CGA’s August & September 2021 Safety Publications (New Releases & Revisions)

October 12, 2021

During August and September 2021, the Compressed Gas Association (CGA) issued the following new and revised safety standards, guidelines, position statements, and technical reports:

CGA C-26, Guideline for the Post Manufacture Tare Weight Marking of Cylinders

Released: August 24, 2021 (2nd Edition)

This publication defines terminology, requirements, and procedures for the post manufacture marking of tare weights on cylinders of 1000 lb (454 kg) or less water capacity to be filled with liquefied compressed gas and other gases where the cylinder could require a tare weight. This publication does not apply to cylinders used in acetylene service.

The information contained in this publication enhances the safety of packaging offered for transportation. These recommendations in no way supersede any existing state or local regulations or regulations of any other jurisdictions.

CGA E-4, Standard for Gas Pressure Regulators

Released: September 30, 2021 (8th Edition)

This publication specifies requirements for regulators used with compressed gases to reduce the supply pressure from a storage cylinder, pipeline, or other source to the use pressure.

This publication contains design and manufacturing requirements relating to materials, construction, performance, test procedures, information, marking, and packaging of pressure regulators. Appendix A provides information relating to regulator flow capacity calculations.

CGA G-6.10, Flammable Gases and/or Oxygen Contamination in Carbon Dioxide Feed Gas

Released: August 24, 2021 (2nd Edition)

This publication alerts carbon dioxide producers and plant operators to potential risks related to changing carbon dioxide feed gas composition. It also discusses the dangers related to excess oxygen or hydrocarbon levels in catalytic oxidation and sulfur and hydrocarbon removal systems used to purify carbon dioxide.

In addition, potential fire hazards that can be encountered when spent adsorbent media is exposed to air during periodic replacement are reviewed in CGA G-6.10. Finally, this publication provides recommendations to prevent fire and explosions related to these causes in by-product carbon dioxide plants.

CGA M-27, Guideline for Complying with Data Integrity Regulatory Expectations

Released: August 24, 2021 (1st Edition)

Both the U.S. Food and Drug Administration (FDA) and Health Canada (HC) have developed guidance documents for their respective current expectations for data integrity to comply with respective Current Good Manufacturing Practices (CGMP) requirements. In the United States, see Data Integrity and Compliance with CGMP Guidance for Industry and in Canada, see Health Canada Guidance Document GUI-0001, Good manufacturing practices guide for drug products.

This publication provides guidance and acceptable practices for the medical gas industry to comply with data integrity. It identifies the acquisition and retention of data obtained to assure it is complete, consistent, accurate, attributable, contemporaneously recorded, and auditable regardless of the form in which it is obtained and maintained.

CGA P-50, Standard for Site Security

Released: August 4, 2021 (4th Edition)

This publication provides instruction to the industrial gas industry for assessing security risks and identifying and implementing preventive security measures at fixed sites. It is intended as a resource to help managers at individual facilities make security decisions based on risk.

CGA P-50 does not attempt to provide an all-inclusive list of security considerations for industrial gas companies nor does it address transportation security and security at customer sites.

CGA P-51, Standard for Transportation Security in the Compressed Gas Industry

Released: August 4, 2021 (4th Edition)

Security measures improve the safe transportation of hazardous materials by reducing the risks from a wide range of threats. Concerns about terrorism, sabotage, theft, or intentional product contamination give companies that transport hazardous materials a compelling reason to implement security measures for transportation of their products. Security measures, like safety measures, protect the general public and the environment, as well as the compressed gas industry and its employees.

This publication is intended for management personnel, transportation specialists, and all other personnel that are responsible for the safe and secure transportation of raw materials and products by highway, rail, air, and pipeline. It contains tools and resources that are useful when assessing security issues related to the transportation of hazardous materials. CGA P-51 provides guidance for compliance with Title 49 of the U.S. Code of Federal Regulations (49 CFR) Part 172.800 (HM-232), Security Requirements for Offerors and Transporters of Hazardous Materials, and 49 CFR Part 385 Subpart E, Hazardous Materials Safety Permits.

The implementation of the information in this publication will vary according to the compressed gas being transported and the mode and route of transportation. Companies should coordinate and communicate their security procedures with employees, carriers, customers, and all others involved in the safe and secure transportation of hazardous products.

CGA P-52, Security Guidelines for Qualifying Customers Purchasing Compressed Gases

Released: August 4, 2021 (4th Edition)

Federal, state, and local government agencies are concerned about the illegal use of hazardous chemicals, including compressed gases. Compressed gas products can be directly or indirectly misused for illicit activity such as:

  • explosive agents
  • illegal inhalation
  • precursors for illegal drug production
  • weapon (direct use or as an improvised explosive device [IED] and/or vehicle borne improvised explosive device)
  • suicide

This publication provides guidelines for qualifying customers purchasing compressed gas products considered at risk for illegal use.

CGA P-60, Guideline for the Use of the North American Industrial Classification System and the Standard Industrial Classification Indices

Released: August 24, 2021 (3rd Edition)

This publication provides guidance for the proper application of NAICS and SIC codes associated with various North American operations and aspects of industrial gas and related businesses. It also includes a summary of applicable codes that should be applied across the industrial gas industry.

CGA P-90, Guideline on Due Diligence Considerations for the Compressed Gas Industry

Released: September 24, 2021 (1st Edition)

This publication was developed to impart a high-level understanding of environmental due diligence including what it is, why it is important, and when it should be conducted.

Although this publication focuses on United States and Canadian regulations, the general concepts, approaches, and information contained within can also be used, as applicable, with other international regulations or in jurisdictions where specific regulations may not exist.

CGA PS-66, CGA Position Statement on Medical Gases and the Potential to Contain Nitrosamine

Released: September 24, 2021 (1st Edition)

The discovery of nitrosamine impurity in one type of drug product in 2018, led the United States Food and Drug Administration (FDA), Health Canada, and other international regulators to begin to investigate the presence of this contaminant in other drugs. With additional drug products being identified leading to recalls in 2019, the FDA and Health Canada required firms to establish plans to conduct risk analysis of their manufactured drug products and the active pharmaceutical ingredients they used for the presence of nitrosamines. If nitrosamines were found to be present, firms were required to ensure that levels did not exceed recommended acceptable intake limits.

Medical gases are classified as drugs in both the United States and Canada, therefore CGA evaluated the production inputs and outputs of common medical gases. CGA members have also received inquiries regarding nitrosamine contamination of gases used by pharmaceutical firms in the manufacture of their products.

This position statement and the associated technical report reflect the results of the evaluation CGA performed and is consistent with CGA’s March 26, 2020 letter to Health Canada in response to DEL Bulletin No 57 regarding nitrosamines.

CGA TR-5, Technical Report on Nitrosamine Impurities in Nitrous Oxide and other Medical Gases

Released: September 24, 2021 (1st Edition)

This publication evaluates the possible synthesis of nitrosamines from the thermal decomposition of ammonium nitrate, in the manufacture of nitrous oxide.