The Cardno ChemRisk View
TSCA Stakeholder Meeting for Risk Assessment and Risk Prioritization- Will Your Business be Ready?
The U.S. Environmental Protection Agency (EPA) held two public meetings to gather input that will inform a proposed rule to establish a risk-based process for chemical prioritization (August 10), in addition to its process for conducting risk evaluations to determine whether a chemical presents an unreasonable risk of injury to health or the environment under TSCA section 6(b) (August 9).
By June 2017, EPA must decide on a risk-based screening process for evaluating new and existing chemicals. The previous “unreasonable risk” standard will be replaced by the “safety standard” for regulating chemicals, which will consider both hazard and exposure in a risk-based approach that is protective of human health and the environment.
During these meetings, stakeholders from government, private industry, academia, non-governmental organizations, as well as medical professionals, offered feedback regarding their suggestions and concerns. Cardno ChemRisk scientists, Dr. Denise Hill and Ms. Claire McMenamy, attended the meetings, and offer the following observations, as well as the selected comments, repeatedly offered by multiple stakeholders:
California's Office of Environmental Health Hazard Assessment (OEHHA) adopted a temporary emergency regulation on April 18, 2016, which implemented warning label method and content provisions specifically for exposures to BPA from canned and bottled foods and beverages sold at retail level. Effective May 11, 2016, BPA exposure warnings must be affixed to the product container or, alternatively, posted on a sign at each point-of-sale (cash register, check-out line) in the retail location; in addition, the emergency regulation stipulates strict warning language requirements that specify the chemical of interest and its health endpoint of concern ("harm to the female reproductive system"). The provisions in the emergency regulation are in effect until October 17, 2016.
On July 29, 2016, OEHHA issued a notice of proposed rulemaking to continue the emergency BPA warning regulation provisions until December 30, 2017. However, this new regulation limits the scope of the point-of-sale warning provisions. To utilize point-of-sale warning signs rather than individual product labels, food and beverage companies that intentionally use BPA must submit the following product identifying information in a "searchable, electronic format" to OEHHA:
• Brand name
• Product description, including FDA product category
• Universal Product Code or other identifying designation
• Where applicable, the last expiration or 'use by' date for the product(s) where BPA was intentionally used
Once submitted, OEHHA will publish the above information on its website, so that consumers can learn where BPA is intentionally used in food and beverage containers. A public hearing on the proposed regulatory amendment is scheduled for 10:00 a.m. on September 12, 2016 in the Sierra Hearing Room at the CalEPA Headquarters building 1001 I Street in Sacramento. The hearing will also be webcast.
Cardno ChemRisk scientist, Denise Hill, will be attending the August 9th and August 10th public meetings hosted by the EPA regarding the amended Toxic Substances Control Act....
Our general findings are as follows:
- One of the two delaminated products that we tested was found to not be in compliance with the current CARB standard; emissions from the other product were equivalent to the standard.
- Our chamber testing results were up to 9-fold lower than results that were previously documented by CBS News.
- Nonetheless, the actual airborne concentrations of formaldehyde measured following the installation of these products in a real-world setting were far below levels at which acute health effects are known to occur.
The abstract of the article can be found on the journal's website and a brief presentation of our results can be found here. If you would like a full copy of the paper, or if you have any questions regarding its content, please contact Dr. Jennifer Pierce.