Document V92Q1gvkgXjzRqvbLQKZ7V2N

TO: Eric Meyer TGG: JCL: ERT: MJH: AJO: RF XF: interoffice Communication FROM: DATE: SUBJ: T. G. Grumbles December 6, 1989 IMPORT AND USE OF CLEAN-WALL AGENT VIS1A I have determined, based on conversations with the EPA TSCA PMN office that the subject product can be imported and used at Aberdeen under TSCA R & D Exemption Procedures. I have attached applicable pages from the regulations regarding the R & D procedures. These procedures require three basic actions: 1. The manufacturer or importer to warn of known or suspected hazards by various means of labeling, written notification, etc. ; 2. The use of the product must be clearly under the supervision of a technically qualified person; and 3. Disposal of any unused material is done according to the regulation (720.36(e)). There will be no restrictions on the resin produced during the use of the product. This is based on EPA's understanding that there will be virtually no contact with the clean wall agent. Let me know if you want to discuss the specifics of the above requirements. Also, I'm assuming things are in order regarding import certification and hazard communication compliance. ---------- T. G. Grumbles dlj cc: Frank Jeansen, W. L. McClain, T. H. Huffman Attachment OOOOOT^31- vvv 40 CFR Ch. I (7.1-88 Edition) i fier, dewatering agent, agglomerating agent, adhesion promoter, flow modi fier, pH neutralizer, sequesterant, co- ? agulant, flocculant, fire retardant, lu bricant, chelating agent, or quality control reagent functions as intented, or (ii) a chemical substance, which is intended solely to impart a specific physiochemical characteristic, func tions as intended. (8) Any nonisolated Intermediate. (i) Any chemical substance which is i manufactured solely for non-commer cial research and development pur poses. Non-commercial research and development purposes include scientif ic experimentation, research, or analy sis conducted by academic, govern ment, or independent not-for-profit re search organizations (e.g,, universities, colleges, teaching hospitals, and re search institutes), unless the activity is for eventual commercial purposes. __C4fl PR 21742. May 13, 1983, as amended at '1 FR 15101. Apr. 22, 19861 .36 Exemption for research and de velopment. (a) This part does not apply to a chemical substance if the following conditions are met: (1) The chemical substance is manu factured or imported only in small quantities solely for research and de velopment. (2) The manufacturer or importer notifies all persons in its employ or to whom it directly distributes the chem ical substance, who are engaged in ex perimentation, research, or analysis on the chemical substance, including the manufacture, processing, use, trans port. storage, and disposal of the sub stance associated with research and development activities, of any risk to health, identified under paragraph <b) of this section, which may be associat ed with the substance. The notifica tion must be made in accordance with paragraph (c) of this section. (3) The chemical substance is used by, or directly under the supervision of, a technically qualified individual. (b)(1) To determine whether notifi cation under paragraph (a)(2) of this section is required, the manufacturer or importer must review and evaluate the following information to deter- gnvironmentol Protection Agency 720.36 jnine whether there is reason to be lieve there is any potential risk to health which may be associated with the chemical substance: U) Information in its possession or control concerning any significant ad verse reaction by persons exposed to the chemical substance which may reasonably be associated with such ex posure. (ii) Information provided to the manufacturer or importer by a suppli er or any other person concerning a health risk believed to be associated with the substance. (iii) Health and environmental ef fects data in its possession or control concerning the substance. <iv) Information on health effects which accompanies any EPA rule or order issued under sections 4, 3, or 6 of the Act that applies to the substance and of which the manufacturer or im porter has knowledge. (2) When the research and develop ment activity Is conducted solely in a laboratory and exposure to the chemi cal substance is controlled through the implementation of prudent labora tory practices for handling chemical substances of unknown toxicity, and any distribution, except for purposes of disposal, is to other such laborato ries for further research and develop ment activity, the information speci fied in paragraph (b)(1) of this section need not be reviewed and evaluated. (For purposes of this paragraph, a lab oratory is a contained research facility where relatively small quantities of chemical substances are vised on a non-production basis, and where ac tivities involve the use of containers lor reactions, transfers, and other han dling of substances designed to be easily manipulated by a single individ ual.) <cKl) The manufacturer or importer must notify the persons identified in paragraph (a)(2) of this section by means of a container labeling system, conspicuous placement of notices in areas where exposure may occur, writ ten notification to each person poten tially exposed, or any other method of notification which adequately informs persons of health risks which the manufacturer or importer has reason to believe may be associated with the substance, as determined under para graph (b)(1) of this section. (2) If the manufacturer or importer distributes a chemical substance man ufactured or imported under this sec tion to persons not in its employ, the manufacturer or importer must in written form: (i) Notify those persons that the substance is to be used only for re search and development purposes. (ii) Provide the notice of health risks specified in paragraph (cXl) of this section. (3) The adequacy of any notification under this section is the responsibility of the manufacturer or importer. (d) A chemical substance is not exempt from reporting under this part if any amount of the substance, in cluding as part of a mixture, is proc essed, distributed in commerce, or used, for any commercial purpose other than research and development, except where the chemical substance is processed, distributed in commerce, or used only as an impurity or as part of an article. (e) Quantities of the chemical sub stance. or of mixtures or articles con taining the chemical substance, re maining after completion of research and development activities may be: (1) Disposed of as a waste in accord ance with applicable Federal, state, and local regulations, or (2) Used for the following commer cial purposes: (i) Burning it as a fuel. (ii) Reacting or otherwise processing it to form other chemical substances for commercial purposes, including ex tracting component chemical sub stances. (f> Quantities of research and devel opment substances existing solely as impurities in a product or incorporat ed into an article, in accordance with paragraph (d) of this section, and quantities of research and develop ment substances used solely for com mercial purposes listed in paragraph (e) of this section, are not subject to the requirements of paragraphs (a), (b), and (c) of this section, once re search and development activities have been completed. (g) A person who manufactures or imports a chemical substance in small 109 VVV 000007232  720.36 40 CFR Ch. I (7-1-88 Edition) | ^yi'ronmvnfoi P the component substances extracted from the byproduct.) (h) The chemical substances de scribed below: (Although they are manufactured for commercial pur poses under the Act. they are not man ufactured for distribution in com merce as chemical substances per se and have no commercial purpose sepa rate from the substance, mixture, or article of which they are a part.) (1) Any impurity. (2) Any byproduct which is not used for commercial purposes. (3) Any chemical substance which results from a chemical reaction that occurs incidental to exposure of an other chemical substance, mixture, or article to environmental factors such as air, moisture, microbial organisms, or sunlight. (4) Any chemical substance which results from a chemical reaction that occurs incidental to storage or disposal of another chemical substance, mix ture, or article. (5) Any chemical substance which results from a chemical reaction that occurs upon end use of another chemi cal substance, mixture, or article such as an adhesive, paint, miscellaneous cleanser or other housekeeping prod uct, fuel additive, water softening and treatment agent, photographic film, battery, match, or safety flare, and which is not itself manufactured or imported for distribution in commerce or for use as an intermediate. (6) Any chemical substance which results from a chemical reaction that occurs upon use of curable plastic or rubber molding compounds, inks, drying oils, metal finishing com pounds. adhesives, or paints, or any other chemical substance formed during the manufacture of an article destined for the marketplace without further chemical change of the chemi cal substance except for those chemi cal changes that occur as described elsewhere in this paragraph. (7) Any chemical substance which results from a chemical reaction that occurs when <i) a stabilizer, colorant, odorant, antioxidant, filler, solvent, carrier, surfactant, plasticizer, corro sion inhibitor, antifoamer or defoaraer, dispersant, precipitation in hibitor, binder, emulsifier, deemulsi fier. dewatering agent, agglomerating agent, adhesion promoter, flow modi, fier, pH neutralizer, sequesterant, coagulant, flocculant, fire retardant, ly. bricant. chelating agent, or quality control reagent functions as intented, or (ii) a chemical substance, which ii intended solely to impart a specific physiochemic&l characteristic, functions as intended. (8) Any nonisolated intermediate. (1) Any chemical substance which i* manufactured solely for non-commer cial research and development pur. poses. Non-commercial research and development purposes include scientlf. ic experimentation, research, or analy. sis conducted by academic, govern ment, or independent not-for-profit re search organizations (e.g., universities, colleges, teaching hospitals, and re search institutes), unless the activity is for eventual commercial purposes. [4B FR 21742. May 13, 1983. as amended at 51 FR 15101. Apr. 22, 19861 9720.36 Exemption for research and de velopment. (a) This part does not apply to a chemical substance if the following conditions are met: <i) The chemical substance is manu factured or imported only in small quantities solely for research and de velopment. (2) The manufacturer or importer notifies all persons in its employ or to whom it directly distributes the chem ical substance, who are engaged in ex perimentation. research, or analysis on the chemical substance, including the manufacture, processing, use, trans port, storage, and disposal of the sub stance associated with research and development activities, of any risk to health, identified under paragraph <b) of this section, which may be associat ed with the substance. The notifica tion must be made in accordance with paragraph (c) of this section. (3) The chemical substance is used by, or directly under the supervision of, a technically qualified individual. (b) (1) To determine whether notifi cation under paragraph (a)(2) of this section is required, the manufacturer or importer must review and evaluate the following information to deter- gjiiie whether t jj^ve there is . wealth which rr l^e chemical sui (1) Inform&tlc control concern verse reaction ttie chemical reasonably be a posure. cii) Informat nj&mifacturer c er or any otht health risk be with the substc (ill) Health feets data in i concerning the civ) Informa which accomp order issued u? the Act that ; and of which porter has kne (2) When ti ment activity laboratory an cal substance the implemen tory practice: substances oi any distribut of disposal, L ries for furth ment activit: fled in parajr need not be (For purpose oratory is a c where relati chemical su non-product: tivities invo for reactions dling of sv easily manit ual.) (0(1) The must notify paragraph means of a conspicuous areas when ten notifies tladly expos notificatior persons ot manufactu to believe 108 >00001 233