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Monthly Archive for: ‘March, 2014’

Call to Action! Comment on proposed FDA rule.

A new rule is being proposed that will allow the tobacco industry to regulate themselves on environmental impacts of tobacco. Comments on the proposed rule are due by April 8, 2014. We have drafted our own comments and would like to share them with everyone and hope that you and your organization will adapt them and comment as well.

Here are our comments:

March 19, 2014

To:  FDA, via its Center for Tobacco Products

Fm: Tom Novotny and Clifton Curtis, Cigarette Butt Pollution Project

Su:  Comments on FDA proposal to exempt tobacco waste related actions from Environmental Impact

Statements or Environmental Assessments, and to instead authorize the tobacco industry to take the lead in addressing those issues21 CFR Part 25 [Docket No. FDA-2013-N-1282]; NEPA; Environmental Assessments for Tobacco Products; Categorical Exclusions


Core Issues:  The FDA’s Center for Tobacco Products is proposing a new rule that would exempt certain tobacco-related actions from having to prepare Environmental Impact Statements (EIS) and/or Environmental Assessments (EA). Instead, it would allow tobacco product manufacturers to submit Substantial Equivalence (SE) applications without an EIS or EA.  The proposed rule reflects the FDA’s decision that, as a matter of policy, new tobacco products approved through the SE pathway do not significantly affect the quality of the human environment.  While FDA would still retain discretion to require an EIS or EA for a particular action even though it is in the class of actions that are being exempted, as a general rule those exemptions would apply universally.

The proposed rule needs to be rejected as it defies sound policy on two fronts:

  • First and foremost, for decades the tobacco industry (TI) has lied, misrepresented and hidden facts and relevant information regarding the adverse impacts of its tobacco products, and it should NOT be given authority or responsibility to prepare decision-documents regarding the environmental impacts of those products; and
  • Second, while new information on the environmental impacts of tobacco product manufacture and disposal (tobacco product waste or TPW) is needed to assess potential health impacts from environmental contamination, consistent with the precautionary principle, there is sufficient information to warrant closer scrutiny.  The environmental impacts of tobacco product manufacture and disposal are best addressed by having FDA retain the lead role in preparing any necessary EIS’s or EA’s.

FDA vs TI: Regarding the TI’s role in addressing EIS and EIA matters, the civil law suit of U.S. v Philip Morris’ final opinion by U.S. District Judge Gladys Kessler in August 2006 states the obvious, that for decades the TI has survived and profited from “selling a highly addictive product which causes diseases that lead to a staggering number of deaths per year, an immeasurable amount of human suffering and economic loss, and a profound burden on our national health care system.  [They] have known many of these facts for at least 50 years or more.  Despite that knowledge, they have consistently, repeatedly and with enormous skill and sophistication, denied these facts to the public, the Government, and to the public health community.”

Going forward, the Framework Convention on Tobacco Control (FCTC), which entered into force in 2005 and currently has 177 Parties from all regions of the world, makes it clear that governments need to be very circumspect and cautious in their dealings with the TI.  As set for in Article 5.3’s “General Obligations”, the Convention states that “in setting and implementing their public health policies with respect to tobacco control, Parties shall act to protect these policies from commercial and other vested interests of the TI in accordance with national laws.”  While that statement references governments’ public health policies, the diverse environmental impacts resulting from TI practices likewise necessitate governments acting to “protect” those policies, especially given Article 18’s parallel interest and concern in calling for the protection of the environment.

National Environmental Policy Act (NEPA) Standards: Regarding NEPA standards and procedures related to the preparation of an EIS or EA, we question the statement of David Ashley and Hoshing Chang that TPW is individually and cumulatively trivial in the context of making a determination that the environmental impact of that TPW “may significantly affect the quality of the human environment.”  Among the 15 referenced source materials provided at the end of the proposed rulemaking statement, reference 13 affirms the toxicity of butt waste leachate on saltwater topsmelt and the freshwater fathead minnow.  Taking into account the precautionary principle, preventive, anticipatory measures are called for when an activity raises threats of harm to the environment, wildlife or human health, even if some cause-and-effect relationships are not fully established scientifically.

Clearly, additional research is needed to explore the actual risks that TPW pose to human and animal life.  As also noted, the growing of tobacco and manufacturing of cigarettes may result in a variety of pesticides, herbicides, insecticides, fungicides and rodenticides being deposited into the environment.  Additionally, 4,000 chemicals may be introduced to the environment via TPW, third-hand, and second-hand smoke. Those include chemicals such as carbon monoxide, hydrogen cyanide, nitrogen oxides, polycyclic aromatic hydrocarbons, ammonia, acetaldehyde, formaldehyde, benzene, phenol and others, over 50 of which are known to be carcinogenic to humans. Absent solid proof that these and other toxins are insignificantly impacting the environment, when neither the individual or cumulative studies have been given adequate attention, it’s very risky to just declare those risks as inconsequential.  Moreover, one could reason that in such a situation, an “exceptional circumstance” might well be recognized as meeting the “may significantly affect” threshold unless and until sufficient studies to make those determinations have been carried out.

For these reasons, we ask the FDA, through its Center for Tobacco Products, to reject the proposed rule.

Respectfully submitted on behalf of the Cigarette Butt Pollution Project,