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Frequent Questions
Azithromycin is a synthetic version of a naturally produced macrolide antibiotic - - erythromycin. It is among the top 10 of the most widely prescribed pharmaceuticals and can be frequently found in environmental samples.
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Consumer Focus
- What are "PPCPs"?
- What are the major sources of PPCPs in the environment?
- What is the overall scientific concern?
- Should we be worried about ecological and/or human health?
- Where are PPCPs found in the environment?
- How is the disposal of unused pharmaceuticals regulated?
- How do I properly dispose of unwanted pharmaceuticals?
- Who can I contact for more information?
Scientific Focus
- Where Did the Acronym PPCPs Originate?
- What was EPA's historical role in this area?
- In what quantities are PPCPs used or introduced to the environment?
- What are the major issues with respect to effects?
- How can I contact scientists working on this topic?
- Where can I find additional information with respect to the wide diversity of scientific disciplines that are relevant to this topic?
Consumer Focus
What are "PPCPs"?
Pharmaceuticals and Personal Care Products as Pollutants (PPCPs) refers, in general, to any product used by individuals for personal health or cosmetic reasons or used by agribusiness to enhance growth or health of livestock. PPCPs comprise a diverse collection of thousands of chemical substances, including prescription and over-the-counter therapeutic drugs, veterinary drugs, fragrances, lotions, and cosmetics.
What are the major sources of PPCPs in the environment?
Sources of PPCPs:
- Human activity (e.g., bathing, shaving, swimming)
- Illicit drugs
- Veterinary drug use, especially antibiotics and steroids
- Agribusiness
- Residues from pharmaceutical manufacturing (well defined and controlled)
- Residues from hospitals
The importance of individuals adding chemicals to the environment has been largely overlooked. The discovery of PPCPs in water and soil shows even simple activities like shaving, using lotion, or taking medication affect the environment in which you live.
People contribute PPCPs to the environment when:
- medication residues pass out of the body and into sewer lines,
- externally-applied drugs and personal care products they use wash down the shower drain, and
- unused or expired medications are placed in the trash.
Personal use and manufacturing of illicit drugs are a less visible source of PPCPs entering the environment.
Many of the issues pertaining to the introduction of drugs to the environment from human usage also pertain to veterinary use, especially for antibiotics and steroids.
The discharge of pharmaceuticals and synthesis materials and by-products from manufacturing are already well defined and controlled. For more information regarding manufacturing discharges, see: Development Document for Final Effluent Limitations Guidelines and Standards for the Pharmaceutical Manufacturing Point Source Category, Office of Water, EPA-921-R-98-005, September 1998.
This poster shows a generalized synopsis of the sources of PPCPs in the environment (PDF). (1pp, poster, 307KB)
What is the overall scientific concern?
Studies have shown that pharmaceuticals are present in our nation's waterbodies. Further research suggests that certain drugs may cause ecological harm. More research is needed to determine the extent of ecological harm and any role it may have in potential human health effects. To date, scientists have found no evidence of adverse human health effects from PPCPs in the environment.
Reasons for concern:
- Large quantities of PPCPs can enter the environment after use by individuals or domestic animals.
- Sewage systems are not equipped for PPCP removal. Currently, there are no municipal sewage treatment plants that are engineered specifically for PPCP removal or for other unregulated contaminants. Effective removal of PPCPs from treatment plants varies based on the type of chemical and on the individual sewage treatment facilities.
- The risks are uncertain. The risks posed to aquatic organisms, and to humans are unknown, largely because the concentrations are so low. While the major concerns have been the resistance to antibiotics and disruption of aquatic endocrine systems (the system of glands that produce hormones that help control the body's metabolic activity) by natural and synthetic sex steroids, many other PPCPs have unknown consequences. There are no known human health effects from such low-level exposures in drinking water, but special scenarios (one example being fetal exposure to low levels of medications that a mother would ordinarily be avoiding) require more investigation.
- The number of PPCPs are growing. In addition to antibiotics and steroids, over 100 individual PPCPs have been identified (as of 2007) in environmental samples and drinking water.
Should we be worried about ecological and/or human health?
Studies have shown that pharmaceuticals are present in some of our nation's waterbodies. Further research suggests that there may be some ecological harm when certain drugs are present. To date, no evidence has been found of human health effects from PPCPs in the environment.
Where are PPCPs found in the environment?
PPCPs are found where people or animals are treated with drugs and people use personal care products. PPCPs are found in any water body influenced by raw or treated sewage, including rivers, streams, ground water, coastal marine environments, and many drinking water sources. PPCPs have been identified in most places sampled.
The U.S. Geological Survey (USGS) implemented a national reconnaissance to provide baseline information on the environmental occurrence of PPCPs in water resources. You can find more information about this project from the USGS's What's in Our Wastewaters and Where Does it Go? site.
PPCPs in the environment are frequently found in aquatic environments because PPCPs dissolve easily and don't evaporate at normal temperature and pressures. Practices such as the use of sewage sludge ("biosolids") and reclaimed water for irrigation brings PPCPs into contact with the soil.
- For more information about biosolids see the National Research Council (NRC) report: Biosolids Applied to Land: Advancing Standards and Practices (2002)
) - USGS: Pharmaceuticals Found in Soil Irrigated with Reclaimed Water
How is the disposal of unused pharmaceuticals regulated by the US EPA?
The Resource Conservation and Recovery Act (RCRA) is a federal law controlling the management and disposal of solid and hazardous wastes produced by a wide variety of industries and sources. The RCRA program regulates the management and disposal of hazardous pharmaceutical wastes produced by pharmaceutical manufacturers and the health care industry. Under RCRA, a waste is a hazardous waste if it is specifically listed by the EPA or if it exhibits one or more of the following four characteristics: ignitability, corrosivity, reactivity and toxicity.
How do I properly dispose of unwanted pharmaceuticals?
In February 2007, the White House Office of National Drug Control Policy issued the first consumer guidance for the Proper Disposal of Prescription Drugs. Proper disposal of drugs is a straightforward way for individuals to prevent pollution.
RCRA does not regulate any household waste, which includes medications/pharmaceutical waste generated in a household. While discarded pharmaceuticals under the control of consumers are not regulated by RCRA, EPA encourages the public:
- to take advantage of pharmaceutical take-back programs or household hazardous waste collection programs that accept pharmaceuticals
- If there are no take-back programs near you,
- contact your state and local waste management authorities (the disposal of household waste is primarily regulated on the state and local levels) with questions about discarding unused pharmaceuticals, whether or not these materials meet the definition of hazardous waste
- follow any specific disposal instructions that may be printed on the label or accompanying patient information
Who can I contact for more information?
You can contact an EPA regional representative or a program office representative.
Scientific Focus
Where Did the Acronym PPCPs Originate?
The acronym "PPCPs" was coined in the 1999 critical review published in Environmental Health Perspectives (PDF) (41pp, 789 KB) to refer to Pharmaceuticals and Personal Care Products. PPCPs comprise a very broad, diverse collection of thousands of chemical substances, including prescription, veterninary, and over-the-counter (OTC) therapeutic drugs, fragrances, cosmetics, sun-screen agents, diagnostic agents, nutraceuticals, biopharmaceuticals, growth enhancing chemicals used in livestock operations, and many others. This broad collection of substances refers, in general, to any product used by individuals for personal health or cosmetic reasons. Since its introduction in 1999, the acronym PPCPs has become the most frequently adopted term in both the technical and popular literature and therefore is a useful keyword for performing literature searches.
What was EPA's historical role in this area?
EPA established a leadership role beginning in 1999 with publication of a critical review (PDF) (41pp, 789 KB) article that attempted to bring together the many different aspects of this complex issue.From the beginning, a major objective has been to stimulate a proactive versus a reactive approach to this environmental issue. The work was driven by goals from the U.S. EPA's Strategic Plan. The relevant goals included:
- Clean and Safe Water
- Preventing Pollution and Reducing Risk in Communities, Homes, Workplaces, and Ecosystems
- Better Waste Management, Restoration of Contaminated Waste Sites, and Emergency Response
- and Sound Science - Improved Understanding of Environmental Risk and Greater Innovation to Address Environmental Problems
In addition, a primary goal of the U.S. EPA's Office of Research and Development is to identify and foster investigation of potential environmental issues/concerns before they become critical ecological or human health problems. Pollution prevention (e.g., source elimination or minimization) is preferable to remediation or restoration to minimize both public cost and human/ecological exposure.
Current Work:
In what quantities are PPCPs used or introduced to the environment?
As a whole, PPCPs are produced and used in large quantities. Personal care products tend to be made in extremely large quantities - thousands of tons per year. But quantities of production or consumption do not correspond with the quantities of PPCPs introduced to the environment. PPCPs manufactured in large quantities may not be found in the environment if they are easily broken down and processed by the human body or degrade quickly. PPCPs made in small quantities could be over represented in the environment, if they are not easily broken down and processed by the human body and make their way into domestic sewers.
What are some major issues with respect to effects?
- The effects of PPCPs are different from conventional pollutants. Drugs are purposefully designed to interact with cellular receptors at low concentrations and to elicit specific biological effects. Unintended adverse effects can also occur from interaction with non-target receptors.
- Environmental toxicology focuses on acute effects of exposure rather than chronic effects.
- Effects on aquatic life are a major concern. Exposure risks for aquatic organisms are much larger than those for humans. Aquatic organisms have:
- continual exposures
- multi-generational exposures
- exposure to higher concentrations of PPCPs in untreated water
- possible low dose effects
- Effects may be subtle because PPCPs in the environment occur at low concentrations. There's a need to develop tests that detect more subtle end-points. Neurobehavioral effects and inhibition of efflux pumps are two examples. Subtle effects that accumulate may be significant.
- There are little aquatic/terrestrial toxicology data for PPCPs. There is substantially more data available for pesticides. For example, brief exposure of salmon to 1 ppb of the insecticide diazinon is known to affect signaling pathways (via olfactory disruption), leading to alteration in homing behavior (with obvious implications for predation, feeding, and mating). There's concern that low doses of PPCPs may also have effects.
- There are many drug classes of concern:
- antibiotics which are actively being researched
- antimicrobials
- estrogenic steroids
- antidepressants. Profound effects on spawning and other behaviors in shellfish can occur with antidepressant selective serotonin reuptake inhibitors (SSRIs).
- calcium-channel blockers. Dramatic inhibition of sperm activity in certain aquatic organisms can be effected by calcium-channel blockers.
- antiepileptic drugs (e.g., phenytoin, valproate, carbamazepine) have potential as human neuroteratogens, triggering extensive apoptosis in the developing brain, leading to neurodegeneration.
- multi-drug transporters (efflux pumps). Possible significance of efflux pump inhibitors (EPIs) in compromising aquatic health.
- musk fragrances are bioaccumulative and persistent
- genotoxic drugs (primarily used at hospitals)
How can I contact scientists working on this topic?
Contact information for research scientists with active research about PPCPs in the environment and government scientists with interest in regulatory aspects, is available. Listing of research scientists and their contact information. (PDF) (2pp, 16KB)