[Pharmwaste] EPA, industry score low on toxics test

PDeLeo at sdahq.org PDeLeo at sdahq.org
Thu Aug 30 11:23:16 EDT 2007

It's unfortunate that ES&T didn't take a more balanced approach with regard
to this article.  First off, you have to give credit to Environmental
Defense (EDF) for doing yeoman's work on this issue.  They have been a
driving force and very engaged for a long time, however, their latest
report doesn't tell the whole story.  I can speak on behalf of my
organization, The Soap and Detergent Association, which has been actively
engaged in the HPV Chemical program for about a decade.  While EDF is
correct about the timeframes, they don't really describe how commitments
have changed over time.  We have nearly doubled our commitment from 126
chemicals in 1999 to nearly 250 today (of the approximately 3,000 HPV
Chemicals), but we are judged by the initial timeframe.  Also, for most of
our chemicals, we chose to go through the more rigorous (and time
consuming) process of the OECD in Europe which includes a government review
component.  Also, we went beyond the minimum requirements of the program to
include screening-level risk assessments with our submissions.

This article is also inaccurate about the Canadian process.  They did a
categorization of the 23,000 chemicals, they didn't review them.  From the
categorization, they identified approximately 4,300 substances that require
assessment, about 200 of which are identified as high priorities for
action.  They are currently going through those 200 chemicals in batches of
about 20 at a time.  There is a "challenge" for data (basically from
industry), and based on the data they receive (or don't receive) they will
make a decision about whether and how a chemical can be used.  So, I don't
think you can really characterize the Canadians as being far ahead of us.

The notion that the European REACh approach is better than what we are
doing in the US also is debatable.  It will certainly burdensome and it
will likely be years before there are any decisions out of the process, but
the real question will be whether there will be any measurable positive
public health impact from the process.  There is no question that there
will be forced and de facto chemical deselection (by virtue of being placed
on a list), but will that have an impact?  Hopefully in some cases, but
certainly not in all.  Perhaps the biggest impact of REACh will be not in
Europe, but in those parts of the world where there can not afford the
regulatory infrastructure or testing regimes.  As I understand it, REACh
will make all of its data open to everyone.

Paul C. DeLeo, PhD.
Director, Environmental Safety
The Soap and Detergent Association
1500 K Street, N.W., Suite 300
Washington, DC 20005
(202) 662-2516 - voice
(202) 347-4110 - FAX
pdeleo at sdahq.org

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                                       [Pharmwaste] EPA, industry score    
                                       low on toxics test                  
             08/30/2007 10:37                                              


News -August 29, 2007

EPA, industry score low on toxics test

The chemical industry fails to deliver on its promise to identify
chemical hazards.

Even by the standard of a "gentleman's C", it's a failure. The chemical
industry deserves a "D" for not providing the U.S. EPA with data it
promised years ago as part of a voluntary chemicals testing program,
according to a new report card from Environmental Defense (ED), an
advocacy group. The poor performance of the EPA-sponsored High
Production Volume (HPV) Chemical Challenge adds fuel to calls from
environmentalists, academics, and even some industry representatives for
overhauling U.S. chemicals management laws, experts say.

The HPV Challenge was designed as a stopgap to address weaknesses in the
Toxic Substances Control Act (TSCA) after a series of studies, including
those from the National Academy of Sciences and the General Accounting
Office (PDF size: 5.3 MB), condemned the lack of information on the
health hazards of commonly used chemicals, says Richard Denison, a
senior scientist and the author of the report card. Passed in 1976, TSCA
sets out procedures for regulating toxic chemicals used in commerce.
Because TSCA limits EPA's ability to ask companies for information, the
agency has managed to demand hazards data on only 200 of the more than
80,000 chemicals on the TSCA inventory, Denison says.

Hoping to head off calls for more onerous mandatory measures, chemical
producers joined ED and EPA to launch the voluntary HPV Challenge in
1998, according to Daryl Ditz, senior policy advisor at the nonprofit
Center for International Environmental Law. The challenge enlists the
manufacturers of chemicals produced in or imported to the U.S. in
quantities exceeding 1 million pounds per year to voluntarily develop
and make public a "base set" of data on hazards, such as acute and
reproductive toxicity. The data rely on testing of acute or subchronic
toxicity, for example, and the ecological endpoints include only
toxicity to aquatic organisms.

Now, more than 2 years after industry's 2004 deadline for submitting
information on the 2200 chemicals, less than half of the final data sets
have been submitted, the report card notes. No companies volunteered to
compile hazard tests for the 10% of HPV chemicals, mostly from the coal,
dye, and pigment industries, that were originally listed in the program
but weren't agreed to by companies-the so-called orphans. ED gave EPA a
"C-", for a tardy launch of the HPV database and for compelling data
development for only 16 of the 265 orphans.

Although the HPV Challenge turned out to be more time-consuming than
industry expected, it has produced more data in a shorter time frame
than any other program, says James Cooper, senior manager of chemicals
policy at the Synthetic Organic Chemical Manufacturers Association, a
trade group.

Many who believe that the U.S. should tighten its rules for the
ever-expanding list of chemicals on the market aren't satisfied by the
industry's efforts. "If Environmental Defense, a contributor to the
program, gives it a bad grade, it's significant and means that the HPV
Challenge has fallen far short of what it promised," Ditz says. The low
score is a blow to voluntary programs, which current EPA and industry
officials have touted as faster and more efficient than regulatory
programs, Denison says. "Voluntary programs only work when there is a
regulatory backup, and here, TSCA's regulatory backup is quite weak," he

"Even if industry had lived up to the HPV Challenge 100%, it still would
not have provided enough information to protect health," adds Bruce
Jennings, a senior advisor to the Environmental Quality Committee of the
California state legislature. The program lacked a depth and diversity
of tests, such as exposure information and neurological and
endocrine-disruption endpoints, he says.

Meanwhile, last year Canada completed a review of 23,000 chemicals after
8 years of study, less than the duration of the HPV Challenge, Jennings
says. The narrow scope of the HPV Challenge also places it behind the
EU's chemicals management law, Registration, Evaluation, and
Authorisation of Chemicals (known as REACH), which compels industry to
provide detailed tests on 30,000 chemicals, Ditz says.

The failure of TSCA and the HPV Challenge, as well as the growing
regulatory gap between the U.S. and other countries, is raising pressure
for reform of chemicals management laws, Jennings says. Bills introduced
in the California legislature this year would encourage use of "green"
chemicals and mandate detailed testing by industry. A TSCA reform bill
is expected to be introduced in the U.S. Congress this year that will
spark hearings on EPA's implementation of the chemicals law, but it is
unclear how quickly Congress would adopt new legislation, Denison says.

Deborah L. DeBiasi
Email:   dldebiasi at deq.virginia.gov
WEB site address:  www.deq.virginia.gov
Virginia Department of Environmental Quality
Office of Water Permit Programs
Industrial Pretreatment/Toxics Management Program
Mail:          P.O. Box 1105, Richmond, VA  23218 (NEW!)
Location:  629 E. Main Street, Richmond, VA  23219
PH:         804-698-4028
FAX:      804-698-4032

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