By Pat Rizzuto
Jan. 9 --The Environmental
Protection Agency must clarify, expand and revise many aspects of its draft
environmental risk assessment of a widely used polycyclic musk fragrance
ingredient before the document can be used for regulatory or other decisions,
an agency peer review panel said Jan. 9.
Seven ecological scientists
met by telephone to critique a draft assessment of
CAS 1222-05-5), which the EPA released in January 2013. The agency concluded
the fragrance ingredient posed a low concern for the environment .
peer reviewers said they would compile their recommendations prior to their
final meeting Feb. 6.
The HHCB assessment is part of an initiative the
EPA's Office of Pollution Prevention and Toxics (OPPT) announced in 2012. That
office is evaluating specific uses of dozens of what it calls “work plan”
chemicals in U.S. commerce .
Six companies made or imported more than
3.1 million pounds of HHCB in 2011, according to information they provided the
EPA under the Chemical Data Reporting rule.
The companies were SC
Johnson & Son Inc., International Flavors& Fragrances Inc., Symrise
Inc., Berje Inc., Firmenich Inc., and a company that told the EPA its name was
confidential business information.
HHCB can be one
of hundreds of chemicals used to make fragrances for detergents, fabric
softeners, shampoos, cleaners and other consumer products, and it is being
released to the environment continuously, the EPA said in information staff presented at the panel's Dec. 4
The draft document is really a draft screening level or hazard
evaluation, not a draft risk assessment, said panel member Duane Huggett, an
associate professor of biological sciences at the University of North Texas,
summarizing a perspective stated by several other peer reviewers.
difference between a screening level assessment and a risk assessment goes to
the types of decisions for which the document could be used.
level assessments can be used to decide a chemical isn't a problem, because
even worst case assumptions found no risk. They also are useful for helping
agencies decide what chemicals warrant additional data or analysis.
Screening level assessments also aren't intended for regulatory decisions
because their rough estimates could result in overly stringent or inadequately
Peter Chapman, a senior environmental scientist
at the Vancouver-based consulting firm Golder Associates Ltd., was among the
peer reviewers who said the agency's draft environmental risk assessment never
clearly said what its purpose was.
The document didn't include the problem formulation information that
ecological risk assessments are supposed to contain, Chapman said.
problem formulation stage of an ecological assessment is supposed to define
the ecological entity--species, group of species, or ecosystem, for
example--the assessment is intended to protect, the EPA said in a description of that stage.
Robert Gensemer, a vice
president and senior ecotoxicologist with GEI Consultants, said he couldn't be
sure the assessment would meet the agency's needs because it lacked a problem
Chapman described a variety of analytical
concerns he had with the EPA's analysis.
For example, in some cases the
agency focused on no-observed-adverse-effect-levels (NOAELs) and
lowest-observed-adverse-effect-levels (LOAELs), Chapman said, referring to
concentration levels that caused no or few problems.
assessments generally do not use those types of concentrations because their
accuracy depends on the concentration of a chemical the researchers used, he
The preferred approach is to use an effect concentration (EC) that
caused some kind of change or problem in 10 percent or perhaps 20 percent of
the animals or plants exposed in a particular test, he said.
Chapman further questioned the agency's use of a
study that found 3.2 milligrams HHCB per kilogram dry weight of sediment
harmed the reproduction of New Zealand mud snails. Those snails are an
invasive species that pose a risk to native species, Chapman said. Tests with
a common algae-eating shell species called hyalella azeca might be more
appropriate, he said.
The EPA also used test data from a marine
copepod, yet the test used was a draft--not final--protocol being developed by
the Organization for Economic Cooperation and Development (OECD), he said. “It
may not matter that much, but it should be noted.”
Other peer reviewers
asked the agency to be sure to use terms consistently throughout the document,
to clarify the meaning of terms, to provide information so readers could know
what measures researchers took to verify the quality of their data and to
provide the criteria it used to decide what studies it would include and
Trade associations commenting on the HHCB assessment included
the International Fragrance Association North America, the American Cleaning
Institute and the American Chemistry Council. No industry or other parties
spoke during the public comment session provided during the Jan. 9 peer
Prior to the meeting, however, the trade associations said they
supported the agency's conclusion that HHCB posed little risk.
provided additional data, analytic approaches and other recommendations to
improve the final assessment.
To contact the reporter on
this story: Pat Rizzuto in Washington at firstname.lastname@example.org
To contact the editor responsible
for this story: Larry Pearl at email@example.com
EPA's draft assessment, public comments and other materials
regarding the HHCB assessment are available at http://www.scgcorp.com/hhcb2013/index.htm.
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