban new non-compete agreements for all workers as of September 4, 2024. The rule will also ban enforcement of existing non-compete agreements in effect on September 4 for all workers except senior executives. The rule has been challenged in two lawsuits in federal court in Texas.

The FTC also issued an advanced notice of proposed rulemaking in November 2022 to address certain deceptive or unfair acts or practices relating to fees that are attached to the purchase of goods or services. On October 11, 2023, the Commission announced that it was publishing a notice of proposed rulemaking to promulgate a rule on unfair or deceptive fees, which would prohibit misrepresenting the total costs of goods and services by omitting mandatory fees from advertised prices and misrepresenting the nature and purpose of fees. The ANPRM noted the FTC was concerned about “junk fees” (no added value) and “hidden fees” (not disclosed to the consumer).

The Department of Labor has issued a final rule to revise Fair Labor Standards Act exemptions from minimum wage and overtime pay requirements for executive, administrative, professional, outside sales, and computer employees. The final rule will raise the standard salary level exemption to $844 per week (equivalent to $43,888 per year). As of January 1, 2025, the exemption threshold will be raised to $1,128 per week (equivalent to $58,656 per year). The Department also added an automatic updating mechanism to adjust these earnings thresholds every three years beginning in July 2027. 

The Department of Transportation’s latest List of Significant Rulemakings indicates the following expected target dates for rulemakings:

• Speed Limiting Devices. The Federal Motor Carrier Safety Administration plans to issue a Supplemental Notice of Proposed Rulemaking in mid-2024. This will replace a 2016 proposed rule issued by FMCSA and the National Highway Traffic Safety Administration. The new SNPRM will consider whether motor carriers operating commercial motor vehicles in interstate commerce with a gross vehicle weight rating or gross vehicle weight of 26,001 pounds or more, whichever is greater, that are equipped with an electronic engine control unit capable of governing the maximum speed be required to limit the CMV to a speed to be determined by the rulemaking and to maintain that setting for the service life of the vehicle.
• Motor Carrier Safety Fitness Procedures. In an August 2023 Advance Notice of Proposed Rulemaking, FMCSA sought information on how it might use data and resources more effectively to identify unfit motor carriers and to remove them from operating CMVs. FMCSA asked for information about the use of available safety data, including inspection data, in determining carrier fitness to operate; possible changes to the current three-tier safety fitness rating structure; and the list of Federal Motor Carrier Safety Regulations that it uses in its safety fitness rating methodology. The agency is now planning to issue a Notice of Proposed Rulemaking in June 2025 and has scheduled three listening sessions to get public input.
• Automatic Emergency Braking Systems. FMCSA and NHTSA plan to issue a Final Rule to require and/or standardize equipment performance for automatic emergency braking (AEB) systems on heavy trucks. The rulemaking will establish performance standards and motor carrier maintenance requirements for AEB systems on heavy trucks and accompanying test procedures for measuring the performance of the AEB systems in NHTSA compliance testing. NHTSA and FMCSA have engaged in a national outreach, educational, and awareness campaign, and data collection analysis which included training materials for fleets, drivers, and maintenance personnel related to AEB technology.
• Hazardous Materials Modal Safety Advancements. The Pipeline and Hazardous Materials Safety Administration plans to issue a Notice of Proposed Rulemaking in May 2024 to adopt a number of modal specific amendments intended to enhance the safe transportation of hazardous materials. PHMSA has consulted with FMCSA, the Federal Railroad Administration, and the United States Coast Guard to propose amendments identified during departmental review and from industry petitions for rulemaking.