Page 1 of 14 UNITED STATES ENVIRONMEN TAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF

CHEMICAL SAFETY AND

POLLUTION PREVENTION

5/13/15

Subject: Response to Citizen Petition for a Ban on Triclosan

This letter constitutes the U.S. Environmental Protection Agency’s (“EPA” or “the agency”) response to the Citizen Petition for a Ban on Triclo san dated January 14, 2010 (“petition”), submitted by Food & Water Watch and Beyond Pesticid es seeking a ban on the antimicr obial pesticide triclosan. This letter also constitutes the agency’s response to the comments received during the public comment period on the petition.

The petition specifically requests th at the agency take the following steps under each of the following

statutes:

Federal Insecticide, Fungicide, and Roden ticide Act (FIFRA) and Federal Food, Drug, and Cosmetic Act (FFDCA): (1) reopen the Reregistra tion Eligibility Decision (RED); (2) issue a notice of cancellation of the registrations of all products containing triclosan; and (3) concurrently issue an emergency order to immediately suspend the existing triclosan registrations.

Clean Water Act (CWA): (1) impose technology-based effluent limitations; (2) establish healthbased toxic pollutant water quality pretreat ment requirements; and (3) impose biosolids regulation for triclosan.

Safe Drinking Water Act (SDWA): conduct a comp rehensive assessment of the appropriateness of regulating triclosan under SDWA.

Endangered Species Act (ESA): (1) conduct a biological assessment; and (2) engage in consultation with the Secretary of the In terior and the Secretary of Commerce.

On December 10, 2010, the EPA published a Notice in the Federal Register (FR) announcing the availability of the petition for a 60-day public comment period. The petition was made available for comment at regulations.gov in docket EPA-HQ- OPP-2010-0548. After extending the comment period for an additional 60 days, the comment period closed on April 8, 2011. During the public comment period, the agency received approximately 785 in dividual submissions. Within those submissions, several organized groups submitted letters with multiple signatures and comments. These submissions to the agency included 48,883 letters or signatures in support of the ban on triclosan and 4,265 signatures in support of allowing the continue d registration of triclosan.Page 2 of 14 Summary of Agency Response to the Petition

After carefully considering the information presen ted in the petition and submitted by commenters, the

EPA determined that the information available at this time does not support gran ting the majority of the relief requested. The agency notes, however, that it is currently engaged across various programs in assessing the risks posed by triclosan, such as the ri sk assessment process in the registration review program, which includes a comprehensive review of human health and ecologi cal risks (under FIFRA), and the risk assessment process for biosolids (under CWA). Depending on the results of these assessments, the EPA may consider regulatory action. To the extent that the petitioners are seeking regulatory actions in advance of sc heduled review and risk assessment processes, the EPA does not plan to take any actions before its an alyses have been completed. Accord ingly, EPA is denying the petition’s requests to reopen the RED, issue a notice of cancella tion of the registrations of all products containing triclosan, and issue an emergency order suspending existing triclosan registrations under FIFRA. The EPA is also denying the petition’ s requests to impose new technology- based effluent limitations for triclosan, to establish water quality pretreatment requirements for triclosan, and to impose biosolids regulation for triclosan under the CWA. Finally, becau se the EPA had already planned to carry out a comprehensive ecological risk assessment that will ev aluate the potential for effects on listed species, the EPA is granting the request to conduct a biological assessment under the ESA.

The EPA is neither granting nor denying the petiti on’s request to conduct a comprehensive assessment of the appropriateness of regulating triclosan under the SDWA because the agency is already engaged in

such an assessment. No further action is necessary to respond to petitioners’ SDWA request.

Consideration of the Petition and Detailed Response

This response addresses both the information contai ned within the petition and the comments received during the 120-day public comment period. Most of th e comments received were submitted in support of the petition and cite reasoning aligne d with the assertions contained in the petition. The agency also received multiple comments in support of the conti nued registration of triclosan and denial of the petition. The petition and all comments can be vi ewed in full at regulations.gov in docket EPA-HQOPP-2010-0548.

Petitioners and some commenters have made th e following assertions, among others, regarding

triclosan:

(1) The ubiquity of triclosan resu lts in endocrine disruption; (2) The ubiquity of triclosan contributes to bacter ial resistance in antibiotic medications and antibacterial cleansers; (3) Triclosan is bioaccumulative and poses an immense body burden; (4) Triclosan is not completely removed from wa stewater and sludge, which may result in food contamination; (5) The EPA’s RED determination faile d to address major degradates; (6) Triclosan is highly toxic to various forms of algae and this can cause ecological damage; and (7) Triclosan fails to provide the benefits claimed on product labels due to bacterial resistance, and is

therefore misbranded in vi olation of the FFDCA.

Commenters that supported contin ued registration of tr iclosan under FIFRA and opposed regulation of

triclosan under the CWA or the SDWA ma de the following assertions, among others:Page 3 of 14 (1) Triclosan is not a cause of e ndocrine related effects to hum ans or aquatic organisms at environmentally relevant concentrations; (2) In situ studies on the impact of triclosan on bacterial resist ance demonstrate no association between triclosan exposure and microbial resistance; (3) Triclosan is not bioaccumulative and its presence in the body does not indicate that triclosan is causing harm; (4) Triclosan is largely removed from wastew ater and sludge, and does not result in food contamination; (5) Triclosan does not pose a ri sk of harm to algae or cause ecological damage; and (6) Triclosan should not be addressed through CW A because publicly owned treatment works (POTWs) would bear the cost of compliance with CWA regulations, not chemical

manufacturers.

The first section of this response discusses the applicable statutory fram ework. The second section discusses triclosan’s regulatory history and backgr ound. The third section sets out the EPA’s responses to petitioners’ arguments in favor of the actions th ey seek under the FIFRA, the FFDCA, the CWA, the SDWA, and the ESA. The final section provides the EPA’s findings and conclusions on the petition.

I. Legal Framework

A. FIFRA and ESA

Subject to limited exceptions, a pesticide may be dist ributed or sold in the United States only if it is registered by the EPA under FIFRA § 3(a), 7 U.S.C. § 136a(a). Under FIFRA, the EPA must register a pesticide if, among other things, the pesticide, when used in accordance with widespread and commonly recognized practice, generally wi ll not cause “unreasonable advers e effects on the environment.” 7 U.S.C. § 136a(c)(5). Section 2(bb) defines “unreasonable adverse effe cts on the environment” as, among other things, “any unreasonable risk to man or the environment, taki ng into account the economic, social and environmental costs and benefits of the use of any pesticide . . . .” 7 U.S.C. § 136(bb)(1). 1 This “risk-benefit” standard requires th e EPA to compare the risks presente d from the use of a pesticide with the benefits to society from the use of the pestic ide. Once a pesticide is registered, the EPA must periodically review that pesticide registration 7 U.S.C. §§ 136a(g), 136a-1.

If the EPA determines at any time that a register ed pesticide, including its approved labeling, no longer meets the standard for registration, the EPA may in itiate cancellation proceedings. 7 U.S.C. § 136d(b). To do this, the agency must: a) prepare a notice of inte nt to cancel the registrati on (NOIC) that states the reasons for the EPA’s proposed decision; b) consult th e Secretary of Agriculture, the Scientific Advisory Panel, and the Secretary of Human Health and Services (when a public health use is affected) for their comments on the NOIC; and c) address any commen ts from those parties. Under the statute’s procedures, the EPA must then send the NOIC to the registrant and publish it in the Federal Register. Within 30 days of receiving the NOIC, a registrant (o r another adversely affected person) can request a hearing to present evidence agains t cancellation. After such a heari ng, the agency may issue an order canceling the registration, require modi fications to the label or packagin g, or withdraw the initial notice. If no hearing is requested, then th e NOIC becomes final and effective 30 days after the date of the

1 The definition of the term in FIFRA section 2(bb) also incl udes “(2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the sta ndard under section 346a of Title 21” (section 408 of the Federal Food, Drug, and Cosmetic Act). However, the petition did not include any assertions regarding a human dietary risk from residues from use of triclosan pesticides in or on food.Page 4 of 14 registrant’s receipt of the NOIC or the date of public ation in the Federal Regist er, whichever is later, 7 U.S.C. § 136d(b).

The EPA may also commence proceedings to suspend the registration of a pesticide during the period necessary to complete cancellation proceedings if it determines that an “imminent hazard” exists from the use of the pesticide. 7 U.S.C. § 136d (c). Se ction 2(l) of FIFRA defi nes imminent hazard as,

[A] situation which exists when the continued us e of a pesticide during the time required for [a] cancellation proceeding would be likely to resu lt in unreasonable adverse effects on the environment or will involve unreasonable hazard to the survival of a species declared endangered or threatened by the Secretary pur suant to the Endangere d Species Act . . . .

If the EPA determines that an emergency exists such that the imminent h azard will occur during the period necessary to complete normal suspension pr oceedings (including issuance of a NOIC), the EPA may issue an immediately effective emergency susp ension order in advance of completing suspension proceedings. 7 U.S.C. § 136d(c)(3). Suspension (i ncluding an emergency suspension order) under FIFRA is an interim remedy that can remain in eff ect only for the duration of a cancellation proceeding;

if the Administrator determines that initiation of a cancellation proceeding is not appropriate, suspension is no longer an option un der FIFRA section 6.

In addition, section 3(g) of FIFRA requires the EPA to periodically review the registrations of all pesticides. The EPA has promulgated regulations to implement this requirement at 40 C.F.R. part 155. The registration review program makes sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory sta ndard of no “unreasonable

adverse effects on the environment.” The EPA initiate s a registration review by establishing a docket for a pesticide registration review cas e and opening the docket for public re view and comment. Each docket contains information on what the agency knows about the pesticide and describe s the anticipated data and assessment needs identified by the agency. The regulations outline subsequent phases of the registration review proce ss and the associated oppor tunities for public comment.

Finally, section 7 of the ESA, 16 U.S.C. § 1536(a)(2), requires all federal agenci es to consult with the

National Marine Fisheries Service fo r marine and anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed wildlife and fr eshwater organisms, if they intend to take an “action” that may affect listed ( i.e. , endangered or threatened) species or their designated critical habitat. Under the Act, the EPA is required to ensure actions are not likely to jeopardi ze the continued existence of a listed species, or result in the destruction or a dverse modification of designa ted critical habitat.

B. Clean Water Act (CWA)

The Federal Water Pollution Control Act (33 U.S.C. §1251 et seq.), also known as the Clean Water Act (CWA), is the primary, statutory basis for protec ting the Nation’s waters. The Act’s main ways to protect waters are by regulating disc harges of pollutants into the waters of the United States through both technology-based and wáter qualit y-based effluent limitations. As set forth in Section 101(a), the CWA’s objective is to restore and maintain the chemical, physical, and biological integrity of the Nation’s waters, including the elimin ation of the discharge of polluti on into the navigable waters, the setting of interim water quality standards providing protection and propagation of fish, shellfish, and wildlife, and the prohibition of the discharge of toxic polluta nts in toxic amounts (33 U.S.C. §1251(a)(1),(2),(3)).

C. Safe Drinking Water Act (SDWA)Page 5 of 14 The Safe Drinking Water Act (SDWA, 42 U.S.C. § 300f-300j-26) authorizes the EPA to set national standards for drinking water to prot ect against both naturally-occurri ng and man-made contaminants that may be found in drinking water. Section 1412(b)(1) of the SDWA, as amended in 1996, requires EPA to publish a Contaminant Candidate List (CCL) every five years. The SDWA specifies that the list include contaminants that are not subject to any proposed or promulgated National Primary Drinking Water Regulations (NPDWRs), are known or anticipated to occur in public water systems, and may require regulation under the SDWA. For each CCL, EPA publis hes a draft list and takes comment prior to issuing the final list. SDWA Sec tion 1412(b)(1)(B)(ii) also requires EPA to make determinations of whether or not to regulate no fewer than five cont aminants from the CCL every five years based upon three statutory criteria. EPA publishes preliminary determinations and takes comment prior to making

final determinations. If EPA determines that these three statutory criteria are met and makes a final determination to regulate a cont aminant, the agency has 24 months to publish a proposed Maximum Contaminant Level Goal (MCLG) and NPDWR. EPA se ts the MCLG at the level at which no known or anticipated effects on the health of persons occur and which allows an adequate margin of safety. EPA typically establishes a Maximum Contaminant Le vel (MCL) as the enforceable NPDWR. After considering costs and benefits, EPA generally sets the MCL as close as feasible to the MCLG. After the proposal, the agency has 18 months, w ith the option of a nine month ex tension, to publish a final MCLG and NPDWR. EPA can enforce the NPDWRs by se nding notice to state and public water systems, issuing administrative orde rs, or taking civil action.

II. Regulatory History and Background for Pesticides that Contain Triclosan

Triclosan (2,4,4’ –trichloro-2’-hydr oxydiphenyl ether) (PC Code 054901) was first registered with the EPA as an antimicrobial pesticide in 1969. Triclo san is currently registered under FIFRA as a bacteriostat, fungistat, and mildewst at for use as a materials preserva tive in residential, public access, commercial, institutional and industrial premises.

The EPA issued a Reregistration Eligibility Decisi on (RED) for triclosan in 2008. As part of that process, the Office of Pesticide Pr ograms (OPP) performed a comprehensive assessment of the hazards, exposures and risks to human health and the environmen t resulting from the registered pesticidal uses of triclosan. All currently registered pe sticidal uses of triclosan were found eligible for reregistration in

2008.

FIFRA does not require, or otherwis e directly address, aggregating e xposure to other potential sources of a pesticide in the context of determining wh ether the use of a non-dietary pesticide will cause

unreasonable adverse effects on human health. In th e case of triclosan, popul ation-based biological monitoring data were available to assess the co-o ccurrence of uses, and EPA developed an aggregate exposure risk assessment for post-application reside ntial exposures to triclosan for the 2008 RED. The best available data to perform an aggregate asse ssment at that time was the National Health and Nutrition Examination Survey (NHANES) biological monitoring data collected by the Centers for Disease Control and Prevention (CDC). NHANES is a program designed to assess the health and

nutritional status of adults and chil dren greater than six years old in the United States by examining a nationally representative sample of about 5,000 persons each year. 2 To capture children younger than six years old, exposure estimates for infant s less than one year old were al so included in the aggregate. Due to the nature of the samples and data collected in the NHANES program , the aggregate risk assessment

2 http://www.cdc.gov/nchs/nhanes/about_nhanes.htmPage 6 of 14 took all sources of exposure to triclosan into acco unt, including both the EPA-registered antimicrobial uses and the Food and Drug Administration (FDA)-re gulated uses such as triclosan-containing toothpaste, hand soaps, and deodorants . Based on available data at that time, the agency concluded that total exposure to triclosan from all sources did not present risks of con cern for human health.

The agency conducted a qualitative environmental ri sk assessment as part of the RED using existing ecotoxicity studies, United States Geological Survey monitored levels of triclosan found in waterways, and consumer environmental modeling. The agency determined that estimated concentrations of triclosan in surface water, when adjusted to repres ent contributions from pes ticidal uses only, did not exceed levels of concern for acute risk, and that chr onic risk was unlikely because of the low probability of triclosan being released into household wastewater and surface waters from either antimicrobial uses of triclosan pesticides or consumer uses of triclosan-treat ed plastics and textiles. The agency issued a post-RED Data Call-In (DCI) requiring monitoring data on the effluent of manuf acturing facilities using triclosan pesticides. The first set of these data were received in April 2012 and will be the starting point for the EPA to assess any additional data needs and to conduct a quantita tive environmental risk assessment during registration review.

Given the rapidly developing scientific database fo r this chemical, the agen cy accelerated the schedule for triclosan’s re-evaluation (i.e., registration review) and issued a Final Work Plan for triclosan in April

of 2014. This review of triclosan will entail new a nd comprehensive human health and ecological risk assessments, including endangered species assessments, for all the EPA-registered uses of triclosan. The

EPA will take into consideration relevant informa tion developed since the RED was issued, including information presented in the petition, comments subm itted in response to the petition, peer reviewed literature, data received in response to the post- RED DCI, and incident reports, as well as any information obtained during the course of the registration review. This information will also include results of the ongoing studies bei ng conducted by the National Toxico logy Program (NTP) on triclosan as a result of the nomination of the chemical to NTP by the FDA, when such results are available. The

EPA will review scientific literat ure studies in accordance with the published Office of Pesticide Programs (OPP) document Guidance for Identifyi ng, Selecting, and Evaluating Open Literature

Studies. 3 A Preliminary Risk Assessmen t is currently scheduled to be completed in late 2018.

Documents associated with the re gistration review are available at regulations.gov in docket EPA-HQOPP-2012-0811.

III. Petition Response

A. Response to Requests for Relief under FIFRA and FFDCA

For the reasons set forth in more detail below, th e EPA denies the request that the EPA suspend and cancel all registered products cont aining triclosan. The agency’s most recent risk assessments of the

risks to human health and the e nvironment found that the antimicrobi al uses of tr iclosan met the applicable statutory standards, and the petiti on and supporting comments did not provide sufficient evidence to significantly change those conclusions. In any event, the pe tition did not show that risks of concern from antimicrobial pesticidal uses of triclo san meet the criteria for suspending and canceling all registered products containing triclosan. Nonetheless, the agency is currently engaged in assessing the risks posed by triclosan through the risk assessment process in the registration review program. In general, the petition did not demonstr ate that use of registered pestic ides containing triclosan is causing

3 http://www.epa.gov/pesticides/s cience/literature-studies.htmlPage 7 of 14 the harm alleged in the petition, or that the requested regulatory action would eliminate the harm alleged. EPA’s responses to the various requests set fo rth in the petition are mo re specifically detailed

below.

1. The petitioners believe that the widespread environmental and human exposure to triclosan has the potential to pose unreasonable risks to human health and the envi ronment, particularly risks of endocrine disruption effects, and they request that the EPA reopen the RED for triclosan. The petition notes that the EPA has not completed the Endocrine Disruptor Screening Progr am (EDSP) required in the Food Quality Protection Act (FQPA) amendments to the FFDCA, and asserts that the RED “did not have the benefit” of whatever new knowledge or an alysis might come out of that program (Pet. p. 22).

EPA Response: FIFRA requires the EP A to periodically review the regi strations of all pesticides. The triclosan RED represents the agency’s regulatory determination as of th e time it was issued. In the RED, the agency committed to examining the endocrine inte ractions of triclosan further. The registration review process will provide the opportunity for the EPA to examine information developed since the RED and to require submission of additional data if necessary. The EDSP w ill provide an additional opportunity to assess the need to issue future orde rs or data call-ins requiri ng the submission of EDSP screening assays for triclosan.

2. The petition asserts that triclosa n has the potential to promote bacterial resistance in humans to antibiotic medications and antibacterial cleansers, which is especially of concern for vulnerable subpopulations such as “persons with impaired immune systems, infants and young children, and persons needing the benefit of antibiotics” (Pet. p. 6). The petition also attributes bacterial resistance to “the widespread use of triclosan – whatever the so urce and whatever agency has regulatory authority,” especially residues of tric losan left on surfaces from use of cons umer products which are not regulated by the EPA (Pet. 27).

EPA Response: While scientists are understandably concerned about the potenti al for development of medication-resistant infectious bacteria, there is curre ntly no direct evidence before the EPA, either from the petition or other sources, of a causal relationship between bacterial resistance in humans and either triclosan “body burden” or residential exposures to tr iclosan residues resulting from the use of consumer products. The agency has reviewed the information submitted in the petition and determined it does not

demonstrate that bacterial resistance in humans resu lts from pesticidal uses of triclosan, or that cancelling the registrations of tric losan-containing pesticide products would have any impact on the development of bacterial resistance since the pesticidal uses of triclosan constitute a very small percent of the triclosan used in the United States. In regist ration review, the agency will take into consideration relevant information developed since the RED was i ssued, including scientific literature studies in accordance with the published OPP document Guidance for Identifying, Selecting, and Evaluating Open

Literature Studies. 4

3. Based on the lipophilic nature of the compound, the petitioners assert that triclosan has the potential to bioaccumulate and pose an “immense body burden” to humans, resulting in the disruption of thyroid and other organ functions. Th ey state that triclosan has been measured in quantifiable amounts in 75 percent of the U.S. population in urine, blood and breast milk.

EPA Response: The presence of triclosan in urine, blood, breast milk, and othe r bodily fluids does not by itself support a characterization of triclosan as bioaccumulative or posing an immense body burden.

4 http://www.epa.gov/pesticides/s cience/literature-studies.htmlPage 8 of 14 The CDC survey that the petitioners cite found triclo san was present in the ur ine of 75 percent of a randomly surveyed population. The survey did not provide any evidence that the measured urine

concentrations correla te with any adverse effects. Dayan (2007) 5 measured concentrations of triclosan in breast milk and concluded that expo sures were well below the level of concern identified in the study for

adverse effects of triclosan from br east milk ingestion. Further, as not ed, biomonitoring studies such as the CDC and NHANES monitoring data account for all exposures of the individu al to triclosan from every source, including those pr oducts and applications that ar e not pesticide products. Based on available data at the time of the 2008 RED, the agen cy concluded that total exposure to triclosan from all sources did not present risks of concern for huma n health. Additionally, since the pesticidal uses of triclosan constitute a very small percent of the triclosan used in the United States, there is no evidence that cancelling the triclosan pesticide registratio ns would meaningfully reduce the perceived body

burden.

4. The petitioners also assert th at secondary exposure to triclo san can result from triclosan not being completely removed from waste water an d sludge, resulting in food and drinking water

contamination.

EPA Response: While the petitioners identified waste water and sludge as potenti al sources of triclosan exposure, the agency would need data or other ev idence of actual triclosan residues in any food or source of drinking water before it could assess the pot ential for such exposure to cause adverse effects. Also, since the NHANES biomonitoring data that the EPA used for the human health risk assessment accounted for exposure to triclosan from all possible sources, if secondary tric losan residues have been present in food or drinking water, that contribution to human exposure has been considered already and found to satisfy the risk-benefit re gulatory standard under FIFRA. Fi nally, without any evidence that triclosan is present in waste water and sludge due to use of pesticides , EPA is unable to determine that any action it might take under FIFRA would actually reduce or mitigate that po tential contribution to human exposure to triclosan. If the EPA finds eviden ce demonstrating exposure to pesticidal uses of

triclosan causes unreasonable adverse effects in the environment during registra tion review, the agency will consider the appropriate regulatory action to take at that time.

5. In addition to exposure to triclosan, the petiti on maintains that the EPA has thus far failed to address major degradates of concern, including dioxins . The petition states that dioxins can be formed as impurities during the manufacture of many products co ntaining triclosan, upon incineration of textile products treated with triclosan, in sunlight and in reaction with free chlorine in tap water.

EPA Response: While the agency did not consider di oxin contaminants as part of the RED, the EPA identified major degradates of concern in the Fina l Work Plan and has also examined the question of dioxin formation during the registra tion review of triclosan. A prelim inary examination shows that the

dioxins that can form from triclosan in chlorinated waters (2,7-dibenzodichloro- p -dioxin; 2,8-dichlorop -dioxin; 1,2,8- and 2,3,7-trichlor odioxins and 1,2,3,8-tetrach lorodioxin) are not among the congeners that have been identified as being of toxicol ogical concern (see the Triclosan Final Work Plan Appendices B and F for this discussion). Thus, EP A does not expect there to be risks of concern

associated with dioxins formed with triclosan. This information is available in the docket for the Triclosan Registration Review at regulat ions.gov, docket EPA-HQ-OPP-2012-0811. The risk assessment that will be performed as part of registration review will include a discussion of dioxin

formation from environmental concentra tions of triclosan pesticide products.

5 Dayan, A.D. 2007. Risk assessment of triclosan [Irgasan] in human breast milk. Food and Chemical Toxicology 45:125–

129.Page 9 of 14 6. In addition to impacts on human health, the petition asserts that there is a potential for adverse ecological impacts from the continued registration of triclosan including bioaccumulation and the potential disruption of the ecosystem due to triclosan’s toxicity to al gae, “the first- step producers in aquatic ecosystems.”

EPA Response: In the RED for triclosan, the EPA relied on a qualitative assessment of the potential for ecological effects to result from use of triclosa n pesticide products, and found that no unreasonable

adverse effects would occur. The EPA intends to further look into poten tial ecological effects and issued a data call-in (DCI) after issuance of the RED for several studies on th e ecological effects and exposure potential of triclosan pesticides. Additionally, it is anticipated that ecological effects data will be required in registration review so that the agency can conduct a comprehensive ecological risk assessment at that time, including the potential for triclosan to bioaccumulate in environmental organisms.

7. The petitioners assert that “triclosan is ‘misbr anded’ in violation of the FFDCA because it fails to provide the benefits claimed on product labels, in marketing and advertising campaigns and in other public statements in a cost-effective, safe manner.”

EPA Response: The only type of product identified in this section of th e petition was hand soap containing triclosan, a product that is regulated by the FDA, not the EPA, under the FFDCA. 6 Since these products do not fall within the EPA’s jurisdic tion under FIFRA, the EPA has no authority to grant any relief in response to this assertion.

B. Response to Requests for Relief under Clean Water Act (CWA)

The petitioners claim that with the continued regi stration of triclosan, the EPA has not restored and maintained the chemical, physical, and biological inte grity of the Nation’s wate rs. They claim that the EPA’s failure to implement properly one federal e nvironmental statute (FIFRA) directly enables a violation of another federal environmental statute (C WA). In the petitioners’ opinion, they view the actions as “arbitrary, capricious” and “otherwise no t in accordance with law. ” The petitioners request relief in three categories under th e CWA. The petitioners request th at the EPA impose technology-based effluent limitations guidelines (ELG), health-bas ed toxic pollutant wate r quality pretreatment requirements, and biosolids regulation for triclosan. Fo r the reasons set forth in more detail below, the EPA is denying the petitioners’ reque sts to impose technology-based effluent limitations guidelines (ELG), health-based toxic polluta nt water quality pretreatment requ irements, and biosolids regulation

for triclosan.

1. The petitioners request that the EPA impose technology-based effluent limitations guidelines (ELG) for triclosan. Petitioners allege that under the CWA, the EPA implements pollution control programs such as those setting wastewater standard s for industry and water quality standards for all contaminants in surface waters. 33 U.S.C. §§1251, 1342, 1362(14) establishes “effluent limitations,” in the form of nationally uniform, technology-based standards, and thos e standards ultimately apply to polluting “point sources.”

EPA Response: There are currently effluent limitation guidelines (ELG) for several of the industries that involve products containing triclosan. There are e ffluent limitations guidelines for Soap and Detergent

6 EPA does regulate pesticide residues in or on food by tolerance regulations under the FFDCA section 408, but that provision is not relevant to the products mentioned in the petition.Page 10 of 14 Manufacturing (1974), Textile Mills ( 1982), Organic Chemicals, Plastics , and Synthetic Fibers (1987), and Plastic Molding and Forming (1984). These are guidelines that cover water quality parameters such pH, Biological Oxygen Demand (B OD) and other parameters.

The EPA biennially publishes a plan , after public notice and comment th at establishes a schedule for the annual review and revision of existing effluent guide lines and identifies any new industrial categories selected for effluent guidelines rulemaking and provides a schedule fo r such rulemaking. The EPA uses four major factors in prioritizing existing effluent guidelines or pr etreatment standards for possible

revision. The first factor the EPA considers is th e amount and type of pollutants in an industrial category’s discharge and the relative hazard posed by that discharge. The second factor the EPA considers is the performance and cost of app licable and demonstrated wastewater treatment technologies, process changes, or pollution prevention alte rnatives that could effectively reduce the concentrations of pollutants in th e industrial category’s wastewater a nd, consequently, reduce the hazard

to human health or the environment associated with these pollutant discharges. The third factor the EPA considers is the economic achievability of the wa stewater treatment technology, process change, or pollution prevention measures identified using the second factor. If the financial condition of the industry indicates that it would be difficult to implement new, more stringent requirements, the EPA might conclude that other approaches to a national rule might be approp riate. The fourth factor the EPA considers is an opportunity to eliminate ineffici encies or impediments to pollution prevention or technological innovation, or opportun ities to promote innovative appr oaches, including within-plant trading.

The EPA’s most recent evaluation of all industry categor ies concluded that discharges from the currently regulated industries involving products contai ning triclosan (including Soap and Detergent Manufacturing; Textile Mills; Orga nic Chemicals, Plastics, and Synt hetic Fibers; and Plastic Molding and Forming) were not a hazard priority. For more information about the EPA’ s most recent evaluation,

see 2012 Effluent Guidelines Program Plan, available at: http://water.epa.gov/scitech/waste tech/guide/304m/upload/Prelimin ary-2012-Effluent-GuidelinesProgram-Plan.pdf

.

2. The petitioners request that the EPA establ ish health-based toxic pollutant water quality pretreatment requirements for triclosan.

EPA Response: Industrial dischargers (manufacturer s and formulators) may choose not to discharge directly into navigable waters and instead discharge indirectly through a publicly owned treatment works (POTW). CWA Section 307(b) (33 U.S.C. §1317(b )(1)) establishes pretreatment standards for pollutants that may be introduced into a POTW that ar e determined not to be susceptible to treatment by

such treatment works or which would interfere with the operation of such treatm ent works. Pretreatment standards are established to prevent the discharg e of any pollutant through a POTW where such pollutant interferes with, passes through, or otherwise is incompatible with such works. Indirect dischargers are subject to the pr etreatment requirements of Sec tion 307(b) of the CWA. The EPA annually investigates indirect i ndustrial dischargers for the pote ntial need for new or revised pretreatment standards concurrently with the ELG evaluation. To inform the most recent (2012) annual review, the EPA evaluated triclosa n data taken from the 2009 Targeted National Sewage Sludge Survey (TNSSS) 7 , discussed further below, to determine whether industrial categories can be identified as

sources of chemicals that were measured in bioso lids and, if so, whether new or revised pretreatment standards would be necessary. The EPA’s evaluation did not find associations between triclosan in

7 TNSSS: http://water.epa.gov/scitech/wastetech/biosolids/Page 11 of 14 sewage sludge and industrial wast ewater discharges. Past EPA studi es were consistent with this conclusion, having found that triclosan is present at highest concentrations in domestic wastewater, not industrial discharges. Thus, in the annual review the EPA determined that a water quality pretreatment standard was not appropriate at th at time. As EPA has no different in formation since that determination, the EPA is, therefore, denying petitioners’ request to establish a water quality pretreatment standard.

3. The petitioners request that the EPA impose bi osolids regulation for tr iclosan, after a thorough

evaluation of its health a nd environmental effects.

EPA Response: The CWA provides for the regulation of biosolids under CWA Section 405. Under Section 405, the EPA has promulgated the Biosolids Ru le (40 C.F.R. part 503), a comprehensive rule for biosolids management, which is based on extensive risk assessments for select chemicals. Pursuant to the CWA, the EPA reviews the Part 503 standards not less than every two years for purposes of evaluating and regulating ne w pollutants, as needed.

In 2009 the EPA published the results of the Ta rgeted National Sewage Sludge Survey (TNSSS) 6 which was designed to gather concentration data on 145 analytes that might occur in sewage sludge. The

collected information was intended to help the EPA assess if exposures to analytes were occurring and

whether the concentrations in sewa ge sludge may be of concern for pub lic health and the environment.

Triclosan was included in the TNSSS and found at c oncentrations ranging from 0.43 to 133 mg/kg. The EPA is evaluating TNSSS pollutants in two phases: 1) Phase I consists of eval uating ten pollutants (i.e., barium, beryllium, manganese, molybdenum, silver, 4-Ch loroaniline, fluoranthene, pyrene, nitrate, and nitrite); the risk evaluations for these ten pollutant s underwent peer review in early 2015, and the agency is addressing peer review comments. Following peer review, the agency will address comments, revise the risk evaluation technical background document, a nd consider any needed risk management options. 2) Phase II pollutants include 135 co mpounds (including triclosan) that the agency may evaluate starting in 2015 once the peer review is comp leted for the ten Phase I pollutants. The peer review for the Phase I pollutants may help inform the methodology for ev aluating risk to humans and ecological (both terrestrial and aquatic) receptors, where sufficient data are available, and help determine if it is appropriate to impose biosolids regulations for the Phase II pollutants. The EPA is denying the petitioners’ request to es tablish biosolids regulati on for triclosan, however, b ecause action is premature while these processes are pending.

C. Response to Request for Relief under the Safe Drinking Water Act (SDWA)

The petitioners claim that with th e continued registration of triclosan, the EPA has violated the SDWA,

in that triclosan would be allowed to contaminate drinking water at leve ls that threaten human health and the environment. The petitioners request that the EPA conduct a comprehensive assessment of the appropriateness of regulati ng triclosan under the SDWA.

EPA Response: As discussed in more detail below, the EPA already assesses triclosan for regulation under the SDWA, so there is no need for any further action under this petition. The EPA is neither granting nor denying the petition with resp ect to the requested SDWA assessment.

The CCL 8 is a list of contaminants th at are currently not subject to any proposed or promulgated national primary drinking water regulations, that ar e known or anticipated to occur in public water systems, and which may require regulation under th e SDWA. EPA uses the CCL to identify priority

8 Drinking Water Contaminant Candidate List (CCL) and Regulatory Determination: http://www2.epa.gov/cclPage 12 of 14 contaminants for regulatory decision making under SDWA and for research and data collection. The

CCL 3 9 was published in October 2009 and includes, am ong others, pesticides, disinfection byproducts, chemicals used in commerce, waterborne pathogens, pharmaceuticals, and biological toxins. The agency

considered the best available data and informati on on health effects and occurrence to evaluate the contaminants on the list. EPA used a multi-step process that was recommended by the National

Academies of Science’s National Research Counc il and the National Drinki ng Water Advisory Council in order to determine which chemicals, chemical groups, or microbiological contaminants should be included on the Final CCL 3. The first step in the CCL 3 process included identifying a broad universe of almost 7,500 potential microbial and chemical drinking water contaminants (called the CCL 3 Universe). EPA then applied screening criteria to the CCL 3 Universe based on a contaminant’s potential to occur in public water systems and the potential for public health concern to identify a Preliminary CCL (PCCL) of about 600 contaminants . EPA then evaluated the contaminants on the

PCCL based on a more detailed assessment of oc currence and health eff ects using a scoring and classification system and expert ju dgment to develop the Draft CCL 3. Public input and expert review were incorporated throughout the CCL 3 process, including an opportunity for public comment on the Draft CCL 3 and review of the draft list by EPA’ s Science Advisory Board. The Final CCL 3 includes 104 chemicals or chemical groups an d 12 microbiological contaminants.

Triclosan was included in the universe of contaminants initially considered and evaluated for the CCL 3. After evaluating the best available health effects a nd occurrence data, triclosan did not pass screening to the Preliminary CCL (PCCL), and it was not included on the CCL 3 because the da ta indicated it did not typically occur in public water systems at levels of concern to human health. EPA sought public

nominations for contaminants to be considered for possible inclusion in the fourth CCL (CCL 4) 10 in May 2012. Triclosan was nominated by the public. No new quantitative health effects data were identified by EPA or submitted by the public during the nominations period that could be used in screening or scoring triclosan for CCL 4. Additiona lly, no new occurrence data were identified by EPA or submitted by nominators that were not alread y considered under CCL 3. On February 4, 2015, EPA published the Draft CCL 4 with an opportunity for public comment, and will consider any relevant new

occurrence and health ef fects data in finalizi ng the CCL 4. 80 FR 6076.

D. Response to Request for Relief under the Endangered Species Act

The petitioners request that the EPA “comply fully” with the ESA by conducting a biological assessment and engaging in consultation with the Secretary of the Interior and the Secretary of

Commerce.

EPA Response: As part of the registration review process, the agency has committed to meet its obligations under the Endangered Species Act to determine whether or not a pesticide’s use has an effect on a threatened or endangered species. As discu ssed above, the agency will perform a comprehensive ecological risk assessment that w ill allow the agency to determine whether triclosan’s use as an antimicrobial pesticide has “no effect” on or “may affect” federally listed threatened or endangered species (“listed species”) or their designated criti cal habitats. That assessment will determine whether the agency will consult with the U.S. Fish and W ildlife Service or the National Marine Fisheries Services (the Services), as appropr iate. Therefore, the EPA grants th e petition’s request for relief under

the ESA.

9 Contaminant Candidate List 3: http://www2.epa.gov/ccl/contaminant-candidate-list-3-ccl-3

10 Draft Contaminant Candidate List 4: http://www2.epa.gov/ccl/draft-contam inant-candidate-list-4-ccl-4Page 13 of 14 IV. Conclusion

For the reasons set forth above, the agency concludes th at the petitioners have not carried their burden of demonstrating the appropriateness of the requested relief. The EPA has previously determined that pesticide products containing triclosan will not cause unreasonable adverse effects on human health or the environment. As part of the EPA’s statutory obligation to periodically review all registered pesticides, the EPA has initiated another comprehensiv e assessment of the risks a nd benefits of triclosan pesticide products through the registration review process. The EPA will take the information provided by the petition and the commenters into account when conducting the registration review risk assessments. The EPA will use that process to dete rmine whether or not regulatory action such as cancellation is warranted. Therefore, the EPA denies the request to cancel triclosan registrations. Suspension of a pesticide’s regist ration is an interim remedy under FIFRA that must be accompanied by the initiation of a cancellation action; because th e EPA has determined that it will not initiate cancellation at this time, th e request that the EPA suspend the regist rations of triclosa n products is also denied. The EPA grants the petition’s request for reli ef under the ESA, in as much as the agency will assess risks to listed species in the triclosan registration review.

The EPA is also denying the petition’s request to establish new regulations for triclosan under the CWA at this time. The agency is engaged in ongoing as sessments and analyses to consider whether new limitations on chemicals, including triclosan, are necessary, including evalua ting the results of the

TNSSS. If such evaluations lead the EPA to conclude in the future th at new controls are necessary, the agency will consider ta king appropriate actions.

The EPA is neither granting nor denying petitioners’ requests to conduct assessments under the SDWA, as the agency is already pursuing these actions.

If you have any questions concerning this respons e, please contact Sandra O’Neill at (703) 347-0141.