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EPA to Expand Chemicals Testing for Endocrine Disruption

Client Alert | 11 min read | 11.16.10

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.

Please contact us if you have questions or concerns regarding applicability of compliance with EPA's notice.

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 ethanesulfonic 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

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