Environmental Factor, August 2007, National Institute of Environmental Health Sciences

NTP Introduces Revised Nomination Review

By Eddy Ball
August 2007

Environmental Toxicology Program Staff Scientist Scott Masten, Ph.D., gave the board a presentation explaining how the revised nomination process would work. Masten was also project leader for the asbestos nomination. (Photo courtesy of Steve McCaw)

Counselor Katharine Hammond, Ph.D., a professor of public health at the University of California-Berkeley, was one of several board members who took advantage of the new process to comment on research concepts for the nominated compounds. (Photo courtesy of Steve McCaw)

Toxicologist Dan Morgan, Ph.D., presented the nomination and draft research concept for studying artificial butter flavorings containing acetoin and diacetyl. (Photo courtesy of Steve McCaw)

During the June 22 meeting of its Board of Scientific Counselors (BSC) in Rodbell Auditorium, the National Toxicology Program (NTP) introduced an important revision to its study nomination review process. This process governs the protocol for moving chemicals from initial nomination for toxicology studies to the point at which NTP has approval to design and initiate those studies.

The new process adds a step following public comment and prior to review by the BSC during a public meeting (see text box). NTP project leaders are now responsible for developing draft research concepts for consideration by the board. A research concept contains in abbreviated form the nomination rationale, a proposed study approach and the significance and expected outcome of a proposed research program tailored for each nomination. Previously, research concept development did not take place until after BSC and NTP Executive Committee review.

NIEHS/NTP Staff Scientist Scott Masten, Ph.D., explained the rationale behind the change during his presentation on the new process. "What we decided to do was to move this step to earlier in the process," he explained, "to have the opportunity for public review and comment as well as to gain the insight from the Board of Scientific Counselors on some of our thoughts about how we should address the nomination."

At the June 22 meeting, NTP scientists tested the new process by presenting research concepts for four of the nine study nominations that underwent federal interagency review in December 2006:

Artificial butter flavorings containing acetoin and diacetyl, nominated by the United Food and Commercial Workers International Union (UFCW), may cause lung disease in exposed flavor manufacturing workers.
Naturally occurring and atypical forms of asbestos, nominated by the Environmental Protection Agency and National Center for Environmental Health/Agency for Toxic Substances and Disease Registry, is of concern for people exposed to the substance near abandoned mines or natural outcroppings.
Nanoscale silver, nominated by the Food and Drug Administration (FDA), is used widely and increasingly in drug, food and cosmetic products and may have similar or more pronounced toxic effects relative to other forms of silver.
o-Phthalaldehyde, nominated by the National Institute for Occupational Safety and Health (NIOSH), is widely used as a disinfectant in health care settings and is suspected of causing skin and respiratory irritation and toxicity.

The board endorsed draft research concepts for all four of the nominations. The board's response to the additional information provided by the revised process was overwhelmingly positive.

During the board's consideration of nanoscale silver, Director of the NTP Center for Phototoxicology Paul Howard, Ph.D., of FDA, praised the revised process. "We [at the FDA] enthusiastically endorse this enhanced review," he said. "The board is [now] interacting more on the scientific merits and doing a more enhanced review."

Not only does the new process benefit the board, Howard continued, "I think this only makes for better [long-term] studies coming out of the NTP.... I think it [also] will be very beneficial to the regulatory agencies."

The board will consider the remaining five nominations during its December 6, 2007 meeting. In the meantime, NTP scientists will be working to develop draft research concepts for studying aminopyridines, diethyl phthalate, 2',2' dithiobisbenzanilide, 2-methoxy-4-nitroaniline, and nanoscale gold.

Revised NTP Study Nomination Review Process

OPEN NOMINATION - Any interested party, including government agencies, academic or interest groups, members of the general public or NIEHS/NTP staff, can submit a nomination(http://ntp.niehs.nih.gov/ntpweb/index.cfm?objectid=53AFB168-BDB7-CEBA-FA3F42E15CD031C5).
NTP SCREENING - The NTP Office of Chemical Nomination and Selection reviews nominations to determine whether they have been adequately tested or have been previously considered by the NTP. At this point, the NTP may initiate an exhaustive literature review.
INTERAGENCY REVIEW - Nominations that merit further consideration are then reviewed by the Interagency Committee for Chemical Evaluation and Coordination (ICCEC), which is composed of representatives from ten federal agencies with research or regulatory interests in toxicology.
PUBLIC INPUT - NTP solicits public comments on the nominations and study recommendations by means of notices in the Federal Register and NTP news outlets.
(NEW STEP) - NTP assigns a project leader, who is an NIEHS, FDA, or NIOSH staff scientist, to develop draft research concepts.
BSC REVIEW - In open meeting, the NTP Board of Scientific Counselors reviews each research concept and provides recommendations on its merit and priority.
NTP EXECUTIVE COMMITTEE REVIEW - The NTP Executive Committee considers input received from all prior review steps and makes a final recommendation to the NTP Director.
IMPLEMENTATION - The NTP Project leader assembles a project team to design the studies outlined in the research concepts.

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