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EPA Report: Pharmaceuticals and Personal Care Products as Pollutants

Posted to OCA site 7/12/2004

From Terressentials Organic Body Care: Following are a few quotes from a very interesting report from the EPA titled "PPCPs as Environmental Pollutants - Pharmaceuticals and Personal Care Products (PPCP's) in the Environment: Overarching Issues and Overview" by Christian G. Daughton, Chief, Environmental Chemistry Branch, ESD/NERL, Office of Research and Development, Environmental Protection Agency, Las Vegas, NV 89119:

( the link to the full EPA report: )

"The fact that PPCPs can be introduced on a continual basis to the aquatic environment via treated and untreated sewage essentially imparts a quality of "persistence" to compounds that otherwise may not possess any inherent environmental stability -- simply because their removal/transformation (by biodegradation, hydrolysis, photolysis, etc.) is continually countered by their replenishment..."

"Perhaps more so than with any other class of pollutants, the occurrence of PPCPs in the environment highlights the intimate, inseparable, and immediate connection between the actions, activities, and behaviors of individual citizens and the environment in which they live. PPCPs, in contrast to other types of pollutants, owe their immediate origins in the environment directly to their worldwide, universal, frequent, highly dispersed, and individually small but cumulative usage by multitudes of individuals -- as opposed to the larger, highly delineated industrial manufacturing/usage of most high-volume synthetic chemicals. PPCPs enjoy true worldwide usage and concomitant potential for discharge to the environment. Their introduction to the environment has no geographic boundaries or climatic-use limitations as do many other synthetic chemicals. They are discharged to the environment wherever people (having access to medication or medical care) live or visit, regardless of season."

"Also note that the numerous ingredients in personal care products and the many bioactive compounds in "nutraceuticals" (e.g., the active ingredient[s] in St. John's wort) are not even considered here."

"Sewage and domestic wastes are the primary sources of PPCPs in the environment (posing concerns for drinking water supplies?): These bioactive compounds are continually introduced to the environment (primarily via surface and ground waters) from human and animal use largely through sewage treatment works systems (STWs), failed septic fields, leaking underground sewage conveyance systems, and wet-weather runoff -- either directly by bathing/washing/swimming (via discharge of externally applied PPCPs, such as fragrances or sun-screen agents, or those excreted in sweat) or indirectly by excretion in the feces or urine of unmetabolized parent compounds. Bioactive metabolites (including reconvertible conjugates) are also excreted. "

"Aquatic organisms -- captive to continual, life-cycle chemical
exposures: Any chemical introduced to the aquatic domain can lead to continual exposure for aquatic organisms. Chemicals that are continually infused to the aquatic environment essentially become "persistent" pollutants even if their half-lives are short. Their supplies are continually replenished and this leads to life-long multi-generational exposures for aquatic organisms."

"Could subtle effects accrete to unnoticed change? A major issue yet to be addressed by ecotoxicological science...Subtle, unnoticed effects could accumulate over time until any additional incremental burden imposed by a new, unrelated stressor could possibly trigger sudden collapse of a particular function or behavior across a population...In a range of articles on behavioral and neuro toxicology (see 45,46, and references cited therein), a cogent argument is presented that neurobehavioral effects (with humans being the subjects of concern) are particularly apt to display with such subtlety that they can escape detection by conventional quantitative approaches."

"Finally, there are potential, intangible benefits in being proactive versus reactive -- the Precautionary Principle - the principle of precautionary action that redistributes the burden of proof ("reverse
onus") because the science required for truly and fully assessing risks lags far behind the requisite supporting science (e.g., see:"

"Importance of Individual Action: EDUCATE public on (i) how their individual actions, activities, and behaviors each contributes to the burden of PPCPs in the environment, (ii) how PPCPs can possibly affect aquatic biota (and even impact drinking water)"

Here are a few additional tidbits from a second EPA report "Pharmaceuticals and Personal Care Products in the Environment: Agents of Subtle Change?" also by Christian G. Daughton and Thomas A. Ternes
of the Environmental Sciences Division, U.S. Environmental Protection Agency (about endocrine disruptors in personal care products):

( the link to the full EPA report )

"Fragrances (musks) are ubiquitous, persistent, bioaccumulative pollutants that are sometimes highly toxic; amino musk transformation products are toxicologically significant. Synthetic musks comprise a series of structurally similar chemicals (which emulate the odor but not the structure of the expensive, natural product from the Asian musk
deer) used in a broad spectrum of fragranced consumer items, both as fragrance and as fixative. Included are the older, synthetic nitro musks (e.g., ambrette, musk ketone, musk xylene, and the lesser known musks moskene and tibetene) and a variety of newer, synthetic polycyclic musks that are best known by their individual trade names or acronyms. The polycyclic musks (substituted indanes and tetralins are the major musks used today, accounting for almost two-thirds of worldwide production) and especially the inexpensive nitro musks (nitrated aromatics accounting for about one-third of worldwide production) are used in nearly every commercial fragrance formulation (cosmetics, detergents,
toiletries) and most other personal care products with fragrance; they are also used as food additives and in cigarettes and fish baits (96).'

'The nitro musks are under scrutiny in a number of countries because of their persistence and possible adverse environmental impacts and therefore are beginning to be phased out in some countries. Musk xylol has proved carcinogenic in a rodent bioassay and is significantly absorbed through human skin; from exposure to combined sources, a person could absorb 240 5g/day (97). The human lipid concentration of various musks parallels that of other bioaccumulative pollutants such as PCBs"

"PARABENS (alkyl-p-hydroxybenzoates) are one of the most widely and heavily used suites of antimicrobial preservatives in cosmetics (skin creams, tanning lotions, etc.), toiletries, pharmaceuticals, and even foodstuffs (up to 0.1% wt/wt). Although the acute toxicity of these compounds is very low, Routledge et al. (112) report that these compounds (methyl through butyl homologs) display weak estrogenic activity in several assays. Although the risk from dermal application in humans is unknown, the probable continual introduction of these benzoates into sewage treatment systems and directly to recreational waters from the skin leads to the question of risk to aquatic organisms. Butylparaben showed the most competitive binding to the rat estrogen receptor at concentrations one to two orders of magnitude higher than that of nonylphenol and showed estrogenic activity in a yeast estrogen screen at 10-6 M ."

"The occurrence of SUNSCREEN agents (UV filters) in the German lake Meerfelder Maar was investigated by Nagtegaal et al. (115). The combined concentrations of six sunscreen agents (SSAs) identified in perch (Perca
fluviatilis) in the summer of 1991 were as high as 2.0 mg/kg lipid and in roach (Rutilus rutilus L) in the summer of 1993, as high as 0.50 mg/kg lipid. Methylbenzylidene camphor (MBC) was detected in roach from three other German lakes. These lipophilic SSAs seem to occur widely in fish from small lakes used for recreational swimming. Both fish species had body burdens of SSA on par with PCBs and DDT. The bioaccumulation factor, calculated as quotient of the MBC concentration in the whole fish (21 5g/kg) versus that in the water (0.004 5g/L), exceeded 5,200, indicating high lipophilicity. The fact that SSAs (e.g., 2-hydroxy-4-methoxybenzophenone [oxybenzone] and
2-ethylhexyl-4-methoxycinnamate) can be detected in human breast milk [16 and 417 ng/g lipid, respectively (116)] shows the potential for dermal absorption and bioconcentration in aquatic species. No data have been published on newer SSAs such as avobenzene (1-[4-(1,1-dimethylethyl)phenyl]-3(4-methoxyphenyl)-1,3-propanedione)."

"The significance of subtle and cumulative impacts is only beginning to be recognized by environmental toxicologists. Weiss (129) wrote that just as the predicted rise in "crack babies" whose pregnant mothers used cocaine was never observed--rather only a small but significant 3% reduction in IQ was observed--the same subtle effects are very likely occurring from environmental toxicants. Weiss points out that the effects on humans by lead (Pb), methyl mercury, PCBs, and endocrine disruptors in general probably are manifested in almost undetectable changes, and these may accumulate over time to yield truly profound changes that would not be distinguishable from natural events. The specter of subtle, cumulative effects could make current toxicity-directed screening largely useless in any effort to test waste effluents for toxicologic end points.'

'Abnormal behavior can masquerade as seemingly normal deviation within a natural statistical variation. Change can occur so slowly that it appears to result from natural events, with no reason to presume artificial causation. It is difficult to connect the issues of cause and ultimate effect, in part because of the ambiguous and subjective nature of subtle effects, but especially when these effects are confounded as aggregations of numerous, unrelated interactions."

Here are definitions of two important words from the USDA National Organic Program's regulations:

Nonsynthetic (natural). A substance that is derived from mineral, plant, or animal matter and DOES NOT undergo a synthetic process as defined in section 6502(21) of the Act (7 U.S.C. 6502(21)). For the purposes of this part, nonsynthetic is used as a synonym for natural as the term is used in the Act.

Synthetic. A substance that is formulated or manufactured by a chemical process or by a process that CHEMICALLY CHANGES a substance extracted from naturally occurring plant, animal, or mineral sources, except that such term shall not apply to substances created by naturally occurring biological processes.

Here's a link to the USDA National Organic Program (NOP) definitions: