Document OEyv3Zx6LdeEGOOq1jr2zxzDj
GARY REICH CT FILM 1701 FIRST AVENUE CHIPPEWA FALLS, WI 54729
1993 June 1
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Dear Mr. Reich,
Per your request I am sending you information on the pending repeal of the food and drug "safe
harbor" provided by section 12713 of Proposition 65. This section exempts food, drugs,
cosmetics and medical devices which comply with FDA standards from warning requirements
of the Prop 65 law.
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The California EPA has agreed to repeal the above referenced section by July 1, 1993. In order to assure continued compliance with Prop 65 without including warning labels on our food packaging products, we request that our suppliers provide us written assurance that the affected materials we purchase from them will not require labeling. This can be accomplished by a statement indicating that: 1. there are no listed materials present in the products we purchase; 2. your product does not require labeling under California Proposition 65; or, 3. providing us with the concentrations of listed materials present or believed to be present in your products. If listed materials are present, we need to know the level(s) so that a risk assessment can be conducted to determine if potential exposures to consumers would require warning labels.
For your convenience, I have attached a copy of a 1992 document listing No Significant Effect Levels, against which risk assessments are compared.
I trust this information is sufficient to meet your needs.
J ;
*
R. W. BARR
cc: D. Arruda, ATC - A E. M. Smith, ATC - A R. M. James, Pittsburgh J. F. Duderstadt, Pittsburgh
511904 0374
SAFE DRINKING WATER & TOXIC ENFORCEMENT ACT OF 1986 (Prop. 65)
No Significant Risk Levels for Carcinogens
Acceptabie Intake Levels for Reproductive Toxicants
(Status Report)
IlJ
CALIFORNIA ENVIRONMENTAL PROTECTIONAGENCY
OEHHA
OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT
July 1992
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Note to Reader: The following table is a compilation of daily intake levels calculated for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), and includes levels which have been formally adopted into regulation as well as levels that are in various stages of the adoption process (see "Status" column). This table will be updated on a regular basis.
Levels adopted into regulation (Title 22, California Code of Regulations, Sections 12705, 12709 and 12711 for carcinogens, and Section 12805 for reproductive toxicants) are intended to provide "safe harbors" for persons subject to the Act, and do not preclude the use of an alternative level that can be demonstrated by its user as being scientifically valid. Levels established under Section 12711 are based on cancer potency estimates taken from existing State or federal risk assessments. Levels established under Section 12709 are intended to be used only when the chemical in question is present as a "trace element". Levels established under Section 12705 -- which supercede levels in Sections 12711 and 12709 - - are based on de novo risk assessments or reviews of State or federal risk assessments conducted by the Office of Environmental Health Hazard Assessment (OEHHA) pursuant to the guidelines set forth in Section 12703. These risk assessments are presented to the Scientific Advisory Panel for review and comment prior to their use as the basis for proposed regulatory numbers. The levels for reproductive toxicants in Section 12805 represent the no observable effect level divided by a 1,000-fold safety factor. Adoption of a regulatory level is carried out following the provisions of the Administrative Procedure Act.
OEHHA has issued a proposed rulemaking Co amend Section 12705 Co establish a three-tiered hierarchy of no significant risk levels, as follows: (1) levels based on de novo risk assessments conducted by OEHHA or based on State or federal risk assessments reviewed by OEHHA; (2) levels based on State or federal risk assessments; and (3) levels based on default risk assessment procedures. Levels based on State or federal risk assessments which currently exist in Section 12711 will be adapted in Section 12705. Levels which were calculated using default risk assessment procedures (see "Expedited Cancer Potency Values and Proposed Regulatory Levels for Certain Proposition 65 Carcinogens," April 1992) for 160 chemicals will be also be adopted, A public hearing on this proposal is scheduled for July 17, 1992. Written comments on the proposed regulation are due on the same date. For ease of reference, levels that have been adopted or that have been proposed for adoption under a separate rulemaking in Section 12711 are still identified as adopted or proposed for adoption in Section 12711. Levels which were calculated using the "expediteddefault procedures are identified as "P/12705d".
Carcinoeen
A-alpha-C (2-Amino-9H-pyrido[2,3-b]indole) Ac e taldehyde Acetamide 2-Ace tylamino fluorene Acrylamide Acrylonitrile Actinomycin D
a. See last page for legend.
Level (ue/d)
2 90 10
0.2 0.2 0.7 0.00008
Status*
P/12705d A/12711 P/12705d P/12705d A/12711 A/12705 P/12705d
I 511904 0376
2- -
Carcinogen
Level (pg/d)
Status
AF-2; [2-(2-furyl)-3(5-nitro-2-furyl)acrylamide]
3
Aflatoxins Aldrin Allyl chloride 2-Aminoanthraquinone o-Aminoazotoluene 4-Aminobiphenyl
0.014 0.04
30 20
0.2 0.03
,
3 -Amino - 9 -ethylcarbazole hydrochloride
9
1-Amino- 2-methylanthraquinone 2-Amino-5-(5-nitro-2- fury1)-1,3,4-thiadiazole
5 0.04
Amitrole
0.7
Aniline
100
o-Anisidine
5
o-Anisidine hydrochloride
7
Aramice Arsenic
20 ej_ "?- 0.0 / (, HA =0'.06--tinh)
10
Asbestos
100 fibersVd (inh)
Auramine
0.8
Azaserine
0.06
Azathioprine
0.4
Azobenzene
6
P/12705d RA/SAP A/12705 A/12711 P/12705d P/12705d P/12705d P/12705d P/12705d P/12705d P/12705d A/12711 P/12705d P/12705d P/12705d P/12705 A/12709 A/12705 P/12705d P/12705d P/12705d A/12711
Benzene Benzidine Benzo[a]pyrene Benzofuran Benzyl chloride Benzyl violet 4B Beryllium Beryllium oxide Beryllium sulfate Bis(2-chloroethyl)ether Bis(chloromethyl)ether Bromodichlorome thane 1,3-Butadiene Butylated hydroxyanisole beta-Butyrolactone
7 0.001 0.06
1 4 30 0.1 0.1 0.0002 0.3 0.02 5 0.4 40000.7
A/12705 A/12705 A/12711 RA/nSAP P/12711 P/12705d A/12709 A/12711 A/12711 A/12705 A/12705 P/12711 A/12711 4 /12705 P/12705d
Cadmium
Carbon tecrachloride Captafol Captan
0.05 (inh) 1 5 5 300
/\ F/12705 A/12709 A/12705 P/12705d P/12705d
b. Document undergoing revision; level will change to 0.02 pg/d. c. Fibers equal to or greater than 5 micrometers in length and 0.3 micrometers in
width, with a length/width ratio greater than or equal to 3:1 as measured by phase contrast microscopy.
511904 0377 r
-3-
Carcinogen
Chlorambucil Chlordane Chlordecone (Kepone) Chlorendic acid Chlorinated paraffins Chlorodibromomethane Chloroethane (Ethyl chloride) Chloroform
Chloromethyl methyl ether (technical grade) 3-Chloro-2-methylpropene 4-Chloro-ortho-phenylenediamine Chlorothalonil p-Chloro-ortho- toluidine Chlorozotocin Chromium (hexavalent)
C.I. Basic Red 9 monohydrochloride Cinnamyl anthranilate Coke oven emissions p-Cresidine Cupferron Cyclophosphamide (anhydrous) Cyclophosphamide (hydrated)
D&C Red- No. 9 Dacarbazine Daminozide Dantron (Chrysazin; 1,8-Dihydroxyanthraquinone) DOT, DDE, DDD (in combination) DDVP (Dichlorvos) 2,4-Diaminoanisole 2,4-Diaminoanisole sulfate 4,4'-Diaminodiphenyl ether (4,4'-Oxydianiline) 2,4-Diaminotoluene Dibenz [a,h1 anthracene Dibromochlo ropropane p-Dichlorobenzene 3,3'-Dichlorobenzidine 1,1-Dichloroethane 1,2-Dichloroethane (Ethylene dichloride) Dichloromethane (Methylene chloride)
Dieldrin Di(2-ethylhexy1)phthalate Diethylstilbesterol Diglycidyl resorcinol ether (DGRE) Dihydrosafrole
Level (pg/d)
Status
0.002 0.5 0.04 8 8 7 200 9 20 (oral) 40 (inh) 0.3 5 40 200 3 0.003 0.001 0.001 (inh)--/ 3 200 0.3 5 3 1 1
P/12705d A/12711 P/12705d P/12705d P/12705d P/12705d RA/nSAP A/12711 RA/nSAP RA/nSAP P/12705d P/12705d P/12705d P/12705d P/12705d P/12705d A/12711 P/12705 P/12705d P/12705d A/12711 P/12705d P/12705d P/12705d P/12705d
100 0.01
40 9 2 2
30 50
5. 0.2 0.2 0.1 20 0.6 100 10 50 200 (inh),/' 0.04 80 0.002 0.4 20
P/12705d P/12705d P/12705d P/12705d A/12705 A/12711 P/12705d P/12705d P/12705d P/12705d P/12705d A/12705 A/12705 A/12705 P/12705d A/12705 A/12711 fit P/12705 A/12705 A/12711 P/12705d P/12705d P/12705d
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r
-4-
Carcinogen
Level iiig/d)
Dimethyl sulfate 4 - Dime thylaminoazobenzene trans-2*[(Dimethylamino)methylimino]-5-
(2 *(5-nitro-2 * furyl)vinyl]-1,3,4-oxadiazole 7,12-Dimethylbenz(a)anthracene Dimethylcarbamyl chloride 1,1-Dimethylhydrazine 1,2-Dimethylhydrazine Dime thylvinylchloride 2,4-Dinitrotoluene 1,4-Dioxane Direct Black 38 (technical grade) Direct Blue 6 (technical grade) Direct Brown 95 (technical grade) Disperse Blue 1
Epichlorohydrin Estradiol 17 Ethyl-4,4'-dichlorobenzilate (Chlorobenzilate) Ethylene dibromide
Ethylene oxide (carcinogen) Ethylene thiourea Ethyleneimine
0.05 0.2
2 0.003 0.05 In progress 0.001 20 2 30 0.09 0.09 0.1 200
9 0.02 7 0.2 (oral) 3 (inh) 2 20 0.01
Folpet Formaldehyde (gas) 2-(2-Formylhydrazino)-4-(5-nitro-2-furyl)thiazole Furmecyclox
200 15 0.3 20
Glu-P-1 (2-Amino-6-methyldipyrido[l,2-a:3',2'-d]imidazole
Glu-P-2 (2-Aminodipyrido[l,2-a:3',2'-d]-imidazole) Glycidol Griseofulvin Gyromitrin (Acetaldehyde methylformylhydrazone)
0.1 0.5 In progress In progress 0.07
HC Blue 1 Heptachlor Heptachlor epoxide Hexachlorobenzene Hexachlorocyclohexane
alpha isomer beta isomer gamma isomer technical grade Hexachlorodibenzodioxin Hexachlo roe thane
Hexamethylphosphoramide
10 0.2 0.08 0.4
0.3 0.5 0.6 0.2 0.0002 20 In progress
Status
RA/nSAP P/12705d
F/12705d P/12705d P/12705d Fall/92 P/12705d P/12705d A/12711 A/12705 P/12705d P/12705d P/12705d P/12705d
A/12705 P/12705d P/12705d A/12705 A/12705 A/12705 P/12705d P/12705d
A/12711 A/12711 P/12705d A/12711
P/12705d P/12705d Fall/92 Fall/92 P/12705d
P/12705d A/12711 A/12711 A/12705
A/12711 A/12711 A/12711 A/12705 A //12705 P/12705d Fall/92
511904 0379
-5-
Carcinogen
Level (/ig/d)
Hydrazine Hydrazine sulfate Hydrazobenzene (1,2-Diphenylhydrazine)
0,04 0,2 0.8
IQ (2-Amino-3-methylimidazo[4,5-f]quinoline)
0.5
Lasiocarpine Lead acetate Lead subacetate
0.0 9 3 20
Me-A-alpha-C (2-Amino- 3-me thy1-9H-pyrido{2,3-b]indole
Melphalan 2-Methylaziridine (Propyleneimine) 3-Methylcholanthrene 4,4'-Methylene bis(2-chloroaniline) 4,4'-Methylene bis(NN-dimethyl)benzeneamine 4,4'-Methylene bis(2-methylaniline) 4,4'-Methylenedianiline 4,4'-Methylenedianiline dihydrochloride Methyl methanesulfonate 2-Methyl-l-nitroanthraquinone (of uncertain purity) N-Methyl-N'-nitro-N-nitrosoguanidine N-Methylolacrylamide Methy1thiouraci1 Metronidazole Michler'-s ketone Mirex Mitomycin C Monocrataline
0.6 0.005 0.03 0.03 0.5 20 , 0.8 0.4 0.6 7 0.2 0.08 2 2j In progress 0.8 0.04 0.00009 0.07
2-Naphthylamine Nickel refinery dust Nickel subsulfide Nitrilotriacetic acid Nitrilotriacetic acid, trisodium salt monohydrate 5-Nitroacenaphthene 5-Nitro-o-anisidine Nitrofen (technical grade) Nitrofurazone 1- [(5-Nitrofurfurylidene)-amino]-2-imidazolidinone N-[4-(5-Nitro-2-furyl)-2-thiazolyl]acetamide N-Nitroso-n-dibutylamine p-Nitrosodiphenylamine N-Nitrosodiethanolamine N-Nitrosodie thylamine N-Nitroso-N-ethylurea N-Nitrosodimethylamine N-Nitrosodiphenylamine
0.4 0.8 0.4 100, 70 6 10 9 0.5 0.4 0.5 0.06 30 0.3 0.02 0.03 0.04 80
Status
A/12711 A/12711 P/12705d
P/12705d
P/12705d P/12705d P/12705d
P/12705d P/12705d RA/nSAP P/12705d P/12705d A/12711 P/12705d P/12705d P/12705d P/12705d P/12705d P/12705d RA/nSAP P/12705d Fall/92 P/12705d P/12705d P/12705d P/12705d
F/12705d A/12711 A/12711 P/12705d P/12705d P/12705d P/12705d P/12705d P/12705d P/12705d P/12705d A/12705 P/12705d A/12711 A/12705 A/12705 A/12705 A/12705
511904 0380
-6-
Carcinogen
Level (/ig/d)
N-Nitrosodipropylamine N-Nitrosomethylethylamine N-Nitroso-N-methylurea N-Nitroso-N-methylurethane N-Nitrosomorpholine N-Nitrosonornicotine N-Nitrosopiperidine N-Nitrosopyrrolidine
0.1 0.03 0.006 0.006 0.1 0.5 0.07 0.3
Ochratoxin A
In progress
Pentachlorophenol Phenacetin Phenazopyridine Phenazopyridine hydrochloride Phenesterin Phenobarbital Phenoxybenzamine Phenoxybenzamine hydrochloride Phenyl glycidyl ether o-Phenylphenate, sodium Polybrominated biphenyls Polychlorinated biphenyls Polychlorinated biphenyls (> 60% chlorine by weight) Ponceau MX Ponceau 3R Potassium bromate Procarbazine Procarbazine hydrochloride 1,3-Propane sultone beta-Propiolactone Propylthiouracil
40 300
4
5 0.005 2 0.2 0.3 5 200 0.02 0.09 0.1 200 40 1 0.05 0.06 0.3 0.05 0.7
Reserpine
0.06
Safrole Selenium sulfide Sterigmatocystin Streptozotocin Styrene oxide Sulfallate
3 9 0.02 0.006 4 4
Tetrachlorodibenzo-p-dioxin (
1,1,2,2-Tetrachloroethane Tetrachloroe thylene Tetranitrome thane Thioacetamide 4-,4' -Thiodianiline
0.000005 0.000005 3 14 0.06 0.1 0.05
Status
A/12705 A/12711 A/12705 P/12705d P/12705d P/12705d P/12705d A/12711
Fall/92
A/12711 P/12705d P/12705d P/12705d P/12705d P/12705d P/12705d P/12705d RA/nSAP P/12705d A/12705 A/12711 RA/SAP P/12705d P/12705d P/12705d P/12705d P/12705d P/12705d P/12705d P/12705d
P/12705d
P/12705d RA/nSAP P/12705d P/12705d P/12705d P/12705d
A/12711 A P/12705
P/12705d A/12711 RA/nSAP P/12705d P/12705d
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-7-
Carcinogen
Thiourea Toluene diisocyanate ortho-Toluidine ortho-Toluidine hydrochloride
Toxaphene Trichloroethylene
2,4,6-Trichlorophenol Tris(1-aziridiny1)phosphine sulfide Tris(2,3-dibromopropyl)phosphate Trp-P-1 (Tryptophan-P-1) Trp-P-2 (Tryptophan-P-2)
(Thiotepa)
Urethane (Ethyl carbamate)
Vinyl bromide Vinyl chloride
Vinyl trichloride (1,1,2-Trichloroethane)
2,6-Xylidine
Level (ftg/d)
10 20
4 5 0.6 60 50 (oral) 80 (inh) 10 0.06 0.3 0.03 0.2
0.7
In progress 0.3 3 (inh)
10
100
Status
P/12705d P/12705d P/12705d P/12705d A/12705 A/12711 4 'E/12705 A -P/12705 A/12705 P/12705d P/12705d P/12705d P/12705d
A/12705
Fall/92 A/12711 P/12705 F/12705d
RA/nSAP
Reproductive Toxicant
Level (fig/d)
Status
Ethylene oxide (reproductive toxicant) Lead (reproductive toxicant) Toluene
20 0.5
7000
A/12805 A/12805 A/12805
Legend: A/12705 - Adopted in Section 12705 A/12709 - Adopted in Section 12709 A/12711 - Adopted in Section 12711 A/12805 - Adopted in Section 12805 Fall/92 - To be completed by the fall, 1992 P/12705 - Proposed for adoption in Section 12705 P/12705d - Proposed for adoption in Section 12705(d). Based on an expedited risk
assessment. See "Expedited Cancer Potency Estimates and Proposed Regulatory Levels for Certain Proposition 65 Carcinogens" (April 1992) P/12711 - Proposed for adoption in Section 12711 P/12805 - Proposed for adoption in Section 12805 RA/nSAP - OEHHA risk assessment completed, but has not been presented to the Scientific Advisory Panel for review RA/SAP -- OEHHA risk assessment completed and reviewed by Scientific Advisory Panel
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