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GOVERNMENT & POLICY CONCENTRATES
FDA’S FOREIGN
INSPECTION PROGRAM
NEEDS OVERHAUL
Better data management and more inspections
are needed to strengthen FDA’s
foreign drug facility inspection program,
according to congressional investigators.
The Government Accountability Office
says the agency isn’t sure how many foreign
establishments produce drugs for
the U.S. market (GAO-08-970). Using a
list of 3,249 plants FDA developed in 2007
to prioritize foreign inspections, GAO
estimates that FDA inspects only about
8% of facilities outside the U.S. each year.
“At this rate, it would take FDA more than
13 years to inspect these establishments
once,” GAO notes. Pharmaceutical plants
in the U.S. are inspected on average every
2.7 years. “This report confirms that we
have reason to be concerned about the
safety of imported drugs,” says House
Energy & Commerce Committee Chairman
John D. Dingell (D-Mich.). “Foreign
inspections are alarmingly low.” The
report also indicates that FDA is failing to
promptly conduct follow-up inspections
after serious violations—such as product
impurities or record-keeping problems—
are found in foreign facilities. From 2002
through 2007, FDA issued 15 warning
letters to foreign drug producers but reinspected
only four of the facilities, the
report notes.—GH
SENATORS ASK EPA
NOT TO ISSUE AIR RULE
EU LISTS CHEMICALS OF CONCERN
Following submissions from various European Union member countries,
the European Chemicals Agency (ECHA) has put 15 chemicals on its candidate
list of “substances of very high concern.” The list is part of the EU’s
new regulatory program under the Registration, Evaluation & Authorization
of Chemicals (REACH). “The inclusion of the substances in the list
generates immediate new legal obligations” for companies producing,
marketing, and using them, ECHA Executive Director Geert Dancet says.
As of Dec. 1, 2011, a producer has to notify ECHA when a product contains
more than 0.1% by weight of a substance on the candidate list, or when
use totals more than 1 metric ton per year. Companies must also provide
sufficient information on the safe use of the chemical or product to customers
and consumers who request it. Inclusion on this list, some project,
will encourage producers to develop more benign replacement chemicals.
Publication of the list is “a welcome start, but a drop in the ocean,” given
“the hundreds of well-known dangerous substances present in products
used every day across Europe,” according to a statement released by a coalition
of environmental and consumer public interest groups.—PLLS
Because a federal court recently overturned
a key Clean Air Act regulation, two powerful
Senate Democrats are asking EPA not
to issue a pending related rule that would
relax some emissions controls on power
plants. The pending rule, which the Bush
Administration says it will finalize in coming
weeks, is expected to boost air pollution
from coal-fired power plants. This in turn
is likely to pressure state environmental
regulators to impose more stringent emissions
controls on other industries, possibly
including chemical plants, to maintain air
quality. Proposed in 2005, the pending rule
would allow utilities to renovate and expand
the operating capacity of older power plants
without having to install modern air pollution
controls. EPA said any increase in annual
pollution from power plants due to these
proposed changes would be offset by another
regulation called the Clean Air Interstate
Rule (CAIR). But in July, a federal appeals
court threw out CAIR (C&EN, July 21, page
12). EPA needs to withdraw the pending rule
because CAIR no longer exists, say Sens.
Barbara Boxer (D-Calif.), who chairs the
Senate Environment & Public Works Committee,
and Thomas R. Carper (D-Del.), who
chairs the panel’s Subcommittee on Clean
Air & Nuclear Safety.—CH
DOE UPGRADES USER
FACILITIES’ CONTRACTS
On Oct. 27, the Department of Energy announced
that it has streamlined access
to user facilities, which offer researchers
access to unique and expensive equipment
and expertise, by making changes to
technology transfer contracts. The new
contracts clarify wording and provide a
universal document that all DOE user facilities
can employ. The two standardized
contracts are designed to make it easier
for university and industry scientists to
use DOE’s research facilities. Under the
proprietary agreement, users pay full cost
for lab equipment use, and with limited
exceptions, the researchers will retain
all rights to the data and new inventions.
For noncommercial and precompetitive
research, researchers can use DOE’s equipment
and collaborate with lab scientists
under the nonproprietary agreement, but
all data would be publicly available. The department
hopes these contracts will speed
up processing time, get researchers on-site,
and increase collaborations. Researchers
who already have contracts to use DOE
facilities can expect the agreements to be
executed as originally written.—RFHB
GROUP PROMOTES USE
OF GREENER CHEMICALS
Executives from the electronics, health
care, retail, and building sectors are
joining with health and environmental
advocates to promote the development
and use of safer chemicals. On Oct. 29,
the Business-NGO Working Group for
Safer Chemicals & Sustainable Materials
unveiled principles designed to encourage
chemical producers to supply compounds
with low to no toxicity and which degrade
into innocuous substances. The principles
call for manufacturers to identify the
chemicals that are used to make or are
contained in a product and for buyers to
request chemical data from their suppliers.
In addition, they call for manufacturers
to determine the hazards of substances
in their products; use chemicals with
inherently low hazard potential; and target
persistent, bioaccumulative, or toxic
compounds for elimination. Roger McFadden,
vice president of product science and
technology for Corporate Express, an arm
of office products retailer Staples, explains
that the principles “mark a significant step
toward incorporating green chemistry into
consumer goods.” —CH
WWW.CEN-ONLINE.ORG 17 NOVEMBER 3, 2008