• EPA to Expand Chemicals Testing for Endocrine Disruption
  • November 18, 2010 | Authors: Bridget E. Calhoun; Warren Lehrenbaum
  • Law Firm: Crowell & Moring LLP - Washington Office
  • On Wednesday, November 17th, the Environmental Protection Agency (EPA) will publish in the Federal Register a list of 134 additional chemicals being considered for "Tier 1 screening" tests under the Endocrine Disruptor Screening Program (EDSP).  The list of chemicals being proposed for testing includes a large number of pesticides, two perfluorocarbon compounds (PFCs), and three pharmaceuticals (erythromycin, nitroglycerin, and quinoline).  The list also includes 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).  The complete list of 134 chemicals can be found at the bottom of this alert.

    You may be potentially affected by this notice if you produce, manufacture, use, consume, work with, or import any of the 134 chemicals on the list. EPA is allowing for a 30 day comment period to receive information that may inform the exclusion or inclusion of the chemicals on the second EDSP list.

    EPA developed EDSP in response to a Congressional mandate in the Federal Food, Drug, and Cosmetic Act (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. Test data requirements are derived from specific test assays, which are divided into two tiers. Tier I test assays (the subject of the November 17th notice) are used to "screen" the chemicals for interaction with the estrogen (E), androgen (A) or thyroid (T) hormonal systems. Tier II test assays may be required for some of the chemicals listed and are intended to test for more specific chemical effects on the endocrine system, and are currently in the process of being developed and validated.

    EPA issued the first list of chemicals of 67 chemicals under the EDSP on April 15, 2009. This list included 58 pesticides and 9 high production volume chemicals and/or inert ingredients of pesticide products. The test screens are estimated to cost approximately $1,000,000/chemical. Industry has raised numerous concerns about the EDSP including:

    • Test guidelines that are overly prescriptive and inflexible;
    • Overly stringent test validation criteria that could lead to repeating otherwise technically sound studies;
    • Screening tests with highly variable test endpoints that could easily result in false positive test results.
    • Inadequate guidance on the criteria that will be applied in deciding whether a substance will be required to complete Tier II testing following the initial screen.

    Final data submissions for the first 67 chemicals undergoing screening are not due until October 2011 (unless extensions are granted), and EPA is not likely to complete its evaluation of these Tier I data until sometime in 2012.  Based on this schedule, EPA will not have an opportunity to apply "lessons learned" from the initial Tier I testing program as it finalizes its list of additional chemicals that will be subject to testing.

    Second EDSP List of Chemicals for Tier 1 Screening

    Chemical Name

    CAS

    Number

    1,1,1 ,2-Tetrachloroethane

    630-20-6

    1,1,1 -Trichloroethane

    71-55-6

    1,1,2-Trichloroethane

    79-00-5

    1,1-Dichloroethane

    75-34-3

    1,1 -Dichloroethylene

    75-35-4

    1,2,3-Trichloropropane

    96-18-4

    1,2,4-Trichlorobenzene

    120-82-1

    1 ,2-Dibromo-3-chloropropane (DBCP)

    96-12-8

    1,2-Dichloroethane

    107-06-2


    Chemical Name

    CAS

    Number

    1,2-Dichloropropane

    78-87-5

    1,3-Dinitrobenzene

    99-65-0

    1,4-Dioxane

    123-91-1

    1-Butanol

    71-36-3

    2,4,5-TP (Silvex)

    93-72-1

    2-Methoxyethanol

    109-86-4

    2-Propen-1-ol

    107-18-6

    4,4'-Methylenedianiline

    101-77-9

    Acetaldehyde

    75-07-0

    Acetamide

    60-35-5

    Acetochlor

    34256-82-1

    Acetochlor ethanesulfonic acid (ESA)

    187022-11-3

    Acetochlor oxanilic acid (OA)

    194992-44-4

    Acrolein

    107-02-8

    Acrylamide

    79-06-1

    Alachlor

    15972-60-8

    Alachlor ethanesulfonic acid (ESA)

    142363-53-9

    Alachlor oxanilic acid (OA)

    17 1262-17-2

    alpha-Hexachlorocyclohexane

    319-84-6

    Aniline

    62-53-3

    Bensulide

    741-58-2

    Benzene

    71-43-2

    Benzo(a)pyrene (PAHs)

    50-32-8


    Chemical Name

    CAS

    Number

    Benzyl chloride

    100-44-7

    Butylated hydroxyanisole

    25013-16-5

    Carbon tetrachloride

    56-23-5

    Chlordane

    57-74-9

    Chlorobenzene

    108-90-7

    cis- 1 ,2-Dichloroethylene

    156-59-2

    Clethodim

    99129-21-2

    Clofentezine

    74115-24-5

    Clomazone

    81777-89-1

    Coumaphos

    56-72-4

    Cumene hydroperoxide

    80-15-9

    Cyanamide

    420-04-2

    Cyromazine

    662 15-27-8

    Dalapon

    75-99-0

    Denatonium saccharide

    90823-38-4

    Di(2-ethylhexyl) adipate

    103-23-1

    Dichloromethane

    75-09-2

    Dicrotophos

    141-66-2

    Dimethipin

    55290-64-7

    Dinoseb

    88-85-7

    Diuron

    330-54-1

    Endothall

    145-73-3

    Endrin

    72-20-8


    Chemical Name

    CAS

    Number

    Epichlorohydrin

    106-89-8

    Erythromycin

    114-07-8

    Ethylbenzene

    100-41-4

    Ethylene dibromide

    106-93-4

    Ethylene glycol

    107-21-1

    Ethylene thiourea

    96-45-7

    Ethylurethane

    51-79-6

    Etofenprox

    80844-07-1

    Fenamiphos

    22224-92-6

    Fenarimol

    60168-88-9

    Fenoxaprop-P-ethyl

    71283-80-2

    Fenoxycarb

    72490-01-8

    Flumetsulam

    98967-40-9

    Fomesafen sodium

    108731-70-0

    Fosetyl-Al (Aliette)

    39148-24-8

    Glufosinate ammonium

    77182-82-2

    HCFC-22

    75-45-6

    Heptachlor

    76-44-8

    Heptachlor epoxide

    1024-57-3

    Hexachlorobenzene

    118-74-1

    Hexachlorocyclopentadiene

    77-47 -4

    Hexane

    110-54-3

    Hexythiazox

    78587-05-0


    Chemical Name

    CAS

    Number

    Hydrazine

    302-01-2

    Isoxaben

    82558-50-7

    Lactofen

    77501-63-4

    Lindane

    58-89-9

    Methanol

    67-56-1

    Methoxychlor

    72-43-5

    Methyl tert-butyl ether

    1634-04-4

    Metolachlor ehtanesulfonic acid (ESA)

    171118-09-5

    Metolachlor oxanilic acid (OA)

    152019-73-3

    Molinate

    2212-67-1

    Nitrobenzene

    9 8-95-3

    Nitroglycerin

    5 5-63-0

    N-Methyl-2-pyrrolidone

    872-50-4

    N-Nitrosodimethylamine (NDMA)

    62-75-9

    n-Propylbenzene

    103-65-1

    o-Dichlorobenzene

    95-50-1

    o-Toluidine

    95-53-4

    Oxirane, methyl-

    75-56-9

    Oxydemeton-methyl

    301-12-2

    Oxyfluorfen

    42874-03-3

    Paclobutrazol

    7673 8-62-0

    p-Dichlorobenzene

    106-46-7

    Pentachlorophenol

    87-86-5


    Chemical Name

    CAS

    Number

    Perchlorate

    14797-73-0

    Perfluorooctane sulfonic acid (PFOS)

    1763 -23-1

    Perfluorooctanoic acid (PFOA)

    335-67-1

    Picloram

    1918-02-1

    Polychlorinated biphenyls

    1336-36-3

    Profenofos

    41198-08-7

    Propetamphos

    31218-83-4

    Propionic acid

    79-09-4

    Pyridate

    55512-33-9

    Quinclorac

    84087-01-4

    Quinoline

    91-22-5

    Quizalofop-P-ethyl

    100646-51-3

    RDX

    121-82-4

    sec-Butylbenzene

    135-98-8

    Sodium tetrathiocarbonate

    7345-69-9

    Styrene

    100-42-5

    Sulfosate

    81591-81-3

    Temephos

    3383-96-8

    Terbufos

    13071-79-9

    Terbufos sulfone

    56070-16-7

    Tetrachloroethylene

    127-18-4

    Thiophanate-methyl

    23564-05-8

    Toluene diisocyanate

    2647 1-62-5


    Chemical Name

    CAS

    Number

    Toxaphene

    8001-35-2

    trans-1 ,2-Dichloroethylene

    156-60-5

    Trichloroethylene

    79-01-6

    Triethylamine

    12 1-44-8

    Triflumizole

    68694-11-1

    Trinexapac-ethyl

    95266-40-3

    Triphenyltin hydroxide (TPTH)

    7 6-87-9

    Vinclozolin

    50471-44-8

    Xylenes (total)

    1330-20-7

    Ziram

    137-30-4


    CAS Number = Chemical Abstract Services Registry Number