CITIZEN PETITION TO THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

________________________________________________ ) FOOD & WATER WATCH, ) ) BEYOND PESTICIDE ) S ) ) Petitioners,

Filed With: ) ) Docket No. ) UNITED STATES ENVIRONMENTAL ) PROTECTION AGENCY and ) Lisa Jackson, Administrator ) ) ) _______________________)

_________________________ Food & Water Watch Suite 300 1616 P Street, NW ashington, DC 20036 202) 683-2500 W ( Beyond Pesticides Suite 200

0003 701 E Street, SE SUBMITTED BY: Washington, DC 2 (202) 543‐5450

ce Perry E. Walla Zelle Hofmann Voelbel

5 & Mason LLP uite 65 . 20006 1700 K St. N.W., S Washington, D.C (301) 675‐5969 Attorney for Petitioners

1CITIZEN PETITION FOR AN A BAN ON TRICLOS

Introduction Petitioners Beyond Pesticides and Food & Water Watch, acting through counsel, hereby submit this Citizen Petition for a Ban on Triclosan ( Petition) . Petitioners are nonprofit organizations engaged in research, e ducation and advocacy on behalf of the public, seeking to protect public health and safety and the environment from the adverse effects of widespread triclosan usage. Petitioners’ Right to Petition This Petition is submitted pursuant to the right to petition government contained in the First Amendment of the United States Constitution, 1 the Administrative Procedure

Act 2 (APA), the Federal Insecticide, Fungicide, and Rodenticide Act 3 (FIFRA), the Federal Food Drug and Cosmetic Act (FFDCA), 4 the Federal Water Pollution Control

Act 5 (Clean Water Act or CWA), the Safe Drinking Water Act 6 (SDWA) and the

1 U.S. Const., Amend. I. (“Congress shall make no law ... abridging ... the right of the people ... to petition Government for a redress of grievances.”). The right to petition for redress of grievances is among the most precious of the liberties safeguarded by the Bill of Rights. United Mine Workers of Am., Dist. 12 v. Illinois State Bar Ass’n , 389 U.S. 217, 222 (1967). It shares the “preferred place” accorded in our system of government to the First Amendment freedoms, and has a sanctity and a sanction not permitting dubious intrusions.” Thomas v. Collins , 323 U.S. 516, 530 (1945). “Any attempt to restrict those First Amendment liberties must be justified by clear public interest, th reatened not doubtful or remotely, but by clear and present danger.” Id . The Supreme Court has recognized that the right to petition is logically implicit in, and fundamental to, the very idea of a republican form of government. United States v. Cruikshank , 92 U.S. (2 Otto) 542, 552 (1875). 2 5 U.S.C. § 553(e) ( 2005) (“Each agency shall give an interested person the right to petition for the issuance, amendment, or repeal of a rule.”). 3 7 U.S.C. § 136w et seq. 4 21 U.S.C. §§ 301 et seq. 5 33 U.S.C. §1251 et seq. 6 42 U.S.C. § 300f-300j-26.

2Endangered Species Act 7 (ESA). Petitioners request that the Administrator of the Environmental Protection Agency (EPA) use he r authority under FIFRA, the FFDCA, the CWA, the SWDA and the ESA to grant any a nd all remedies available under relevant

federal law. Triclosan; Characteristics, Uses and Regulatory Agencies Triclosan is a synthetic, broad-spectrum an timicrobial chemical that is currently used extensively in a wide range of c onsumer products. These products fall under the jurisdiction of both the Unite d States Food and Drug Admini stration (FDA) and the EPA. For those products under EPA’s jurisdiction, EPA decided in 2008 that the currently registered uses of triclosan ar e eligible for “reregistration.” 8 This Petition is submitted based primarily on the steadily increasing scientific knowledge and consensus about

triclosan’s adverse effects on public health and safety and the environment. Petitioners also address the EPA RED’s analysis in order to illustrate the inadequacies of past EPA analyses and conclusions about triclosan. Summary of Relief Sought and Scientific Grounds 1. Specific Relief Requested Petitioners urge the Administrator to gr ant the following relief in this Petition:

FIFRA and FFDCA

• Reopening the RED;

• Suspension and Cancellation (Petitioners ’ principal requested relief) ; and

• Any Other Remedies Called for by Federal Law.

7 7 U.S.C. §136; 16 U.S.C. §460 et seq. 8 Environmental Protection Agency, Final Reregistration Eligibility Decision for triclosan (RED).

3CWA

• Technology-Based Effluent Limitations;

• Health-Based Toxic Pollutant Water Quality Pretreatment Requirements;

• Biosolids Regulation.

SDWA

• Comprehensive assessment of appropri ateness of listing and regulation.

ESA

• Consultation with the Secretary of the Interior and the Secretary of Commerce;

• Preparation of a Bi ological Assessment. 2. The Remedy Should Be Based on “Transparency and Sound Science.” Petitioners believe that applicable law and science justify the relief requested

below and that therefore the Administrator should act decisivel y. In this regard, Petitioners endorse the approach and the pol icies applied by the Administrator in EPA’s decision to launch “a comprehensive new ev aluation of the pesticide atrazine to

determine its effects on humans.” 9 In the case of triclosan, however, Petitioners will

demonstrate that the scientific evidence and th e legal authorities are so substantial as to require suspension of the registered uses of triclosan pending agency deliberations regarding cancellation. In making its “new evaluation” of atrazine, EPA will investigate its potential effects with respect to cancer and non-cancer effects on hu mans, birth defects,

9 See EPA. EPA Begins New Scientific Evaluation of Atrazine . 10/07/2009. http://yosemite.epa.gov/opa/admpress.nsf/d0cf6618525a9efb85257359003fb69d/554b6abea9d0672f852576 48004a88c1!OpenDocument

4low birth weight, premature births and amphibians and aquatic ecosystems. 10 Steve Owens, Assistant Administrator for EPA’s Office of Prevention, Pesticides and Toxic Substances, explained EPA’s decision to rec onsider its past approva ls of atrazine as

follows:

One of Administrator Jackson’s top pr iorities is to improve the way EPA manages and assesses the risk of chemicals, including pesticides, and as part of that effort, we are taking a hard look at the decision made by the previous administration on atrazine ...O ur examination of atrazine will be based on transparency and sound scien ce, including independent scientific peer review, and will help determine whether a change in EPA’s regulatory position on this pesticide is appropriate.” 11

Petitioners believe that the same scientific and legal grounds exis t in regard to the potential adverse health and environmental effect s of triclosan as do in regard to atrazine, and, given the widespread public and environmen tal exposure to it, a mandate exists for urgent action to suspend the uses stipulated in this Petition. Accordingly, Petitioners assert that the relief requested below is soundly based and is justified. 3. Summary of Major Scientific Points The major points presented in this Petition are the following:

• Endocrine Disruption. Endocrine disruption is a nother potentia l result of triclosan bioaccumulation in the body. This effect, in turn, poses serious

10 Id. 11 Id.

5threats to thyroid and other organ fu nctions, and it can also influence the development of cancer.

• Bacterial Resistance. Bacterial resistance to antibiotic medications and antibacterial cleansers is just one cat egory of threats emanating from the growing body burden of triclosan. Su ch resistance renders humans (especially vulnerable subpopulations ) wide open to bacteria-induced illnesses and death;

• Body Burden. The presence of triclosan in the human body (as evidenced by scientific studies of its activity in blood, urine and br east milk) imposes an immense and dangerous “body burden.” This presence raises concerns about a multitude of threats to humans;

• Wastewater, Sludge and Food Contamination. Wastewater contamination by triclosan is a serious health threat. Impor tantly, triclosan products used in the home and in th e workplace typically yield residues

that flow into wastewater from rinsing, cleaning and other normal

activities. Because these residue s are not rendered harmless by the wastewater treatment process, they are free to reenter the environment— and ultimately the human body;

• Failure to Address Major Degradates. Once in the larger environment, triclosan poses numerous additional dangers:

6o It may be transformed into dioxin and chloroform when exposed to sunlight under certain conditions, th us creating the threat of cancer development;

• Aquatic and Other Ecosystem Impacts. Because it is present in the larger environment, triclosan can be highly toxic to di fferent types of algae, thus creating both specific threats as well as potential destruction of larger ecosystem balance. Threatened and endangered species and their habitat, to the extent they come into contact with sufficient quantities of triclosan, are vulnerable.

• Efficacy. Numerous scientific studies and reports indicate that triclosan is not any more effective than many safer, less-expensive products. Therefore, consumers and other users of triclosan products suffer, at a minimum, economic detriment from having purchased a product that is unnecessarily costly, and, in the worst case, poses potential danger to their health and safety.

• Organizational Actions and Decisions Targeting Triclosan. As a result of the rapidly mounting evidence, serious concerns about triclosan’s safety and efficacy have led a number of go vernmental, professional, corporate and other organizations to condemn or reject that substance as appropriate for many uses in society.

7These points are discussed in deta il in Section II of this Petition.

I. Environmental Laws Violated by Triclosan Usage, and the Administrator’s Authority to Take Action to Protect Public Health and Safety and the Environment and the Requested Relief The Federal Insecticide, F ungicide and Rodenticide Act, 12 (FIFRA) and the Federal Food, Drug and Cosmetic Act 13 (FFDCA) are the principal statutes relied upon in this Petition. Nonetheless, the pervasive and widespread us e of triclosan, along with its particular characteristics and th e nature of its authorized uses, has also triggered actual or potential violations of certai n other federal statutes. This section describes the various statutes invoked by this usage.

A. Federal Insecticide, Fungicide and Rodenticide Act and the Federal Food, Drug and Cosmetic Act

1. Objectives, Structure and Relevant Legal Provisions Under FIFRA, EPA may not register a “pesticide” unless the chemical will perform its intended function without causing any “unreasonable adverse effects on the

environment.” 14 This effect is defined as “any unreasonable risk to man or the environment, taking into account the econom ic, social, and environmental costs and benefits of the use of any pesticide.” 15 Regulatory Jurisdiction of EPA and FDA EPA and the FDA both have major regulator y mandates regarding substances like

triclosan. 16 Further, the two agencies have concu rrent jurisdiction over certain substances

12 7 U.S.C. § 136w et seq. 13 21 U.S.C. §§ 301 et seq. 14 7 U.S.C. § 136a(c)(5)(C). 15 7 U.S.C. §136(bb). 16 Memorandum of Understanding Between the Environmental Protection Agency and the Food and Drug Administration, Drug/Pesticide Products for Use on or in Animals, 48 Fed. Reg. 22799 (May 20, 1983); Enforcement of the Federal Insecticide, Fungicide an d Rodenticide Act, Registration, Reregistration and

8and uses. Examples include: sanitizers fo r food contact surfaces; microbiocides in packaging coming into contact with food; anti microbial agents used on medical devices; and substances used to control microorganisms in cane sugar and beet sugar mills. 17 EPA Regulation Although EPA’s regulatory mandate under FI FRA covers a number of activities, the most pertinent ones to this Petition are registration (including re registration), labeling and pesticide residue tolerances. FIFRA Section 3(a) prohibits the distribut ion or sale of a pesticide that is not registered under that statute. 18 The Administrator will register a pesticide upon a determination, subject to any a pplicable restrictions, that: it s composition is such as to warrant the proposed claims about it; its la beling and other submitted material comply with FIFRA; it will perform its intended f unction without unreasonable adverse effects on the environment; and when used in acco rdance with widespread and commonly recognized practice it will not generally ca use unreasonable adverse effects on the

environment. 19 The reregistration review requirement s imposed on EPA by FIFRA reflect an increasing concern for protecti on of human health and the en vironment. Indeed, a series of statutory amendments to FIFRA, includi ng the Federal Insecticide, Fungicide and Rodenticide Act Amendments of 1988, the Food Quality Protection Act of 1996 and the

Classification Procedures, 44 Fed. Reg. 63749 (Nov. 5, 1979) (Update to Memorandum of Agreement); Agreement Between Department of Health, Educatio n and Welfare and Environmental Protection Agency, Notice Regarding Matters of Mutual Responsibility, Amendment , 38 Fed. Reg. 24233 (Sept. 6, 1973)(regulatory exemption from FIFRA of certain products subject to the FFDCA); Agreement Between Department of Health, Education and Welfare and Environmental Protection Agency, Notice Regarding Matters of Mutual Responsibility , 36 Fed. Reg. 24234 (Dec. 22, 1971).(Memorandum of Agreement). 17 E Brown, A Claassen, C Hathaway, J Homstead , T Powell, W Wehrum, K Weinstein, Pesticide Regulation Deskbook, 12 (2000). 18 7 U.S.C. § 136a(a). 19 7 U.S.C. § 136a(c)(5)(A)-(D).

9Pesticide Registration Improvement Act of 2003, all evidence a growing consensus in society and among public policymakers that strict regulation of pesticid es is vital to the health and safety of humans and the ecosystems of which they are a part. 20 Each Phase of the reregistration revi ew process reflects this emphasis. In particular, currency and completeness of per tinent data and studies , as well as thorough and comprehensive assessment by the agency, lie at the heart of the pr ocess. Section 4 (a) of FIFRA requires the EPA Ad ministrator to reregister each registered pesticide containing any active ingredient contained in any pesticid e first registered before November 1, 1984. 21 Triclosan was first registered by EPA in 1969. Having completed

Phase V of its reregistration review for tric losan, has issued the present final RED. FIFRA contains several statutory provisions authorizing the Adm inistrator to ban or otherwise restrict the manufacture, labeling and sale of a pesticide when use of that pesticide would have unreasonable adverse effects on hu mans and the environment. These provisions include: registration and re‐regi stration; suspension and cancellation of pesticide registrations; special review; n otice of warning; civil penalties; civil administrative proceedings; supplemental environmental projects; stop sale, use, or removal orders; seizure; injunction; and crimin al proceedings. The Federal Food, Drug and Cosmetic Act 22 (FFDCA) was first enacted by Congress in 1938 to provide a comprehensive mandate for the federal Food and Drug

20 See, FIFRA Amendments of 1988, Press Release, October 26, 1988, available at http://www.epa.gov/history/topics/fifra/01.htm . "I am pleased with this bill and want to commend Congress for this action," said EPA Administrator Lee M. Thomas. "It will go a long way toward assuring safer pesticide use." 21 7 U.S.C. § 136a-1(a). 22 21 U.S.C. §§ 301 et seq.

10Administration (FDA) in its oversight of food, drug, and cosmetic safety. 23 FFDCA Section 408 authorizes EPA to set tolerances, or maximum residue limits, for pesticide

residues on foods. The FFDCA was amended in 1996 by the Food Quality Protection Act to impose enhanced standards for the protec tion of not only adults , but also children,

infants and other vulnerable subpopulations. In setting to lerances, EPA must make a finding that the tolerance is “safe.” Safe is de fined as meaning that there is a "reasonable certainty that no harm will result from a ggregate exposure to the pesticide residue." 24 EPA possesses certain authority to protec t the public from unsafe pesticide residues. This authority includes: establishm ent of a tolerance or grant of a tolerance exemption; modification, suspension or re vocation of the tolera nce; requirement of

submission of additional data or information.

2. Violations of Law and Requested Relief

In their December 2008 Comments on EPA/OPP Reregistration Eligibility Decision for Triclosan (EPA Comments) 25 , Petitioners described the FIFRA violations being allowed by EPA’s reregistration of triclosan: EPA ... continues to ignore serious risks posed to public health. The agency has failed to address the impa cts posed by triclosan’s degradation products on human health and the envir onment, failed to conduct separate

assessments for triclosan residues in contaminated drinking water and food and is complacent in seriously addressing concerns related to

antibacterial resistance and endocrine disruption. As such, the agency has

23 21 U.S.C. §301 et seq. 24 21 U.S.C. § 346a (a)-(c). 25 Comment on Proposed Rule,Triclosan: Reregistration Eligibility Decision, Notice of Availability. Document ID: EPA-HQ-OPP-2007-0513 -0053. (EPA Comments), Available at www.regulation.gov . See Appendix B for complete list of signatories.

11still not proven that triclosan poses “no unreasonable adve rse effects” to

human health and the environment. 26 Petitioners take the position that the EP A RED, depending on the specific topic addressed, contains incomplete data, inadequate analysis, or both. Such a failure, in Petitioners’ view is “arbitrary, capricious” a nd “otherwise not in accordance with law.” 27 Even EPA itself acknowledged the substantial un certainty lying at th e core of its own decision. Noting the “considerab le amount of ongoing research regarding triclosan” and the “rapidly developing scient ific database” for the chemical, EPA intends to “accelerate the schedule for the reregistrati on review process” by ten years. 28 Indeed, the research has been ongoing a nd the scientific database has developed considerably. It is, in fact, in light of not only the resear ch studies and organizational responses identified and discussed in Petiti oners’ EPA Comments but also in light of subsequent studies and responses to them that this Petition is being submitted. Because of the agency’s incomplete and inadequate asse ssments in its past decisions, Petitioners request that the Administrator now take decisive action. Petitioners strongly believe that the suspension/cancellation remedy is the most appropriate remedy, in light of the magnitude of the health threat posed by triclosan. .

The hazards associated with triclosan use and exposure during the pendency of a long

review does not meet EPA’s stat utory duty to protect health a nd the environment. That is,

because scientific studies demonstrate that th e substance is used so pervasively that is present in most people’s bodies, EPA must ta ke the most protective steps provided for

26 Id. 27 5 U.S.C. § 506(2)(a). See also, Love v. Thomas, 858 F.2d 1347 (9th Cir. 1988); National Grain Sorghum Producers Assoc., Inc. v. EPA, 84 F.3d 1452 ( D.C. Cir. 1996). 28 EPA RED, p. 41.

12under the statute to protect public health. Again, the suspension/cancellation remedy was expressly contemplated by Congress as remedy fo r such a potent threat. In this regard, Petitioners request that EPA (1 ) issue a notice of cancellation of the registrationso of all products containing triclosan, pursuant to 7 U. S.C. § 136d(b)(1), and (2) at the same time issue an emergency order pursuant to 7 U.S.C. § 136d(c)(3) to suspend immediately those registrations. Further, Petitioners’ pref erred remedy of suspension/can cellation is particularly appropriate because EPA’s decisions allowing, in effect, violations of FIFRA and the

FFDCA also “enable” violations of other federal environmental statutes. (See the discussions below of the CWA, the SDWA and the ESA.) Petitioner’s overall point in this regard is that EPA’s ma ndate under FIFRA and the FFDCA must be viewed in the context of its overall mandate as an agency to protect public health and the environment. Indeed, this point has met with the approval of the federal courts, as reflected in the following sections below.

B. Clean Water Act 1. Objectives, Structure and Relevant Legal Provisions

The Federal Water Pollution Control Act 29 (Clean Water Act or ( CWA) is the primary statutory basis for regulating discharg es of pollutants into the waters of the United States and for regulating water qual ity standards. The United States Supreme

Court has observed that in th e CWA, Congress intended to re gulate water pollution to the

full extent of the United States Constitution’s Commerce Clause. 30 As set forth in Section 101(a), the CWA’s objective is “to restore and maintain the chemical, physical, and

29 33 U.S.C. §1251 et seq. 30 United States v. Riverside Bayview Homes, 474 U.S. 121 (1985).

13biological integrity of the Nation’s waters,” including the elimination of “the discharge of pollution into the navigable waters, the se tting of interim water quality standards providing “protection and propagation of fish, shellfish, and wildlife . ” and the prohibition of “the discharge of toxic pollutions in toxic amounts. 31 Technology-Based Regulation Under the CWA, EPA has implemented pollu tion control programs such as those setting wastewater standards for industry and water quality standards for all contaminants

in surface waters. Pertinent to this Petition, CWA Section 301 (a) makes “the discharge of any pollutant by any person ... unlawful” unl ess that discharge is in compliance with relevant CWA provisions. 32 Accordingly, the statute requ ires the Administrator to establish “effluent limitations,” in the fo rm of nationally uniform, technology-based standards, and those sta ndards ultimately apply to polluting “point sources.” 33 The vehicle for imposing these standards upon indi vidual point sources is the “National Pollutant Discharge Elimination System” (NPDES) permit, which allows the “discharge” of pollutants into navigable waters by point sources--subject to such “conditions” as will assure compliance with the statute’s objectives. 34 Health-Based Water Quality Regulation; Toxic Pollutants In addition to the imposition of technol ogy-based effluent limitations for point source discharges, the CWA also authorizes the establishment of water-quality-based

standards. 35 These more stringent health-based st andards recognize that technology-based

31 33 U.S.C. §1251(a)(1),(2), (3). 32 33 U.S.C. §1311(a). 33 33 U.S.C. §§1251, 1342, 1362(14). 34 33 U.S.C. §1342(a). 35 33 U.S.C. §§1312, 1313. See, Natural Resources Defense Counc il v. Environmental Protection Agency, 915 F.2d1314 (9 th Cir. 1990).

14effluent limitations alone may not achieve the desired levels of water quality in a given circumstance. Among these standards are those for regulation of “toxic pollutants” under

Section 307. CWA Section 307(a)(1) au thorizes the Administrator to revise the list of regulated toxic pollutants originally identified in that statute by adding or removing a pollutant. In so doing, the Administrator “shall take into account toxicity of the pollutant, its persistence, degradability, the usual or potential presence of affected organisms in any waters, the importance of affected organisms, and the nature and extent of the effect of the toxic pollutant on such organisms.” 36 Effluent limitations issued taking Section 307 toxic pollutants into account “shall be set at that level which the Administrator determines provides an ample margin of safety .” 37 (Emphasis added) Pretreatment of Toxic Pollutants Industrial dischargers may choose not to di scharge directly into navigable waters. Instead, they discharge “indi rectly” into navigable wate rs through a POTW. Indirect dischargers, unlike direct di schargers, are not subject to a national permit program, but they are subject to the pretreatment requirements of CWA Section 307(b). 38 CWA Section 307(b) requires that the Administrator establish pretreatment standards for [toxic pollutants] that may be introduced into publicly owned treatment works (POTW) that are “determined not to be susceptible to treatment by such treatment works or which would interfere with the opera tion of such treatment works” Pretreatment

standards “shall be establishe d to prevent the discharge of any pollutant through [POTW]

36 33 U.S.C. §1317(a)(1). 37 33 U.S.C. §1342(a)(4). 38 See, 2 W. RODGERS, ENVIRONMENTAL LAW 463-64 (1986).

15which pollutant interferes w ith, passes through, or otherwise is incompatible with such

works.” 39 Regulation of Biosolids The CWA also provides for the regulation of “biosolids,” which are the nutrientrich organic solid, semisolid or liquid residue generated duri ng the treatment of domestic sewage in a POTW. 40 Biosolids may be recycled and app lied as fertilizer to soils, or it may be disposed of in other wa ys. CWA Section 405(a) provides: [W]here the disposal of sewage sl udge resulting from the operation of a treatment works ...would result in any pollutant from such sewage sludge entering the navigable waters, such disposal is prohibited except in accordance with a permit issu ed by the Administrator. 41 Pursuant to CWA Section 405, EPA has de veloped regulations for the permitted disposal and utilization of bi osolids, including the identificat ion of toxic pollutants that:

on the basis of available informati on on their toxicity, persistence, concentration, mobility, or potential for exposure, may be present in sewage sludge in concentrations whic h may adversely affect public health

or the environment. 42 As mandated by CWA Section 405, EPA ha s promulgated the “Biosolids Rule,” 43 a comprehensive rule for biosolids manageme nt that the agency asserts is based on

39 33 U.S.C. §1317(b)(1).. 40 “Sewage sludge” is (the name for the solid, semisolid or liquid residue generated during the treatment of domestic sewage in a treatment facility) 41 33 U.S.C. § 1345(a). 42 33 U.S.C. § 1345(d)(2)(A)(i). 43 40 C.F.R. Part 503. See also, 58 Fed. Reg. 9248-9404, Feb. 19, 1993.

16extensive risk assessment. 44 EPA’s earlier attempts at establishing a biosolids management rule were rejected by the fe deral courts as inadequate on numerous occasions. Ultimately, these rejections, as well as Congressional action, in the form of the Water Quality Act of 1987, forced proper action by the agency. 45 The EPA Administrator’s authority to set standards regulating pollutant discharges and water quality—and take action against violations-- is considerable. This authority includes: effluent limitations ; tox ic and pretreatment effluent standards triclosan degradate 2,4 dichlo rophenol is a noted CWA prio rity pollutant under Section 307(a); pretreatment is required under Secti on 307(b) to protect wa stewater treatment plants); r ecords and reports; inspections; enforcement ( administrative, civil, or criminal penalties; injunctive relief; administrative or ders; civil judicial action; compliance orders; civil penalties; criminal penalties) ; oil and hazardous substance liability ; national pollutant discharge elimination system (NPDES) ; permits for dredged or fill material ; disposal or use of sewage sludge (EPA Biosolids rule protects public health from certain pollutants and contaminants present in wa stewater residues (40 CFR part 503); and

emergency powers (imminent and substantial endangerment). 2. Violations of Law and Requested Relief With the continued registra tion of triclosan, EPA has allowed the chemical and biological integrity of the nation’s waterways. As noted in Section II(D) of this Petition,

the USGS finds that triclosan is one of th e most frequently detected compounds and at

44 See US Environmental Protection Agency, Office of Wastewater Mana gement, A Plain English Guide to the EPA Part 503 Biosolids Rule , EPA/832/R-93/003, at 1 (September 1994). 45 See generally, Natural Resources Defense Council v. EPA , 790 F.2d 289 (3d Cir. 1986); Chicago Ass’n of Commerce & Indus. V. EPA , 873 F.2d 1025 (7 th Cir. 1989); Armco, Inc. v. EPA , 869 F.2d 975 (6 th Cir. 1989. See also, Sierra Club v. EPA, 992 F.2d 337 (D.C. Cir. 1993) (holding that EPA’s 1991 revisions to the sludge management guidelines complied with CWA Se ction 405(d)); Water Quality Act of 1987, Public Law No. 100-4.

17some of the highest concentra tions in of the nation’s wate rways and levels of concern (LOCs) are already exceeded for aquatic plan ts according to EPA’s own assessment. As Sections II(A) and (F) of this Petition observe, studies have found that triclosan accumulates in fish, shellfish and possibly other aquatic organisms which may result in endocrine disrupting activities in these or ganisms. Endocrine disruption impairs the reproductively of many aquatic species with devastating effects on species, including their population size and propagation. Notably, 2,4-Dichlorophenol (2,4-DCP), which is a transformation product of triclosan, has been listed in accordance with Sec 307(a) and as a result, has established water quality standards for surface waters. Ac cording to scientific studies and EPA’s 2008 assessment, described in Section II(E) of this Petition, triclosan in waterways transforms (93.8-96.6%) to 2,4-dichlorophenol, po tentially leading or contributing to the violation of the set water quality standards set under the CWA. This is an example of how EPA’s failure to implement properly one federal environmen tal statute (FIFRA) directly enables a violation of another fede ral environmental statute (CWA). Further, caselaw has firmly established that even in situations in which FIFRA has not been violated the CWA must be respected: [W]here the herbicide will enter the waters of the United States, FIFRA provides no method for analyzing the local impact and regulating the discharge from a particular point source. The NPDES permit requirement under the CWA thus provides the local monitoring that

FIFRA does not. 46 (Emphasis supplied)

46 Headwaters, Inc. v. Talent Irrigation Dist., 243 F.3d 526, 531 (9 th Cir. 2001).

18In conclusion, numerous studies , including those of EPA, have established the substantial presence, and therefore the serious threat , of triclosan to human health and the environment through the means of pollution of the nation’s navi gable waters. EPA’s failures in this regard, in Petitioners’ view are “arbitrary, capricious” and “otherwise not

in accordance with law.” 47 Therefore, the Administrator should use her authority under

the act to evaluate these h ealth and environmental effect s thoroughly and act decisively,

based on the abundance of scientific evidence and the express require ments of the CWA, to require proper regulation of triclosan. She should us e her authority to impose technology-based effluent limitations, heal th-based toxic poll utant water quality pretreatment requirements, and biosolids regulation. Safe Drinking Water Act 1. Objectives, Structure and Re levant Legal Provisions The Safe Drinking Water Act 48 (SDWA) authorizes the United States Environmental Protection Agency (US EPA) to set national health-b ased standards for drinking water to protect ag ainst both naturally-occurring and man-made contaminants that may be found in drinking water. US EPA, states, and water systems then work together to make sure that these standards ar e met. EPA sets a health goal based on risk (including risks to the most sensitive people, such as infants, children, pregnant women, the elderly, and the immuno-compromised). EPA then sets a legal limit for the contaminant in drinking water or a required treatment technique. This limit or treatment technique is set to be as close to the health goal as feasible. The Administrator has numerous powers under the SDWA to regulate against the

47 5 U.S.C. § 506(2)(a). . 48 42 U.S.C. § 300f-300j-26.

19health and environmental thr eats sought to be avoided unde r that statute. These powers include: listing and regulation of a contam inant under National Primary Drinking Water Regulations; notice to state and public water system; issuance of administrative order; civil action; and enforcement in nonprimacy states. 49 2. Violations of Law and Requested Relief

In the same manner as is true with the CWA, EPA’s reregistra tion decision setsthe stage for a violation of SDWA, in that tr iclosan would be allowed to contaminate drinking water at levels that threaten human health and the environment. For this reason, Petitioners request that the Administrator conduct a compre hensive assessment of the appropriateness of regulati ng triclosan under the SDWA.

C. Endangered Species Act 1. Objectives, Structure and Relevant Legal Provisions The Endangered Species Act 50 (ESA) provides a program for the conservation of threatened and endangered plants and animal s (species) and their habitats. Under ESA, federal agencies are prohibited from author izing, funding, or carryi ng out activities that are likely to jeopardize the continued existe nce of any listed species or result in the

destruction or adverse modifi cation of their designated crit ical habitats. The law also prohibits any action that cause s a "taking" of any listed sp ecies of endangered fish or

wildlife.

The ESA confers certain ma ndates and authorities upon the Administrator, in aid of protection for threatened and endangered species and their habi tats. These include:

49 42 U.S.C. § 300g-3(a)-(b). 50 7 U.S.C. §136; 16 U.S.C. §460 et seq.

20consultation with the Secretary of the Interior or the S ecretary of Commerce 51 and preparation of a Biological Assessment. 52 2. Violations of Law and Requested Relief Because triclosan is present in the larger environment, EPA’s registration of that substances creates potential jeopardy for listed threatened and endangered species and may destroy or adversely modify designated cr itical habitats. This presence has been abundantly demonstrated throughout this Peti tion. Accordingly, Petitio ners request that the Administrator comply fully with the ES A, including the consu ltation and biological assessment requirements. Petitioners note, in this regard, that notwithstanding FIFRA’s primary rule in regulating pesticides, courts have held that EPA must comply with ESA

in its administration of FIFRA. 53

II. Statement of Scientific Grounds A. The Ubiquity of Triclosan Results in Endocrine Disruption In its RED, EPA admits that it retained its current endpoints notwithstanding that it is aware of recent research conducted by its Office of Research and Development on the effects of triclosan on thyroid homeostasi s in the rat. EPA determined, however, that “further investigation is needed on th e effects of triclosan on the thyroid” 54 before inclusion of this endpoint. T hus, EPA declined to require fu ll and rigorous assessment of this significant health threat even th ough it acknowledges that there exists “some

evidence that triclosan disr upts thyroid hormone homeostas is and interacts with the

51 16 U.S.C. § 1536(a). 52 16 U.S.C. § 1536(c). 53 See, Defenders of Wildlife v. EPA, 882 F.2d 1294 (8 th Cir. 1989). 54 EPA RED, p. 13.

21androgen and estrogen receptors.” 55 As the discussion below de monstrates, there exists considerable evidence of these effects, and, further, that evidence continues to mount. Indeed, research conducted and recently publis hed by EPA scientists demonstrates that triclosan interferes with circulating levels of thyroid and testoster one hormone levels in male juvenile rodents. 56 Further, EPA was recently a dvised by the National Research

Council to consider the cumulative effects of chemicals with similar toxicological outcomes, including neurodevelopmental toxins. 57 Finally, in its failure to perform a proper assessment, EPA flouted a Congressional determination that endocrine di sruption is a serious health threat that merits proper evaluation of substances that can potentially cause that phenomenon. That is, in the Food Quality Protection Act amendments to the Federal Food, Drug and Cosmetics Act (FFDCA), EPA was required to establish an E ndocrine Disruptor Screening Program 58 (EDSP). Yet, establishment of the EDSP has not been completed, and thus the RED process did not have the be nefit of its potential for promoting more complete and accurate assessment of this important threat to human health. General Endocrine Disruption

Triclosan has been demonstrated to bio accumulate and have endocrine effects in

55 EPA RED, p. 35. 56 Crofton, KM; Paul, KB; DeVito, MJ; Hedge, JM. Short-term in vivo exposur e to the water contaminant triclosan: Evidence for disruption of thyroxine . Environ Toxicol Pharmacol. 2007. 24: 194–197, and Zorrilla LM, Gibson EK, Jeffay SC, Crofto n KM, Setzer WR, Cooper RL, Stoker TE. The effects of triclosan on puberty and thyroid hormones in male Wistar rats. Toxicol Sci. 2009 Jan;107(1):56-64. Epub 2008 Oct. 21. 57 National Research Council of the National Academies of Science. Phthalates and Cumulative Risk Assessment The Task Ahead, 2008. National Academies Press. Washington, D.C. http://www.nap.edu/cata log.php?record_id=12528 58 FFDCA §408(p)(1), 7 U.S.C. §346a(p)(1).

22amphibians and fish. 59 Notable in the research is its structural similarity to thyroid hormones. This similarity, along with eviden ce of human exposures, “ have increased concern about the possible endocrine disrupting effects of triclosan.” 60

Recent studies have shown that triclosan can alter endocrine function in a variety of species. For example, one study sought to determine the effects of triclosan on pubertal development and thyroid hormone concentrations in the male Wistar rat. While the study demonstrated that triclosan exposure does not alter androgen-depende nt tissue weights or onset of preputial separation, th e study did determine that triclosan exposure significantly impacts thyroid hormone concentra tions in male juvenile rats. 61 The protocol for the study employed th e Endocrine Disruptor Screening Program (EDSP) male pubertal protocol, administeri ng triclosan daily by oral gravage until

necropsy. 62 The study clearly demonstrated that tric losan exposure in the juvenile male rat suppresses total serum t hyroxine (T4) concentrations significantly and in a dosedependent manner, leading the researchers to conclude: Because triclosan is present in such a variety of personal care and household products, in the ecosystem, and in human body fluids, there is a serious concern for

59 Tatarzako, N., H. Ishibashi, K. Teshima, K. Kishi, and K. Arizono, Effects of Triclosan on Various Acquatic Organisms, Environmental Sciences 11(2), 133-40, (2004). ; Foran, C. M., Bennett, E. R., and Benson, W. H., Developmental Evaluation of a Potential Non-Steroidal Estrogen: Triclosan, Mar. Environ. Res. 50, 153-56 (2000); Ishibashi, H., Matsumura, N., Hirano, M., Matsuoka, M., Shiratsuchi, H., Ishibashi, Y., Takao, Y., and Arizono, K. , Effects of Triclosan on the Early Life Stages and Reproduction of Medaka Oryzias Latipes and Induction of Hepatic Vitellogenin, Acquat. Toxicol. (Amst.) 67, 167-79 (2004); Veldhoen, N., Sk irrow, R.C., Osachoff, H., Wigmore, H., Clapson, D.J., Gunderson, M. P., Van Aggelen, G., and Hebing, C.C., The Bactericidal Agent Triclosan Modulates Thyroid Hormon-Associated Gene Expression and Disrupts Postembryonic Anuran Development, Acquat. Toxicol. 80, 217-27 (2006). 60 Kevin M. Crofton, Katie B. Paul, Michael J. DeVito, Joan M. Hedge, Short-term in vivo Exposure to the Water Contaminant Triclosan: Evidence for disruption of Thyroxine l Environmental Toxicology and Pharmacology 24, 194-97 (2007). 61 Leah M. Zorrilla, Emily K. Gibson, Susan C. Jeff ay, Kevin M. Crofton, Woodrow R. Setzer, Ralph L. Cooper, and Tammy E. Stoker, The effects of Triclosan on Puberty and Thyroid Hormones in Male Wistar Rats, Toxicological Sciences 107(1) 56-64 (2009). 62 Id. at 57.

23adverse effects on human health. Although inters pecies differences exist, effects on the thyroid of this magnitude, particularly T4, should be carefully evaluated due to thyroid hormone status of pregnant women on the fu ture neuropsychological development of the

child. 63 Another similar study, conducted by a research group that included three

scientists from the EPA Office of Research and Development, pe rformed experiments that “clearly demonstrate ... that triclosan decreases circulating concentrations of T 4 [thyroxine] in rats.” 64 These findings were deemed suffici ently strong that the researchers

called for future research into triclosan’s e ffects on thyroid homeostasis and the relevance

to humans. 65

Breast Cancer Another important research area concerns the relation between triclosan usage and endocrine disruption leading to breast cancer. The breast is an endoc rine-sensitive organ. So, in a modern environment of exposure to numerous endocrine-disrupting chemicals, it should not be a mystery that “disorders of th e breast have become so widespread and that cancer in this organ has become the majo r cancer of women in the Western world.” 66 Indeed, although diet, smoking, alcohol and radiati on have been identified as risk factors, “the main influence in the development of breast cancer remains lifetime exposure to

63 Id. at 61-62. 64 Kevin M. Crofton, Katie B. Paul, Michael J. DeVito, Joan M. Hedge, Short-term in vivo Exposure to the Water Contaminant Triclosan: Evidence for Disruption of Thyroxine, Environmental Toxicology and Pharmacology 24, 194-97 (2007). 65 Id. at 196. 66 P.D. Darbre, Environmental Oestrogens, Cosmetics, and Breast Cancer, Best Practice & Research Chemical Endocrinology & Metabolism, Vol. 20, No.1, pp. 121-43, at 122 (2006).

24oestrogen.” 67 Cancer is caused by gene tic changes in somatic cells of the breast that result in the loss of growth c ontrol in the affected ce lls. The potential for breast cancer as a resu lt of regular, directapplication of xenooestrogens to the breast area has been the subject of significant research. Researchers have noted the rapidly-increas ing, widespread use of cosm etics, some of which are applied around the breast, in cluding underarm antiperspi rant/deodorant products, body lotions, body sprays, moisturizing creams, tanning creams and suncare products. Further, many of these cosmetics are not rinsed off, as are shampoos or soaps, but are left on the skin so that accumulation, absorption through th e dermis, and entry of the cosmetics into the tissues are considerably more likely. 68 Triclosan is known to be one of the substances in cosmetics that alter cell DNA and interfere with normal growth regulatory pathways (including oestrogen action). 69 Petitioners note that while approval and regulation of many of these triclosan applications comes within the ambit of the FDA, it is the

cumulative impact of triclosan in the body (wha tever the source and whatever the regulatory scheme) that poses these dangers.

67 Id. See also, Lipworth, L., Epidemiology of Breast Cancer, European journal of Cancer Prevention 4, 7-30 (1995); Key, T.J, Verkasalo, P.K. U Banks, E., Epidemiology of Breast Cancer , The Lancet Oncology 2, 133-40 (2001). , 68 Darbre, Environmental Oestrogens, Cosm etics, and Breast Cancer, at 127. 69 Ciniglia, C., Cascone, C., Giudice, R.L. et al., Application of Methods for Assessing the Geno- and Cytotoxicity of Triclosan to C. ehrenbergii, Journal of Hazardous Materials 122, 227-32 (2005); AdolfssonErici, M., Pettersson, M., Parkkonen, J., and Sturve, J. , Triclosan, a Commonly Used Bactericide Found in Human Milk and in the Acquatic Environment in Sweden, Chemospere 46, 1485-89 (2002).

25B. The Ubiquity of Triclosan Contributes to Bacterial Resistance in Antibiotic Medications and Antibacterial Cleansers

“The major driving force for development of resistance in bacteria to antimicrobial agents ... is the use of antimicrobials themselves.” 70 In the specific instance of triclosan, numerous recen t studies provide substantia l evidence that it promotes

bacterial resistance to both antibiotic medications and an tibacterial cleansers. This, of course, renders the antibiotics and the antibact erials ineffective for their intended use. Necessarily, users of the medications and clean sers are completely unaware of this nonfunctionality and are simply vulnerable to whatever consequences may ensue. At a minimum, they will have paid for a useless pr oduct. But in other instances, they may be left wide open to sign ificant health risks. Bacterial resistance may occur through mutation of the gene constitutions or the uptake of new genetic elements through horizon tal gene transfer. Such resistance may cause multiple threats, since widespread use of the triclosan may not only result in

bacteria that are resistant to triclosan but may also create resistance to other, including unrelated, antimicrobials and antibiotics (c ross-resistance or co-resistance). Further, while some have argued that th e high concentration of triclosan found in articles like soap (for example, 2,500 μ g/ml) is sufficient to kill even resistant bacterial strains, research has shown this is not necessarily true. One study examined triclosan activity in a commercial soap. Achievemen t of a 90% death rate in wild-type E. coli required exposure to 150 μ g/ml of triclosan in soap for 2 hours at 37° C. Obviously, the

70 Siamak P. Yazdankhah, Anne A. Scheie, E. Arne Høiby, Bjørn-Tore Lunestad, Even Heir, Tor Øystein Fotland, Kristine Natersta d, and Hilde Kruse, Triclosan and Antimicrobial Resistance in Bacteria: An Overview, Microbial Drug Resistance, Vo l. 12, No. 2, 2006, at 83.

26time, temperature and amount of the substan ce needed in the study far exceeded that for the average hand washing. 71 Even in instances where triclosan may effectively inhibit bacteria in its principal application, potential problems still exist. The problem, particularly in triclosancontaining consumer products, is residues. These products usually leave residues (on kitchen and bathroom floors, countertops and other surfaces) and these residues will typically be diluted (in comparison to the product itself). At these “sublethal” concentrations, the residues can no longer inhi bit or destroy bacteria l action. In a similar vein, toothpastes often contain agents designed to increase the retention and effect of triclosan, promoting a more prolonged ( but gradually decreasing) effect on the microflora. Important here is the fact that studies have shown that “at sublethal concentrations, triclosan inhibi ts a specific bacterial target, and several mechanisms of

resistance to triclosan have been demonstrated.” 72 The problem, therefore, is the widespread use of triclosan—whatever the source and whatever agency has regul atory authority—giving rise to increased and cumulative exposure. And this should be distinguished from the more restricted, knowledgeable and careful use of it by medical professionals. 73 Just a few years ago, “only a few dozen products containing antibacterial agents were being marketed for the home. Now more

than 700 are available.” 74 Triclosan’s broad-spectrum antibacterial properties have

71 Steward B. Levy, Antibacterial Household Products: Cause for Concern, Conference Presentation, Emerging Infectious Diseases, Vol. 7, No. 3 Supplement, June 2001, at 513. 72 Triclosan and Antimicrobial Resistance in Bacteria: An Overview, at 88. 73 Siamak P. Yazdankhah, Anne A. Scheie, E. Arne Høiby, Bjørn-Tore Lunestad, Even Heir, Tor Øystein Fotland, Kristine Natersta d, and Hilde Kruse, Triclosan and Antimicrobial Resistance in Bacteria: An Overview, Microbial Drug Resistance, Vol. 12, No. 2, 2006. 74 Antibacterial Household Products: Cause for Concern, at 512.

27caused it to be utilized in an increasingl y diverse and extensive range of uses. The implications of this broad, rapid increase for public hea lth, however, are important:

There is a link between antibiotic and antibacterial resistance. Overuse or improper usage of antibacterials in the home can potentially enhance the selection process for resistance to th ese [antibacterial] products and to

antibiotics. 75 While ordinary, healthy adults are indeed at risk because of triclosan-induced bacterial resistance, cert ain subpopulations are particularly vulnerable. These subpopulations include persons with impa ired immune systems, infants and young children, and persons needing the benefit of antibiotics. One steadily rising and increasingly vulnerable subpopulation is that of persons recently returning home from hospitals and health care facilities who must c ontinue to take antibio tics. It is well known that today hospital stays have become much s horter, both to lower hospital costs and to protect patients from problems such as nosocomial inflections. 76 Patients returning home

who continue to take antibiotics enter an environment rife with antimicrobial and other products containing triclosan. Hence, the danger of the antibiotics being rendered ineffective could be dangerously high. 77

EPA’s RED states that there is curr ently “some research attempting to

demonstrate a connection between antimicrobial resistance and antibiotic resistance in regard to triclosan, but the linka ge has not been expressly proven.” 78 But to the contrary, as discussed above, several peer-reviewe d studies highlighting the concerns many

75 Stuart B. Levy, Antibiotic and Antiseptic Resistance: Impact on Public Health, Pediatric Infectious Disease Journal, Vol. 19, No. 10, Oct. 2000, at S121. 76 Id. 77 Id. 78 EPA RED, p. 40.

28scientists have with regard to triclosan’s role in antibacterial resistance. In spite of important research findings such as those described above, EPA chose to take an approach directly contrary to the precautionary principle. Thus, the agency requires that the connection between antimicrobi al resistance and antib iotic resistance be “expressly proven,” 79 rather than taking action based on what is substantial and credible evidence of such a connection. Further, the seri ous nature of the thr eat posed in this area by triclosan merits more than having the agency merely “look into the issue,” or participate in the work of the Interage ncy Task Force on Antimicrobial Resistance 80 (Task Force). EPA even admits that “none of the goals [of the Task Force] are associated with a specific active ingredient.” 81

C. Triclosan is Bioaccumulative and Poses an Immense Body Burden. Because of its widespread usage and its properties, triclosan can be found in blood, 82 urine, 83 and breast milk 84 in people around the world. And while consumers of triclosan-containing products re tain the highest levels of th e substance, even persons not using those products are vulne rable to exposure through food, water, and even household

dust. 85 Indeed, one study, conducted by scientists at the Center for Disease Control and Prevention (CDC), found triclosan in 75 per cent of the U.S. gene ral population [a study of 2.517 urine samples using the NHANES met hod] and took particular note that the

79 EPA RED, p. 40. 80 Id. 81 Id. 82 Allmyr, M. F. Harden, L.L. Toms, et al., The Influence of Age and Gender on Triclosan Concentrations in Australian Human Blood Serum, Science of the Total Environment 393, 162-67 (2008). 83 Calafat, A.M, X Ye, L.Y. Wong et al., Urinary Concentrations of Triclosan in the U.S. Population: 2003-2004, Environmental Health Perspectives 116(3), 303-07 (2008). 84 Allymyr, Mats et al., Triclosan in Plasma and Milk from Swedish Nursing Mothers and Their Exposure Via Personal Care Products, Sci. Total Environ. 372(1), 87-93 (2006). 85 Canosa, P., I Rodriguez, E. Rubi, and R. Cela, Determination of Parabens and Triclosan in Indoor Dust Using Matrix Solid-Phase Dispersion and Gas Chromatography with Tandem Mass Spectrometry, Analytical Chemistry 79(4), 1675-81 (2007).

29“high frequency of detection is most likely with daily use by the U.S. general population of [triclosan-containing] consumer products.” 86 As described throughout this Petition, given the dangers of each individual source of triclosan, the notion of a cumulative effect from all sources of this lipophilic (bioaccumula tive in fatty tissues) substance truly makes clear the gravity of the health th reat and the dire need for action. EPA used data from the National Health and Nutrition Examination Survey (NHANES) 87 to determine population e xposures to triclosan in its RED risk assessment. Petitioners take the position that NHANES data are useful only as a supplement to the risk assessment process. It is commendabl e that EPA has become receptive to using improved methods for carrying out its responsibi lities with the use of real-world data. But NHANES data on triclosan exposure, standi ng alone, are insufficient to adequately

determine human risk. Petitioners’ EPA Comme nts made the following significant points about NHANES methodology and capacity:

• Urine Testing is Inadequate Becaus e Triclosan Accumulates in Fatty

Tissue

o Measurements of triclosan under NHANES are based on concentrations in spot urine samples. 88 Urine is not the appropriate

fluid to quantitatively assess triclosan e xposure, though it does provide useful qualitative information on population exposure to

triclosan.

86 Calafat, A.M, X Ye, L.Y. Wong et al., Urinary Concentrations of Triclosan in the U.S. Population: 2003-2004, Environmental Health Perspectives 116(3), 303-07 (2008); CDC. Fourth National Report on Human Exposure to Environmental Chemicals. Department of Health and Human Services Centers for Disease Control and Prevention (2009) 87 NHANES data for triclosan can be found at http://www.cdc.gov/nchs/nhanes.htm

. 88 Risk Assessment, p. 27. S ee also, Calafat, A.M, X Ye, L.Y. Wong et al., Urinary Concentrations of Triclosan in the U.S. Population: 2003-2004, Environmental Health Perspectives 116(3), 303-07 (2008).

30o Quantitative estimates require more detailed testing, including testing using breast milk, blood, and fat tissue sampling.

• The Rapidly Growing List of Uses for Triclosan Renders the 2003-2004 NHANES Data Inadequate as a Basis for a Useful Assessment

o The current RED document is based on exposure information captured from the NHANES 2003-2004 data set. These data are simply unable to estimate the risk associated with the ever growing

use of hundreds of triclosan-cont aining consumer products that

have entered the market since 2003.

• Food Contamination Must be Assessed by EPA

o EPA’s RED and its Dietary Risk Assessment for Triclosan for the

RED Process 89 (Dietary Risk Assessment) concluded that “[n]one

of the indirect food contact scenar ios appear [sic] to exceed [the] Agency’s level of concern.” 90

o EPA acknowledges, however, that “[e]xposures can occur where there is the possibili ty of indirect food migration (including paper/pulp use, use in ice-maki ng equipment, adhesives, cutting boards, counter tops, and conveyer belts).” 91

o Yet, EPA admits that “no residue chemistry data based on [agency guidelines] were submitted nor was it requested.” 92

89 EPA’s Dietary Risk Assessment for Triclosa n for the RED Process, August 11, 2008 (Dietary Risk Assessment). 90 Dietary Risk Assessment. (unpaginated) 91 EPA RED, p. 15. 92 Dietary Risk Assessment.

31o Petitioners believe that failure to perform a dietary risk assessment

on triclosan- contaminated fish a nd shellfish ignores the evidence

that triclosan is indeed r eadily absorbed via the human gastrointestinal tract and that th is route of exposure could impact

overall risk. 93 NHANES may capture many triclosan use patterns, but a complete evaluation of di etary risk from food and drinking water indirectly contaminated by triclosan is necessary.

• Total Reliance on NHANES Misses Health Impact on Users

o NHANES does not specifically enab le the evaluation of triclosan exposure and resulting residues in the body for those who use triclosan or triclosan-treated produc ts. It instead identifies exposure to the general population, among a mi xture of users and nonusers. Reliance solely on NHANES for the agency’s exposure assessment, therefore, provides in adequate protection of triclosan

users. 1. Infants and Children Are Especially Vulnerable to Triclosan Reliance Many parents are misled into thinking that antibacterial products are better to protect their children against germs and bacter ia. However, children are especially put at risk when they are exposed to antibact erial toothpaste, soap s, baby creams, hand sanitizers and wipes that leave triclosan residues on their skin. This is especially so for products coming into contact with their hands, as this could ultimately result in oral exposures to the chemical as a direct result of hand –to-m outh activity. Babies' skin is

93 Sandborgh-Englund et al. 2006. Pharmacokinetics of triclosan following oral ingestion in humans. J. Tox. and Environ. Health. Part A 69:1861-1873

32also more permeable than an adult's, 94 leading to increased dermal absorption. As previously mentioned, triclosan is also found in breast milk and accumulates in the human body, directly exposing babies pre- and po st-natal to concentrat ions of triclosan.

Studies have shown that children face unique hazards from chemical exposure. 95 They take in more chemical relative to thei r body weight than adults from the products to which they are exposed. Their developing orga n systems often make them more sensitive to toxic exposure. The body of evidence in sc ientific literature shows that chemical exposure can adversely affect a child's neur ological, respiratory, immune, and endocrine system, even at low levels. 96

2. Triclosan Poses Health Risks for Health Care Professionals Triclosan even poses thr eats to health care professionals. In a 2009 report, Physicians for Social Responsibility announced the results of a study demonstrating that “health care professionals are exposed—through the workpl ace or in their personal lives—to a wide range of chem icals [including triclosan] known or suspected to cause health problems.” 97 Hazardous Chemicals In Health Care discussed the body burden and other threats posed by triclosan and conclude d with several recommendations designed to protect health care professionals and the public. 98

94 Silver, L. 2007. Baby Care Products. Prevention and Practice. Learning and Developmental Disabilities Initiative. Institute for Children’s Environmental Health (ICEH). 95 US EPA, Office of the Administrator, Environmenta l Health Threats to Children, EPA 175-F-96-001, September 1996. See also: http://www.epa.gov/pesticides/food/pest.htm

. 96 Weiss, B., et al. 2004 April. “Pesticides,” Pediatrics 113(4): 1030-1036; National Research Council. 2000. Scientific frontiers in developmental toxicology and risk assessment. Washington, DC: National Academy Press; Physicians for Social Responsibility, The National Environmental Trust, and the Learning Disabilities Association of America. 2000. Polluting our future: Chemical pollution in the U.S. that affects child development and learning. http://www.net.org/h ealth/tri_report. pdf (accessed 6/2/05). 97 Report: Hazardous Chemicals In Health Care , Physicians for Social Responsibility, p. 23, October 9, 2009. (also available at http://www.psr.org/assets /pdfs/hazardous-chemic als-in-health-care.pdf ). 98 Id. at 22,-24 26-30.

333. Triclosan Usage Poses Health Risks for the Skin Because of its Toxicity Numerous studies attest to the problems triclosan can cause for the skin. Reports observe such problems as dermatitis, or skin irritation, 99 photoallergic contact dermatitis, 100 eczematous rash, and even immunotoxic and neurotoxic reactions to the

substance. 101

D. Triclosan is Not Completely Removed from Wastewater and Sludge, Which May Result in Food Contamination Triclosan products eventua lly enter the larg er environment through wastewater and otherwise, and then adversely affect human, animal and other environmental

resources. Because 95% of triclosan use is in consumer products that are disposed of down residential drains, sewage and wastewat er provide a prime me dium of triclosan entry into the larger environment. As e xplained below, even where it does reach wastewater treatment plants (as some runo ff from both residential and commercial sites streams directly into the environment), tric losan still may re-enter the environment and pose health threats. A major source of triclosan in waterways is sewage sludge. Triclosan accumulates in sewage sludge from municipal wastewater treatments. 102 The sewage sludge is spread on land, and triclosan leaches down through the soil and runs off into surface water from

99 Strer, E., K.J. Koh, and L. Warren, Severe Contact Dermatitis as a Resu lt of an Antisepti c Bath Oil, Australasian Journal of Dermatology 45(1), 73-75 (2004). 100 Durbize, E., M. Vigan, E. Puzenat, et al., Spectrum of Cross-photosensitiz ation in 18 ConsecutivePatients with contact Photoallergy to Keptoprofen: Associated Photoallergies to Non-benzophenonecontaining Microbes, Contact Dermatitis 48(3), 144-49 (2003). 101 Stafford, J., Germ Warfare, Voices, Health and Fictio n, C2-C3 (May 5, 1997). 102 Heidler, J and RU Halden, Mass Balance Assessment of Triclo san Removal During Conventional Sewage Treatment, Chemosphere 66: 362-69, (2007)

34the fields. 103 Triclosan has been shown to persist in the runoff from treated fields for as long as 266 days after biosolid application and to persist in the sediment for long periods

of time. 104 EPA, in its Targeted National Sewage Sludge Survey Report, presented the results of certain studies, specifically, the Targeted National Sewage Sludge Survey Sampling and Analysis Technical Report ("Technical Report"), and the Targeted National Sewage Sludge Survey Statistical A nalysis Report ("Statistical Report").

Triclosan was detected in 79 of a total of 84 sludge samples used in the survey, and both its minimum and maximum observed dry-weig ht concentrations were significant. 105 Wastewater, in fact, is “the principal pathway of [triclosan ] contamination” in estuarine

sediments. 106 As discussed below, the health and environmental implications of these characteristics are significant. The EPA RED acknowledged that “triclos an has been detected in natural waterways,” and thus it was “prudent to conduct a qualitative ri sk assessment using surface water monitoring data.” 107 Therefore, the agency conducted an assessment using various studies and methods, including a Tier 1, Down-the-Drain (DTD) module and a

Probabilistic Dilution Model (PDM). In doing so, EPA found that “triclosan may be susceptible to biodegradation based on th e presence of methyl-triclosan following

103 Lapen, D.R., E. Topp, C.D. Metcalfe, et al., Pharmaceutical and Personal Care Products in Tile Drainage Following Land Application of Municipal Biosolids, Science of the Total Environment, 2008. Topp, E., S.C. Monteiro, A. Beck, et al., Runoff of Pharmaceuticals and Personal Care Products Following Application of Biosolids to an Agricultural Field, Science of the Total Environment, 296: 52-59, 2008. 104 Topp, et al. Wilson, B., J. Zhu, M. Canwell, and C.R. Olsen, Short-Term Dynamics and Retention of Triclosan in the Lower Hudson River Estuary, Marine Pollution Bulletin (2008). 105 See, Technical Report, Table 12, p 41.. 106 Todd R. Miller, Jochen Heidler, Steven N. Chillr ud, Amelia DeLaquil, Jerry C. Ritchie, Jana N. Milhalic, Richard Bopp, and Rolf U. Halden, Fate of Triclosan and Evidence for Reductive Dechlorination of Triclocarban in Estuarine Sediments, Environ. Sci. Technol. 42(12), 4570-4576, 2008. 107 EPA RED, p. 28.

35wastewater treatment.” 108 Interestingly, for a number of areas of health and environmental impacts, EPA reached no ultimate conclusion. Rather it shifted the responsibility for (and the contro l over) to applicants for re registration at a later date: At this time this testing is not requ ired for triclosan, but is dependent upon

the results of environmental modelin g and monitoring which are required to support reregistra tion of triclosan. 109 In this regard, it is noteworthy that on October 8, 2008, EPA proposed revisions to its data requirements for antimicrobial pe sticides under FIFRA, in conjunction with its wider effort to update and streamline its data requirements for all pesticides. 110 Among the new requirements are certain ones intended for use in a screening-level assessment on the fate of antimicrobials with the potential to reach a wastewater treatment plant. These products would include “down-th e-drain” products as well as microbiocides used in industrial process and water systems. The proposal has been viewed favorably by many concerned agencies. 111 In other areas, EPA admitted to cons iderable uncertainty about ecological exposure and risk. 112 Petitioners submit that these scenarios call out for a pplication of the precautionary principle. That is, in the face of credible evidence of health and environmental threats, a regulatory agency must not allow continued use of a suspect substance until scientific study and evidence clearly demonstrate the safety of that

substance.

108 Id. at 29. 109 Id. at 110 Data Requirements for Antimicrobia Pesticides. 73 Fed. Reg. 59382 (Oct. 8, 2008). 111 See, e.g., Comments of the National Association of Clean Water Agencies, the California Association of Sanitation Agencies, and the San Francisco Department of the Environment. 112 EPA RED at 31-33.

36A study by researchers from the U.S. Ge ological Survey, using five newly developed analytical methods, sought to measure concentrations of 95 organic wastewater contaminants (OWCs). The study took water samples from a network of 139

streams across 30 stat es during 1999 and 2000. 113 Sampling site selection was biased in favor of streams susceptible to contamina tion, such as waters downstream of intense urbanization and livestock production. Results revealed that triclosan was one of the 30 most frequently detected OWCs. 114 The researchers observed: Surprisingly, little is known about the extent of environmental occurrence, transport, and ultimate fate of many synthetic organic chemicals after their intended use, particularly hormonally active chemicals, personal care products and [certain] pharmaceuticals. 115 Subsequently, researchers have expanded the base of knowledge about triclosan’s presence and impact in the environment. One study evaluated a full-scale activated sludge facility (one representative of most U. S. plants) to determin e its effectiveness in controlling triclosan. The study concluded that “the beneficial reuse of digested municipal sludge as agricultural fertilizer represents a mechanism for the reintroduction of substantial amounts of TCS [triclosan] into the environment.” 116 Thus, not only is triclosan present in the environment initially, but it remains in the environment even after the wastewater treatment process.

113 Dana W. Kolpin, Edward T. Furlong, Michael T. Meyer, E. Michael Thurman, Steven D. Zaugg, Larry B. Barber, Herbert T. Buxton, Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, 1999-2000: A National Reconnaissance, Environ. Sci. Tech. 36, 1202-1211, at 1202, (2002). 114 Id. at 1207 (Fig. 2), 1208. 115 Id. 116 Jochen Heidler, Rolf U. Halden, Mass Balance Assessment of Triclosan Removal During Conventional Sewage Treatment, Chemosphere 66, 362-369, at 368, (2007).

37A study of triclosan in Swiss water bodies found high concen trations of the substances in several lakes and rivers, as we ll as lower levels of methyl triclosan, a byproduct. (Methyl triclosan is more lipoph ilic than triclosan and is thus more

bioaccumulative. 117 ) Generally, therefore, triclosan is present in a large number of waterways, and thus humans and animals are vu lnerable to its effects. Accordingly, there are numerous potential adverse impacts. E. EPA Failed to Address Major Degradates As the following discussion shows, EPA has failed to address adequately the subject of the health and envi ronmental threats posed by majo r degradates of triclosan. Dioxins are highly carcinogenic that can cause immune system compromise, decreased fertility, altered sex hormones, misca rriage, birth defects, and cancer. It can be present or be formed in many ways, includ ing as a synthesis impurity of triclosan 118 during the manufacture of many products, and upon the incineration of triclosan. 119

Researchers who added triclosan to river wate r and shined ultraviolet light on the water found that between one and twelve percent of the triclosan was converted to dioxide in the water. This suggests that sunlight coul d transform triclosan in to dioxin naturally. 120 Further, triclosan-tainted water at water treatment plants pose the danger of sunlight converting chlorinated triclosan into highly to xic forms of dioxins. Yet another potential

117 Anton Lindstrom, Ignaz J. Buerge, Thomas Poiger, Per-Anders BergqVist, Markus D. Müller, and Hans Rudolf Buser, Occurrence and Environmental Behavior of the Bactericide Triclosan and its Methyl Derivative in Surface Waters and in Wastewater, Environ. Sci. Technol. 36, 2322-2329 (2002). 118 Menoutis, J. and A.I. Parisi, Triclosan and its impurities, Triclosan Review Series, Quantex Laboratories, Inc., available at http://www.quantexlabs.com/triclosan.htm

. 119 Kanetoshi, A., H. Ogawa, E. Katsura, H. Kaneshima, and T. Miura, Formation of Polychlorinated Dibenzo-p-dioxins Upon Combustion of Commercial Textile Products Containing 2,4,4-Trichloro2 Hyroxydiphenyl Ether, Journal of Chromatography A 454, 145-55 (1988). 120 Latch, D.E., J.L. Packer, W. A. Arnolda, and K. McNeill, Photochemical Conversion of Triclosan to 2,8- Dichlorodibenzo-p- in acqueous solution, Journal of Photochemistry and Photobiology A: Chemistry 158 (1), 63-66 (2000).

38danger is that exposure of sunlight to solid-s tate triclosan, such as on commercial textile products, causes formation of small amounts of dioxin. 121 A study by researchers at the Virginia Po lytechnic Institute and State University found that triclosan reacts with free chlorine in tap water to form a number of chlorinated triclosan intermediates, including 2,4 dich lorophenol, which photochemically generates highly chlorinated dioxins. These are some of the most toxic forms of dioxin. Those

researchers found that these ch lorinated intermediates can be formed in kitchen sinks simply by using dishwashing liquid containing triclosan. 122 Additionally, it should be noted that degradate 2,4 dichlorophenol is a noted CWA priority pollu tant, as well as a potential endocrine disruptor. Some of the same studies concluding that triclosan reacts with tap water under dishwashing conditions to form dioxins also found that this comb ination also produces significant quantities of chloroform gas. 123 Chloroform has been classified as a probable human carcinogen. 124 F. Triclosan is Highly Toxic to Va rious Forms of Algae and This Can Cause Ecological Damage

Triclosan can have detrimental effects on aquatic ecosystems. Triclosan has been found to be highly toxic to different types of algae. 125 Triclosan effluents affect both the

121 Kanetoshi, A., H. Ogawa, E. Katsura, H. Kaneshima, and T. Miura, Formation of Polychlorinated Dibenzo-p-dioxins Upon Combustion of Commercial Textile Products Containing 2,4,4-Trichloro2 Hyroxydiphenyl Ether, Journal of Chromatography A 454, 145-55 (1988). 122 Rule, K.L., V.R. Ebbett, and PlJ. Vikesland, Formation of Chloroform and Chlorinated Organics by Free-Chlorine-Mediated Oxidation of Triclosan, Environ. Sci. Technol., April 2, 2005. 123 Ibid. 124 EPA, Office of Pesticide Programs, List of Chemicals Evaluated for Carcinogenic Potential, updated July 19, 2004. 125 Tatarzako, N., H. Ishibashi, K. Teshima, K. Kishi, and K. Arizono, Effects of Triclosan on Various Acquatic Organisms, Environmental Sciences 11(2), 133-40, (2004).

39structure and the function of algal communities in stream ecosystems. 126 Because algae are the first-step producers in aquatic ecosystem s, high levels of tric losan discharged into the environment may cause widespread negati ve consequences, including “the possible

destruction of the bala nce of the ecosystem.” 127 The risks are especially high immediately downstream from wastewater treatment plants. 128 Because of its lipophilic nature and re sistance to degradation, triclosan in waterways is readily available for absorp tion and bioaccumulation by aquatic organisms

in the environment. 129 Researchers in Sweden found high levels of triclo san were present in the bile of fish that were placed in cages downstream of sewa ge treatment works in

Sweden. 130 Methyl triclosan, a transformation product of triclosan, has been found in

fish. 131 Although little is k nown about the effects on fish, triclosan has been found to be highly toxic to Japanese medaka fish in th eir early life stages, and it may cause weak endocrine disruption a well. 132 The EPA RED observed that in aquatic e nvironments, “triclosan is expected to absorb to [sic] suspended solids and sediments and may bioaccumulate...posing a

126 Wilson, B.A., V.H. Smith, F. deNoyelles Jr., an d C.K. Larive, Effects of Three Pharmaceutical and Personal Care Products on Natural Freshwater Al gal Assemblages, Environmental Science and Technology 37(9), 162A-164A (2003). 127 Tatarzako, N., H. Ishibashi, K. Teshima, K. Kishi, and K. Arizono, Effects of Triclosan on Various Acquatic Organisms, Environmental Sciences 11(2), 133-40, (2004). 128 Reiss, R., N. Mackay, C. Habig, and J. Griffin, An Ecological Risk Assessment for Triclosan in Lotic Systems Following Discharge from Wastewater Treatment Plants in the United States, Environmental Toxicology and Chemistry 21 (11), 2483-2492 (2002). 129 Tatarzako, N., H. Ishibashi, K. Teshima, K. Kishi, and K. Arizono, Effects of Triclosan on Various Acquatic Organisms, Environmental Sciences 11(2), 133-40, (2004). 130 Ibid. 131 Balmer, M. E., T. Poiger, C. Droz, K. Romanin, et al., Occurrence of Methyl Triclosan, a Transformation Product of the Bact ericide Triclosan, in Fish from Various Lakes in Switzerland, Environmental Science and Technology 38, 390-95 (2004). 132 Ishibashi, H., N. Matsumura, M. Hirano, M. Matsuoka, et al., Effects of Triclosan on the Early Life Stages and Reproduction of Medake Oryzias Latipes and Induction of Hepatic Vitellogenin, Acquatic Toxicology 67, 167-79 (2004).

40concern for acquatic organisms. 133 In fact, its own qualitative environmental risk assessment determined that levels of concern “were exceeded for aquatic plants.” 134 But,

as noted in this Petition’s discussion of wastewater treatment, EPA’s analysis was incomplete. In some areas, no conclusions we re drawn and further testing was left to registrants. In other instances, EPA admitted that the studies and data were incomplete, but the agency declined to apply the precautionary principle. 135 G. Efficacy

Petitioners assert that triclosan is “m isbranded” in violation of the FFDCA because it fails to provide the benefits cl aimed on product labels, in marketing and advertising campaigns and in other public stat ements in a cost-effective, safe manner.

As discussed in Section II (B) of this Petition, developm ent of bacterial resistance

to triclosan itself from triclosan use and exposure render the substance ultimately ineffective for the purposes claimed. But further, numerous studies demonstrate that triclosan, in its initial use, confers no real added benefits to consumer users. One study

concludes there are no added h ealth benefits (that is, none beyond those provided by soap and water) for consumer use of triclosan. Said the study:

The results of our review call into question the marketing of soaps containing triclosan as a product providing efficacy beyond the use of plain soap in the community setting ...Current findings warrant actions by the FDA for evaluating consum er product advertising claims. 136

133 RED, p. 28-29

. 134 RED, p. 31. 135 See, e.g., EPA RED, pp. 30-31

. 136 Aiello, A.E., E.L. Larson, and S.B. Levy, Consumer Antibacterial Soaps: Effective or Just Risky?, Clinical Infectious Diseases 45, 13 7-47 (2007); Siamak P. Yazdankhah, Anne A. Scheie, E. Arne Høiby, Bjørn-Tore Lunestad, Even Heir , Tor Øystein Fotland, Kristine Naterstad, and Hilde Kruse, Triclosan and Antimicrobial Resistance in Bacteria: An Overview, Microbial Drug Resistance, Vol. 12, No. 2, 2006.

41As early as 2000, the American Medi cal Association (AMA) expressed doubt about the efficacy of antimicrobial ingredie nts in consumer products. The AMA Council

on Scientific Affairs stated th at “[n]o data exist to support their efficacy when used in such products or any need for them.” 137 Further, while lack of efficacy is important, what rendered this lack of evidence concerning was that “increasing data now suggest growing acquired resistance to these commonly used antimicrobial agents.” 138 Especially for these

reasons the AMA Council recommended that:

• The FDA “expedite its regulation of the use in consumer products of antimicrobials for which acquired re sistance has been demonstrated;”

• The AMA “monitor the progress of the cu rrent FDA evaluation of the safety and effectiveness of antimicrobials for consumer use;” and

• The AMA encourages “continued research” on the use of common antimicrobials in consumer products and its impact on the major health problem of antimicrobial resistance. ” 139 These and other influential expression s set forth a clear and sound mandate for action by the EPA. H. Organizational Decisions Criticizing, Condemning or Rejecting Triclosan Usage

As the scientific evidence against widespread triclosan usage mounts, numerous organizations have criticized, condemned or rejected that substance in formal and definitive ways. These organizations run the gamut, including governmental units,

137 American Medical Association, 2000 Annual Meeting, Reports of the Council on Scientific Affairs, at 4 (2000). 138 Id. 139 Ibid.

42corporate entities, research societies and professional a ssociations. The following are prominent examples: Corporate Retreats from Triclosan In March 2009, Ciba, the creator of tr iclosan, formally filed with the EPA a request for the “voluntary cancellation of the registrations for tric losan regulated by the”

EPA. 140 This request seeks to cancel the use of Ci ba triclosan “as an antimicrobial for the protection of polymers/pl astics and textiles.” 141 The company decided “to pull out of ancillary markets such as household items.” In taking this step, the company sought to “differentiate Ciba triclosan products, which [it claims] are supported by an exhaustive database of safety research, from the proliferation of tric losan made by other

manufacturers.” 142 Petitioners query whether this decision to “differentiate” Ciba triclosan products

is actually a reflection of the growing scientific evidence against many of the varied and pervasive uses of triclosan. After all, Ciba could well have “differentiated” those nowabandoned products through the traditional methods of marketing, advertising and informational campaigns about their safety and effectiveness—as it has attempted to do with the products it continues to produce. At a minimum, such a substantial strategic change 143 must be viewed against the background of the growing scie ntific consensus and public concern about triclosan usage. A dditionally, and necessarily, the rationale for

140 EPA, Notice of Receipt of Requests To Voluntarily Cancel Certain Pe sticide Registrations, Docket No. EPA-HQ-OPP-2007-0513; FRL-8410-6, Federal Register: April 22, 2009, Volume 74, Number 76. 141 Ciba website, available at http://www.ciba.com/ind-pc-triclosan-prod-safe.htm

. 142 Id. (Emphasis added) 143 See, 2008 Ciba Annual Report, Notes to Consolidated Financial Statements, Note 4, Acquisitions and discontinued operations, available at http://www.ciba.com/2008-ciba-annualreport.pdf , observing that Ciba sold its Textile Effects business in 2006 and sold its Performance Polymers business in 2000. The transactions involved significant restructuring costs.

43the decision is nothing less than a serious indi ctment against those “o ther manufacturers”

to which Ciba refers. Decisions of Other Governmen tal Entities about Triclosan 1. European Commission, Scientific Committee on Consumer Products. Petitioners query whether Ciba’s deci sion was influenced by a recent opinion, adopted just two months earlier, by the Eu ropean Commission's Sc ientific Committee on

Consumer Products 144 (SCCP Opinion). The SCCP Opini on found that “continued use of triclosan as a preservative at the current concentration limit of maximum 0.3% in all cosmetic products is not safe for the consumer because of the magnitude of the aggregate exposure.” 145 That opinion also determined that triclosan usage of certain “leave-on products (e.g. body lotions) and in mouthwashes is not considered safe for the consumer due to the resulting high exposures.” 146 Finally, although the SCCP Opinion did not find triclosan use unsafe, at a maximum concentration of 0.3%, in toothpast es, hand soaps, body soaps/shower gels and deodorant sticks, face powders and blemish c oncealers, it readily admitted a significant qualification to this finding: Importantly, before a final conclusi on on the safety of triclosan in cosmetic products can be reached, the potential development of resistance

144 European Commission, Health & Consumer Protection Directorate-General, Scientific Committee on consumer Products, Opinion on Triclosan, COLIPA No. P32, SCCP/1192/08, adoped at 19 th plenary of 21 January 2009. 145 Id. at p. 123. 146 Id.

44to triclosan and cross -resistance by certain micr o-organisms must be assessed. This aspect is not covered in this document.... 147 Thus, the SCCP withheld a decision on tr iclosan’s dangers in these areas pending further research on the substance’s propensit y to promote bacterial resistance and crossresistance. Petitioners refer to the discussion in Section II (B) of th is Petition citing the substantial and compelling evid ence confirming the reality, and thus the threat, of such

resistance.

2. California Environmental Pr otection Agency, Office of

Environmental Health Hazard Assessment. The Ciba decision might also reflect cer tain deliberations on the dangers of triclosan usage by the California Envir onmental Protection Agency’s Office of

Environmental Health Hazard Assessme nt (OEHHA). In March, 2009, OEHHA included triclosan among 38 chemicals to be reviewed by the state Carc inogen Identification Committee (CIC) for potential “listing” under the California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). Although Ciba recommended “against accepting triclosan” for inclusion in the pr ocess potentially leading to a listing, 148 OEHHA nonetheless included triclosan in its prioritization groupings. 149 3. British Royal Commission on Environmental Pollution Yet another significant and relevant decision is one by the British Royal Commission on Environmental Pollution. (British Royal Commission) In 2003, the

147 Id. Also, the SCCP Opinion did not assess inhalation exposure to triclosan from spray products (e.g. deodorants). Id. 148 See, Letter from Lisa Navarro, of Ciba, to OEHHA, May 4, 2009, available at http://.oehha.ca.gov/prop65/public_meetings/052909coms/triclosan/CibaCorpTriclosan.pdf

. 149 See, OEHHA, “Meeting Synopsis and Slide Presentations Carcinogen Identification Committee Meeting Held on May 29, 2009”, available at http://www.oehha.ca.gov/prop65 /public_meetings/cic060509.hmtl

.

45British Royal Commission Recommended a regulato ry ban on synthetic chemicals. What is significant about this deci sion is the application--in star k contrast to EPA’s complete rejection--of the “precautionary principl e.” The British Royal Commission stated: We recommend that where synthetic chemicals are found in elevated concentrations in biologi cal fluids such as breast milk and tissues of humans, regulatory st eps be taken to remove them from the market immediately. 150

Thus, the British Royal Commission’ s recommendation was an exemplary application of the preca utionary principle, as it reco mmended “that action be taken to

reduce risk from chemicals in the face of uncertain but suggestive evidence of harm.” 151 Decisions of Profe ssional Associations The following examples show that some professional associ ations are stepping forward to express formally their serious reservations about triclosan usage.

1. American Medical Association As discussed in Section II (G) of this Petition, the American Medical

Association’s Council on Scie ntific Affairs stat ed its significant concerns about the efficacy of triclosan. That body recommended se veral protective steps aimed at acquiring additional scientific knowledge while protecting public health and safety.

2. Canadian Medical Association

150 Royal Commission on Environmental Pollution, Twenty-fourth Report, Chemicals in Products: Safeguarding the Environment and Human Health, June 3, 2003. The Royal Commission on Environmental Pollution (RCEP) is an independent standing body established in 1970 to advise the Queen, Government, Parliament, the devolved administrations and the public on environmental issues. Although funded by the Department for Environment, Food and Rural Affairs, the Royal Commission is independent of Government Departments. 151 Pesticide Action Network International (PAN), Briefing Paper on the Precautionary Principle, 09/14/06, available at http://www.panap.net/uploads/med ia/PAN_precaution_14_Sep_06.pdf (PAN Paper).

46In 2009, the Canadian Medical Associati on, at its Annual Meeting, Adopted the following Resolution:

The Canadian Medical Association cal ls upon the federal government to

ban the sale of household antibacterial products due to the risk of bacterial resistance and to recognize that soap and alcohol-based solutions are as effective in preventing household infection. 152 3. Physicians for Social Responsibility In a 2009 report, Physicians for Social Re sponsibility announced the results of a study demonstrating that “health care prof essionals are exposed—t hrough the workplace or in their personal lives—to a wide range of chemicals [i ncluding triclosan] known or suspected to cause health problems.” 153 Hazardous Chemicals In Health Care concluded with several recommendations designed to protect health care professionals and the public. 154 The foregoing discussion illustrates that the momentum of the concern about the dangers of triclosan is growing steadily and rapidly. Further, both substantial corporate and governmental actors are attesting to the seriousne ss and the soundness of that concern through their actions.

152 Canadian Medical Association Resolution No. 74, Resolutions Adopted at General Council, 17-19 August 2009, 142nd Annual Meeting Saskatoon, SK (also available at http://www.cma.ca/index.cfm/ci_id/89632/la_id/1.htm ).

153 Report: Hazardous Chemicals In Health Care , Physicians for Social Responsibility, p. 23, October 9, 2009. (also available at http://www.psr.org/assets /pdfs/hazardous-chemic als-in-health-care.pdf ). 154 Id. at 26-30.

47Conclusion

Petitioners have demonstrated in this Petition that a s ubstantial body of scientific studies, reports and other sources support the position that th e constantly-expanding, pervasive and diverse uses of triclosan pose an actual a nd imminent threat to human health and the environment. Therefore, tric losan usage in EPA-approved applications is unsafe and ineffective, in violation of FIFR A and the FFDCA, and the agency must take such action as required by law to bring its re gulation of triclosan into compliance with

these statutes and other rele vant statutes, including CWA, SDWA, and ESA. In the interests of the protection of human health and the overall environment that supports it, Petitioners request that the EPA ban triclosan and apply in additional, ancillary remedies provided for in federal law.

Respectfully Submitted

_____________________________ Perry E. Wallace, Esq. a 5 Zelle Hofmann Voelbel M uite 65

. 20006 son LLP 1700 K St. N.W., S Washington, D.C ( 301) 675‐5969

ners Attorney for Petitio January 14, 2010

48Appendix A Petition Signatories

1. Beyond Pesticides 2. Food and Water Watch 3. Alaska Community Action on Toxics 4. American Federation of Teachers 5. Ban Pesticides in Ulster County 6. Bernhoft Center for Advanced Medicine 7. Beyond Pesticides Ohio 8. Biological Pest Management 9. Black Warrior Riverkeeper 10. Blue Ridge Environmen tal Defense League 11. Breast Cancer Fund 12. BURNT 13. California Safe Schools 14. Californians for Alternatives to Toxics 15. Cancer Awareness Coalition 16. Cape Fear COASTKEEPER® 17. Center for Biological Diversity 18. Center for Environmental Health 19. Chemical Sensitivity Disorders Association 20. Choctawhatchee Riverkeeper 21. Citizens Campaign for the Environment 22. Citizens for Reform of Pesticide Spraying 23. Clean Production Action 24. Concerned Citizens for Clean Air 25. Deirdre Imus Environmental Ce nter for Pediatric Oncology 26. Donaldson Farms 27. Ecological Health Organization 28. Ecology Center 29. Environment and Human Health, Inc. 30. Environmental Working Group 31. Equal Exchange 32. Farmworker Association of Florida 33. Fearless Fund 34. Fluoride Action Network 35. Friends of Hurricane Creek 36. Galveston Baykeeper 37. Grass Roots the Organic Way (GROW) 38. Grassroots Environmental Education 39. Great Neck Breast Cancer Coalition 40. Green Science Policy Institute 41. Greenpeace US 42. Healthy Building Network

4943. Healthy Child Healthy World 44. HELP New Paltz (HEalthy Lawns Project) 45. Hilltown Anti-Herbicide Coalition 46. Huntington Breast Cancer Action Coalition 47. Informed Choices 48. Informed Green Solutions, Inc. 49. Kids for Saving Earth 50. Maryland Pesticide Network 51. Massachusetts Breast Cancer Coalition 52. National Center for Environm ental Health Strategies 53. National Toxic Encephalopathy Foundation 54. Natural Resources Council of Maine 55. Neuse RIVERKEEPER® Foundation 56. New Jersey Environmental Federation 57. No Spray Nashville 58. Oregon Toxics Alliance 59. Osborne Organics 60. Parents for a Safer Environment 61. Pesticide Action Network North America 62. Pesticide Awareness and Alternatives Coalition 63. Pesticide Watch 64. Physicians for Social Responsibility 65. PODER 66. Warren Porter, Ph.D., Univers ity of Wisconsin-Madison 67. Protect All Children's Environment 68. Rochesterians Against the Misuse of Pesticides 69. SaferBuilding 70. Safer Pest Control Project 71. Satilla Riverkeeper 72. Shenandoah Riverkeeper 73. Sustainable Agriculture and Pesticide Policy (SAPP) Group 74. Sustainability Institute at Molloy College 75. Terry Shistar, Ph.D. 76. TEDX (The Endocrine Disruption Exchange) 77. Tualatin Riverkeeper 78. Toxic Free North Carolina 79. Virginia Eastern SHOREKEEPER 80. Western Lake Erie Waterkeeper 81. Women's Environmental Institute 82. Women's Voices for the Earth

5051 Appendix B Organizations Supporting December 2008 Comments on the Proposed Rule: Triclosan; Reregistration Eligibility Decision (EPA-HQ-OPP-2007-0513-0053)

Action Now Alaska Community Action on Toxics American Bird Conservancy Beyond Pesticides Ohio Breast Cancer Fund BURNT California Safe Schools Californians for Alternatives to Toxics Center for Environmental Health Chemical Sensitivity Disorders Association Citizens Campaign for the Environment Ecology Center Environmental Health Network Environment and Human Health, Inc. Grass Roots the Organic Way (GROW) Greenpeace US Healthy Building Network Healthy Child Healthy World Maryland Pesticide Network National Center for Environm ental Health Strategies Natural Resources Council of Maine Natural Resources Defense Council No Spray Nashville Northwest Coalition for Alternatives to Pesticides Oregon Toxics Alliance Pesticide Action Networ k North America (PANNA) Pesticide Watch Warren Porter, PhD, University of Wisconsin Protect All Children's Environment Safer Pest Control Project San Francisco Baykeeper Sierra Club TEDX (The Endocrine Disruption Exchange) Women's Environmental Institute Women's Voices for the Earth