Document V2w4Xxa94owG12G8bmMpjNp4

V. What C o j5 m u ie > SirBSTAjrriAX. R isk s A "substantial risk" erf Injury to health or the environment" is a risk of considerable concern because of (a> the seriousness of the effect [see Sub parts (a), (bX and (c> below for arr Il lustrative list of effects of concern], and (b) the fact or probability of its occurrence. (Economic or social bene fits of use, or costs o f restricting use, are not to be considered In determin ing whether a risk is "substantial".) These two criteria are differentially weighted for different types of effects. T h e human health effects- listed in Subpart CaXbelow far example, are so serious that, relatively little weight, is given to exposure; the mere fact the Implicated chemical is in commerceconstitutes sufficient evidence of expo sure- In contrast- the remaining effed s listed In- Subparts, (bi- and (cl below must involve, or be accompanied by th e potential: for, significant levels of exposure (because of general pro duction levels persistence,, typical uses- common means of disposal, or other pertinent faetorsX Note that: (1) The effects outlined below should not be reported if the re spondent has actual knowledge that the Administrator is already Informed of them. (li) Information respecting these ef fects can be obtained either directly, by observation of their occurrence, or inferred from designed studies as dis cussed in Part VI. The Agency considers effects for which substantial-risk Information must be reported to Include the fol lowing: <a) Humanhealth effects--(1) Any instance of cancer, birth defects, mu/ tagenicity, death, or serious' or pro/ longed Incapacitation, including the f loss of or inability -to use a normal bodily function with a consequent rel atively serious Impairment of normal activities. If one (or a few) chemlcal(s) is strongly implicated. (2) Any pattern of effects or evi dence which* reasonably supports the conclusion that the chemical sub stance or mixture can produce cancer, mutation, birth defects or toxic effects resulting In death, or serious or pro longed incapacitation. (b) Environmental effects--(1) Wide spread and previously unsuspected dis tribution In environmental media, as indicated in studies (excluding materi als contained within appropriate dis posal facilities). (2) Pronounced biaccumulation. Measurements and Indicators of proi nounced bioaccumulation heretofore unknown to the Administrator (includ ing bioaccumulation in fish beyond 5.000 times water concentration In a 30-day exposure or having an n-octanol/water partition coefficient greater than 25.000) should be report ed when coupled with potential for widespread exposure and any non-trfvlal adverse effect. (3) Any non-trivlal adverse effect, heretofore unknown to the Adminis trator. associated with a chemical known to have bioaccumulated to a pronounced degree or to be wide spread In environmental media. (4) Ecologically significant changes in species' interrelationships; that Is. changes In _ population behavior, growth, survival, etc. that in turn affect other species' behavior, growth, or survival Examples include: (1) Excessive stim ulation of primary producers (algae, macrophytes) in aquatic ecosystems, e.g., resulting in nutrient enrichment, or eutrophication, of aquatic ecosys tems. (U) Interference with critical biogeochemical cycles, such as the nitrogen cycle. (5) Facile transformation or degra dation to a chemical having an unac ceptable risk as defined above. (c) Emergency incidents o f environ mental contamination--Any environ mental contamination by a chemical substance or mixture to which any of the above adverse effects has been as cribed and which because of the pat tern, extent, and amount of contami nation (1) seriously threatens humans with cancer, birth defects, mutation, death, or serious or prolonged inca pacitation. or (2) seriously threatens n n n . h r m a n organisms with large-scale or ecologically significant population destruction. NOTICES - Federal Register Vol. 43, No. 52 Thurs., March 16, 1978 Pages 11111-11112 IX. R eT'ORTXNG R EQU V B JX D T T s Notices shall be delivered to the Document Control O fficer, Chem ical Inform ation Division. O ffice of T oxic Substances (W H -557). Environm ental Protection A g e n c y . 401 M S tre e t SW .. W ashington, D.C. 20460. A notice should: (a ) B e se n t by c e rtifie d m ail, or In any o th er way p erm ittin g verification of its receipt by th e Agency. (b) S ta te th a t it is being subm itted In accord an ce w ith s e c tio n 8(e), (c) Contain the Job title, name, ad dress, telephone nu m ber, and signa ture of the person reporting and the name and address of th e m anu factu r ing. processing, or distributing estab lish m en t w ith w h ich h e Ls associated , (d) Id entify the chem ical substance or m ixture (including, if known, the CAS R egistry Num ber), (e) Sum m arize th e adverse effects being reported, describing the nature and the e x te n t of th e risk involved, and (f) Contain the specific source of the Inform ation together with a sum mary and the source of any available sup porting technical data. - For em ergency incidents of environ mental contam ination (see P art V (c)), a person sh all rep o rt th e Incident to the A dm inistrator by telephone as soon as he has knowledge of the in ci dent (see below fo r appropriate te le phone contacts). T h e rep ort should contain as m uch of th e inform ation re quired by instru ction s (b ) through (f? above as p o ssible. A w ritte n re p o rt, ir. accord an ce w ith in s tru c tio n s (a ) th ro u g h (f ) above, Is to be su b m itted w ithin 15 days. T w en ty -fo u r h ou r emergency telephone num bers are: Region I (M aine, R hod e Island. Connecti cut, V erm ont, M a ssa ch u setts, New H am p shire). 617-223-7265. FLegion I I (New Y o r k , New J e r s e y . P u e rto P Jco . Virgin Isla n d s). 2 0 1 -5 4 8 -8 7 3 0 . Region M (Pennsylvania, W est Virginia. Virginia. M aryland. D elaw are, D istrict of Colum bia). 215-597-9898. Region IV (K en tu cky. Tennessee. N orth Carolina. Sou th C arolina. G eo rgia A la bam a M ississippi Florid a). 404-881-4062. Region V (W isconsin. Illinois. Indiana. M ichigan. O hio. M in nesota). 312-3532318. Region V I (New M exico. T ex a s, O k lah o m a Arkansas. Louisiana). 214-749-3840. R egion VTI (N ebraska. Io w a M issouri. K ansas). 816-374-3778. Region VTII (C olorado. U tah . W yom ing. M ontana N orth D a k o ta South D akota). 303--8 3 7 -3 S80. R egion EX (C a lifo r n ia N ev ad a A rizo n a Haw aii. G u am ). 4 1 5 -5 5 6 --625-4. Rerion X (W ashington. Oregon. Idaho. Alaska). 306-442-120O. NOTICES - Federal Register Vol. 43, No. 52 Thurs., March 16, 19 Page 11113