Regulatory Developments

EPA Rolls Out Newly Proposed Option for OPPT Reorganization

May 1, 2018

The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT or the Office) has decided to delay its pending reorganization to take and consider staff comments on the revised reorganization. The new plan proposes a six division structure that has separate new and existing chemical risk management divisions complemented by separate new and existing chemical risk assessment divisions. OPPT’s other functions are proposed to be distributed into a mission operations division and a division that sweeps together chemical right-to-know, economics, information reporting, and the Safer Choice/Design for the Environment (DfE) program. In an internal memo, OPPT Director Jeffery Morris, Ph.D., noting the thoughtful and insightful staff comments received on the earlier proposed reorganization, provides a two-week internal commenting period for the new proposal ending on May 9, 2018.

Dr. Morris is to be commended for soliciting and, more importantly, seriously considering feedback from OPPT staff. Staff often have a very different view of an office and its operations than that of senior managers, therefore, it is important that the Office Director (OD) hears from both when considering something as important as a major reorganization. Dr. Morris clearly took staff input to heart and continues to solicit staff views on how to ensure the effective and efficient functioning of the Office. On this point alone, the reorganization is much more likely to succeed if it has staff buy-in.

How to organize OPPT has been a perpetual conundrum with shifting “best approaches” over time. From our perspective, merging the existing chemicals function of the Chemical Control Division (CCD) with those of the National Program Chemicals Division (NPCD) into an Existing Chemicals Management Division makes sense. The existing NPCD branches that cover legacy chemical issues (e.g., lead, polychlorinated biphenyls (PCB), mercury, and asbestos) will presumably become risk management branches tasked with overseeing risk management activities for those chemicals under the amended Toxic Substances Control Act (TSCA or new TSCA). The other “first ten” risk evaluation chemicals that are currently being managed by the existing chemicals staff in CCD will become other risk management branches in the new structure. Creating a separate New Chemicals Management Division also makes sense in light of the challenges encountered by the office in its early implementation of Section 5 under new TSCA. Such a division will ensure a tight management focus on new chemicals issues without the need to also juggle complex existing chemicals issues. While this could present concerns regarding divergent decisions and policies between the two divisions, this seems to be less of an issue since the requirements in Sections 5 and 6 differ so much.

We can also see benefits in the proposed approach to complement this structure with parallel new and existing chemicals science divisions since these are the areas where the Office’s work must focus over the coming years. Support for this structure can be found in the argument that new and existing chemicals risk assessments are very different, with the former operating in a data-poor environment, while the current crop of existing chemicals risk assessments deal with data-rich chemicals. It is critical, however, that the underlying science and interpretation of the science be consistent across TSCA programs. Achieving that consistency will be a management challenge once the functions are separated into two divisions.

To complicate matters, having separate assessment branches further balkanizes expertise. For this to be successful, the Directors of the two new science divisions will have to make a concerted effort to ensure that the experts are communicating and coordinating to provide consistent assessments of the toxicology, exposure, releases, and fate for new and existing chemicals. Dr. Morris calls this out in his memo, asking for additional input in “promot[ing] flexibility and coordination between the two science divisions and across the office.”

The success of this approach, however, will hinge on the Office receiving adequate hiring authority to meet its scientific needs and then being able to locate and hire the needed technical experts. While Dr. Morris seems optimistic regarding the first, the second will present a major challenge to the Office in securing technical expertise in the areas in demand. These include expertise in hazard assessment (including reproductive/developmental toxicity, neurotoxicity, metabolism and pharmacokinetics, environmental toxicity, and environmental fate); consumer, environmental, and occupational exposure; organic and inorganic industrial chemistry; and specialized expertise concerning the products of biotechnology and nanotechnology. In our experience, expertise in these areas is perpetually in short supply. Whether new hiring will allow this to be surmounted remains to be learned and the answer will be critical in determining OPPT’s future success.

Having structured the office to focus on meeting the assessment and management demands under new TSCA, the proposal places the other OPPT functions into two divisions. One is focused on human resources, budget, communications, Confidential Business Information (CBI), and information management and technology. Interestingly there are two CBI branches; this perhaps reflects OPPT’s recognition of the demands presented by new TSCA in this area. The second of these divisions (entitled the Chemical Right-to-Know, Analysis, and Innovation Division) seems to be the catch-all for the remaining functions. These include the Toxic Release Inventory (TRI), Chemical Data Reporting (CDR), Safer Choice/DfE, innovation, Pollution Prevention (P2), and the important responsibility for economics/cost-benefit analysis (this will be a key need and demand in successfully regulating existing chemicals).

Below are some other aspects that also deserve comment.

  • One question concerns responsibility for developing TSCA Section 4 rules, orders, and enforceable consent agreements; and the second concerns responsibility for the TSCA Section 8 information-gathering rulemaking. Seemingly these responsibilities should reside in the existing chemicals risk management division to ensure that the program’s requirements for test data and chemical information are being met in a manner that is tightly coordinated with and responsive to program priorities and needs. Developing such actions, especially regarding testing, benefits from having staff experienced in such efforts, given the complexities that can be involved. This could argue for a branch having such work within its portfolio.
     
  • Another important shift is to put the chemists in the new chemicals science branch; while it makes sense given the role they play in new chemicals, Dr. Morris’ memorandum makes clear that the group will continue to support chemistry activities across the office, including their stewardship of the existing chemicals Inventory. Presumably this also includes responsibility for the new work regarding “active” versus “inactive” chemicals.
     
  • One question concerns the location of the Green Chemistry program, a responsibility historically managed by the chemists. It is unclear if this will be retained in that unit or if it will be placed in one of the innovation or sustainability branches in the chemical right-to-know division.
     
  • A second question concerns the Safer Choice/DfE program that is located in the chemical right-to-know division. It is unclear whether this unit will continue to be responsible for the scientific assessments that underpin its work in reviewing and accepting safer alternatives, or if EPA will look to the science divisions to provide this expertise while this office retains responsibility for managing the Safer Choice/DfE program, including its recognition aspects. The drifting apart that we have seen between DfE’s technical assessments and those coming out of the current Risk Assessment Division (RAD) has caused us growing discomfort and we hope the responsibility for scientific and technical assessments is tightly knitted into the new science divisions in the new organization. As we noted above, it is critical that the underlying science and interpretation of the science be consistent across TSCA programs, including Safer Choice/DfE.

 
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