EPA to Expand Chemicals Testing for Endocrine Disruption
Release date: 11/16/2010
Contact Information: Latisha Petteway email@example.com 202-564-3191 202-564-4355
WASHINGTON – The U.S. Environmental Protection Agency (EPA) has identified a list of 134 chemicals that will be screened for their potential to disrupt the endocrine system. Endocrine disruptors are chemicals that interact with and possibly disrupt the hormones produced or secreted by the human or animal endocrine system, which regulates growth, metabolism and reproduction. Administrator Lisa P. Jackson has made it a top priority to ensure the safety of chemicals, and this is another step in this process. “Endocrine disruptors represent a serious health concern for the American people, especially children. Americans today are exposed to more chemicals in our products, our environment and our bodies than ever before, and it is essential that EPA takes every step to gather information and prevent risks,” said EPA Administrator Lisa P. Jackson. “We are using the best available science to examine a larger list of chemicals and ensure that they are not contaminating the water we drink and exposing adults and children to potential harm.”
The list includes chemicals that have been identified as priorities under the Safe Drinking Water Act (SDWA) and may be found in sources of drinking water where a substantial number of people may be exposed. The list also includes pesticide active ingredients that are being evaluated under EPA’s registration review program to ensure they meet current scientific and regulatory standards. The data generated from the screens will provide robust and systematic scientific information to help EPA identify whether additional testing is necessary, or whether other steps are necessary to address potential endocrine disrupting chemicals.
The chemicals listed include those used in products such as solvents, gasoline, plastics, personal care products, pesticides, and pharmaceuticals, including benzene, perchlorate, urethane, ethylene glycol, and erythromycin.
Also being announced today are draft policies and procedures that EPA will follow to order testing, minimize duplicative testing, promote equitable cost-sharing, and to address issues that are unique to chemicals regulated under the SDWA. After public comment and review, EPA will issue test orders to pesticide registrants and the manufacturers of these chemicals to compel them to generate data to determine whether their chemicals may disrupt the estrogen, androgen and thyroid pathways of the endocrine system.
EPA is already screening an initial group of 67 pesticide chemicals. In October 2009, the agency issued orders to companies requiring endocrine disruptor screening program data for these chemicals. EPA will begin issuing orders for this second group of 134 chemicals beginning in 2011. EPA has the most comprehensive mandated testing program for hormone effects in the world. The program is the result of a multi-year effort that includes validation of the science through a transparent scientific review process.More information: http://www.epa.gov/endo ENVIRONMENTAL PROTECTION AGENCY
Endocrine Disruptor Screening Program; Second List of Chemicals for Tier 1
Screening AGENCY: Environmental Protection Agency (EPA).ACTION: Notice. SUMMARY: This document announces the second list of chemicals and substances for which EPA intends to issue test orders under the Endocrine Disruptor Screening Program (EDSP). EPA established the EDSP in response to section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA). This second list of chemicals expands the EDSP in an effort to include all pesticides, required by FFDCA, and adds priority drinking water chemicals into the program for screening as authorized by SDWA section 1457. Today’s publication provides public notice of EPA’s tentative decision-making in advance of the actual issuance of EDSP testing orders.
DATES: In order for the Agency to consider information and/or comments that may be relevant to the inclusion or exclusion of chemicals contained on the second EDSP list,
Today’s document announces the second list of chemicals that the Agency intends to include in its EDSP. Through the issuance of orders, the Agency intends to require the submission of Tier 1 Screening data for these chemicals. Elsewhere in today’s issue of the Federal Register, EPA also is announcing the policies and procedures expected to be followed for certain chemicals on this list. Information on EDSP and Tier 1 Screeningdata is available on the Agency’s website at http://www.epa.gov/endo.
B. What is the Agency’s Authority for Taking this Action?
EPA’s authority for taking this action is based on several different Congressional actions, including FFDCA, the Safe Drinking Water Act (SDWA), and the House Appropriations Committee report for EPA’s FY 2010 appropriations.
EPA developed the EDSP in 1998 to implement FFDCA section 408(p), which requires EPA to ‘‘develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as [EPA] may designate.’’ (21 U.S.C. 346a(p)). The statute generally requires EPA to “provide for the testing of all pesticide chemicals” and gives EPA discretionary authority to “provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed to such asubstance.” (21 U.S.C. 346a(p)(3)). The statute also authorizes EPA to exempt achemical upon a determination that ‘‘the substance is anticipated not to produce anyeffect in humans similar to an effect produced by a naturally occurring estrogen.’’ (21 U.S.C. 346a(p)(4)).
Section 1457 of SDWA provides that “in addition to the substances” referred to in FFDCA section 408(p)(3)(B), “the Administrator may provide for testing under the screening program authorized by section 408(p) of such Act, in accordance with the provisions of section 408(p) of such Act, of any other substance that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance.” (42 U.S.C. 300j-17). EPA used its authority under SDWA to identify a portion of the chemicals on the second EDSP list.
In addition, in Congress’s House Appropriations Committee report for EPA’s FY 2010 appropriations (H.R. 2996, H.Rept. 111-180) (Ref. 1), it directed EPA “to publish within 1 year of enactment a second list of no less than 100 chemicals for screening that includes drinking water contaminants, such as halogenated organic chemicals, dioxins, flame retardants (PBDEs, PCBs, PFCs), plastics (BPA), pharmaceuticals and personal care products, and issue 25 orders per year for the testing of these chemicals.”
III. Background EPA developed EDSP in response to a Congressional mandate in FFDCA “to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as [EPA] may designate” (21 U.S.C. 346a(p)). As part of EDSP, EPA issues orders to collect certain test data on listed chemical substances. Unit II.B. describes the authority for listing a chemical. Test data requirements are derived from specific test assays, which are divided into two tiers. Tier I test assays are used to screen the chemicals for interaction with the estrogen (E), androgen (A) or thyroid (T) hormonal systems. Tier II test assays are intended to test for more specific chemical effects on the endocrine system, and are currently in the process of being developed and validated. Further information regarding EDSP and requirements for Tier I and Tier II can be found on theAgency’s EDSP Web site, at http://www.epa.gov/endo/.
IV. Development of the Second EDSP List In developing the second EDSP list, EPA focused on a subset of chemicals and substances that have been listed as priorities within EPA’s drinking water and pesticides programs. While the Agency has not included some chemicals or substances on the second EDSP list as explained in Unit IV.A., non-inclusion does not mean that these other chemicals or substances may not be subject to testing in the near term nor in the future. In addition, based on current information, the public should not presume that the listing of a chemical or substance indicates in any way that EPA currently suspects that such chemical or substance interferes with the endocrine systems of humans or other species simply because it has been listed for screening under the EDSP. At the present time, EPA believes that these chemicals or substances should be candidates, at least for screening purposes, under EDSP testing based only on their pesticide registration status and/or because such substances may occur in sources of drinking water to which a substantial population may be exposed.
A. Basis for Chemical Selection
The Agency considered chemicals contained on the Office of Water (OW) and Office of Pesticide Programs (OPP) priority lists for inclusion on the second EDSP list.
1. Initial compilation of OW candidate chemicals. The Agency identified candidate chemicals that are either contaminants regulated with a national primary drinking water regulation (NPDWR) (40 CFR part 141) (Ref. 2) or are unregulated contaminants that are listed on the third Contaminant Candidate List (CCL 3) (USEPA, 2009) (Ref. 3). EPA began with the 85 regulated drinking water contaminants with existing NPDWRs and the 116 unregulated contaminants listed on CCL 3 because these represent many of the priority contaminants for the drinking water program. Most of the regulated drinking water contaminants with NPDWRs were designated by Congress under the 1986 or the1996 SDWA amendments. Because Congress designated these contaminants for regulation due to concerns about occurrence in drinking water and adverse impacts on human health, EPA believes that each such substance meets the statutory testing criteria from SDWA section 1457. SDWA section 1412(b)(9) requires the Agency to periodically review the existing NPDWRs and revise them, if appropriate.
Information about the potential for endocrine disruption will assist the Agency in updating human health assessments, which the Agency considers in its periodic review of NPDWRs to ensure that they are protective of human health.
SDWA section 1412(b)(1) requires the Agency to develop a list of unregulated contaminants that are known or anticipated to occur in public water systems (PWSs) and may require regulation under SDWA. The Agency is required to develop the CCL list every 5 years. In determining whether a substance may occur in drinking water, EPA considers not only public water system monitoring data, but also data on ambient concentrations in surface water and ground water, and releases to the environment reporting data from the Toxics Release Inventory). The Agency believes that such data are sufficient to anticipate contaminants that may occur in public water systems and furthermore, also represent those substances that may be found in sources of drinking water and to which a substantial population may be exposed. In selecting contaminants for the CCL, SDWA section 1412(b)(1)(C) requires that the Agency “take intoconsideration, among other factors of public health concern, the effect of such contaminants upon subgroups that comprise a meaningful portion of the general population (such as infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subpopulations) that are identifiable as being at greater risk of adverse health effects due to exposure to contaminants in drinking water than the general population.” The protocol that EPA used to develop CCL 3 was reviewed by internal experts, as well as external experts such as the National Drinking Water Advisory Council and the Science Advisory Board (Ref. 3). The CCL 3 has undergone a rigorous listing and expert review process, including a public nomination and comment period, and therefore, represent an excellent source of potential drinking water candidates to consider for EDSP screening. The information about the potential for endocrine disruption will assist the Agency in evaluating the human health impacts of unregulated drinking water contaminants. In the CCL listing, EPA already has made the component of the SDWA section 1457 determination that such substances may occur in sources of drinking water. The final CCL 3 listing also represents EPA’s determination that a substantial population may be exposed to such substance for the purposes of SDWA 1457.
In listing drinking water contaminants on the CCL 3, EPA closely evaluated the nature of the occurrence and prevalence information supporting each such CCL 3 listing.
Evaluating occurrence, EPA considered and evaluated data based on occurrence in finished drinking water and ambient water, as well as based on total releases to the environment, pesticide application rates, and production volumes (73 FR 9628, February 21, 2008) (FRL-8529-7). In deciding whether to move a possible drinking water contaminant from the preliminary CCL 3 to the proposed CCL 3, EPA scored each such contaminant based on, among other attributes, its occurrence attributes (at 73 FR 9640-41, February 21, 2008). The occurrence attributes were weighted more heavily based on a hierarchy representing prevalence of the contaminant in the water environment or likely release to the water environment. The results of that scoring are described at 73 FR 9644, February 21, 2008. The administrative record supporting the CCL 3 ultimately published in 2009 includes contaminant-by-contaminant information sheets that document the occurrence data upon which EPA relied for the listing of CCL 3 contaminants. The basis for EPA’s inclusion of the CCL 3 contaminants on its tentative testing list, therefore, also provides the basis for EPA’s determination that a substantial population may be exposed to each such substance for the purposes of SDWA section 1457.
2. Initial compilation of OPP candidate chemicals. The Agency identified candidate chemicals from OPP based on pesticides that were scheduled for Registration Review during fiscal years 2007 and 2008. This selection is part of the Agency’s intent to efficiently expedite the testing of pesticides by conducting the testing in parallel or as part of the OPP Registration Review program.
3. Streamlining the second EDSP list. Consolidating the lists of OW and OPP chemicals resulted in over 200 chemicals. A listing of these chemicals is available in the docket for this notice (Ref. 4). The Agency streamlined this initial second EDSP list by excluding any chemical that fell into one or more of the following categories:
i. Biological agent and naturally occurring chemicals (e.g., microbials, microbial toxins, inorganics, radionuclides).
ii. Chemicals for which the manufacturer, importer or registrant cannot be clearly identified (e.g., disinfection byproducts or DBPs, microbes, microbial toxins, degradate compounds with more than one possible source).
iii. Chemicals already included on the first EDSP list because these chemicals have already received an EDSP order. Note however that if no one agreed to provide data in response to that order, additional orders may be issued under a SDWA determination.
iv. Chemicals that are hormones with confirmed endocrine effects.
v. Chemicals not likely to be biologically active or which are incompatible with testing assays for various reasons due to one or more of their physiochemical properties (e.g., gases, strongly acidic or basic, solubility, vapor pressure molecular weight).
vi. Pesticides that are scheduled for registration review after FY 2008.
Although these chemicals have been excluded from the second EDSP list for one or more of these reasons, it is important to note that these exclusions do not imply that the Agency has no interest in the potential for endocrine disruption activity for these chemicals. In some instances, the Agency recognizes that information on endocrine effects is already available (e.g., for the hormones) or the Agency is currently collecting information (e.g., through the first EDSP list). In other cases, the Agency simply realizes that at this time there is some difficulty with collecting the information about endocrine effects through the EDSP (i.e., because of the Agency’s inability to identify a manufacturer, importer, or registrant or because the contaminant is incompatible with the testing assays). In addition, EPA recognizes that some of the naturally occurring chemicals also have anthropogenic sources and should be considered for the EDSP. In no way should it be inferred that removal from this initial second EDSP list signifies that a chemical does not have the potential to be placed on a future EDSP chemical list. The Agency intends to reexamine currently excluded chemicals for future EDSP chemical lists.
EPA is interested in receiving information from the public that may help the Agency resolve the difficulties with the currently excluded chemicals so that the Agency will be able to consider adding them to future EDSP chemical lists.
B. Second EDSP List of Chemicals There are approximately 134 chemicals on the second ESDP list (see Table 1).
This list includes a large number of pesticides, two perfluorocarbon compounds (PFCs), and three pharmaceuticals (erythromycin, nitroglycerin, and quinoline). This list also consists of an array of other chemicals, ranging from those used for industrial manufacturing processes, as plasticizers, or in the production of pharmaceutical and personal care products (PPCPs). EPA is interested in receiving information and/or comment that may inform the exclusion or inclusion of chemicals on the second EDSP list. The Agency does not plan to respond formally to information or comments that may be submitted on this document, but will add such information to the notice docket as public record. EPA will consider such information and/or comment before finalizing the second EDSP list and publishing the Schedule for Issuance of Orders along with the second EDSP list. In addition, please note that by relying on the CCL 3 as part of this effort, the Agency does not intend to reopen CCL 3 for public comment or any of the individual lists used to create the second list of EDSP chemicals and does not intend to respond to any such comments so submitted.
Table 1.— Second EDSP List of Chemicals for Tier 1 Screening
Chemical Name CAS Number SDWA PAI RR
1,1,1,2-Tetrachloroethane 630-20-6 X
1,1,1-Trichloroethane 71-55-6 X
1,1,2-Trichloroethane 79-00-5 X
1,1-Dichloroethane 75-34-3 X
1,1-Dichloroethylene 75-35-4 X
1,2,3-Trichloropropane 96-18-4 X
1,2,4-Trichlorobenzene 120-82-1 X
1,2-Dichloroethane 107-06-2 X
1,2-Dichloropropane 78-87-5 X
1,3-Dinitrobenzene 99-65-0 X
1,4-Dioxane 123-91-1 X
1-Butanol 71-36-3 X
2,4,5-TP (Silvex) 93-72-1 X
2-Methoxyethanol 109-86-4 X
2-Propen-1-ol 107-18-6 X
4,4′-Methylenedianiline 101-77-9 X
Acetaldehyde 75-07-0 X
Acetamide 60-35-5 X
Acetochlor 34256-82-1 X X
Acetochlor ethanesulfonic acid (ESA) 187022-11-3 X
Acetochlor oxanilic acid (OA) 194992-44-4 X
Acrolein 107-02-8 X X
Acrylamide 79-06-1 X
Alachlor 15972-60-8 X X
Alachlor ethanesulfonic acid (ESA) 142363-53-9 X
Alachlor oxanilic acid (OA) 171262-17-2 X
alpha-Hexachlorocyclohexane 319-84-6 X
Aniline 62-53-3 X
Bensulide 741-58-2 X X FY 2008
Benzene 71-43-2 X
Benzo(a)pyrene (PAHs) 50-32-8 X
Benzyl chloride 100-44-7 X
Butylated hydroxyanisole 25013-16-5 X
Carbon tetrachloride 56-23-5 X
Chlordane 57-74-9 X
Chlorobenzene 108-90-7 X
cis-1,2-Dichloroethylene 156-59-2 X
Clethodim 99129-21-2 X X FY 2008
Clofentezine 74115-24-5 X FY 2007
Clomazone 81777-89-1 X FY 2007
Coumaphos 56-72-4 X FY 2008
Cumene hydroperoxide 80-15-9 X
Cyanamide 420-04-2 X FY 2008
Cyromazine 66215-27-8 X FY 2007
Dalapon 75-99-0 X
Denatonium saccharide 90823-38-4 X FY 2008
Di(2-ethylhexyl) adipate 103-23-1 X
Dichloromethane 75-09-2 X
Dicrotophos 141-66-2 X X FY 2008
Dimethipin 55290-64-7 X X
Dinoseb 88-85-7 X
Diuron 330-54-1 X X
Endothall 145-73-3 X X
Endrin 72-20-8 X
Epichlorohydrin 106-89-8 X
Erythromycin 114-07-8 X
Ethylbenzene 100-41-4 X
Ethylene dibromide 106-93-4 X
Ethylene glycol 107-21-1 X
Ethylene thiourea 96-45-7 X
Ethylurethane 51-79-6 X
Etofenprox 80844-07-1 X FY 2007
Fenamiphos 22224-92-6 X X FY 2008
Fenarimol 60168-88-9 X FY 2007
Fenoxaprop-P-ethyl 71283-80-2 X FY 2007
Fenoxycarb 72490-01-8 X FY 2007
Flumetsulam 98967-40-9 X FY 2008
Fomesafen sodium 108731-70-0 X FY 2007
Fosetyl-Al (Aliette) 39148-24-8 X FY 2008
Glufosinate ammonium 77182-82-2 X FY 2008
HCFC-22 75-45-6 X
Heptachlor 76-44-8 X
Heptachlor epoxide 1024-57-3 X
Hexachlorobenzene 118-74-1 X
Hexachlorocyclopentadiene 77-47-4 X
Hexane 110-54-3 X
Hexythiazox 78587-05-0 X FY 2007
Hydrazine 302-01-2 X
Isoxaben 82558-50-7 X FY 2008
Lactofen 77501-63-4 X FY 2007
Lindane 58-89-9 X
Methanol 67-56-1 X
Methoxychlor 72-43-5 X
Methyl tert-butyl ether 1634-04-4 X
Metolachlor ehtanesulfonic acid
Metolachlor oxanilic acid (OA) 152019-73-3 X
Molinate 2212-67-1 X
Nitrobenzene 98-95-3 X
Nitroglycerin 55-63-0 X
N-Methyl-2-pyrrolidone 872-50-4 X
N-Nitrosodimethylamine (NDMA) 62-75-9 X
n-Propylbenzene 103-65-1 X
o-Dichlorobenzene 95-50-1 X
o-Toluidine 95-53-4 X
Oxirane, methyl- 75-56-9 X
Oxydemeton-methyl 301-12-2 X X FY 2008
Oxyfluorfen 42874-03-3 X X
Paclobutrazol 76738-62-0 X FY 2007
p-Dichlorobenzene 106-46-7 X X
Pentachlorophenol 87-86-5 X X
Perchlorate 14797-73-0 X
Perfluorooctane sulfonic acid (PFOS) 1763-23-1 X
Perfluorooctanoic acid (PFOA) 335-67-1 X
Picloram 1918-02-1 X X
Polychlorinated biphenyls 1336-36-3 X
Profenofos 41198-08-7 X X FY 2008
Propetamphos 31218-83-4 X FY 2008
Propionic acid 79-09-4 X FY 2008
Pyridate 55512-33-9 X FY 2007
Quinclorac 84087-01-4 X FY 2008
Quinoline 91-22-5 X
Quizalofop-P-ethyl 100646-51-3 X FY 2008
RDX 121-82-4 X
sec-Butylbenzene 135-98-8 X
Sodium tetrathiocarbonate 7345-69-9 X FY 2008
Styrene 100-42-5 X
Sulfosate 81591-81-3 X FY 2007
Temephos 3383-96-8 X FY 2008
Terbufos 13071-79-9 X X FY 2008
Terbufos sulfone 56070-16-7 X
Tetrachloroethylene 127-18-4 X
Thiophanate-methyl 23564-05-8 X X
Toluene diisocyanate 26471-62-5 X
Toxaphene 8001-35-2 X
trans-1,2-Dichloroethylene 156-60-5 X
Trichloroethylene 79-01-6 X
Triethylamine 121-44-8 X
Triflumizole 68694-11-1 X FY 2007
Trinexapac-ethyl 95266-40-3 X FY 2008
Triphenyltin hydroxide (TPTH) 76-87-9 X X
Vinclozolin 50471-44-8 X X
Xylenes (total) 1330-20-7 X X
Ziram 137-30-4 X X
CAS Number = Chemical Abstract Services Registry Number
SDWA = Drinking water chemical based on CCL 3 List or chemicals with National
Primary Drinking Water Regulations
PAI = Pesticide active ingredient (Current pesticide registration exists)
RR = OPP Registration Review date
The following is a list of the documents that are specifically referenced in this document. These references are available in the docket number identified under General Information (Section I.B).
1. U.S. Congress. House Report 111-180. Available at:
2. USEPA. 2009. National Primary Drinking Water Regulations. May 2009.
EPA 816-F-09-004. Available at: http://www.epa.gov/safewater/consumer/pdf/mcl.pdf.
3. USEPA. 2009. Drinking Water Contaminant Candidate List 3—Final Notice. Federal Register. Vol, 74. No 194. p. 51850. October 8, 2009
4. Initial Compilation of Chemicals and Substances Considered for the Second
Endocrine Disruptor Screening Program List.
List of Subjects
Environmental protection, Chemicals, Drinking water, Endocrine disruptors, Pesticides.
Dated: September 28, 2010.
Steve A. Owens Assistant Administrator, Office of Chemical Safety and Pollution Prevention.
[FR Doc. 2010-28818 Filed 11/16/2010 at 8:45 am; Publication Date: 11/17/2010