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