For the first time
in the US,
take-back
responsibilities
fall on producers
A federal district court in California recently upheld the Alameda County Safe Drug
Disposal ordinance, an extensive prescription
drug product stewardship program. Under
the program, drug manufacturers and producers that sell, offer for sale, or distribute certain
prescription drugs in the county must operate
and finance a take-back program that provides
for the collection, transportation, and proper
disposal of these drugs. Drug producers can
share the costs of operating the product stewardship plan, but may not add a fee at the point
of sale to cover its costs. Manufacturers can
establish their own program or participate in a
privately funded program operated by another
organization.
While many local jurisdictions implement
their own drug take-back programs to collect
unwanted drugs, Alameda County’s ordinance
is the first in the U.S. to put responsibility for
drug take-back on the producer. There are no
similar requirements at the state or federal level.
In the case, Pharmaceutical Research and
Manufacturers of America et al. v. Alameda
County, California et al., three pharmaceutical
trade associations challenged the ordinance,
claiming it violates the Commerce Clause of the
constitution. A state or local law that directly regulates or discriminates against interstate
commerce violates the Commerce Clause,
which reserves the power to regulate interstate
commerce for the federal government. Because the ordinance does not allow producers
to add a fee at the point of sale, producers will
likely have to distribute additional costs across
Enhesa Flash Nov/Dec 2013
all consumers, not just those in Alameda County. The ordinance imposes the local costs of the
product stewardship program on drug manufacturers, which are generally out-of-state companies.
However, the court rejected the challenge
and found that the ordinance does not directly
regulate interstate commerce. It reasoned that
producers would not have to alter their business
practices in other jurisdictions, only in Alameda
County, and that the ordinance is a cost of doing business in Alameda County that does not
unduly burden interstate commerce. The court
relied on a precedential Supreme Court case
stating that a law isn’t necessarily discriminatory simply because the burden of the law falls
primarily on out-of-state entities. The court’s
decision has been appealed to the Ninth Circuit Court of Appeals, but most likely will not be
resolved before the ordinance’s requirements
begin going into effect in May 2014.
If the ordinance is upheld on appeal, we
could see more of these producer responsibility
programs surface in other localities. Similar programs could focus not only on pharmaceuticals
but also on other consumer products. It is also
possible that a successful local-level program
could pave the way for development of a similar
broader, state-level, initiative.
Enhesa monitors issues that directly affect
multinationals and their EHS compliance in over
200 jurisdictions. Contact us today to learn
more about our monitoring service and tools for
maintain compliance.
Kimberly Stefanski,
EHS Regulatory Consultant
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