Pharmaceuticals in Water
Nick SchroeckExecutive Director
Great Lakes Environmental Law Centerwww.GLELC.org
Great Lakes Environmental Law Center
Dedicated to protecting the world’s greatest freshwater resource, and the communities that depend upon it
Work in all 3 branches of government
Litigation on specific matters
501(c)(3) non profit www.GLELC.org Follow us on Facebook
Transnational Environmental Law Clinic
Students at Wayne Law work on projects and cases with the GLELC
Gain work experience in environmental law
Students engaged in the development of environmental law and policy
Partnership with University of Windsor, forming the first ever Transnational Environmental Law Clinic
How do Pharmaceuticals get into our water?
The Drugs
Most Prevalent: Antibiotics, steroids and other hormones, cancer therapies, lipid regulators and anti-inflammatory drugs
Hormonally Active Agents Biological Effects at low
levels
Unknown Toxic Cocktails
Mode of Action (MOA)
The Threat to Aquatic Life
Inhibited Growth Smaller Adult Size Reduced Egg
Production Abnormal Growth
Patterns Shortened Life Spans Increased Disease Bacterial Resistance Endocrine Disruption
Concerns
Intersex Fish Populations
Ecosystem Interference Impact microorganisms,
phytoplankton, plants, crustaceans, fish & insects
Potential Drinking Water Issues
Bioaccumulation
The FDA’s Regulatory Scheme
FDA regulates the drugs that enter the market Must submit a New Drug
Application (NDA)
Categorical Exclusion: < 1 ppb can forego environmental consideration process Primary tool used by
agencies to comply with NEPA
Result: Many drugs enter the market without any environmental considerations
NDA
NEPA EA process
Denied Approved
Claim Exclusio
n
Approved if < 1ppb
Addressing the Issue
Scientific Change WWTP Technology
Who pays? Breaking down chemicals
before enter system
Regulatory Change Federal (EPA, FDA)
Limit use of certain chemicals/Rx
Strict EA process State Agencies Public Trust like Set-Up
A Balanced Effort
GLELC & NRDC FDA PETITION
Petitioned the FDA to rescind 21 C.F.R. § 25.31 Current regulatory loophole, categorical
exclusion 1 ppb is proven to have detrimental effects on
the environment. Supposed to limit CE application where there are
extraordinary circumstances (40 C.F.R. § 215) The petition requests that the FDA rescind this
regulation. Weakness: Doesn’t address drugs already on the
market or the agricultural aspect of this issue
References
Slide 2:Bureau of Labor Statistics, U.S. Department of Labor, Occupational
Outlook Handbook, 2010-11 Edition, Bulletin 2800. Superintendent of Documents, U.S. Government Printing Office, Washington, DC, 2006, available at http://www.bls.gov/oco/ocos229.htm (last visited June 24, 2010).
Christopher T. Nidel, Regulating the Fate of Pharmaceutical Drugs: A New Prescription for the Environment, 58 FOOD & DRUG L.J. 81 (2003).
Slide 3:Kavanagh et al, Endocrine Disruption and Altered Gonadal Development in
White Perch (Morone Americana) from the Lower Great Lakes Region, 112 ENVIRON HEALTH PERSPECT 898, 898 (2004).
Dana W. Kolpin, Edward T. Furlong, Michael T. Meyer, E. Michael Thurman, Steven D. Zaugg, Larry B. Barber & Herbert T. Buxton, Pharmaceuticals, Hormones, and other Organic Wastewater Contaminants in U.S. Streams, 1999-2000: A National Reconnaissance, 36
Christian G. Daughton and Thomas A. Ternes, Pharmaceuticals and Personal Care Products in the Environment: Agents of Subtle Change?, 107 ENVIRONMENTAL HEALTH PERSPECTIVES 907, 924 (1999).
Sliide 4:B. Halling-Sorensen, S. Nors Nielsen, P.F. Lanzky, F. Ingerslev, H.C.
HoltenLutzhoft& S.E. Jorgensen, Occurrence, Fate and Effects of Pharmaceutical Substances in the Environment-A Review, 36 CHEMOSPHERE 357, 372-82 (1998).
Slide 5: Kavanagh et al, Endocrine Disruption and Altered Gonadal Development in
White Perch (Morone Americana) from the Lower Great Lakes Region, 112 EHP 898, 898 (2004).
B. Halling-Sorensen, S. Nors Nielsen, P.F. Lanzky, F. Ingerslev, H.C. HoltenLutzhoft& S.E. Jorgensen, Occurrence, Fate and Effects of Pharmaceutical Substances in the Environment-A Review, 36 CHEMOSPHERE 357, 372-82 (1998).
Christopher T. Nidel, Regulating the Fate of Pharmaceutical
Drugs: A New Prescription for the Environment, 58 FOOD & DRUG L.J. 81 (2003).
J. Laurel Standley et al, Wastewater-Contaminated Groundwater as a Source of Endogenous Hormones and Pharmaceuticals to Surface Water Ecosystems. 27 ENVIRONMENTAL TOXICOLOGY AND CHEMISTRY 2457, 2468 (2008). Id.
Anastasia Nikolaou, SureyyaMeric&DespoFatta, Occurrence patterns of pharmaceuticals in water and wastewater environments, 387 ANALYTICAL AND BIOANALYTICAL CHEMISTRY 1225 (2007).
Slide 6:Council on Environmental Quality, “Categorical
Exclusion Draft NEPA Guidance” (Jan. 2010), available at http:..ceq.hss.does.gov/nepa/Categorical Exclusion Draft NEPA Guidance FINAL 02182010.pdf.
21 C.F.R. § 25.31