Have we learned anything in the last 4 decades when it comes to allowing chemicals like PCBs onto the market?

Richard Denison, Ph.D., is a Lead Senior Scientist.  Stephanie Schwarz, J.D., is a Legal Fellow.

The Science section of today’s New York Times reports “Killer Whales Face Dire PCBs Threat” – more than four decades after Congress largely banned PCBs (polychlorinated biphenyls).

Concentrations of the chemicals in the blubber of orcas living in waters off the coasts of industrialized countries remain high, and new research indicates the contamination presents an existential threat to the survival of these populations.

Reading the article brought to mind concerns we have raised in recent comments to EPA on proposed rules it has issued for new chemicals under the Toxic Substances Control Act (TSCA). 


When Congress passed the original TSCA in 1976, it banned the manufacture, processing, and distribution of PCBs “other than in a totally enclosed manner.”   It also authorized the Environmental Protection Agency (EPA) to allow manufacture, processing, and distribution of PCBs “in a manner other than in a totally enclosed manner” if EPA found that the activity would “not present an unreasonable risk to health or the environment.”

EPA’s implementation of these requirements and allowances resulted in a phase-out of manufacture of PCBs, with some uses EPA deemed not to be totally enclosed allowed to continue.

PCBs are emblematic of a large group of chemicals of high concern.  Congress imposed restrictions on PCBs because PCBs had been found to be PBTs – persistent, bioaccumulative and toxic – exceedingly slow to break down in the environment and capable of building up in the food chain to the point of harming the health of humans or other organisms due to their toxicity.

EPA’s PBT policy for new chemicals

Concern over the potential for new chemicals to be introduced into commerce that might be or degrade into PBTs led EPA in 1999 to adopt a new policy and establish a “Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances,” under which it would more closely scrutinize, require testing of, and impose market restrictions on new chemicals expected or suspected to be PBTs.  The restrictions could range up to a “ban pending testing” for chemicals deemed to be very persistent and very bioaccumulative.  EPA stated:  “Because of the increased concern, more stringent control action would be a likely outcome, up to a ban on commercial production until data are submitted which allow the Agency to determine that the level of risk can be appropriately addressed by less restrictive  measures.”

In recent months, EPA has issued five “batches” of proposed significant new use rules (SNURs) for new chemicals for which it earlier negotiated consent orders under section 5 of TSCA.  Those orders were issued because EPA had determined either that these new chemicals “may present an unreasonable risk” or that EPA lacked sufficient information to conduct a reasoned evaluation of the chemicals’ risks.  In some cases, EPA also found that there will be significant production and there will or may be substantial human exposure to the chemical.

EDF has carefully reviewed these proposed SNURs, and to date has submitted comments on the first four batches (the fifth one is still open for public comment).  EDF strongly supports the issuance of SNURs for these chemicals to ensure that EPA is notified in advance of companies seeking to deviate from certain conditions when manufacturing, processing, distributing, using, or disposing of the chemicals, so that EPA can conduct a review of the potential risks.

EPA deviates from its own policy

However, as we conducted our review of the proposed SNURs, we were struck by just how many of these chemicals EPA indicated may be PBTs.  As we dug deeper, we found that for many of these potential PBTs, the evidence indicated they also are likely to meet EPA’s criteria for being both very persistent and very bioaccumulative.  Specifically:

  • EPA indicated that as many as 21 of the new chemicals may be PBTs.
  • As many as 15 of these appear to meet EPA’s criteria for being designated both very persistent and very bioaccumulative.

When we looked at the testing requirements and conditions being imposed on these chemicals through the consent orders and SNURs, however, we found frequent, serious deviations from EPA’s own PBT policy.  Among other concerns:

  • With respect to testing, in a number of the cases EPA has imposed less testing than its policy calls for, and in at least three cases, EPA required no testing at all.
  • For those chemicals meeting EPA’s criteria for being both very persistent and very bioaccumulative, EPA has allowed those chemicals to enter commerce even in advance of the testing required under its policy having been conducted.

More detail is available in our comments here and here.

It is disturbing that EPA is failing to adhere to its own longstanding policy regarding new chemicals that are potentially PBTs.

This situation also suggests that we have yet to learn the lessons we should have learned from PCBs, chemicals that are still wreaking havoc in our environment decades after Congress called for them to be banned.


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