HomeMy WebLinkAboutAgenda Bill PresentationLate1 11/02/2009®.
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November 1, 2009
Petaluma City Council
City of Petaluma
11 English St.
Petaluma, CA 94952
RE: Contaminated Waste Water
Dear City Council:
Petalumans for Fair Utility Rates
P. O. BOX C
Petaluma, CA 94953
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Enclosed, please find the Food and Drug Administration (FDA) Consumer Antiseptic Drug Products
Review dated August 22, 2005.
This paper effectively outlines how biocides including Pharmaceuticals and personal care products
(PPCPs) are present in treated wastewater and lead to abnormal physiology or reproductive impairment
in aquatic organisms, increased incidence of cancer, the development ofantibiotic-resistant bacteria and
the potential increased toxicity of chemical mixtures.
Having spent a few hours researching these concerns via the Internet, I have found a dozen recent
articles which all support this research.. I also have learned that the FDA is currently developing Federal
guidelines on the safe disposal of waste water which will probably ban the use of wastewater in aquatic
ecosystems.
Please protect our environment and stop having the Water Resources Department contaminate the new
wetlands park with waste water. By using groundwater to service this park, The City of Petaluma can
save millions of dollars in environmental clean-up costs.
Sincerely,
Petalumans for Fair Utility Rates
r
James Fitzgerald
t'~~ ,~~ ~" ~ ;~,~~ ~ i ~ ~`~ C®I~TST71i~E Al~`~ISEP'I'IC
~~ ~~ .. _ . _ ;~~ \ DRLT4~ P®I)I1CTS REVIEW
._. -~.:~
®ffice of Nonprescription Products (HF'D-560)
Center for Drug Evaluation and Research ®Food and Drug Administration
REVIEW DATE:
FDA DOCKET NO.:
PHARMACOLOGIC CATEGORY:
REVIEWER:
August 22, 2005
75N-0183H
Consumer Antiseptic Drug Products
Colleen Kane Rogers, Ph.D.
I. Purpose
This review provides a general overview of the literature relating to potential environmental
hazards of the active ingredients used in consumer antiseptics. A PubMed literature search.
was performed using combinations of the following search terms: "benzalkonium,"
"benzethonium," "chloroxylenol OR PCMX," "trichlorocarbanilide," "triclocarban," or
"triclosan," with "algae," "environment," "fish," "soil," or "water." Pertinent references
from the bibliographies of key articles also were included. The following overview is limited
to articles written in English and published prior to July 2005, with an emphasis on articles
published since 2000. Furthermore, please note that only a subset of environmental journals
is represented in the PubMed database. ~.
II. ®verview and Summary
Previously unrecognized environmental pollutants are now being discovered due to more
vigilant monitoring and improved analytical detection techniques. Pharmaceuticals and
personal care products (PPCPs) comprise one broad class of these environmental pollutants.
PPCPs include a wide range of chemicals from products such as prescription and
nonprescription drugs, fragrances, sunscreens, detergents, and toothpastes. One reason for
concern is that these chemicals are not completely removed during wastewater treatment. As
a result, humans may be exposed to minute quantities of these chemicals via alternate routes
of exposure, with unknown consequences. Other potential concerns from the environmental
presence of these compounds include abnormal physiology or reproductive impairment in
aquatic organisms, increased incidence of cancer, the development of antibiotic-resistant
bacteria, and the potential increased toxicity of chemical mixtures.`
While FDA does not monitor or regulate biocides in the environment, we felt it was
important to consider this issue as a potential hazard resulting from the use of consumer
antiseptics. FDA is required under the National Environmental Policy Act of 1969 (NEPA)
to consider the environmental impacts of approving new drug and biologics applications as
an integral part of its regulatory process. For these environmental assessments, FDA
considers harm to the environment to include not only toxicity to environmental organisms
but also environmental effects other than toxicity, such as lasting effects on ecological
community dynamics. In contrast, environmental assessments are not usually considered as
part of the over-the-counter drug revieWV.
i~,'lost antiseptic products are disposed of down residential drains, where they undergo
treatment by local wastewater treatment plants (WV~'TPs}. During wastewater treatment,
rr~ar~y of tl~e chertticals, inc}udir?g biocides, are removed, but sortie cl?er~~icals still reach
surface waters (e.g., rivers and lakes}. The effcieney with which WWTFs remove
contaminants depends upon the particular chemical and also on the technology used (e.g.,
physical, biologic}. However, no municipal sewage treatment plants are en~,ineered to
remove PPCPs.'
By far the roost inforrttatiort we found pertained to the oceul•rence and fate of triolosan in the
environrtrent. Much of the information about the presence of triolosan in surface waters
::%rttes from? Europe, although recent studies 1?aye exarttined rivers artd streams in the liS.
r3~ era11, these studies suggest that many organic contaminants, including triolosan, survive
~f aster,-ater treatrttertt artd biodegradation, arrd can be detected at ic~~~ lei-cis in the
environment, par€icularly in surface waters and sedirrrertt.
3~cspEie t~'L?ntrlt€1211 Ilttl'() dllCt?(iCt l)f t?'1Cli)tiarl rti€i) ~V2itt;1 ti(~€lrCe~, lc~ear~hci's 1laVC ,de:ntr~led 2t
nurt3ber of mechanisms for its removal. Same ofthe triolosan [eaves surface waters and
~~'t~%TP influer?t via sedirtterttation. I{t additio{?. several investi~~ator•s have sho~~~n .that
triclosar? in surface waters can be degraded in the presence ot'sunii~~ht. However, this
pltotodc-~~radatic~r? can resLrlt in ita{-rttfirt products. sLrclt as dio~~ir?. The ;,alculated half-life 'of
triolosan. exposed to sunlight ranged from less than an hour to 200Q day's. depending on the
l~Itit£Ide {?d time e~f ~> ear. t7rt the other ha{ci, triclos~.r? dyes {t'ot hire to it ~-e a ion's half-life
€o persist in the environment. constan€ irr€roduction in€u surface waters tvorrld have €he same
~ffeCtaS pe{'srstertCe. Tr{Closar? Can a1St~ ti{?d:r~?~ 'Jt1L~r t!'~3nS:f~~ri11t1tiOC1 S?.~J~~SS~S. SL1Clt C1S
methvlation. But. the fate anc~ effect of these environmental transforn?anon products is
lar~'ely uni:nown.
~?.?ally', tr{Closa{? has soil?te adver'se e~7eCt5 '~{? aCt~attC Or`a{?{S{tl~. T{'{CloSa{t ~ I~•,.~eaCS t0 InltCl?ii
the grov<-th ofalgae and reduce alga[ species diversitt'_ This is notable because the biocide is
~~ff.:'t{C?` ~~r`_'arl{~CttS at tltC l".~~ttOCl? ~f the 1OOd Chat[?, ~F,'{tit L'.{?iiI?Ll?'Ct COt:SC;'lLl4',C1C".5 (3Ct
or~?anisrr~s hi<~her up the chain. lrt hi_~her or~~anisms. triolosan appears to be toxic to early
life-stages offsh. but does not appear to have an adverse effec€ art their reproductive
carabilities. I-lowever. tl-icloSat~t induced behavioral.ciYart~~es in bath tadpoles and fish ttlat
may affect their abilifl~ to evade predatars ar feed praperiti--~.
III. Literature Sumrnarv
A, T~rQcvn~e {2f 1~irlrir]Qc in t~P F:rjvirnt~mPnt
Hottseh~old. indtatriaL and cotrtlaerciai liciuid Waste is carried via sewersto a colttltton
treatment facility. knavvn as a WWTP. Wastewater treatment frectuently involves several
steps to make the effluent ft to be received in the environment, ine[uding physical, chemical.
or hiolc~~~ical lt~athc~ds. Tri:, osali tins been c~etectec~ in Vhl~%TP inf~ients at conceiitr~aie~ns
ran~in~ from 62 to 2f.9Q0 nJL.`°° "°-t°-- The amount of triclosan, or other chemicals. that is
removed fram this influent depends upon the vvastevv°ater treatment method emptayed.
St<,dies froltl both the LAS attd Europe lta~-~ s}to~~~t. that apnti~~itnately ~~°%c of tl~e trio-lawn it1
~yastev:~ater is eliminated via the activated s[ud~e mechanism of treatment u, -~'' -° However.
~~'t~%TP that use other tre~~tntent Inecltaf.islns, for eYalttple tricatililtn f ltel-, are not as efficient
at removing triciosan from tivastewater (fram 58 to 97%):` '° As a result of incomplete
r~n?o~~at, a percenta«e of the tricivsan enterin« Vt'~~'TPs !eaves titoug.l plant effluent ancz is
introduced into the ens=iranment via receivina 4vaters.
Tric[osan has been measured in W~~~TP effluents and, perhaps not surprisinaly-
ct~ncentratians ~~~ere higher in these efuuents than in strrface~4~~aiers. Triciosan ~~~as detected •
at 1 {~(t to 44Q nn/L in \k 4~~'TP cfttuents in l~an~~ay."' Simi}arty.. tric[osan tivas detected at
t 0 to ~QC) nt~~L in Germany,' and at =!2 to 2 j 3 n~~; L in V+rGt'"F•I' effluents in Stivitzerl;?nd.`~`
to the I'S. triclosan concentratit>ns in WV>-rT'P et~Iuents i~an~ed fral~~ ~2r0 to 2?4~fJ 1~,~/i~.~~ to
contrast, a stu~dl: condlacted it. Louisiana fout:d triclosan itt 1~~'i~~TP eftlttet .It col;ces~tratians
of only 1Q to ~l n~r`L_° Furthermore. triciosan ryas pat detected in t~~tississippi River water or
in drin(:in~ water purification plant samples from Louisiana or f~ntaria. Canada.
PPi;'Ps in !~'1~'`t'P er~luents are :lilt:tted oln:e the eftltteiit rrti~es ~~-it1~ st..-f~3ce ;t-at~:.-s..L>espite
this. PPCPs can sti31 be. detected fram a variety of water sources. Triclasan has keen detected
in various bodies of water throu~hotat~Europe. Samples from Germany demonstrated a
ma~irntrm triciosan concentration of i t;+ nt7iL in fxuhr River water, ~~~hich receives ~'i~%i~P
cttlttel~t and also serves as a source ter drinl:inn tivater pur.iticatial~ plants.' SEA iss rivers
receiyil~~ ~~'t~~TP effluent were found to have be#i~~een 1 1 and 9R n~!L triclt~sarl --, and
trfCl(?ti~ t',`~~ d~te:aed 111 C:371Celltl'at7onS ill' tip ~~~ n<<?it. !n SeYerrtl [a~-;es 2?nd ~I rTy'CT' ill ~7~{?Fk*`r
C~x._ cY~s~~. li; Ili ~.;~rstrwct tr:~E:ec:3? a-a~ bei~,}T t~? l;l;?.t C,~fdet~~c:t:on f~'1:.:-~ :1„%t µ
`~.i I t .4~ f' IF~
iiiOUuu~n iat~i itiii~ r%Ci;l'v`eu' iiv J4'v~` i i'' CfttUC'.ni.
to t_atiiSlalla, in~~eSt'`:~rit31"s detected trlclasan at a ?l]allnltl:S1 O$ ~. i n`2iL ill cl t s'i~tiss'sslpp.
River and up to [=[.9 ng;L in Lake Pontchartrain.' [n Ne~v Orleans. storm~1°aier is diverted
tl?rt~t3`'tS d1'al'3'1`~l i:~nals at~d disCt~l1''-rt'd Int'J ti.i: iL'~ISs3S~lt?pl t~.1~,'c',' :~tld ~`.afll' Yti;:~tll~.ltr;lilt.
[nterestin~l~. up to'9 n~/L triclosan was detected in these starmivater canals. which do pat
:"ecel', C 1~'l~t%TP efllt3ent. t3ete': tiOt; :?r PPC.Ps ~t%~S `~+'CZ~i~r dilr9n~ +`~ :l~T~lii. 1j. ~4s:~9] ~~~tts
attributed to camamination afthe canals with setya~e from the a~Tin~~ server system.
E~olpin and colleagues from the fJS Geolo,ical Survey recenti~' conducted the first
nationwide reconnaissatlce of 17e o::currer:ce of a broad rarf~e of orf~anic «-aste~vater
contaminants in US water resources." V~-ater samples from 139 streams in 30 states were
sanlnled for the c~resence of ~}5 or~`anic contaminal~ts. including triclosan. The investigators
chose streams that tivere considered susceptible to contamination from various wastewater
sc;urces. sr; the resrllts are rrTt ?-enresertt^ti~~e ~fai! streams. t~t tt7e r77 c~mn~uncls aralv~.ed.
tric:li7san vas the sixth-most-common chemical detected. Furthermore. triclosari was
detected in nearly 6E}% of the samples analyzed, at a maximum concentration of 2300 n~IL.
Tric(r}carban (TCC:}. like iriclosan. is a common antimicrobial ingredient in personal care
products; ho~~~ever, ille ervirc~nn7ental fate ufTC'C is iar~ei~~ llni~nowr7. Haiden and Paul!
developed methods to detect TCC in aquatic environments at the n~; L level.y TCC tivas
found in river water and wastewater at concentrations of up to X600 and 670 na; L,
respc~;tivel~. F'or7versel~~, TC'C ~j~as not detected in drinkin~~ ~~~~iter'. in a subsec7uent stlrc~~,
both triclosan and TCC were detected in six urban streams in the greater Baltimore area.i°
The reslrlts of this siud~' suggest that TCC likel~~ ranks in the top t C in occurrence rate anti in
the top ?J ir7 r77i3xinlunl concentration ~.n7on<< tt,e or~iarlic nolllrtatits considered b~~ Koipit7 and
collea~~ues." The authors note that contamination was not s~lcly due to incomplete removal
Calll'Ir7` t` ;l~.t~`{'aier treatment: the b10'.'Ide~ tilal' l7aVe bcer7 IrlIroduCeCj 1nt0 tt'~e strea tl7s due t'~
se~va~e spills and leakage. The authors also note that the TCC concentrations found in ibis
i-; ! '?G(t f;t ~ ~.. .~ri. .,-E~:` '-':eF .n• i i i -~•l i
~l~i ~' {C7. _ - tt` ~.-1 iirZ 1, [~,e n~ui i:l`eS..i ic~~e.S tt7~ ii7i71E1illril. jC~.' ~Oi7Cti: rllrati`.}rls ~ ~~=t Ull ~i~t_;i
Eased ~,, tl7e EPA, for evaluating the ~coli}~ical and hui~nan.health risks of this chemical.'''
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