Document jyXaoEnn9d3rKZRkdpBLEKQ2R

T O : See Distribution Please note particularly Page 3 of the attachment dated 12/15/78 covering emergency incidents and the text of Parts V and IX of the EPA Policy Statement. W.R.C. 4-2017) LOYEES RE ITANTIAL RISK IN 8(e) INT ROL A C T MAP IRC >. Res. MCI MPR l :h Labs C. T h r o d a h l S. P ark Roush, Jr. DID E2NE. A2SA Please see that all personnel in your Operating Company or your Organizational Unit in Grade Level 34 and above receive a copy of the attached packet of procedures and guidelines for compliance with the legal requirements o f S e c t i o n 8 (e) of. TSCA. This packet consolidates all information that has been communicated to our employees and includes the original Internal Procedures and Supplements thereto. It gives each employee ready reference to his obligations and rights, together with Company policy with respect to the handling of substantial risk information. I know you recognize the need for maintaining a high degree of awareness amongst our employees on Section 8(e) and I very much appreciate your cooperation in helping me achieve this end. Will you please confirm to me when this requested distri bution has been completed. W R C :ms Attachments W. R. C o r e y / Director, TOSCA N O T I F I C A T I O N OF EMPLOYEES RE TRANSMITTAL OF SUBSTANTIAL RISK INFORMATION S E C T I O N 8(e) TOXIC SUBSTANCES CONTROL ACT SECT I O N 8(e) N O T I C E TO A D M I N I S T R A T O R OF S U B S T A N T I A L RISKS "Any person who manufactures, processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such a substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information." INTERNAL PROCEDURES FOR TRANSMITTAL OF SUBSTANTIAL RISK INFORMATION TO THE DIRECTOR OF DMEH MONSANTO COMPANY The Toxic Substances Control Act obligates the Company to report immediately to the U. S. Environmental Protection Agency any information it obtains which reason ably supports the conclusion that a chemical substance or mixture manufactured, processed or distributed in cornerce by the Canpany presents a substantial risk of injury to health or the environment. (Information need not be reported if it is known that the U. S. EPA already has it.) In order to fulfill this obligation, it is necessary to establish a ccmmunicatiohs network within the operating companies and other specified organizational units to facilitate the transmission of pertinent information. Each specified organizational unit shall have a designated individual to whom such information should be ccrrmunicated. They are as follows: C. F. Callis W. D. Carpenter R. K. Flitcraft P. H. Hobson D. E. Morris J. B. Duncan W. B. Papageorge R. H. Schlattman A. W. Andrews P. 0. DeGarmo MIC MAP MPC MTC Corp. Research Tabs MGP MCI MPR CED DMEH The procedure described below shall be followed in order to provide.for a rapid and orderly flew of such information. Anyone obtaining information of the type described above should immediately submit such information to his supervisor. The supervisor shall immediately relay the information to the location or department manager, whichever is applicable, who in turn transmits it to the proper designated individual in his. organizational unit* The information is then transmitted directly to the Director of the Department of Medicine and Environmental Health. It is imperative that the flow of information through this transmittal chain be rapid. In the event of non-availability of a member of the communication's network at the time information is first obtained, such member should be by-passed in the interest of speed. All individuals involved in submission of substantial risk information to the Director of DMEH should keep a record of date of receipt and pertinent identifying details. With respect to all information received by the Director of DMEH under Section 8 (e) , a Committee comprised of the Director of DMEH, Environmental Counsel and the ap propriate Operating Company Director, Environmental Operations will determine on behalf of the Company whether a reporting obligation exists and will act accordingly. Personnel through whom the information was submitted shall be informed of the decision concerning reporting and the reasons for the action taken. S t, n / Q /in / SUBSTANTIAL RISK INFORMATION TO THE DIRECTOR OF DMEH, JOSANTO CTiPANY On-March 16, 1978, the ERA published in the Federal Register its "Statement of Interpre tation and Enforcement Policy" which describes the Agency's interpretation of Section 8(e)_ of the Toxic Substances Control Act. The Statement asserts that the reporting obligation on. substantial risk information applies to individual officers and employees of a ccrrpany who are capable of appreciating the significance of pertinent information as well as the company itself. However, the Statement continues by saying that the individual reporting obligation can be fully discharged by notifying a designated company official of the perti nent information in accordance with procedures established by the Ccrrpany. Monsanto established such procedures shortly after passage of the Act. and subsequently, in accordance with policy adopted by the Environmental Policy Ccncnittee on November 14, 1977, reissued its internal procedural mechanisms and you have received the revised re-, porting procedure dated December 9, 1977. The EPA Statement I'also described certain provisions which should be part of a company *s internal procedures governing notifications. In order to fully comply with the EPA recom mendations, this supplement to the previous procedure is being distributed, | WHAT CONSTITUTES SUBSTANTIAL RISK Section 8'(e}. of TSCA does not define what constitutes substantial risk .information. . Hcwever, a "substantial; risk of injury to health or the environment'*' is a risk of consider- able concern because of: ^(a). the seriousness of the effect; (bl the fact or probability of its occurrence; Cc} the nature and extent of exposure to the risk. .- These criteria need to be weighted differently for different types of effects, both human and environment. If there is any doubt as to whether' information should be reported, it should be, submitted in accordance with our procedures to your designated organizational unit individual for review by the cxrrraittee established for this purpose. It should be noted that'information need not be reported if you have knowledge that the EPA has already been informed of it or it has been published in the scientific literature. EMPLOYEES H I G H S Monsanto's policy and its internal substantial risk reporting procedures state that em ployees who submit information through Caapany channels will be notified of action taken, together with the reasons for such, action. If the employee disagrees with the Company's decision Ithat the information need not be reported, he has the right to report such infor mation directly to the EPA and the Act provides that no employer may discharge or other wise discriminate against an employee because that employee assisted or participated in an action to carry out the purposes of the Act,. PENALTIES ! Section 16 cf -TSCA contains specific penalties for violation of Section 8 Cel- These are Cl), a civil penalty not to exceed $25, QQQ per day, and (2L in the event of knowing or willful violation, -criminal penalties consisting"of a fine of not more than $25,QQQ per day or imprisonment for not more than one year, or both. If you have any questions concerning this Section 8 (el, you should address them to the designated individual for your organizational unit, 5/5/78 notificatif:; o SUBS \TIAL RISK EMERGENCY INCIDENTS OF ENVIRONMENTAL CONTAMINATION Part V of the EPA Statement of Interpretation and Enforcement Policy c o v e r i n g n o t i f i c a t i o n of s u b s t a n t i a l r i s k u n der S e c t i o n 8(e) of the Toxic Substances Control Act deals with the types of information a p e r s o n o b t a i n s w h i c h the E P A believes' " c o n s t i t u t e s u b s t a n t i a l r i s k 11/ r T and thus should be reported. The full text of this Part V of the EPA Statement is reproduced and attached herewith, together with P a r t IX c o v e r i n g " R e p o r t i n g R e q u i r e m e n t s ." This communication is being issued to draw your particular attention to S u b s e c t i o n (c) of P a r t V w h i c h d e a l s w i t h " E m e r g e n c y i n c i d e n t s of e n v i r o n m e n t a l 1c o n t a m i n a t i o n " an d to the last s e c t i o n of P a r t IX which spells out how such incidents should be reported. Emphasis on review of these specific subsections is being urged because of the timing of the report to EPA with respect to information concerning an emergency incident of environmental contamination which reasonably supports the conclusion that such contamination presents a substantial risk of injury to health or the environment. EPA has established in its enforcement policy that the incident should be r e p o r t e d by t e l e p h o n e w i t h i n 24 h o u r s , f o l l o w e d by a w r i t t e n r e p o r t within 15 days. Our existing internal procedures for transmitting any type of sub s t a n t i a l r i s k i n f o r m a t i o n to t he D i r e c t o r of `the D e p a r t m e n t of M e d i c i n e and Environmental Health should be followed except that, in the case o f e m e r g e n c y i n c i d e n t s , the f o l l o w i n g p a r a g r a p h f r o m the D e c e m b e r 9, 1977 instructions should be invoked: "It is imperative that the flow of information through this transmittal chain be rapid. In the event of non availability of a member of the communications network at the time information is first obtained, such m e m ber should be by-passed in the interest of speed". Immediately upon receipt by the Director of D M E H , of information referred to above, he will determine its reportability to EPA and act accordingly. Persons through whom the information was submitted shall be informed of the decision concerning reporting and the reasons for the action taken. W hen an i n c i d e n t is r e p o r t e d to the EPA, a follow-up w r i t t e n r e p o r t w i l l b e p r e p a r e d and s u b m i t t e d d u r i n g the p r e s c r i b e d 15 d ay t i m e - f r a m e 12/15/78 V. W il u C o a s rrru T E s S ubsta-htlax. R isk s. A "substantial risk of injury to health or the environment** is a risk of considerable concern because of (a> the seriousness of the effect Tsee Sub parts (a). (bX and (e> below for an il lustrative list of effects of concern], and Co) the- fact or probability of Its occurrence. (Economic or social bene fits of use. or costs of restricting use, are not to be considered in determin ing- whether a risk is "substantia]".) These two criteria are diflerentialTy weighted for different types of effects. T he human health effects listed in Subpart f&i below, for example, are so serious that, relatively little weight is given to exposure: the mere fact the implicated- chemical is hr commerceconstitutes sufficient evidence of expo sure. In contrast, the remaining efiects listed in- Subpaxts. (b> and (cl below njust involve, or be accompanied by- th e potential for, significant levels of exposure (because of general pro duction levels, persistency, typical uses, common- means of rfi.gfwmi, or other pertinent faetoreX 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. (ii) 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) Hwnan health effects--(1) Any Instance of cancer, birth defects, mu tagenicity, death, or serious or pro longed incapacitation, including the 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) chemicaKs) is strongly implicated. (2) Any pattern of effects or evi dence which* reasonably supports the conclusion that th e 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 bioaccumulation. Measurements and indicators of pro nounced bioaccumulatlon heretofore unknown to the Administrator (includ ing bioaccumulation tn fish beyond 5.000 times water concentration In a 30-day exposure or having an n-oetanol/wzter partition coefficient greater than 25,000) should be report ed when coupled with potential for widespread exposure and any non-trivlal 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: (i) Excessive stim ulation of primary producers (algae, macrophytes) In aquatic ecosystems, e.g., resulting in nutrient enrichment, or eutrophication, of aquatic ecosys tems, (il) 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 non-human organisms with large-scale or ecologically significant population destruction. NOTICES - Federal Register V o l . 43, No. 52 T h u r s ., M a r c h 16, Pages 11111-11112 1978 XX. R eporting R cqulrements Notices shall be delivered to the Document Control Officer, Chemical Information Division. Office of Toxic Substances (WB-S57), Environmental Protection Agency. 401 M Street SW..* Washington, D.C. 20460. A notice should: (a) Be sent by certified mail, or in any other way permitting verification of Its receipt by the Agency, (b) State that It is being submitted in accordance with section 8(e), (c) Contain the Job title, name, ad dress, telephone number, and signa ture of the person reporting and the name and address of the manufactur ing. processing, or distributing estab lishment with which he is associated, (d) Identify the chemical substance or mixture (Including, if known, the CAS Registry Number), (e) Summarize* the adverse effects being reported, describing the nature and the extent of the risk involved, and (f) Contain the specific source of the Information together with a summary and the source of any available sup porting technical data. For emergency incidents of environ mental contamination (see P a r t V(c)), a person shall report the incident to the 'Administrator by telephone as soon as he has knowledge of the inci dent (see below for appropriate tele phone contacts). The report should contain as much of the information re quired by instructions (b) through (f) above as possible. A written report, in accordance with instructions (a) through (f) above, is to be submitted within 15 days- Twenty-four hour emergency telephone numbers are: Region I (Maine. R hode Island. Connecti cut. Vermont, M assachusetts, New Hamp shire), 617-223-7265. Region n (New Y ork. New Jersey, Puerto RJco, V irgin Islands), 201-5-18-8730. Region III (Pennsylvania, W est Virginia. Virginia. M aryland. D elaw are. D istrict of ' Columbia). 215-597-9898. Region IV (K entucky, Tennessee. N orth Carolina, South Carolina. Georgia. Ala bama. M ississippi, Florida), 404-881-4062. Region V (Wisconsin. Illinois. Indiana. Michigan. Ohio, M innesota). 312-3532318. Region VI (New Mexico, Texas, Oklahoma, Arkansas, Louisiana), 214-749-3840. Region VII (Nebraska. Iowa. Missouri. Kansas). 816-374-3778. Region VIII (Colorado. U tah, Wyoming, M ontana. N orth D akota. South D akota). 303-837-3880. Region DC (C alifornia. Nevada, Arizona, H aw aii Guam). 415-556-6254. Region X (W ashington. Oregon. Idaho, Alaska). 206-442-1200. NOTICES - Federal Register V o l , 43, No. 52 T h u r s ., M a r c h 16, 19 7 Page 11113