Chemicals-in- I h ff , „ r< ! - M 'i i ress !' I I -pcc^f.. npctJSB —>ii -f- _ %3l.^ Office of Toxic Substances -T J •' *•« -awifcte'... . _ $ ai s( (OTS) Vol. 6, No. 2 May 1985 INSIDE What's Happening In OTS by Don R. Clay, OTS Director Updating the TSCA Inventory Page 2 REPORT on FORMALDEHYDE INVESTIGATION Page 4 TSCA TESTING ACTIVITIES New Data Available on Nine Substances EPA Reports on PDAs Page 4 Page 2 TSCA NEW CHEMICAL REVIEW Expedited PMN Review for Low Volume Chemicals Page 2 TSCA REPORTING REQUIREMENTS Latest Substantial Risk Notices New FYI Submissions Page 4 Page 5 SIGNIFICANT NEW USE RULES (SNURs) Propose SNUR for MBOCA Page 3 FOR YOUR INFORMATION EPA Seeks Data on CHIPs Page 5 INVENTORY Plan Removal of 106 Substances EPA Adds 56 Chemicals Page 2 Page 6 1 ------- What's Happening In OTS - Don R. Clay I n March, we issued a proposed rule to update the TSCA Inventory data base. I thoug ht I would share with you our thinking on this proposed rule. As most of you know, the Inventory was originally composed of over 60,000 chemicals in commercial use in 1977. Since then, about 2,000 new chemicals were added. The proposed rule would not change the chemicals that are listed on the Inventory. Rather, it wou Id update certain production information on those chemicals. This rule is important because the infor- mation we now have is obsolete; it is primarily a snapshot of the chemical industry in the mid-1970s. Since then, the industry has changed significantly. We therefore need to update the information to set priorities for the chemicals; investigate the health and environmental effects of chemicals; determine commercial status of chemicals; communicate with manufacturers on risks associated with chemicals; and help Federal and State agencies carry out their responsi- bilities. The rule, as proposed, would require initial reporting on all of the reportable substan- ces and recurring reporting every second year, but only if there is a major change in production or use patterns. Don R. Clay, Director, Office of Toxic Substances OTS is seeking an update only for the types of chemicals for which we think we really might need the information. Based on information available from the current Inventory, we estimate that this will cover about 15,000 chemicals. Excluded from the proposed reporting require- ments are chemicals such as polymers which are generally regarded as low-risk chemicals. In addition, if the production volume of the chemical is under 10,000 pounds, it need not be reported. If we need information on an excluded chemical, we can obtain the information under a separate rule. Since this rule is being proposed under section 8(a) of TSCA, the small manufacturers exemption that is applicable to section 8(a) rules will apply in this case as well. The comment period closed on May 13, and we anticipate issuing a final rule before the end of this year. OTS FACES Linda A. Travers, Acting Director of OTS' Information Man- agement Division, is responsible for the proposed updating of the TSCA Inventory data base. Linda's division is the hub of EPA's chemical information data sources. She developes and manages the automatic data processing systems that support all TSCA activities, from data collection and dissemination to analysis and rulemaking. Under her direction, a staff of about 80 people receive and control all documents resulting from TSCA rulemaking activi- ties. Linda is responsible for the security of all TSCA confidential business information. Her staff operates a chemical information library that is a primary EPA chemical information source. EPA to Drop 106 Substances from TSCA Inventory EPA will soon be issuing a Federal Register notice proposing to remove 106 chemical substances from the TSCA Chemical Substance Inventory. In general, the identities of these chem- ical substances were found to be incorrectly reported and listed; therefore, they appear ineligible for continued inclu- sion in the TSCA Chemical Substance Inventory. For each of the substances with an incorrectly reported identity, the orig- inal submitter has provided EPA with the correct identity which has been added to the Inventory. The purpose of this notice is to determine whether these incorrectly reported substances have been actually manufactured by persons other than the original submitters. Contact the TAO at (800) 424-9065 for details regarding this notice. Expedited PMN Review tor Low Volume Chemicals Beginning on June 10,1985, manufacturers and importers of new low volume chemicals will be eligible for an expedited PMN review under section 5 of TSCA. The term "low volume'' is defined as 1,000 k ilograms (approximately 2,000 pounds) or less a year. The TSCA rule was published on April 26,1985 (50 FR 16477). A chemical eligible for this exemption will undergo an expe- dited 21-day review rather than a 90-day PMN review by EPA, and information requirements will be reduced from the full PMN requirements. EPA can deny an exemption during the shortened period if there are significant unresolved issues concerning risk. The Agency can also revoke the exemption at any time if new data indicate the substance does not meet the exemption criteria. If, after an exemption is granted, there is a desire to change a manufacturing site or use of the chemi- cal, then the rule requires the filing of a new exemption notice. A full PMN must be submitted before production exceeds 1,000 kg/yr. Approximately 20 percent of all new chemicals have esti- mated production volumes of less than 1,000 kg/yr and there- fore are potentially eligible for abbreviated review. The Agency has issued a limited exemption for these chemicals because of their low production volume and therefore rela- tively low exposure potential. ------- EPA Proposes SNUR for MBOCA EPA is proposing a significant new use rule (SNUR) for a chemical on the TSCA Inventory. The chemical is 4,4'- methylenebis(2-chloroaniline) or MBOCA (CAS 101-14-4). The rule proposes that the manufacture of MBOCA in the United States be identified as a significant new use of the substance [April 26,1985 (50 FR 16519)]. The final rule would require persons intending to manufacture MBOCA in the United States to submit a SNUR notice to EPA at least 90 days prior to commencement of manufacture. For purposes of this proposed rule the term "manufacture" would not include the importation of MBOCA into the United States. EPA believes MBOCA is a potential human carcinogen. Sev- eral studies indicate that the substance causes malignant tumors in mice, rats, and dogs when administered orally. MBOCA can be absorbed dermally, and studies indicate that the substance is distributed rapidly through the body and extensively metabolized. MBOCA has not been manufactured in the United States since 1979, but it has been imported in recent years. The primary use of imported MBOCA is as a hardener or curing agent in the manufacture of polyurethane plastics. There appears to be no consumer exposure to MBOCA. Did you know? SNURs may be written for new or existing chemicals. A SNUR may be issued for a chemical that has gone through the premanufacture notice review process of TSCA (referred to by EPA as a "new" chemical, even though the substance may be added to the TSCA Inventory). A SNUR also may be issued for a chemical that was on the original TSCA Inventory (referred to by EPA as an "existing" chemical). SNURs ensure that EPA will receive information on significant new uses of potentially hazardous substances before such uses occur. See page for a report on a proposed SNUR rule for an existing chemical, MBOCA. For a more detailed explanation of SNURs, see page 7. New Significant New Use Notices EPA has recently published these new proposed SNUR rules covering a total of 10 chemicals. For an explanation of SNURs, see page 7 and "Did you know?" (above). 5(e) 5(a)(2) PMN Chemical Identification Consent Proposed or or Final Unilateral SNUR Order G = Generic Name* 84-105 106 & 107 G G Substituted tetrafluoro alkene Disubstituted tetrafluoro alkane 6/13/84 Proposed 50 FR 11384 3/21/85 50525 84-176 177 G a Alkanetrlol dlmethacrylate, substituted Pofyrtlis»kw#g|ycol.mono-methacrylj^, substituted 181 182 183 184 G G G G Polyalkyl-alkanediol mono-acrylate, substituted Alkanetrlol polyalkylene glycol ester acrylate, substituted Alkylene glycol mono-methacrylate, substituted Polyalkyl-alkanediol mono-methacrylate, substituted 5/25/84 Proposed 50 FR 12046 3/27/85 50524 84-417 G Methylphenol, bis (substituted alkyl) 8/13/84 Proposed 50 FR 11391 3/21/85 SOS 28 ** 4,4'-Methylenebis(2-chloroanillne) (MBOCA) Proposed 50 FR 16519 4/26/85 50523 *A generic name In this list may be different from the generic name listed when the PMN was first published In the Pectoral Register. During SNUR negotiations a more specific generic chemical Identification may have been assigned. "SNUR on MBOCA Is an "existing chemical SNUR," therefore there Is no PMN. ------- New Data Available on Nine Substances OTS received new test data submissions on nine chemicals and categories of chemicals that are subject to negotiated testing agreement programs under TSCA [February 8,1985 (50 FR 5421)]. The data are available for inspection at the Office of Toxic Substances (OTS) Public Reading Room, first floor, East Tower, Waterside Mall, 401 M Street, S.W., Wash- ington, D.C. Persons wishing to obtain copies of the data may write: EPA, Freedom of Information, Ms. Jeralene Green, (A-101), Wash- ington, D.C. 20460. There is a 20 cent charge for duplicating each page. The data on each chemical listed below number over 100 pages. The chemicals are: Alkyl phthalates* Acrylamide 4-Chlorobenzotrifluoride 2-Chlorotoluene Methyl isobutyl ketone/methyl ethyl ketone Isophorone 4-(1,1,3,3-Tetramethylbutyl) phenol Tris(2-ethyIhexyl) trimellitate Bis(2-ethylhexyl terephthalate 79-06-1 98-56-6 95-49-8 108-10-1 and 78-93-3 78-59-1 140-66-9 3319-31-1 6422-86-2 "Submissions cover 13 alkyl phthalates, see Federal Register notice cited above for the substances' names. EPA Reports on PDAs EPA reaffirmed an earlier decision not to require health and environmental testing of 34 of 47 phenylenediamine (PDA) category members under TSCA. The notice [January 30,1985 (50 FR 4287)] said the other 13 PDAs will be the subject of future TSCA section 4(a) actions for proposed health effects, chemical fate or environmental effects testing. The entire PDA category was recommended to EPA for test- ing under TSCA by the ITC in 1980. In 1982 EPA responded to the designation by issuing an Advance Notice of Proposed Rulemaking (ANPR). In that notice EPA said 34 PDAs had low or no production subject to TSCA. Therefore the Agency could not make the appropriate finding under section 4(a) for test rule development. The ANPR did propose that 13 other high volume PDAs would be considered for test rule devel- opment because of potential exposure and available toxico- logical information. EPA also asked for comments on Its deci- sion. The comments received persuaded EPA to subdivide the 13 high production PDAs into two subcategories for future test rule consideration under TSCA. Based on the comments, EPA was able to reaffirm that it could not make the approp- riate section 4(a) finding with respect to the 34 low production PDAs. Did you know? If you manufacture, import, or process a substance listed in the section 8(d) model Health and Safety Data Reporting Rule and initiate a study of this substance, then you must notify OTS of your actions. The section 8(d) model rule requires you to notify OTS within 30 days of Initiating certain studies of listed substances and requires you to submit a copy of the study whenever it is completed. Persons interested in learning more about the section 8(d) model rule requirements are encouraged to review 40 CFR Part 716, or call or write the TAO for a Federal Register reprint of the section 8(d) model ru le (47 FR 38780) and an up-to-date list of section 8(d) substances. EPA REPORTS ON REGULATORY INVESTIGATION OF FORMALDEHYDE On May 23,1984, EPA determined under section 4(f) of TSCA that there may be a significant risk of widespread harm from formaldehyde exposure to residents of mobile and conven- tionally-built homes made with urea-formaldehyde wood products and employees manufacturing durable-press apparel. In the Federal Register notice announcing this deci- sion (49 FR 21898), EPA stated that it would report semian- nually on the progress of its formaldehyde investigation. This is the second such report; the first appeard in the November 1984 issue of Chemicals-in-Progress Bulletin. In March, the Office of Pesticides and Toxic Substances (OPTS) reviewed progress on the formaldehyde project. OPTS decided to further assess the non-cancer health risk before determining whether formaldehyde exposure risks are unreasonable. A draft risk assessment covering cancer risks had been completed by the Existing Chemical Assessment Division and is now being revised to incorporate discussion of the non-cancer health effects. in its residential exposure work since November, OPTS has received, reviewed, and placed in the docket a contractor report on possible substitutes for formaldehyde-emitting wood products and a contractor report on cost estimates for control options for wood products. OPTS has received and is reviewing an exposure assessment for wood products: this document Is scheduled to be completed and placed in the docket in mid-June. For apparel, OPTS has received draft reports on substitutes for formaldehyde-emitting resins, ventilation, and cost esti- mates for control options. These reports will be entered into the docket after internal review. A decision by the Agency on all regulatory options is now scheduled for August. OPTS will expand and revise its risk assessment, including its assessment of non-cancer health risks, with scheduled completion by mid-May, and will have it peer-reviewed. The documents covering technical options, exposures, and coats of exposure reduction options are scheduled to be completed by mid-June. Section 8(e).. .Substantial Risk Below is a list of recent initial section 8(e) notices placed in EPA's public file. For an explanation of section 8(e)ah(JTfiSW copies of notices can be acquired see page 8. [CAS No.] Log No. 8EHQ 1284-0540 S A mixture of imidazole and 2-ethyl-4- methylimidazole 288-32-4 and 931-36-2 Summary results from three acute dermal application studies in rabbits 1284-0541 S Benzofurazan-1-oxide 480-96-6 Summary results from two in vitro genotoxicity studies 0185-0542 S Nitrite-containing metalworking cutting fluids Information concerning nitrosamlne formation in nitrite-containing metalworking cutting fluids continued on next page 4 ------- 0185-0543 Vinyl acetate 108-05-4 Summary results from a two-generation reproduction study in rats 0285-0544 [[[3,5-bis(1,1-Dimethylethyl)-4- 80387-97-9 hydroxyphenyl]methyl]thio]acetic acid, 2-ethylhexyl ester Summarized final results from an oral range-finding study in rats and summarized preliminary results from an ongoing teratology study in rats Latest FYI Submissions EPA has received in recent weeks 11 FYI (For Your Informa- tion) submissions. The notices are listed below. For additional information on FYls see page 7. Document Control No. FYI- Chemlcal Name(s) CAS No. OTS-0185-0378 et. seq. Dicyandiamide/Diethylenetriamine/ 67953-54-2 Epichlorohydrin (DDE) Resin Information for CHIP in preparation OTS-0185-0379 et. seq. Dimethyl Hydrogen Phosphite 868-85-9 Information for CHIP in preparation OTS-0285-0380 et. seq. Tri (Alkyl/Alkoxy) Phosphates Chemical Class Information for CHIP in preparation ^X-0285-0381 Raw and Hydrotreated Shale Oils 68308-34-9 Final results from a 28-day subchronic dermal toxicity study in rats AX-0285-0382 Gasoline Unknown Feasibility analysis for an epidemiological study OTS-0285-0383 p-Chloroanlline 106-47-8 Preliminary results from a carcinogenicity bioassay in mice and rats AX-0285-0384 Vanadium 7440-62-2 Chemical literature review OTS-0285-0385 Coal Tar Chemicals Chemical Class Final results from an epidemiological study OTS-0285-0386 S CGA-448 (an R&D Pesticide) Confidential Summary results from a rat teratology study OTS-0385-0388 et. seq. DDE Resin 67953-54-2 Information for CHIP in preparation AX-0385-0389 Middle Distillate Fuels Chemical Class Toxicity and exposure profile OTS-0385-0390 Acrylonltrlle 107-13-1 Methacrylonitrile 126-98-7 Chemical literature review, including antidotal information OTS Seeks CHIP Data OTS is asking the public for unpublished information about the following chemicals: Chloromethylpropene 563-47-3 Vinylcyclohexene 100-40-3 4-Nonylphenol (para) 104-40-5 (ortho) 136-83-4 (mixed) 25154-52-3 C. 1. Basic Red 9 monohydro- chloride (salt) 569-61-9 (free base) 479-73-2 The chemicals have been selected for preliminary assessment review. Information should be sent to: TSCA Document Control Office (TS-793) ATTN: Mr. Terry O'Bryan Washington, D.C. 20460 Persons who have unpublished data about the chemicals, but who also want answers to questions prior to responding should contact John Leitzke of the OTS Chemical Screening Branch, (202) 382-3507, as soon as possible. All information submitted in response to the solicitations will be placed in a public file and made available for public inspec- tion, unless the submitter is able to assert a claim of confident- iality, in accordance with the provisions of section 14 of TSCA. EPA will handle all confidentiality claims in accord- ance with its procedures governing the confidentiality of bus- iness information. The OTS review of the chemicals when completed will be in reports called Chemical Hazard Information Profiles (CHIPs). A CHIP is a brief summary of readily available information concerning the health and environmental effects and poten- tial exposure to a chemical. CHIP candidates are chosen on the basis of information indicating a potential for adverse health or environmental effects along with the evidence of significant production or some type of exposure. When OTS searches the literature in preparing a CHIP It generally limits the search to automated data bases and refer' ence works. But OTS encourages individuals and firms to submit unpublished or recently published reports and all other hard-to-obtain studies on a chemical selected for a CHIP. Relevant studies from the public could include data on health effects, environmental effects, commercial productioh and uses, exposed populations, environmental levels, or any other material that could aid In the assessment of the chemi- cal's impact on health or the environment. OTS is also inter- ested in information on current testing of a CHIP candidate or assessment activities by other organizations. The TAO will notify individuals and organizations by letter every time OTS starts a new CHIP. Persons who think they can aid the CHIP information-gathering process will have their names added to our CHIP list if they contact the TAO, (800) 424-9065. The TAO is distributing copies of the following recently com- pleted CHIP: Dlallyl Phthalate 131-17-9 OTS encourages comments on the aocuracy and thorough- ness of information presented In the CHIP. 5 ------- New Chemicals Added to TSCA Inventory EPA has received commencement of manufacture notices for 56 chemicals since publication of the March 1985 Chemicals-in-Progress Bulletin. These chemicals, listed below, have been added to the TSCA Chemical Substance Inventory. See page 8 for an explanation of commencement of manufacture notices. FR PMN no. Submitter Chemical Identification Citation CBI ~ Confidential Business Information G = Generic Name' Do = Ditto 81-605 CBI G 82-10 Minnesota Mining & Manufacturing Co. 82-141 Takeda U.S.A., Inc. 82-216 Do 82-423 CBI G 82-635 Do G 82-645 Do G 83-408 Rhone-Poulenc, Inc. G 83-534 CB) G 83-628 Do 83-664 American Cyanamid Co. G 83-667 CBf G 83-861 Do G 83-899 Do G 83-989 Do G 83-1166 E.I. du Pont de Nemours G & Co., Inc. 64-7 The Sherwln Williams Company 84-111 CBI G 84-250 Amchem Products, Division of H«nKel Corporation 84-314 CBI G 84-437 Adhesive Engineering G Company 84-464 Ethyl Corporation G 84-473 CBI G 84-507 Cordova Chemical Company of Michigan 84-594 CBI G 84-658 Do 84-675 Aceto Chemical Co., Inc. 84-676 CBI ® 84-695 MeWhorten, Inc. « Substituted benzophenone reacted with methyl silsesquioxane 2-Ethyimercapto-3-ethylbenzthiazole iodide Adduct of bis(isocyanatomethyl) benzene with 2-ethyl-2-(hydroxyme1hyl)-1,3-propanediol Adduct of 1,3-bis(isocyanatomethyl)-cyclohexane with 2-ethyl-2(hydroxymethyl)-1,3-propanedioi Polyhaloalkoxyalkylphenone Alkyl acid esters Condensate of formaldehyde and an organic base T rlazine trisisocyanate Etheric aromatic eater Reaction product of diglycidyl ether of bisphenol A, dimer acid, soya fatty acid, dimethyloi propionic acid Substituted benzoic acid Pentasubstituted benzimidazolium salt Substituted vinyl polymer Alkyl(hydroxy aryloxy) atkanoate Substituted carboxylated cocoimidazollne Monosubstitutedphenyl magnesium bromide N,N,N\N'-tetraglycidy-1-'f,3-bisaminomethyl cyclohexane Substituted aromatic polymer Nickel fluorotttanate Partially oxidized polysaccharide Amine adduct of epoxy resin Halogenated aromatic ether Isocyanate modified phenolic resin Polymer of dodecane, 1-amine (laurylamine), ethyienlmlne, hydrochlotic acid Dimer acids, dlcartjoxyllc acid, diamines poiyamlde resin Polymer of epsllon caprolactam, 2,4-toluene dilsocyanate, epsilon caprolactone triol 4-Benzoyl-N1N,N-trlmethylbenzene methanaminimum chloride Methacrylate copolymer Oil modified polyester 46 FR 60055 12-6-81 47 FR 2399 1-15-82 47 FR 10073 3-9-82 47 FR 13037 3-26-82 47 FR 26234 6-17-82 47 FR 39884 9-10-82 47 FR 41165 9-17-82 48 FR 5304 2-4-83 48 FR 11499 3-18-83 48 FR 17385 4-22-83 48 FR 20490 5-6-83 Do 48 FR 30434 7-1-83 48 FR 32381 7-15-83 48 FR 35713 8-5-83 48 FR 41638 9-16-83 48 FR 46851 10-14-83 48 FR 50944 11-4-83 48 FR 55916 12M0-83 49 FR 1787 1-13-84 49 FR 7654 3-1-84 49 FR 9013 3-9-84 49 FR 9954 3-16-84 49 FR 13746 4-6-84 49 FR 18833 4-20-84 49 FR 19110 5-4-84 49 FR 20000 5-11-84 Do 49 FR 22128 5-25-84 6 ------- 84-727 84-731 E.I. du Pont de Nemours & Co., Inc. CBI G 84-740 Do G 84-741 Do G 84-785 Do G 84-845 Kay-Fries, Inc. G 84-890 CBI G 84-911 84-1066 Naarden International USA, Inc. CBI G 84-1071 Ajinomato U.S.A., Inc. 84-1101 The Dow Chemical Company 84-1109 CBI 84-1155 Do 84-1156 Do 84-1157 84-1158 84-1159 84-1180 84-1222 85-1 85-9 85-14 85-26 85-38 Do Do Do Do Do Do G G G G G G G G G G Ethox Chemicals, Inc. Petrarch Systems, Inc. 5-[(3,5-Dinltrophenyl)methylthio]-1- phenyl-1 H-tetrazole Polymer of aliphatic diacid, aliphatic polyamines and substituted alkane Substituted dianhydride and cyclic amine polymer Substituted dianhydride, cyclic amine and substituted amine terminated polymer Disubstituted naphthoic acid Vinyl trialkoxy silane Substituted polystyrene Cyclododecane, (2-methoxyethoxy)- Substltuted trlsazo dye, salt Alkoxy aluminum alkylacetoacetate Type I anion exchange resin, bicarbonate/carbonate form Modified resin Quaternary polyamlne Quaternary ammonium chloride of an oxyalkylated polyamine Oxyatkyiated phenolic ester Quaternary ammonium chloride of an oxyalkylated polyamine Oxyalkylated tetrol-2-butenedioic acid ester Propoxylated imidazoline Polymer of substituted methacryiic acid and polydlmethylsiloxane Aromatic oxime Fatty alcohol, ethoxylated, propoxylated, fatty acid ester Dimethy (s((a-17-crown-6 CBI Do G G Substituted phenyl disulfide Hydroxyl terminated polyurethane 85-40 85-64 85-65 Do Do Do Do Do 49 FR 22865 6-1-84 Do 49 FR 23916 6-8-84 49 FR 25676 6-22-84 49 FR 28614 7-13-84 49 FR 28616 7-13-84 49 FR 33721 8-24-84 Do 49 FR 35414 9-7-64 Do 49 FR 37458 9-24-84 Do Do Do Do Do 49 FR 39370 10-5-84 49 FR 41100 10-19-84 Do 49 FR 41102 10-19-84 Do 49 FR 43105 10-26-84 Do Do DO % S5SS5T.W*""' 0 Sub.muMWto.IK.non. WM„w. A •Tn.p-ov"* sub——,. name may be assigned to the compound by EPA when pu Below are explanations of sections of TSCA that are cited in this provisions, call (800) 424-9085 or write the TAO. For Your Information For Your Information (FYI) submissions are notices received by the Office of Toxic Substances on chemical toxicity and for exposure. FYla are submitted by chemical manufacturer*, processors and distributors, trade associations, labor organi- sations, Federal, State and local agencies, foreign govern- ments, academia, public Interest and environmental groups, as well as the general public. These submissions are provided to epa on a voluntary basis and not in reaponae to a manda- tory reporting provision ot TSCA. Microfiche copies of these submissions are located In the OTS Public Reading Room, first floor, East Tower, Waterside Mall, 401 M Street, S.W., Washington, O.C. To obtain s copy of an FYI, follow the procedure outlined In section 8(e) Substantial Risk Informs- t/on on a*m6. Issue of the Bulletin, For additional Information about TSCA's Significant New Ua* Rules Under section 5(a)(2) EPA may determine by rule that certain uses of chemical substances are significant new uses. .These rules are referred to as Sign Meant New UseHule»{8HyRt),ln making me determination, the Agency oo«»W*rtthe potential exposure associated with the use.andbther relevant factors such as the toxicity assficlated with the GhemlcaJ, and whether the use Is ongoing at the tlm# the rt?le is proposed. Persona subjected to a SNUR must notify EPA st least 90 days before manufacturing, importing, or processing the chemical substance Identified in the SNUR for the defined significant new use or uses. A SNUR may be issued for any TSGA chemical substance. SNURs may be written for indivldual ehemfcals, forvhtmleal categories, and fomew or existing chemicals. Nfymchemlcsl SNURs may be written In conjunction with section 5(e) orders. ------- Section 8(e).. .Substantial Risk Under section 8(e) persons who obtain new information which reasonably supports the conclusion that a substance presents substantial risk of injury to human health or the environment must notify EPA within 15 days. These notices are then reviewed by the Office of Toxic Substances (OTS) and an initial evaluation is prepared containing, if appro- priate, followup questions to the submitter, referrals to other agencies, and recommended OTS/EPA followup actions. The 8(e) notices represent a company's first review of a situation and a judgment in compliance with the statute to submit a notice within 15 days of obtaining the information. EPA publishes its evaluations of 8(e) notices to make this information widely available and understandable to a broad public. The submissions and the initial evaluations are located in the OTS Public Reading Room, first floor, East Tower, Waterside Mall, 401 M Street, SW, Washington, D.C. Persons wishing to obtain a copy of section 8(e) notices may write: EPA, Freedom of Information, Ms. Jeralene Green, (A- 101), Washington, D.C. 20460. There is no charge for duplicat- ing the first 49 pages, but at page SO of a request for duplica- tion there is a $10.00 fee and a 20$ charge for each additional page (e.g., 51 pages cost $10.20). Single copies of the 8(e) initial evaluation (not the full submis- sion) are available from the TAO. Testing ot Chemical Substances and Mixtures.. .Section 4 Section 4 of TSCA gives EPA authority fo require manufac- turers or processors of chemicals to test the toxic effects of a designated substance. To require testing EPA must find that the chemical may present an unreasonable risk; that there are insufficient data available with which to perform a reasoned risk assessment; and that testing is necessary to generate such data. A test rule may also be based on an EPA finding of substantial production and exposure to humans or the envir- onment, in addition to findings of insufficient data and need for testing. Under section 4(e) an Interagency Testing Committee (ITC) was established to recommend chemicals to EPA for priority consideration for the promulgation of section 4 test rules. The ITC can designate up to 50 chemicals or categories of chemi- cals for testing and must make revisions to this section 4 priority list as needed. In turn, EPA must respond within one year after the ITC adds a substance to the priority list by starting rulemaking under section 4 or giving reasons for not doing so. The ITC is made up of appointed members from eight Federal agencies, as specified in TSCA. Representatives from six additional Federal agencies serve in a liaison capacity. Manufacturing and Processing Notices ...Sections Section 5 of TSCA gives EPA authority to quickly review and control, if necessary, new chemicals and new uses of chemi- cals to prevent large scale distribution before a substance's effects on health or the environment are fully determined. Commencement ot Manufacture Notices Under section 5(a)(1)(A) a person who intends to introduce into commerce a chemical substance not on the TSCA inven- tory must notify EPA at least 90 days before beginning manu- facture or import. TSCA Assistance Office (TS-799) °,,ic'al Office of Pesticide & Toxic Substances or priva,e u" U.S.E.P.A. Washington, D.C. 20460 First Class Mall Postage and Fees Paid EPA Parmlt No. G-35 THE TSCA CHEMICALS-IN-PROGRESS BULLETIN ------- |