Interest in pharmaceuticals and personal care products (PPCPs) in the environment has grown substantially over the past 10 or so years, with about half of the >15,000 known scientific and policy reports published in just the past few years. PPCPs are increasingly undergoing scrutiny and regulatory control by federal agencies, states, municipalities, and other countries. For example:
- The US Food and Drug Administration (FDA), US Environmental Protection Agency (EPA), US Department of Interior (DOI), and US Department of Agriculture (USDA) recently initiated an interagency workgroup to improve and sustain federal coordination and collaboration on pharmaceuticals in water.1 - FDA recently began increasing its assessments of the cumulative impacts of prescription drugs in the environment,2 regulating drugs for endocrine disruption potential,3 and evaluating National Environmental Policy Act (NEPA) environmental review processes.4 - EPA has been assessing prescription and over-the-counter (OTC) drugs in the environment5 and developing rules under the Safe Drinking Water Act (SDWA) that include a number of PPCPs.6 But many questions remain regarding a broad range of topics: 7 - Prioritization of PPCPs - Pathways of exposure - Antibiotic resistance - Bioavailability and uptake - Effects characterization - Risk management - Risk and relative risk And very little literature has been published for the pharmaceutical scientist audience. Therefore, in partnership with The American Association of Pharmaceutical Scientists (AAPS) Journal, we are seeking articles for a "rolling online" theme issue, Pharmaceuticals and Personal Care Products (PPCPs) in the Environment.8 If you are interested in contributing to this theme issue, please send me a proposal/abstract for review. Thanks, Jim Laurenson Toxicologist/Environmental Officer Office of Pharmaceutical Science Center for Drug Evaluation & Research U.S. Food & Drug Administration 10903 New Hampshire Ave., Bldg. 21, Rm. 1626 Silver Spring, MD 20993 james.lauren...@fda.hhs.gov References: 1 FDA, et al. 2012. Memorandum of Understanding on Sustainability of Federal Collaboration on Pharmaceuticals in Drinking Water. http://www.fda.gov/aboutfda/partnershipscollaborations/memorandaofunderstandingmous/domesticmous/ucm335474.htm 2 Laurenson JP, Bloom RA, Page S, and Sadrieh N. 2014. Ethinyl Estradiol and Other Human Pharmaceutical Estrogens in the Aquatic Environment: A Review of Recent Risk Assessment Data. The AAPS Journal. Online January 28, 2014. 3 FDA. 2013. FDA issues proposed rule to determine safety and effectiveness of antibacterial soaps (news release). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm378542.htm FDA. 2013. Guidance for Industry: Endocrine Disruption Potential of Drugs: Nonclinical Evaluation (Draft). FDA/CDER, Rockville, MD. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm369043.pdf 4 FDA. 2013. Response to Citizen Petition to the FDA Commissioner Under the National Environmental Policy Act and Administrative Procedure Act Requesting an Amendment to an FDA Rule Regarding Human Drugs and Biologics. Docket No. FDA-2010-P-0377. 5 Kostich MS, Batt AL, and Lazorchak JM. 2014. Concentrations of prioritized pharmaceuticals in effluents from 50 large wastewater treatment plants in the US and implications for risk estimation. Environmental Pollution. 184:354-359. EPA. 2010. Triclosan Facts. http://www.epa.gov/oppsrrd1/REDs/factsheets/triclosan_fs.htm 6 For example, see: EPA. Revisions to the Unregulated Contaminant Monitoring Regulation (UCMR 3) for Public Water Systems. 77 Federal Register 26071; 2012. 7 Boxall ABA, Rudd MA, Brooks BW, Caldwell DJ, Choi K, Hickmann S, et al. 2012. Pharmaceuticals and Personal Care Products in the Environment: What are the Big Questions? Environ Health Perspect. 120(9):1221-9. 8 See http://www.pharmagateway.net/ListThemedIssues.aspx?JournalID=12248 for current theme issues.
