DOJ Nominee: Cos. Filling Gaps In Environmental Regulation

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By Rachel Leven

Sept. 29 — Companies are filling gaps in international and federal environmental rules by studying unregulated areas and implementing their own affirmative compliance standards, John Cruden, the nominee to head the Justice Department's Environment and Natural Resources Division, said Sept. 29.

This phenomenon, known as “private governance,” can be seen in issues such as regulating pharmaceutical residue in the environment, which the Environmental Protection Agency doesn't yet regulate. Additionally, some nongovernmental entities offer “certification standards” for compliance on issues such as food security and obtaining timber in an environmentally sensitive manner, Cruden said.

By conducting its own private governance, a company could bolster its brand, improve environmental impacts across its supply chain and give itself an economic edge over its competitors, Cruden said. Moreover, companies' own compliance standards that are set to proactively protect the environment could be considered as best practices if the government moves to create regulations, Cruden said.

“Fundamentally, this is a concept of enforcement … being governed by nongovernment entities, primarily by [nongovernmental organizations] and corporations,” said Cruden, who is yet to be confirmed to the DOJ position and is the president of the Environmental Law Institute. Cruden made the comments at the Environmental Compliance and Commitment Legal Summit.

AstraZeneca Case Study

Cruden highlighted work by AstraZeneca to address pharmaceutical residue in the environment as an example of private governance. The pharmaceutical company proactively researches the potential risks and effects of exposure for the environment and the public, Cruden said.

AstraZeneca used its research to determine Environmental Reference Concentrations, or average concentrations of certain pharmaceutical ingredients in its surface water discharges that would be unlikely to harm the environment.

The company also identified Maximum Tolerable Concentrations, or “short term peak emissions associated with batch-wise production and cleaning activities,” for certain pharmaceutical ingredients, AstraZeneca said on its website.

The company aims to comply with safe concentration levels at manufacturing facilities inside and outside of the U.S., it said.

To contact the reporter on this story: Rachel Leven in New York at

To contact the editor responsible for this story: Larry Pearl at

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