pharmaceuticals and personal care products (ppcps): disposal, scientific, and regulatory challenges

Environmental Quality Management / DOI 10.1002/tqem / Autumn 2010 / 39

© 2010 Wiley Periodicals, Inc.Published online in Wiley Online Library (wileyonlinelibrary.com).DOI: 10.1002/tqem.20270

Small concentra-

tions of pharma-

ceuticals (including

a range of antibiot-

ics) have been found

in environmental

media throughout

the United States.

These substances

can enter drinking-water sources, including wa-

tersheds, surface-water bodies, and groundwa-

ter. Although pharmaceuticals and personal care

products (PPCPs) are emerging as environmental

contaminants of concern, the regulatory response

to them so far has been slow and fragmented.

PPCPs and the Environment: BackgroundThe United States Environmental Protection

Agency (US EPA) defines PPCPs to include “any

product used by individuals for personal health

or cosmetic reasons or used by agribusiness to

enhance growth or health of livestock.” This

definition encompasses “thousands of chemical

substances, including prescription and over-the-

counter therapeutic drugs, veterinary drugs, fra-

grances, and cosmetics.”1

The Agency

notes, “PPCPs have

probably been pres-

ent in water and the

environment for

as long as humans

have been using

them. The drugs

that we take are not

entirely absorbed by our bodies, and are excreted

and passed into wastewater and surface water.”2

PPCPs also enter the environment because

of improper disposal. Many disposal problems

arise because there is no one regulatory agency

in charge of PPCPs and no comprehensive leg-

islation in place to guide and regulate how they

should be handled. Agencies as diverse as US EPA

and the United States Drug Enforcement Admin-

istration (US DEA) have jurisdiction over various

aspects of PPCP use and disposal.

PPCPs have been identified in drinking-water

sources, wastewater and water-treatment efflu-

ents, groundwater, soil, and sediments from

Kathleen Gibson

Pharmaceuticals and Personal Care Products (PPCPs): Disposal, Scientific, and Regulatory Challenges

A growing problem for industry

and consumers alike

scribed pharmaceuticals in the United States are

antibiotics.

Concerns are growing about antibiotic overuse,

which can lead to microbial antibiotic resistance.

According to the United States Centers for Disease

Control and Prevention (CDC), “Each year in the

United States, an estimated 50 million antibiotic

prescriptions are for illnesses such as colds or flu

for which antibiotics offer no benefit.”5

Many of these substances eventually are dis-

charged into the environment. Studies indicate

that sewage discharged from hospitals can con-

tribute to antibiotic resistance among organisms

in wastewater treatment plants, sometimes creat-

ing “superbugs.” Research studies over the past

several decades “have shown hospital effluent to

contain higher levels of antibiotic-resistant bacte-

ria than waste from other sources.”6

Antibiotics in Animal Feed and AquacultureIt is estimated that 40 percent of the antibi-

otics produced in the United States are used by

the farming industry to treat animal diseases and

promote animal growth.7 These pharmaceuticals

typically are added to animal feed at subthera-

peutic levels. Antibiotics are also commonly used

in aquaculture, where they may be added to fish-

ery waters.8

Antibiotics Used in Crop ProductionAnother 300,000 pounds of antibiotics are

used annually for growing plant crops commer-

cially. The pharmaceuticals typically “are sprayed

on high-value crops such as fruit trees to prevent

bacterial infections.”9 Much of this antibiotic

spray eventually washes off onto the surround-

ing soil, where it moves into surface water and

groundwater.

Household Antibacterial ProductsAntibacterial substances (such as triclosan) in-

creasingly are being used in household products,

around the country. The substances are also pres-

ent in landfills and stormwater effluents.

In general, the concentrations of PPCPs found

in these media are very small (with levels of a few

parts per billion or trillion). These concentrations

are “far below the levels of a medical dose.”3

Advances in technology have improved science’s

ability to detect and measure tiny amounts of

these chemicals but have not necessarily en-

hanced its ability to quantify their potential en-

vironmental effects.

Similarly, little research has been done to

evaluate the potential detrimental effects that

exposure to trace amounts of pharmaceuticals

might have on human

health. However, there

is concern that low-

level exposures to

PPCPs could pose risks,

particularly to sensi-

tive subpopulations,

including fetuses,

people with chemical

sensitivities, or people

with existing disease burdens that could be exac-

erbated by inadvertent exposure.

Antibiotics and Other Pharmaceuticals in Environmental Media

As US EPA notes, “Large quantities of PPCPs

can enter the environment after use by indi-

viduals or domestic animals.”4 Studies show that

these substances, especially antimicrobials, have

changed the antibiotic susceptibility of microbes,

leading to an increase in antibiotic-resistant or-

ganisms. They have also altered the mix of pre-

dominant microbes in the environment.

Pharmaceuticals for Human UsePharmaceuticals intended for human use in-

clude both prescription and over-the-counter

medications. Some of the most commonly pre-

Kathleen Gibson40 / Autumn 2010 / Environmental Quality Management / DOI 10.1002/tqem

Advances in technology have improved science’s ability to detect and measure tiny amounts of these chemicals but have not necessarily enhanced its ability to quantify their potential environmental effects.

2008. AP reported that pharmaceuticals had

“been detected in the drinking water supplies

of 24 major metropolitan areas”13 around the

United States, including Philadelphia, San Fran-

cisco, Tucson, and Washington, D.C.

The report noted, among other findings, that

testing in Philadelphia found “56 pharmaceu-

ticals or byproducts in treated drinking water.”

These included “medicines for pain, infection,

high cholesterol, asthma, epilepsy, mental ill-

ness and heart problems.” On the West Coast,

“Anti-epileptic and anti-anxiety medications

were detected in a portion of the treated drink-

ing water for 18.5 million people in Southern

California.”14

The AP investiga-

tion also discovered

that pharmaceuticals

had been found in 28

watersheds that pro-

vide drinking water to

major population cen-

ters.

Agricultural Watershed Study In 2006, US EPA funded a study to investigate

the presence of antibiotics and hormones in an

agricultural watershed in Maryland. Researchers

collected water samples from a range of locations

throughout the watershed over all four seasons

of the year.

The study detected antibiotics, hormones,

and feed additives in the water samples and in

sediment. This study confirmed that watersheds

can be affected by antibiotic residues from agri-

culture.15

Wastewater Effluent StudyFrom 2002 to 2004, US EPA conducted a

study to identify the chemicals that are present in

wastewater effluent and to “quantify their persis-

tence downstream from wastewater treatment.”16

in items ranging from toothpaste to sweat socks.

These consumer products ultimately make their

way into the environment after being disposed

via landfills or sewers.10

“Treatment-Resistant” PharmaceuticalsMany pharmaceuticals cannot be removed

by the processes that are currently used to treat

drinking water and wastewater. Among these

“treatment-resistant” pharmaceuticals are some

cholesterol-lowering medications, tranquilizers,

and anti-epileptic drugs.11

Key Studies on Contaminants in the Environment

Although PPCPs have been entering the en-

vironment for many decades, little research or

regulatory attention has been paid to them until

recently. A study from 1999 entitled “Pharmaceu-

ticals and Personal Care Products in the Environ-

ment: Agents of Subtle Change?” noted:

There are only two major activities with

respect to managing the release of phar-

maceuticals in the environment. One re-

sults from the research that has occurred

in various European/Scandinavian coun-

tries over the last few decades, culminat-

ing in guidelines from the EU. The other

comes from the FDA [United States Food

and Drug Administration].12

Since that time, more studies have been con-

ducted on PPCPs and related contaminants in

the environment, sometimes outside the regula-

tory sector. The following paragraphs summarize

some of the key studies in this area.

AP InvestigationThe Associated Press (AP) conducted a five-

month investigation on PPCPs in the environ-

ment, the results of which were released in early

Environmental Quality Management / DOI 10.1002/tqem / Autumn 2010 / 41Pharmaceuticals and Personal Care Products (PPCPs)

Although PPCPs have been entering the environment for many decades,

little research or regulatory attention has been paid to them

until recently.

Fish Tissue Study in September 2009. The study

reflected a four-year effort to “estimate the na-

tional distribution of selected persistent, bioac-

cumulative and toxic (PBT) chemical residues in

fish tissue from lakes and reservoirs in the lower

48 states.”

Although the study did not specifically target

PPCPs, it indicated the levels of chemical con-

tamination present in the nation’s water bodies.

The Agency noted that some of the chemicals

studied, including mercury, “were detected in

every fish sample from all 500 lakes and reser-

voirs” involved in the study.18

Widespread Findings of PPCPs in the Environment

From this brief literature review, it is clear that

PPCPs are widespread throughout the environ-

ment. So who is in charge of regulating PPCPs,

and what is being done about their increasing

presence in environmental media?

Who Is in Charge of Regulating PPCPs? There is no one agency that is in charge of

regulating PPCPs. Nor is there any comprehen-

sive legislation in place to deal with PPCPs. US

EPA, US DEA, and various state and local entities

all have adopted regulations that cover some (but

not all) aspects of the PPCP universe.

Unfortunately, where regulatory jurisdictions

overlap, there tend to be inconsistencies and

conflicts. In the case of PPCPs, the lack of clear

leadership and control increases the likelihood

that products will be disposed of improperly. This

in turn makes it more likely that PPCPs will be

released into the environment.

In the absence of a coordinated regulatory

strategy, nongovernment stakeholders (such as

the Joint Commission and the American Society

of Consultant Pharmacists) have entered the

discussion. These organizations can provide valu-

able analyses of the issues and offer suggestions

Researchers analyzed water samples for 110 chemi-

cals. Of the compounds investigated, “78 were

detected at least once” in effluents and in surface

waters surrounding wastewater treatment plants.

The study confirmed that chemicals could

show different levels of environmental persis-

tence. Some were found to be short-lived. Other

substances (for example, caffeine) were found to

be “ubiquitous and exhibited no statistically sig-

nificant difference in concentration between any

of the sampling sites within a given location.”

Study of Wastewater Pharmaceuticals Treated With Chlorination

US EPA has also reviewed how treatment

with chlorination af-

fects pharmaceuticals

in wastewater. In ex-

plaining the need for

the study, the Agency

noted, “Reports in the

literature show a re-

moval of pharmaceu-

ticals during waste and

drinking water treat-

ment, but they do not determine if the com-

pounds are removed from the influent water, or if

they are transformed into other chemicals.”17

Researchers investigated 14 chemicals, col-

lecting paired samples and adding sodium hy-

pochlorite to one sample from each pair. Results

indicated that six of the substances studied (aspi-

rin, aspartame, caffeine, cotinine, 1,7-dimethyl-

xanthine, and 6-methyl-17-hydroxy progesterone

acetate) were “not affected by the chlorination.”

Another six chemicals (amoxicillin, cephalexin,

cimetidine, diltiazem, trimethoprim, and warfa-

rin) “were oxidized, but not chlorinated.”

National Lakes Fish Tissue StudyUS EPA’s Office of Science and Technology

released its final report on the National Lakes


In the case of PPCPs, the lack of clear leadership and control increases the likelihood that products will be disposed of improperly.

effect, loosen the storage requirements for RCRA-

regulated pharmaceuticals.

In making the proposal, US EPA was careful

to note that “this rulemaking does not affect the

Controlled Substance Act or regulations issued

there under [by] the Drug Enforcement Adminis-

tration (DEA).” Thus, the Agency noted, entities

that are attempting to reduce consumer disposal

of pharmaceuticals (such as organizers of collec-

tion events for leftover consumer prescription

drugs) “will still be required to contact DEA to

ensure compliance with the federal laws and

regulations concerning controlled substances.”21

US DEA RegulationsUS DEA’s Office of

Diversion Control reg-

ulates the disposal of

controlled substances

(which includes a sub-

set of PPCPs). The pri-

mary goal of the US

DEA regulations is to

eliminate diversion of

legitimately manufac-

tured or used controlled substances into the

illicit drug market. Under the regulations, there

are several options for disposing of controlled

substances:22

return to the manufacturer;•

destruction by “witness burn,” which in-•

volves transporting waste substances to a US

DEA–approved incinerator, where they are de-

stroyed in the presence of official witnesses;

transfer to a reverse distribution registrant •

(this options transfers ownership of the waste

substance to a US DEA–approved pharmaceu-

tical “returns processor” for reuse, resale, or

destruction); and

sewering (disposing less than one pound of •

waste to the sewer system).

for integrating regulations, with an eye to both

easing the regulatory burden and protecting the

environment.

Some of the key players involved with regulat-

ing and controlling PPCPs are briefly highlighted

in the paragraphs that follow. This discussion is

not intended to be comprehensive. It also does

not attempt to cover requirements imposed by

state and local environmental, health, and safety

agencies since such provisions are too numerous

and varied to summarize here. Keep in mind,

however, that state and local entities can exercise

overlapping jurisdictions and may impose con-

flicting requirements relating to PPCPs.

US EPA RegulationsSeveral federal laws administered by US EPA

(including the Clean Water Act and the Safe

Drinking Water Act) regulate aspects of PPCPs in

the environment. The Agency also influences the

manufacture and use of PPCPs through its Endo-

crine Disruptor Screening Program.19

In addition, US EPA regulates certain aspects

of PPCPs pursuant to its Resource Conservation

and Recovery Act (RCRA) rules on waste gen-

eration, storage, and disposal. It should be noted,

however, that the way RCRA identifies these

chemicals has changed very little since 1978.

Some in the pharmaceutical industry argue that

RCRA regulations have not kept pace with drug

development and that, as a result, these rules do

not adequately regulate a significant number of

hazardous drugs.

In December 2008, US EPA proposed a rule

change that would allow RCRA-regulated haz-

ardous pharmaceutical waste to be handled and

disposed of as universal waste. The Agency states

that the proposed change could “reduce hazard-

ous waste in the municipal solid waste stream

by making it easier for universal waste handlers

to collect these items and send them for proper

disposal.”20 The proposed approach would, in


The primary goal of the US DEA regulations is to eliminate diversion

of legitimately manufactured or used controlled substances into the

illicit drug market.

Put the mixture into a disposable con-3.

tainer with a lid, such as an empty marga-

rine tub, or into a sealable bag.

Conceal or remove any personal infor-4.

mation, including Rx number, on the

empty containers by covering it with

black permanent marker or duct tape, or

by scratching it off.

Place the sealed container with the mix-5.

ture and the empty drug containers in the

trash.

Joint Commission “Environment of Care” Standard

The Joint Commission (formerly known as the

Joint Commission on Accreditation of Healthcare

Organizations) has issued “Environment of Care

Standard 3.10” for health care organizations that

manage hazardous materials and waste risks.

The standard provides that organizations should

establish and implement “processes for selecting,

handling, storing, transporting, using and dispos-

ing of hazardous materials and wastes from receipt

or generation through use and/or final disposal,

including managing the following: chemicals, che-

motherapeutic materials, pharmaceuticals, radioac-

tive materials and infectious and regulated medical

waste including sharps.” The standard refers di-

rectly to the applicable RCRA requirements.

American Society of Consultant PharmacistsThe American Society of Consultant Pharma-

cists (ASCP) is a national professional association

that represents consultant and senior-care phar-

macists. On March 26, 2009, ASCP published a

white paper entitled “Reducing Pharmaceutical

Waste.”24 The paper outlined the problems faced

by pharmacists, health care providers, and pa-

tients regarding the proper disposal of pharma-

ceuticals and other PPCPs. The paper also made

suggestions for integrating and improving PPCP

disposal guidelines.

In order to be considered “destroyed,” con-

trolled substances must be rendered “beyond

reclamation.” Two health care professionals must

document the destruction.

White House ONDCP Guidelines on Disposal of Prescription Drugs

Concerns about PPCPs in the environment

have led government

authorities to discour-

age the practice of

flushing leftover pre-

scription drugs into

the sewer system. In

October 2009, the

White House Office of

National Drug Control

Policy (ONDCP) of-

fered the following guidance to consumers on

the proper disposal of prescription drugs:23

Do not flush prescription drugs down the •

toilet or drain unless the label or accompany-

ing patient information specifically instructs

you to do so. For information on drugs that

should be flushed, visit the FDA’s Web site.

To dispose of prescription drugs not labeled •

to be flushed, you may be able to take advan-

tage of community drug take-back programs

or other programs, such as household haz-

ardous waste–collection events, that collect

drugs at a central location for proper dis-

posal. Call your city or county government’s

household trash and recycling service and

ask if a drug take-back program is available

in your community.

If a drug take-back or collection program is •

not available:

Take your prescription drugs out of their 1.

original containers.

Mix drugs with an undesirable substance, 2.

such as cat litter or used coffee grounds.


Concerns about PPCPs in the environment have led government authorities to discourage the practice of flushing leftover prescription drugs into the sewer system.

making the health industry the second-largest

contributor to landfills after the food industry.”26

Reprocessing of medical equipment and devices is

one pathway to reducing the amount of waste gen-

erated by hospitals and other health care facilities.

More than a quarter of hospitals in the United

States now reprocess some medical equipment and

devices. Most of these hospitals reprocess single-use

devices categorized as Classes I and II (meaning

they pose low or medium risk in reprocessing). De-

vices in these categories include items such as surgi-

cal scissors, compression sleeves, and laparoscopic

equipment. Most facilities do not reprocess Class III

items (which are considered higher risk) since they

generally cannot do so

without FDA approval.

In 2008, one large

reprocessing company

in the United States re-

ported that its services

had allowed hospitals

to save over $138 mil-

lion in costs while di-

verting 4.3 million pounds of medical waste from

landfills.27

ASCP Recommendations ASCP suggests some steps that could further

reduce pharmaceutical waste. Among its recom-

mendations are the following:28

Reduce the number of unused doses of •

medicine.

Offer convenient disposal options and imple-•

ment take-back programs.

Provide incentives for the utilization of more •

environmentally friendly incinerators.

US EPA Enforcement and Guidance Efforts on Hospital Waste

In the past few years, US EPA has begun to

focus more attention on how hospitals manage

Regulatory Confusion and the Need for Updated Rules

As the foregoing discussion makes clear, ju-

risdictional conflicts and patchwork rulemaking

have led to gaps in the regulation of PPCPs. More-

over, there is limited information and direction

available regarding the appropriate disposition of

PPCPs. It is no wonder that the regulated com-

munity is confused.

Given the potentially disastrous effects that

PPCPs could have on the environment and

human health, it is critical that the relevant

regulatory agencies and professional organiza-

tions begin serious discussions with stakeholders

in order to expedite the development of updated

and more comprehensive regulations.

What Is Being Done to Address PPCPs in the Environment?

The following paragraphs outline some cur-

rent efforts and initiatives that may help reduce

the level of PPCPs entering environmental media,

while also allowing researchers to understand

what effects these chemicals have on the environ-

ment and human health.

US EPA PPCPs Web SiteUS EPA maintains a Web site on pharmaceu-

ticals and personal care products.25 The site pro-

vides much valuable information, including links

to research and guidance documents on PPCPs.

Waste Minimization Through Reprocessing of Medical Devices

Pollution prevention and waste minimization

ultimately offer the best option for addressing

PPCPs. Such measures can help reduce the quan-

tity of PPCPs that are introduced into publicly

owned treatment works and municipal landfills.

Health care facilities in the United States report-

edly “dispose of over four billion pounds of waste

annually in landfills and commercial incinerators,


Pollution prevention and waste minimization ultimately offer the

best option for addressing PPCPs.

The new rules tighten requirements for medi-

cal waste incinerators, lowering the levels of pol-

lutants they can emit and imposing new testing

requirements on incinerators in rural areas. The

regulations also remove an exemption that once

allowed incinerators to exceed emissions limits

during periods when they were starting up, shut-

ting down, or malfunctioning.

It should be noted that US EPA’s new rule is

already facing a legal challenge. On December

7, 2009, the Medical Waste Institute and the

Energy Recovery Council filed a lawsuit chal-

lenging the rule in D.C. Circuit Court, seeking

to weaken the new regulations as they apply to

hospital, medical, and infectious waste incin-

erators.34

US FDA Draft Guidance on Use of Antimicrobial Drugs in Food-Producing Animals

In June 2010, US FDA issued draft guidance

intended to limit the use of antibiotics by the

animal industry.35 Citing growing concerns about

antibiotic resistance, US FDA stated that the in-

dustry should avoid “unnecessary or inappropri-

ate use” of antimicrobial drugs in food-producing

animals (a category that would include chickens,

pigs, and cattle).

US FDA is particularly concerned about the use

of antimicrobials for promoting animal growth.

Accordingly, the agency recommends that use

of “medically important antimicrobial drugs” in

food-producing animals be limited to cases where

the drugs “are considered necessary for assuring

animal health.” The guidance also recommends

that such drugs be used only with “veterinary

oversight or consultation.”

Representatives from the animal-production

industry have voiced disagreement with the new

draft guidance. Given this opposition, the fate of

the US FDA effort is uncertain. An article in the

New York Times noted:

waste.29 For example, the Agency’s Regions 1

and 2 have both conducted enforcement efforts,

with Region 2 imposing fines that ranged up to

approximately $280,000 on hospitals found to

be out of compliance with applicable hazardous

waste rules.30

In addition, US EPA Region 1 has part-

nered with an organization called Hospitals for

a Healthy Environment (H2E) to develop more

environmentally responsible methods for manag-

ing pharmaceutical waste.31

US EPA Standards for Medical Waste Incinerators

Safe disposal of PPCPs can be impeded by a

lack of incinerator ca-

pacity—and the high

costs that result from

this shortage. Medi-

cal waste incinerators

have been a source of

environmental contro-

versy for many years,

in large part because

of the pollutants they

emit, which can include substances such as heavy

metals and dioxins.

US EPA originally promulgated new source

performance standards and emissions guidelines

for medical waste incinerators in 1997. These

regulations were challenged almost immediately

by environmental groups, who charged that the

standards did not meet the requirements set by

the federal Clean Air Act.32 Litigation in these

cases continued for over a decade.

In response to court rulings resulting from

this litigation, US EPA finally promulgated new

rules for medical waste incinerators in October

2009. The Agency estimates that these regula-

tions will reduce emissions of mercury, dioxins,

lead, and other dangerous pollutants by 393,000

pounds per year.33


Safe disposal of PPCPs can be impeded by a lack of incinerator capacity—and the high costs that result from this shortage.

human exposure is limited, there can be little

doubt that we are being exposed to PPCPs, their

derivatives, and their breakdown products. The

short- and long-term effects of this exposure are

not known.

Despite growing concerns about PPCPs in the

environment, it is unclear how much progress is

being made to address the problem, outside of

data collection, the occasional imposition of

fines, and halting efforts at regulatory guidance.

It is clear, however, that the issue will continue

to increase in importance. At some point, PPCP

exposure could precipitate a health or environ-

mental crisis that demands immediate regula-

tory attention.

Given this background, all affected stake-

holders—including manufacturers and sellers of

PPCPs, regulatory officials, nongovernment orga-

nizations, and consumers—would be well advised

to inform themselves about PPCPs in the envi-

ronment and the potential risks they create.

Notes1. US EPA Pharmaceuticals and Personal Care Products (PPCPs) Web site, http://www.epa.gov/ppcp/.

2. Ibid.

3. Donn, J., Mendoza, M., & Pritchard, J. (2008, March 10). Pharmaceuticals lurking in U.S. drinking water: AP probe found traces of meds in water supplies of 41 million Americans. Available online at http://www.msnbc.msn.com/id/23503485/ns/health-more_health_news/page.

4. See note 1.

5. US CDC. (2001, March 19). Health experts issue “Principles for Appropriate Antibiotic Use” for adults with upper respira-tory infections. Press release. Available online at http://www .cdc.gov/media/pressrel/r010319.htm.

6. CBC News. (2009, December 1). Battling germs that keep getting stronger. Available online at http://www.cbc.ca/health/story/2009/02/12/f-superbugs.html#ixzz0sGiEu6X7.

7. University of Delaware. (2009). USDA awards grant to study hormones, antibiotics in runoff. Available online at http://denin.udel.edu/news/usda-awards-grant-study-hormones-antibiotics-runoff.

8. Meade-Callahan, M. (2001, January). Microbes: What they do & how antibiotics change them. Available online at http://www.actionbioscience.org/evolution/meade_callahan.html.

9. Ibid.

10. Ibid.

[T]he Food and Drug Administration has

tried without success for more than three

decades to ban such uses. In the past,

Congress has stepped in at the urging

of agricultural interests and stopped the

agency from acting.

In the battle between public health and

agriculture, the guys with the cowboy hats

generally win.36

USGS’s Emerging Contaminants ProjectThe United States Geological Survey (USGS) has

an ongoing Emerging Contaminants Project aimed

at developing information on chemical and micro-

bial constituents (including PPCPs) that historically

have received little attention but that appear to be

“present in the environment on a global scale.”37

The project seeks to obtain information on

these substances in order to evaluate the threat

they may pose to the environment and human

health. The research activities of the Emerging

Contaminants Project involve:

developing analytical methods to measure •

chemicals and microorganisms (or their

genes) in a variety of environmental matrices

down to trace levels,

determining the environmental occurrence of •

these potential contaminants,

characterizing the sources and source path-•

ways that determine contaminant release to

the environment,

defining and quantifying processes that de-•

termine contaminants’ transport and fate

through the environment, and

identifying potential ecological effects from ex-•

posure to these chemicals or microorganisms.

Conclusion: No Clear Path ForwardIt appears that PPCPs are becoming ubiqui-

tous in the environment. And although data on


25. See note 1.

26. Kwakye, G., Pronovost, P. J., & Makary, M. A. (2010, March). Commentary: A call to go green in health care by reprocessing medical equipment. Academic Medicine, 85(3), 398–400. Available online at http://journals.lww.com/ academicmedicine/Fulltext/2010/03000/Commentary__A_Call_to_Go_Green_in_Health_Care_by.10.aspx.

27. Ibid.

28. See note 24.

29. See US EPA Office of Solid Waste and Emergency Re-sponse. (2003, July). OSWER innovations pilot: Collaborative partnership to improve environmental performance in the healthcare sector. Available online at http://www.epa.gov/oswer/docs/iwg/Hospitals_6_25_03_final.pdf.

30. Smith, C. A. (2004). Risk management of pharmaceuticals entering POTWs and municipal landfills from routine hospi-tal waste management practices. Available online at http://www.keepantibioticsworking.com/new/resources_library .cfm?refID=37598.

31. US EPA Office of Solid Waste and Emergency Response. (2003, July). OSWER innovations pilot: Expanding pharmaceu-tical waste management in hospitals. Available online at http://www.epa.gov/oswer/docs/iwg/2004_h2e_pharmaceuticals_ draft3.pdf.

32. Sierra Club v. EPA, 167 F.3d 658 (D.C. Cir. 1999).

33. US EPA. (2009, October 6). Standards of performance for new stationary sources and emissions guidelines for existing sources: Hospital/medical/infectious waste incinerators, 74 Fed. Reg. 51368–51415.

34. Medical Waste Institute and Energy Recovery Council v. U.S. Environmental Protection Agency, Case No. 09-1297 (D.C. Cir., December 7, 2009).

35. US FDA. (2010, June 29). Draft guidance: The judicious use of medically important antimicrobial drugs in food-producing animals, 75 Fed. Reg. 37450–37451.

36. Harris, G. (2010, June 28). Antibiotics in animals need limits, FDA says. New York Times. Available online at http://www.nytimes.com/2010/06/29/health/policy/29fda.html.

37. For more information, see the USGS “Emerging Contami-nants in the Environment” Web page at http://toxics.usgs .gov/regional/emc/index.html.

11. See note 3.

12. Daughton, C. G., & Ternes, T. A. (1999). Pharmaceuticals and personal care products in the environment: Agents of subtle change? Environmental Health Perspectives Supple-ments, 107(S6), 907–938. Available online at http://ehp.niehs .nih.gov/members/1999/suppl-6/907-938daughton/daugh-ton-full.html.

13. See note 3.

14. Ibid.

15. Arikan, O. A., Rice, C., & Codling, E. (2008). Occurrence of antibiotics and hormones in a major agricultural watershed. Desalination, 226(1–3), 121–133.

16. US EPA Pharmaceuticals and Personal Care Products (PPCPs) Web site. Occurrence, transport, and fate of phar-maceuticals and other emerging contaminants present in wastewater, http://www.epa.gov/ppcp/projects/occurrence .html.

17. US EPA Pharmaceuticals and Personal Care Products (PPCPs) Web site. The effects of disinfection on pharmaceu-ticals in drinking water supplies, http://www.epa.gov/ppcp/projects/disinfection.html.

18. US EPA National Lake Fish Tissue Study Web site, http://www.epa.gov/waterscience/fish/study.

19. See US EPA Endocrine Disruptor Screening Program Web site, http://www.epa.gov/endo/.

20. US EPA. (2008, December 2). Amendment to the uni-versal waste rule: Addition of pharmaceuticals, 73 Fed. Reg. 73519–73544. Available online at http://edocket.access.gpo .gov/2008/pdf/E8-28161.pdf

21. Ibid.

22. For more information, see the US DEA Office of Diver-sion Control Web site at http://www.deadiversion.usdoj.gov/index.html.

23. White House Office of National Drug Control Policy. (2009, October). Proper disposal of prescription drugs. Avail-able online at http://www.whitehousedrugpolicy.gov/publi-cations/pdf/prescrip_disposal.pdf.

24. American Society of Consultant Pharmacists. (2009). Re-ducing pharmaceutical waste. Available online at http://www .ascp.com/advocacy/briefing/upload/Reducing%20Pharm% 20Waste%20White%20Paper.pdf.


Kathleen Gibson is general manager of the WSP Environment & Energy office in Somerset, New Jersey. She can be contacted at [email protected].

pharmaceuticals and personal care products (ppcps): disposal, scientific, and regulatory challenges

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