Regulatory Policy Implications of 1,4-Dioxane - Environmental Investigation and Remediation - page 475

What requirements should society demand of new and existing chemical products or any other
technology with potential to cause harm to human health and the environment? The question leads
back to the precautionary principle: environmentally conscious decision-makers would not start
with the question, “How much of this pollutant can we stand?” Instead, they would ask, “Is there
an alternative to this polluting activity? Does society need this activity in the i rst place? What are
the implications for future generations?” (McKenna and Sylvester, 2004). Chlorinated solvents
were extremely useful to industry, and they could not be used effectively without solvent stabiliz-
ers like 1,4-dioxane. Yet, after the 1996 Montreal Protocol ban on using methyl chloroform,
industry has adapted to i nd alternatives and to eliminate virtually all solvent emissions from
those vapor degreasing operations that still use chlorinated solvents. When challenged, industry
has proven itself remarkably adaptable and innovative, surviving and even thriving in a changed
regulatory environment.
The existing regulatory framework for testing new chemicals entering the marketplace is a vol-
untary right-to-know program called the U.S. High Production Volume (HPV) Challenge Program. *
The program was adopted in 1998 after the environmental nonproi t group Environmental Defense
published a report called Toxic Ignorance (Environmental Defense, 1997). The report advised that
more than 70% of industrial chemicals in active, high-volume use in the U.S. marketplace lacked
sufi cient data on toxicity and environmental fate to permit basic evaluation of potential environ-
mental and human health hazards, as determined from the review of publicly available records.
Follow-on surveys by both USEPA and the CMA found that the number of chemicals lacking basic
hazard data was even greater than Environmental Defense reported: more than 90% of the HPV
industrial chemicals in U.S. commerce lacked sufi cient publicly available hazard-screening data.
The i ndings led to a joint effort to develop a more effective means of ensuring an increased level of
testing for new and existing chemicals. The effort was undertaken by Environmental Defense,
USEPA and CMA (now the American Chemistry Council), and led to the adoption of the HPV
Challenge Program. The HPV Challenge Program calls for chemical producers to voluntarily i ll
gaps in basic screening-level hazard data for HPV chemicals—those produced in the United States
in amounts of one million pounds or more annually (Denison, 2004).
The HPV Challenge program originally called for the development and public release of screening-
level hazard data for nearly 2800 chemicals; however, 532 of the chemicals originally included in
the program were either never sponsored (by companies who will fund the research to develop
screening-level hazard data) or have had initial sponsorships withdrawn. Of these 532 “unspon-
sored” chemicals, 156, and perhaps as many as 259, are “orphans.” Until they are sponsored, gaps
will persist in the public availability of important environmental data (Denison, 2004).
USEPA's National Center for Computational Toxicology performed a more extensive review of
the availability of basic data for chemicals in the marketplace. The survey found that of 9912 chemi-
cals reviewed, at least some acute hazard data were publicly available for 66% of the chemicals,
while no toxicology data were available for 34%. Data were less available for specii c disease end-
points: carcinogenicity data were available for 26%, developmental toxicity for 29%, reproductive
toxicity for 11%, and genotoxicity for 28% of the 9912 chemicals (Judson et al., 2008). The survey
underscores the ongoing need for chemical testing and evaluation, and the monumental task required
to keep pace with new chemicals entering the marketplace. We need a new approach for developing
and introducing new chemicals, with their environmental fate and human health impacts as a start-
ing consideration in the product development process. That new approach is Green Chemistry.
Green Chemistry refers to design of chemical products and processes with the objective of reducing
or eliminating the use and generation of hazardous substances, minimizing energy consumption,
minimizing or eliminating waste generation, and incorporating renewable raw materials (Goosey,
2008). The main idea behind Green Chemistry is to carefully select and control chemicals at the
* For more information on the HPV Challenge program, see http://www.epa.gov/chemrtk/index.htm