EPA to require reporting of mercury use

The National Association of Manufacturers is asking the EPA to leave mercury-containing tools and equipment used in manufacturing processes from the agency's new inventory reporting requirements.

The fabricated structural metal manufacturing sector (NAICS 332312) and miscellaneous fabricated metal product manufacturing segment (NAICS No. 332999) are on the Environmental Protection Agency’s list of industries that may be affected by the agency’s upcoming rule calling for companies to report the use of mercury in manufacturing processes.

The agency, which also is requiring the participation of manufacturers of air-conditioning and heating equipment, office machinery, and pumps, wants to create an inventory of mercury supply, use, and trade in the U.S. This new regulatory effort is required under the Frank R. Lautenberg Chemical Safety for the 21st Century Act enacted on June 22, 2016. It contains a number of required tasks the EPA has to perform under the Toxic Substances Control Act (TSCA). The deadline for finalization of new reporting requirements is to take place no later than June 22, 2018.

One of the definitional issues in the proposed rule is the definition of “otherwise intentional use of mercury in a manufacturing process.” The National Association of Manufacturers (NAM) wants the EPA to clarify that the “manufacturing process” is limited to the actual chemistry performed during the process in which the mercury is used.

“Moreover, the final rule should explicitly state that mercury-contained tools and equipment used in a manufacturing process are excluded from the inventory reporting requirements,” said Ross Eisenberg, NAM’s vice president of energy and resources policy. “For example, tools such as a mercury-contained manometer used to determine the vacuum level in a manufacturing process should not be included in a mercury inventory. In addition, EPA must specifically state what would not be covered under this regulation.”

Machining Changes Could Trigger Medical Device Reporting

The Food and Drug Administration (FDA) just issued a final guidance document that is asking manufacturers to step up reporting efforts when design changes are made to medical devices.

More specifically, the FDA wants manufacturers of medical devices to submit what is called a 510(k) when they make manufacturing changes to a medical device already on the market and, subsequently, already having achieved FDA approval. This is a big deal for companies such as Boston Scientific, Medtronic, Johnson & Johnson, and thousands of smaller companies.

In the guidance document, which supersedes one issued in 1999, the FDA offers up a metal manufacturing example of when a manufacturer would have to submit a 510(k). If a medical device manufacturer decided to change the manufacturing process for a patient-contacting part from a machining process to a stamping process, this could be cause for alarm under the new FDA guidance. The use of the stamping process might require a change in the grade of stainless steel and result in a change of the dimensional tolerances. A specified hierarchy of potential changes in the guidance document can help to guide manufacturers to see if they would have to submit new reports. Anyone interested in the details of this guidance can view it by going first to www.regulations.gov and then typing in FDA-2011-D-0453-0086.

OSHA Cites Updated Welding Standard

In December the Occupational Safety and Health Administration (OSHA) updated the standards it would use in enforcement proceedings.

Among the updated standards the agency will use is ANSI Z49.1-2012, Safety in Welding, Cutting, and Allied Processes, sections 4.3 and E4.3. OSHA had been using the 2005 version. ANSI Z49.1-2012 provides guidance for the protection of people and equipment from damage by fire and explosions arising from welding, cutting, and related processes.