[Pharmwaste] Pharm industry challenge to Alameda County, CA Drug Take Back program

[Catherine]

Thanks Deborah for sending clarification of the briefs filed in Almeda
County v. Pharma.  Some very interesting arguments.  I'm particularly taken
with: " PhRMA argues the ordinance is illogical because it expects drug
companies to engage in waste disposal functions "which they are neither
equipped nor competent to perform." 

 

That argument, can get Pharma into even more trouble as an admission of poor
waste management practices.  

 

Very truly yours,

 

Catherine Zimmer, MS, BSMT

Zimmer Environmental Improvement, LLC

St. Paul, MN 

Ph:  651.645.7509

 <mailto:zenllc at usfamily.net> zenllc at usfamily.net

 

From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of DeBiasi,
Deborah (DEQ)
Sent: Thursday, February 20, 2014 10:31 AM
To: (pharmwaste at lists.dep.state.fl.us)
Subject: [Pharmwaste] Pharm industry challenge to Alameda County, CA Drug
Take Back program

 

Advocates Cite Health Benefits In Bid To Preserve Novel Drug Take-Back Plan 

Posted: February 18, 2014 

Environmentalists, local government organizations and the California
attorney general are urging an appellate court to reject an industry
challenge to a California county's novel pharmaceutical waste collection
program, arguing the county has authority to establish the program and
emphasizing the program's environmental and public health benefits.

The Natural Resource Defense Council (NRDC), California State Association of
Counties (CSAC), the League of California Cities (LCC) and California
Attorney General (AG) Kamala Harris (D) all filed amicus briefs late last
month in Pharmaceutical Research and Manufacturers of America (PhRMA), et
al., v. Alameda County, et al., where pharmaceutical manufacturers are
asking the U.S. Court of Appeals for the 9th Circuit to declare an Alameda
County drug take-back program unconstitutional because it places unnecessary
burdens on interstate commerce.

The amicus briefs echo arguments made by Alameda County that local
governments have the right to determine waste disposal requirements and that
any cost to pharmaceutical manufacturers is de minimis compared to the
program's health and safety benefits. But they also warn that if the
district court's ruling supporting the program is overturned, that could
threaten numerous other extended producer responsibility (EPR) programs in
California and across the country.

The case's importance to the future of EPR programs has also been noted by
its opponents, including free-market and industry groups that have argued
the district court's endorsement of the precedent-setting approach could
lead to the widespread transfer of local disposal costs to other industry
sectors through an expansion of EPR programs.

EPR is a mandatory type of product stewardship that requires producers to be
responsible for the post-consumer management of their products and
packaging, including shifting financial and management responsibility away
from the public sector.

At issue is Alameda County's first-in-the-nation 2012 ordinance requiring
pharmaceutical companies whose products are sold in the county to establish,
run and finance a drug take-back program for unwanted medications. Many
local governments and citizen groups are concerned that a lack of such
programs leads consumers to flush medications into wastewater systems, where
they are eventually discharged and cause adverse developmental effects in
fish and possibly humans.

But industry charges the ordinance violates the Constitution's Commerce
Clause because it shifts the costs from a local program directly onto
interstate commerce.

Judge Richard Seeborg of the U.S. District Court for the Northern District
of California rejected industry's arguments against the Alameda County
regulations, ruling the ordinance does not meet any of three criteria for
proving a violation of the Commerce Clause: directly regulating interstate
commerce, discriminating against interstate commerce, or favoring in-state
economic interests over out-of-state interests.

Public Health

NRDC warns in its amicus
<http://insideepa.com/iwpfile.html?file=feb2014%2Fepa2014_0277a.pdf>  brief
that a ruling in favor of PhRMA would have long standing impacts on the work
of health and environmental advocates, threatening their ability "to promote
state and local extended producer responsibility programs that protect
public health and the environment by making product manufacturers
responsible for the entire lifecycle of their products, including their
take-back, recycling and final disposal."

Additionally, NRDC writes that since 1991 at least 70 similar EPR laws and
policies for multiple products have been enacted across the United States,
making the approach commonplace despite industry's concerns.

In California alone, NRDC says, producers already are required to fund and
manage end-of-life recycling and recovery programs for cell phones,
thermostats, paint, carpets, mattresses and rechargeable batteries.

California's AG rebukes PhRMA for insinuating that the Alameda ordinance
"runs afoul of the dormant Commerce Clause," and says her office filed the
brief due to a strong interest in "ensuring that the dormant Commerce Clause
continues to be interpreted in a way that preserves the abilities of state
and local governments to adopt innovative programs to address threats to
public health and welfare and the environment -- programs like Alameda's
Ordinance." A number of the state's laws have been challenged recently under
the Commerce Clause--including California's greenhouse gas reducing fuels
regulation and a ban on shark fin sales-- which Harris says shows why the
office has a strong interest in seeing the doctrine interpreted correctly.

Harris also notes the county's ordinance sets an important precedent for the
state's EPR laws, especially since California is in the stages of
implementing a Safer Consumer Products law, which she says will require
manufacturers of certain products to establish and maintain end-of-life
management programs that include comprehensive product stewardship plans.

CSAC and LCC in their joint brief say a ruling in PhRMA's favor would depart
from long-established Commerce Clause jurisprudence. "PhRMA ignores
controlling authority and asks this Court to adopt a rule that would
invalidate a wide array of state and local laws, thereby curtailing the
longstanding authority of state and local governments to regulate waste,"
the local government groups say.

Drug Collection

CSAC and LCC further defend Alameda County's right to mandate pharmaceutical
companies, who sell products within county lines, to fund and collect used
and unwanted drugs within its borders. Citing Maine v. Taylor extensively,
the two associations argue that, "State and local laws imposing costs on
manufactures to protect local residents from harms associated with products
that arrive through a national chain of commerce involving multiple
intermediaries are commonplace."

They also take issue with PhRMA's argument that "Alameda County is not
exercising its authority over waste disposal, but is instead 'transferring
its traditional police power responsibility of waste disposal to [private]
interstate actors.'" The groups counter that the Commerce Clause does not
control a government's decision as to whether government or the private
sector should provide waste management services, and they cite Maine to
reiterate that "the states retain authority under their general police
powers to regulate matters of legitimate local concern, even though
interstate commerce may be affected."

PhRMA, meanwhile, in a Jan. 31 response brief, acknowledges that Alameda has
the authority to defray the costs of its medicine disposal program by
collecting taxes and fees on sales and operate the program through its
government, a system it says is comparable to waste collection programs
across the country. But the industry group says the county violates the
Commerce Clause because it mandates that pharmaceutical companies run the
collection programs themselves.

"The county requires manufacturers who are located well beyond the County's
jurisdiction and have no contact with the country," it writes, "to come into
the county and develop, finance and operate a waste disposal program" which
"forces these out-of-jurisdiction manufacturers to absorb all of the costs
associated with this program and specifically prohibits them from recouping
any or all of the costs of the program locally."

PhRMA argues the ordinance is illogical because it expects drug companies to
engage in waste disposal functions "which they are neither equipped nor
competent to perform." It alleges that Alameda and its supporters could not
identify a "single precedent" that showed its novel ordinance was
constitutional under the dormant Commerce Clause and that there's no
precedent supporting the proposition that local governments can place total
cost burdens of a program benefiting only local residents onto citizens
located beyond the jurisdiction.

The ordinance, it writes "leverages the presence of an interstate product in
the County to compel the product's manufacturer to enter the county and
perform Alameda's public functions, regardless of whether the manufacturer
has any other contract with the county."

 

 

 

Deborah L. DeBiasi
Email:   Deborah.DeBiasi at deq.virginia.gov
WEB site address:  www.deq.virginia.gov <http://www.deq.virginia.gov/> 
Virginia Department of Environmental Quality
Office of Water Permits 
Industrial Pretreatment/Whole Effluent Toxicity (WET) Program
PPCPs, EDCs, and Microconstituents

http://www.deq.virginia.gov/Programs/Water/PermittingCompliance/PollutionDis
chargeElimination/Microconstituents.aspx

Mail:          P.O. Box 1105, Richmond, VA  23218
Location:  629 E. Main Street, Richmond, VA  23219
PH:         804-698-4028      FAX:      804-698-4032

 

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