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July/August 2018

Regulatory Landscape Remains Challenging in Chemicals; Activity in State and Federal Agencies Will Persist, but U.S. Must Not Lose Its Leadership Role

Environmental Business Journal

EBJ: With the Trump administration, well over a year in, we generally believe the position on environmental policy is to uphold current law but to reduce regulatory burden and eliminate or diminish any executive actions taken by the previous administration or by previous leadership of the Environmental Protection Agency. Do you generally agree this is the way things have panned out so far?

Culleen: Based on my experience in dealing virtually daily with requirements pertinent to pesticides and to chemical substances generally, it is apparent the current Administration at EPA is concentrating on making sound decisions that have a basis in science and the law.

The Administration has shown itself to be very committed to ensuring the 2016 amendments to the Toxic Substances Control Act (TSCA) are being implemented in a timely way. To that end, the Agency has been successful in meeting all of the very challenging deadlines under the amended law. EPA staff and managers alike in the "chemicals" programs are working very hard and accomplishing a great deal.

EBJ: During 2017, we experienced high tension between EPA policies and state/regional regulations. Has the heat turned up or what is the path in 2018?

Culleen: Certain states have been active in efforts to prohibit or limit the uses of certain chemicals of concern due to the substances' potential effects on human health and the environment. To the extent the legislatures and regulatory authorities in those states perceive that the current Administration at EPA is not doing enough to restrict uses of those substances, I think it is very likely those states will continue to be active.

Our clients find that regulatory landscape to be particularly challenging – and we do our best to keep them apprised of new developments coming out of the states. Our presence in multiple locations, including our offices in California and in New York, are indispensable in this regard. To assist our clients, we have developed a quarterly newsletter that we publish to inform them of these kinds of important legal and regulatory developments that can affect their businesses. We also track and report on important environmental litigation of which our clients need to be aware.

EBJ: Do you agree much of the activity on new programs and initiatives, if not regulations, have shifted from federal to the states or cities? Any specific examples representative of the trend?

Culleen: The regulatory issues affecting my clients, who include the makers and users of chemical substances and pesticides, have a strong basis in federal government programs where there are a great many initiatives underway, and significant state and local features. I would not say that a "shift" has occurred, but there certainly are a great many states that have become "players" in the chemical-regulatory "space."

EBJ: Do you think the recent trade and tariff rhetoric back-and-forth has any impact on environmental standards and future developments related to International environmental agreements?

Culleen: I hope trade and tariff disputes do not adversely affect the US government's ability to be a respected leader in the area of international environmental law and regulation. It is imperative for the US government to have a "seat at the table" in the day-to-day development of international and regional requirements that will affect the authorization of chemicals and products that move within international and regional markets that are increasingly regulated.

There is so much that occurs within the complicated processes of governments and bureaucracies and the implementation of national and international environmental regulatory requirements. Many of these aspects are governed and influenced by treaties and negotiations of which the US very much needs to be a part. I believe business leaders in the international arena recognize the need for their governments and institutions to have credibility, access, and an ability to influence outcomes.

EBJ: Have there been any significant developments to the Toxic Substance Control Act (TSCA) in the last couple years? If so, how has it impacted com­pliance or product development?

Culleen: The 2016 Amendments to TSCA have generated a whirlwind of activity at EPA. We are very actively assisting clients who are: a) responding to a multitude of risk evaluations and rulemakings that can threaten existing products; b) facing multiple new deadlines and several new reporting requirements; and c) confronting challenges working through complications that have emerged in the authorization process for new chemicals and new technologies trying to break into the US market.

There is quite simply a lot going on and it's rather exciting to be in a position to provide timely and helpful guidance to clients in some very sophisticated industries. Having worked for many years at EPA in both the TSCA program and the pesticide program enables me to help clients better comprehend the Agency's policies and develop strategies to work effectively with EPA personnel.

It also is an exceptional period for technical consultants and those who work in the fields of product safety and health and environmental effects testing as EPA is committed under the 2016 amendments to TSCA to encouraging and assisting in the development of new methods of analysis that can reduce the need for animal testing.

EBJ: What changes do you anticipate now that Scott Pruitt has resigned? Do you believe Andrew Wheeler will be more effective at implementing Trump's anti-environmental agenda?

Culleen: I think Mr. Wheeler is likely to look for ways in which EPA can meet its legal responsibilities while imposing few new regulatory requirements. Mr. Wheeler's familiarity with Washington, from his experience at EPA, on the Hill and through his work at a law firm, might make him very adept at accomplishing the Administration's goals in this regard.

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Lawrence Culleen is a partner in the Washington, DC offices of the international law firm, Arnold & Porter. He generally specializes in chemical-regulatory laws and the requirements affecting commercial and consumer use chemicals, pesticides and antimicrobials, as well as the products of biotechnology and nanoscale materials. Most of his clients deal with laws and regu­lations overseen by the US Environmental Protection Agency (EPA), the US Department of Agriculture, the US Food and Drug Administration, and the Consumer Product Safety Commission, as well as a growing number of state requirements affecting their products. Mr. Culleen held a number of different positions within the US EPA, where he served as a manager in various risk-management programs which oversee pesticides, chemical substances, and biotechnology products.