April 20, 2018 Celeste Monforton, DrPH, MPH 0Comment

One of the many amendments in 2016 to the Toxic Substances Control Act (TSCA) involved healthcare providers and their ability to gain access to confidential information about a chemical. Such toxicity data might provide essential info to help a physician diagnosis a patient, such as a worker who is exposed to chemical substances in the course of their job.

Chemical manufacturers have been notorious for stamping “confidential business information” (CBI) on data they are required to submit to EPA.  Their secrecy prevents health care providers from obtaining documents from EPA—documents that might shed a light on why an individual or group of individuals is experiencing adverse health effects.  If material was stamped “CBI,” EPA would not disclose it—not even to a health care provider who had an immediate need related to patient care.

A revision to TSCA Section 14(d) established a pathway for health professionals to obtain CBI information from EPA.  The Environmental Defense Fund—a key player in the bill’s passage—said the new CBI provision represented “unprecedented transparency.”

Under the previous law, EPA could not share information about a chemical with poison control agencies, emergency responders, or medical professionals if a company claimed the information was confidential.  With respect to the new law, Congress said its intent is for EPA to

“share CBI with health and environmental protection professionals in certain cases and under certain conditions.”

They modeled the change after provisions in the Emergency Planning and Community Right to Know Act. Congress said CBI disclosure applies to

“treating physicians, nurses, agents of poison control centers, public health or environmental officials of a State or political subdivision of a State, and first responders.”

But what Congress said and what Scott Pruitt’s EPA does is another matter.

EPA recently issued draft guidelines that stipulate how health officials would access CBI pursuant to the new law. One guidance document addresses emergency situations and the other non-emergency situations.  Public health and medical care groups are concerned that EPA is wiggling away from Congress’ intent.

The American Public Health Association (APHA), the American Academy of Pediatrics (AAP), and the American College of Obstetricians and Gynecologists (ACOG) sent a letter this week to EPA’s Pruitt. They are urging the agency to consult with CDC before finalizing the guidelines and they note that the law required EPA to do so.  The groups write that coordinating with CDC will ensure that the two documents:

“…as well as the processes put in place to operationalize the request and notification system – including both the statement of need and confidentiality agreement – meet the letter and spirit of the law in establishing a system that is responsive to the needs of health professionals and their patients.”

APHA, AAP, and ACOG also point out numerous places in EPA’s guidance documents where the agency appears to narrow the definition of who is eligible to obtain the CBI.  As written, certain poison control centers, privately-employed first responders, registered nurses, nurse practitioners, licensed practical nurses, and certified nurse mid-wives would not meet the EPA definition.

The health groups also note that the agency’s definition of “medical emergency” is overly narrow.  They explain that disclosure of CBI to health professionals should include scenarios:

“that could result in potentially serious symptom(s) or that constitute a potential, not just actual, threat to health. This threshold is more consistent with medical practice, where health professionals respond to both suspected and confirmed emergencies.”

The Environmental Defense Fund (EDF) also sent comments to EPA, listing dozens of examples where the agency shows “consistent confusion” about the law’s new requirements.  EDF reminds the agency that the law’s provision on CBI disclosure to health professionals is “mandatory, not discretionary.”  Their comments are punctuated over and over again with excerpts from the bill that read: “must” and “shall.”

Kudos to all four groups for keeping their eyes on EPA and not allowing the agency to wiggle away from Congress’ intent.

Leave a Reply

Your email address will not be published. Required fields are marked *