Document vV7nJYkeO0Jod69zoO86vBBo6
TO:
Distribution
Interoffice Communication
FROM: DATE:
SUBJ:
M. J. Horowitz December 18, 1989
TSCA SECTION 8 REQUIREMENTS
Vista Chemical has a continuing regulatory obligation to record allegations of significant adverse health or environmental affects resulting from the manufacture and use of our chemical products. These requirements are listed in Section 8(c) and 8(e) of the Toxic Substances Control Act, or TSCA, and are summarized below:
Section 8(c):
Requires records and reports of all allegations that chemical substances cause significant adverse reactions to health or the environment.
Section 8(e):
Requires reporting to the EPA where information which reasonably supports the conclusion that a chemical substance presents a substantial risk of injury to the health or environment is obtained.
Vista employees with frequent customer or community contact have the potential to hear health or environmental effects allegations regarding Vista products. Keep in mind, allegations are defined as "statements made without formal proof or regard for evidence. Allegations recorded to date have come to our attention from plant employees, TSR's and Research and Development personnel.
All Section 8 allegations should be documented and reported to
Houston Environmental.
Environmental will review all Section 8
allegations to determine whether any further action is necessary.
The corporate 8(c) file will also be kept by Environmental.
Copies of the regulation and reporting forms are enclosed. If you are a supervisor, please provide a copy of this information to those employees you believe need to be aware of these requirements.
Michael J. Horowitz dlj
Attachment
VVV 000011011
716.18
40 CFR Ch. I (7-1-86 Edition)
SI FR 17340. May 12. 1986: 51 FR 18326. May 19. 19861
716.IS Additions to lists of chemicals and mixtures to which this subpart ap plies.
The requirements of this subpart
will periodically be extended to cover additional substances and designated mixtures. Two procedures will be used to add substances and mixtures.
(a) Except as provided in paragraph (b) of this section, substances and des ignated mixtures will be added after publication in the Federal Register of a notice of proposed amendment of this subpart. There will be a 30-day public comment period on the notice; after consideration of the comments, a final amendment will identify the sub stances and mixtures added.
<b) Except as provided in paragraph (c) of this section. chemical sub stances. mixtures and categories of chemicals that have been added to the TSCA section 4(e) Priority List by the Interagency Testing Committee, estab lished under section 4 of TSCA. will be added to 716.17 30 days after publica tion of a notice to that effect in the
Federal Register. (c) Prior to the effective date of an
amendment under paragraph (b) of this section, the Assistant Administra tor for Pesticides and Toxic Sub stances may for good cause withdraw a chemical substance, mixture or catego ry of chemicals from 716.17. Any in formation submitted showing why a chemical should be withdrawn from S 716.17 must be received by EPA within 14 days after the date of publi cation of the notice under paragraph <b) of this section. If a chemical sub stance, mixture or category of chemi cals is withdrawn, a Federal Register notice announcing this decision will be published no later than the effective date of the amendment under para graph (b) of this section. Any informa tion submitted must be addressed to: Document Control Officer. Office of Pesticides and Toxic Substances, (TS793). Environmental Protection Agency, 401 M Street SW.. Washing ton. D.C. 20460. ATTN: 8(d) Auto-ITC.
(47 FR 38791. Sept. 2. 1982. as amended at 50 FR 34812. Aug. 28. 1985)
716.19 Sunset provision.
(a) Effective October 3. 1985. the re porting period for the substances listed in 716.17(a)(1). (a)(2). and (a)(3) shall terminate on October 4, 1986.
<b) Tor all listed substances and mix tures other than those specified in paragraph (a) of this section, the re porting period on a substance or desig nated mixture will terminate no later
than three years after that substance or designated mixture is added to the list in i 716.17, or October 4, 1986, whichever occurs later. The automatic termination date for the three year re porting period on a substance or mix ture will be the annual sunset date (May 1 or November 1) that falls no later than three years after reporting begins, e.g., a reporting requirement taking effect on January l, 1984 would
expire not later than November 1, 1986. A notice will be published in the Federal Register announcing the ter mination date for reporting for the substances and designated mixtures listed in 716.17 (a) and (b). An earlier termination date may be published for a substance or designated mixture at
the discretion of the Assistant Admin istrator for Pesticides and Toxic Sub stances.
1
(Approved by the Office of Management and Budget under control number 20700004)
[50 FR 39667. Sept. 30. 1985]
PART 717--RECORDS AND REPORTS OF ALLEGATIONS THAT CHEMICAL SUBSTANCES CAUSE SIGNIFICANT ADVERSE REACTIONS TO HEALTH OR THE ENVIRONMENT
Subpart A--General Provisions
Sec. 717.1 Scope and compliance. 717.3 Definitions. 717.5 Persons subject to this part. 717.7 Persons not subject to this part. 717.10 Allegations subject to this part. 717.12 Significant adverse reactions that
must be recorded. 717.15 Recordkeeping reauirements. 717.17 Inspection and reporting require
ments. 717.19 Confidentiality.
Authority: 15 U.S.C. 2607(c).
70
VVV 000011012
Environmental Protection Agency
717.3
Source: 48 FR 38187. Aug. 22. 1983, unless otherwise noted.
Subparl A--General Provisions
717.1 Scope and compliance.
Section 8 (c> of the Toxic Substances Control Act <TSCA) requires manufac turers. processors, and distributors of chemical substances and mixtures:
(a) To keep "records of significant adverse reactions to health or the en vironment. as determined by the Ad ministrator by rule, alleged to have been caused by the substance or mix ture."
(b) To "permit inspection and submit copies of such records", upon reauest of any designated representa tive of the Administrator. This rule implements section 8(c) of TSCA. It describes the records to be kept and prescribes the conditions under which certain firms must submit or make the records available to a duly designated representative of the Administrator.
717.3 Definitions.
The definitions set forth in section 3 of TSCA and the following definitions apply to this part:
<a) "Allegation" means a statement, made without formal proof or regard for evidence, that a chemical sub stance or mixture has caused a signifi cant adverse reaction to health or the environment.
<b) "Firm" or "company" means any person, that is subject to this part, as defined in 717.5.
(c) (1) "Known human effects" means a commonly recognized human health effect of a particular substance or mixture as described either in:
(1) Scientific articles or publications abstracted in standard reference sources.
<ii) The firm's product labeling or material safety data sheets cMSDS).
(2) However, an effect is not a "known human effect" if it:
(i) Was a significantly more servere toxic effect than previously described.
(ii) Was a manifestation of a toxic effect after a significantly shorter ex posure period or lower exposure level than described.
(iii) Was a manifestation of a toxic effect by an exposure route different from that described.
(d) "Manufacture" or "process"
means to manufacture or process for commercial purposes.
(e) (1) "Manufacture for commercial
purposes" means to import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manu facturer. and includes, among other things, such "manufacture" of any amount of a chemical substance or mixture:
(1) For distribution in commerce, in cluding for test marketing.
(ii) For use by the manufacturer. In cluding use for product research and development, or as an intermediate.
(2) "Manufacture for commercial purposes" also applies to substances that are produced coincidentally during the manufacture, processing, use. or disposal of another substance or mixture, including both byproducts that are separated from that other
substances or mixture and impurities that remain in that substance or mix ture. Such byproducts and impurities may, or may not. in themselves have
commercial value. They are nonethe less produced for the purpose of ob taining a commercial advantage since they are part of the manufacture of a
chemical product for a commercial purpose.
(f) "Person" Includes any individual,
firm, company, corporation, joint ven ture. partnership, sole proprietorship, association, or any other business entity, any State or political subdivi sion thereof, and any department, agency, or instrumental^ of the Fed eral Government,
(g) "Process for commercial pur poses" means the preparation of a chemical substance or mixture, after its manufacture, for distribution in
commerce with the purpose of obtain ing an immediate or eventual commer cial advantage for-the processor. Proc essing of any amount of a chemical substance or mixture is included. If a chemical substance or mixture con taining impurities is processed for
commercial purposes, then those im purities are also processed for com mercial purposes.
71
VVV 000011013
717.5
40 CFR Ch. I (7-1-84 Edition)
(h) "Retailer" means a person who distributes in commerce a chemical substance, mixture, or article to ulti
mate purchasers who are not commer cial entities.
<i) "Significant adverse reactions" are reactions that may indicate a sub
stantial impairment of normal activi ties. or long-lasting or irreversible damage to health or the environment.
(j) "Site" means a contiguous prop erty unit. Property divided only by a public right-of-way is considered one site. There may be multiple manufac
turing. processing, or distribution ac tivities occurring within a single site.
(k) "Substance" means a chemical substance or mixture unless otherwise indicated.
S 717.5 Person* subject to this part.
(a) Manufacturers. (1) All manufac turers of chemical substances are sub ject to this part except as provided in 717.7(a). If manufacture of a chemcial substance occurs at any site owned or controlled by a firm then that firm is subject to this part.
(2) A manufacturer must collect: (l) Any allegation identifying a chemical substance it manufactures
and any allegation identifying the op erations in the manufacture of any chemical substance it manufactures.
(li) Any allegation identifying any of Its own processing or distribution in commerce activities with respect to any chemical substance it manufac tures.
(ill) Any allegation identifying emis sions. effluents, or other discharges from activities described in this para graph.
(lv) Any allegation identifying a sub stance produced coincidentally during
processing, use. storage or disposal of a chemical substance it manufactures.
(3) For the purpose of this part,
owned or controlled means ownership of 50 percent or more of a firm's voting stock or other equity rights, or the power to control the management and policies of that firm.
(b) Processors. (1) A person who processes chemical substances, who is not also a manufacturer of those chemical substances, is subject to this Part if (i) the person processes chemi
cal substances to produce mixtures, or
<ii) the person repackages chemical substances or mixtures.
(2) As a processor subject to this part such person must collect:
(i) Any allegation identifying any mixture it produces and distributes in
commerce and any allegation identify ing any chemical substance or mixture it repackages and distributes in com merce.
(li) Any allegation identifying any of its own further processing or distribu tion in commerce activities of the products described in paragraph (b)(2)(i) of this section.
(iii) Any allegation identifying emis sions. effluents, or other discharges from activities described in this para graph.
(iv) Any allegation identifying a sub stance produced coincidentally during the processing, use. storage or disposal of the products described in paragraph (b)(2Xi) of this section.
(c) SIC code. SIC codes applicable to this part are published in Standard In dustrial Classification Manual--1972 and the 1977 Supplement. This manual and supplement may be ob tained from the U.S. Government Printing Office. Washington. D.C. 20402--stock number 4101-0006 and stock number 003-005-0170-0 respec tively. Where there is a conflict be tween the SIC code use of a term and the definition of that term in this part, the definition in this part ap plies.
[48 FR 38187. Aug 22. 1983. as amended at SO FR 46769. Nov. 13. 1985]
717.7 Persons not subject to this para
(a) Afanu/acfurers. <1) Persons or site activities are exempt from this part if the means by which they man ufacture a chemical substance solely involves mining or ocher solely extrac tive functions, e.g.. those companies or sites within a company whose sole function is to mine mineral ores, ex tract petroleum or natural gas. quarry non-metallic minerals (including ex traction of salts from seawater or brines), mine or otherwise extract coal, or separate gases from the atmos phere. This exemption may include, but is not necessarily limited to. firms engaged in activities as described in
72
yVV 00001101*
Environmental Protection Agency
717.10
SIC Division B--Mining and SIC Code
2313 --Industrial Cases.
12) A person is not subject to this
Part if the chemical substances that
person causes to be produced are limit
ed to:
(i) Chemical substances that result
from chemical reactions that occur in
cidental to exposure of another chemi
cal substance, mixture, or article to en
vironmental factors such as air, mois
ture. microbial organisms, or sunlight.
(ii) Chemical substances that result
from chemical reactions that occur in
cidental to storage or disposal of other
chemical substances, mixtures, or arti
cles.
(iii) Chemical substances that result
from chemical reactions that occur
upon end use of other chemical sub
stances. mixtures, or articles such as
adhesives, paints, miscellaneous clean
ers or other housekeeping products,
fuel additives, water softening and
treatment agents, photographic films,
batteries, matches, or safety flares,
and that are not themselves manufac
tured or imported for distribution in
commerce for use as chemical interme
diates.
(iv) Chemical substances that result
from chemical reactions that occur
upon use of curable plastic or rubber
molding compounds, inks, drying oils,
metal finishing compounds, adhesives,
or paints, or other chemical substance
formed during the manufacture of an
article destined for the marketplace
without further chemical change of
the chemical substance.
<v) Chemical substances that result
from chemical reactions that occur
when (A) a stabilizer, colorant, odor
ant, antioxidant, filler, solvent, carri
er, surfactant, plasticizer, corrosion in
hibitor. antifoamer or defoamer, dis
persant.
precipitation-inhibitor,
binder, emulsifier, deemulsifier, dewa
tering agent, agglomerating agent, ad
hesion promoter, flow modifier. pH ad
juster. sequestrant, coagulant, floccu-
lant, fire retardant, lubricant, chelat
ing agent, or quality control reagent
functions as intended, or <B) a chemi
cal substance, which is intended solely
to impart a specific physicochemical
characteristic, functions as intended.
(b) (Reserved!
<c) Sole distributors. A person solely engaged in the distribution of chemi cal substances is exempt from this
part, unless such person is also a man ufacturer or processor subject to this part. For example, a "distributor" who repackages chemical substances or mixtures is considered to be a proces sor and, thus, is not a sole distributor. Sole distributors may include, but are not limited to, those firms that distrib ute chemical substances as described in the wholesale trade SIC codes 5161--Chemicals and Allied Products, 5171--Petroleum Bulk Stations and Terminals, and 5172--Petroleum and Petroleum Products Wholesalers, Except Bulk Stations and Terminals.
<d) Retailers. A person who is a re tailer is exempt from this part unless such person is also a manufacturer or a processor subject to this part.
(48 FR 38187. Aug 22. 1983. as amended at 50 FR 46770, Nov. 13, 19H5)
S 717.10 Allegations subject to this part.
(a) Allegations subject to this pari are those allegations received on or after November 21, 1983 by persons subject to this part.
(b) Allegations subject to this part are those that:
(1) Are submitted either in writing and are signed by the alleger. or are submitted orally. In the case of an oral allegation, the firm must transcribe the allegation Into written form, or it must inform the alleger that such alle gation may be subject to this part and request that the alleger submit such allegation to the firm in writing and signed.
<2> Implicate a substance that caused the stated significant adverse reaction by one of the following:
(i) Naming the specific substance. (ii) Naming a mixture that contains a specific substance. (iii) Naming an article that contains a specific substance. (iv) Naming a company process or operation in which substances are in volved.
(v) Identifying an effluent, emission, or other discharge from a site of man ufacturing, processing or distribution of a substance.
73
VVV 0000X1015
717.12
(c> Allegations subject to this part may be made to a firm by any person, such as an employee of the firm, indi vidual consumer, a neighbor of the firm s plant, another firm on behalf of
Us employees or an organization on
behalf of its members. <d) EPA intends that firms should,
to the maximum practical extent, pro vide allegers with information regard ing the ultimate disposition of their al legations. For example, firms could provide a brief notice to the alleger stating that a record was created under this part based upon their alle gation, or that a record was not cre ated and briefly explain the reasons why not.
717.12 Significant adverse reactions that must be recorded.
(a) Except as provided in paragraph <b) of this section, significant adverse reactions to human health that must be recorded include but are not limited to:
(1) Long-lasting or irreversible damage, such as cancer or birth de fects.
(2) Partial or complete impairment of bodily functions, such as reproduc tive disorders, neurological disorders or blood disorders.
(3) An impairment of normal activi ties experienced by all or most of the persons exposed at one time.
(4) An impairment of normal activi ties which is experienced each time an individual is exposed.
(b) Firms are not required to record significant adverse reactions that are known human effects as defLned in i 717.3<c).
(c) Except as provided in paragraph (d) of this section, significant adverse reactions to the environment that must be recorded, even if restricted to the environs of a plant or disposal site, include but are not limited to:
(1> Gradual or sudden changes In the composition of animal life or plant life, including fungal or microbial or ganisms. in an area.
<2) Abnormal number of deaths of organisms ce.g., fish kills).
<3) Reduction of the reproductive success or the vigor of a species.
(4) Reduction in agricultural produc tivity, whether crops or livestock.
40 CFR Ch. I (7-1-86 Edition) j
(5) Alterations in the behavior or
distribution of a species. (6) Long lasting or irreversible con-
tamination of components of the physical environment, especially in the case of ground water, and surface water and soil resources that have Jimited self-cleansing capability.
(d) Firms are not required to record a significant adverse reaction to the environment if the alleged cause of
that significant adverse reaction can be directly attributable to an acciden
tal spill or other accidental discharge, emission exceeding permitted limits, or other incident of environmental contamination chat has been reported to the Federal Government under any applicable authority.
: { 1 : *
(Approved by the Office of Management and Budget under control number 20700017)
148 FR 38187. Aug. 22. 1083. as amended at 40 FR 23183. June 5. 1984)
717.15 Recordkeeping requirement*.
(a) Establishment and location of records. A firm subject to this part shall establish and maintain records of significant adverse reactions alleged to have been caused by chemical sub stances or mixtures manufactured or processed by the firm. Such records shall be kept at the firm's headquar ters or at any other appropriate loca tion central to the firm's chemical op erations.
(b) Contend of records. The record shall consist of the following:
(1) The original allegation as re ceived.
(2) An abstract of the allegation and
other pertinent information as fol lows:
(i) The name and address of the plant site which received the allega tion.
<ii) The date the allegation was re ceived at that site.
(iii) The implicated substance, mix ture, article, company-process or oper ation. or site discharge.
<iv> A description of the alleger (e.g.. "company employee." "Individual con sumer." "plant neighbor"). If the alle gation involves a health effect, the sex and year of birth of the individual should be recorded, if ascertainable.
vvv 000011016
Environmental Protection Agency l
717.17
<v) A description of the alleged" health effect(s>. The description must relate how the effect(s) became known and the route of exposure, if explained in the allegation.
vi> A description of the nature of the alleged environmental effcct(s),
identifying the affected plant and/or animal species, or contaminated par* tion of the physical environment.
(3) The results of any self-initiated investigation with respect to an allega tion. (EPA does not require persons subject to this part to investigate alle
gations received, and no provision of this part shall be construed to imply that EPA recommends, encourages or requires such investigation.)
(4> Copies of any further required records or reports relating to the alle gation. For example, if an employee allegation results in a requirement for the firm to record the case on Occupa tional Safety and Health Form 101 or appropriate substitute (see 29 CFR Part 1904 for requirements under the Occupational Safety and Health Act
of 1970), a copy of that OSHA record must be included in the allegation record.
(c) File structure. Records must be retrievable by the alleged cause of the significant adverse reaction, which cause may be one of the following;
(1)A specific chemical identity.
(2) A mixture.
(3) An article.
(4) A company process or operation.
(5) A site emission, effluent or other discharge.
<d) Retention period. Records of sig nificant adverse reactions to the health of employees shall be retained for a period of 30 years from the date
such reactions were first reported to or known by the person maintaining such records. This provision requires persons subject to this part to retain for 30 years an employee health relat ed allegation, arising from any em ployment related exposure, whether or not such allegation was submitted by or on the behalf of that recordkeeper's own employee. Any other record of significant adverse reactions shall be maintained for a period of five years from the date the information
contained in the record was first re-
ported to or known by the person maintaining the record.
(e> Transfer of records. (1) If a firm ceases to do business, the successor must receive and keep all the records that must be kept under this part.
(2) If a firm ceases to do business and there is no successor to receive and keep the records for the pre scribed period, these records must be transmitted to EPA. See 5 717.17(c) for the address to which such records must be sent.
(Approved by the Office of Management and Budget under control number 20700017)
(48 FR 38187. Aug. 22. 1983. as amended at 49 FR 23183. June 5. 1984)
717.17 Inspection and reporting require ments.
(a) Inspection. Firms must make records of allegations available for in spection by any duly designated repre sentative of the Administrator.
(b) Reporting. Each person who is required to keep records under this part must submit copies of those records to the Agency as required by the EPA Administrator or appropriate designee, EPA will notify those re sponsible for reporting by letter or will announce any such requirements for submitting copies of records by a notice in the Federal Register. Such letter or notice will be signed by the Administrator or appropriate designee, and will specify which records or por tion of records must be submitted. The reporting period will be specified by the letter or notice but in no case will such reporting period be less than 45 days from the date of the letter or the effective date of the notice.
(c) How to report When required to report, firms must submit copies of records (preferably by certified mail) to the Document Control Officer, Office of Pesticides and Toxic Sub stances (TS-793), Environmental Pro tection Agency. Washington. DC 20460.
(Approved by the Office of Management and Budget under control number 20700017)
148 FR 38187. Aug. 22. 1983. as amended at 49 FR 23183. June S. 1984]
VVV 000011017
717.19
40 CFR Ch. I (7-1-86 Edition)
717.19 Confidentiality.
<a> Any person submitting copies of records may assert a business confi dentiality claim covering all or part of the submitted information. Any infor mation covered by a claim will be dis closed by EPA only as provided in pro cedures set forth at Part 2 of this title.
(b) If no claim accompanies a docu ment at the time it is submitted to EPA, the document will be placed in an open file available to the public without further notice to the respond ent.
(c) To asset a claim of confidential ity for information contained in a sub mitted record, the respondent must submit two copies of the document.
(1) One copy must be complete. In that copy, the respondent must indi cate what information, if any, is claimed as confidential by marking the
specific information on each page with a label such as '`confidential'', "propri etary", or "trade secret" and briefly state the basis of the claim.
(2) If some information is claimed as confidential, the respondent must submit a second copy of the record. The second copy must be complete, except that all information claimed as confidential in the first copy must be deleted.
(3) The first copy will be for internal use by EPA. The second copy will be placed in an open file to be available to the public.
<4? Failure to fumtsh a second copy when information is claimed as confi dential in the first copy will be consid ered a presumptive waiver of the claim of confidentiality. EPA will notify the respondent by certified mail that & finding of a presumptive waiver of the claim of confidentiality has been made. The respondent will be given 30 days from the date of receipt of notifi cation to submit the required second copy. If the respondent fails to submit the second copy within the 30 days, EPA will place the first copy in the public file.
PART 720--PREMANUFACTURE NOTIFICATION
Subpart A--Gonoral frevitiant
Sec. 720.1 Scope. 720.3 Definitions.
Subpart 6--Applicability
720.22 Persons who must report. 720.25 Determining whether a chemical
substance is on the Inventory. 720.30 Chemicals not subject to notifica
tion requirements. 720.3$ Exemptions for research and devel
opment. 720.38 Exemptions for test marketing.
Subpart C--Notica Form
720.40 General. 720.45 Information that must be included
tn the notice form. 720.50 Submission of test data and other
data concerning the health and environ mental effects of a substance. 720.57 Imports.
Subpart 0--Disposition of Notica*
720.60 General. 720.62 Notice that notification is not re
quired. 720.65 Acknowledgment of receipt of a
notice: errors in the notice: Incomplete submissions: false and misleading state ments. 720.70 Notice in the Federal Register. 720.75 Notice review period. 720.78 Recordkeeping.
Subpart E<--Confidentiality and Public Accett ta Information
720.80 General provisions. 720.85 Chemical identity. 720.87 Categories or proposed categories of
uses of a new chemical substance. 720.90 Data from health and safety stud
ies. 720.95 Public file.
Subpart t--CommaneomanJ of Manufacture or
Impart
720.102 Notice of commencement of manu facture or import.
Subport G--Compliance and Inspection*
720.120 Compliance. 720.122 Inspections.
Affewoix A--Premancfactore Notice foe New Chemical Substances
76
VVv 000011018
VISTA
Vista Chemical Company Vlsto Polymers Inc.
Report of a Possible Adverse Effect To Health or the Environment
If you think a chemical substance or mixture has caused an adverse human effect, identify that substance and describe how affected. If you think the environment (for example, the air, water, soil, animals, or plants) has been adversely affected by one of the facility's chemical substances or mixtures, identify the substance (if known) and the affected plant and/or animal or contaiminated area of the environment.
If you cannot identify the suspected chemical substance or mixture, identify the product, material, or item believed to be the cause of the adverse effect or describe the process or operation or the effluent, emission, or discharge from the facility that you think has caused the adverse effect.
Signature of Reporter
Name of Reporter (Printed)
Send Completed Form To:
Date of Report Date Adverse Effect Secured
vw 000011019
TOXIC SUBSTANCES CONTROL ACT (TSCA) RECORDING
AND REPORTING REQUIREMENTS UNDER SECTIONS 8(c) AND 8 (e)
Responsibilities for You and VISTA TSCA requires Vista Chemical to follow certain record keeping and reporting procedures if adverse effects arise from the manufacture, processing or distribution of our products. If significant adverse reactions to human health or to the environment are suspected, Vista Chemical must keep records of the allegations. If substantial risk of injury to health or the environment results from our operations, Vista Chemical must report the situation to the Environmental Protection Agency (EPA).
Vista Chemical intends to comply fully with the provisions of this law and its regulations...and wants all employees to assist.
What Should You Report? Significant adverse reactions from exposure to chemical substances which substantially impair your normal activities or cause long-lasting damage to your health or to the environment should be brought to the attention of your supervisor. Any information which leads to a belief that a substance poses a substantial risk to health or the environment should also be brought to the attention of your supervisor. Conclusive proofof adverse reactions or substantial risk is not necessary.
What Not to Report Information need not be reported if we are sure that EPA already has it. Information in published EPA reports, scientific literature, or in technical and trade journals should not be reported. Some information submitted to EPA or other federal agencies as part of mandatory reporting requirements of other laws (e.g., oil spills) may also be excluded from the notification requirements.
How You Initiate a Report Supervisors have a supply of the forms which you must use for reporting any information.
Ask your supervisor for assistance if you need help in completing the form.
How Vista Chemical Meets the Law's Requirement All Vista Chemical departments have established procedures which enable employees to provide written reports of significant adverse reaction or of substantial risk to health or the environment. Qualified professionals within the company will evaluate the submission. If the information is determined to be recordable or reportable to EPA, Vista Chemical will take appropriate actions.
You will receive a written reply on how your submittal was handled.
VW 0000II020
September 1986
The Best of
Chemical Week
.. in 4-coior, 2-color, or
black and white.
ORDER REPRINTS OF:
NEWS
But the Du Pont projects, to be conitructed throughout the 1990s, constiute by far the largest effort to put nylon production capability in the region. At he moment, Monsanto (St. Louis), vhich has all of its nylon production in he U.S., says it has no plans to make the naterial in Asia. And while ICI (Lonlon) has proposed building a $255nillion purified terephthalic acid plant br the region, the company's interest in he region "doesn't include nylon," iccording to a spokesman.
"Du Pont is the major supplier of lylon," says Robert M. Aiken, group rice president/petrochemicals. "By the pear 2000, we should have the same market share [in Asia] that we have in he rest of the world, which is 25%." Aiken says Du Pont has "a very small market share" in Asia--less than 5%.
Du Pont will first build an adipic acid plant, partly, says Aiken, because
the intermediate is "somewhat short" globally. The $200-million plant, ex pected on stream in 1993, will be lo cated in Singapore. Its projected capac ity of more than 200 million lbs/year will hike Du Pont's adipic acid capacity to more than 1.5 billion lbs/year. Re cently, Du Pont expanded its other ad ipic acid facilities in Maitland. ON and Victoria, TX; it has also been authorized to expand at Sabine River Works, TX, but it is not specifying by how much.
Aiken says the Singapore plant will be Du Pont's "core facility" in the re gion. It will have polymerization capa bility, expected on-line in 1993, to serve compounding plants that will be built or expanded in Korea, Japan, and Sin gapore. In the late '90s the company plans world-scale production capabil ity in the region for adiponitrile and hexamethylene diamine.
FI.T.FM GOLDBAUM
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12 Chemicalweek/January 17. 1990
EPA GETS
TOUGH ON
TSCA
The Environmental Protection Agency has issued warning to U.S. chemical companies that they may be breaking the law by. withholding key risk-assessment data from the agency. In a letter to 700 companies, Charles Elkins, EPA's director/office of toxic substances, warned the companies not to substitute their own risk criteria for those mandated by section 6(e) of the Toxic Substances Control Act (TSCA). TheEPA move signals astronger "proac tive effort" to enforce the law, notes Elkins.
Under section 8(e), all companies that make, process, or ship chemicals must report within 15 days to EPA any new information "that reasonably sup ports a conclusion that [a substance] presents a substantial risk of injury to healthorthe environment," Elkins says in the letter. DuPont (Wilmington, DE), Monsanto (St. Louis), Dow Chemical (Midland, Ml), and American Cyanamid (Wayne, NJ) were among the companies to which EPA sent the letter, says an agency spokesman.
Sending such a letter "is not com mon" procedure, says Elkins. He ex plains that the agency had run across " a number of cases" showing that some companies were interpreting the law differently. "Based on these recent
events, we're going to be putting much more emphasis on this section of [TSCA]," he says. Companies "will be hearing from us in less gentle ways." Elkins says he sent the letter because he "thought it would be helpful to give them an early warning, so when inspec
tors arrive no one will be surprised," Earlier this month Monsanto agreed
to pay EPA $196,230 for a section 8(e) violation. Monsanto also must review all past toxicology studies to determine theextent ofits compliance. Thatproba bly will be an expensive undertaking, says Elkins, as each violation calls for a fine of $25,000/day. Such fines will be assessed for the approximately 100 reports Monsanto will send to EPA, he says.
Says aMonsanto spokeswoman, "We interpreted [TSCA] one way; EPA inter preted it another." She maintains that the agency's guidance on the law "changed over time" from what was first given to Monsanto. Replies Elkins: i "If that were really the case, they could have taken it to court. We feel we inter preted the act consistently. " Monsanto's differing view "may be in the eye ofthe beholder," he says.
Dow does not substitute its judg ment for EPA's, according to Joseph LeBeau, director/health and environ mental sciences for the company. If a material shows toxicity but exhibits no biologically or statistically significant risk, Dow may run another study on it, says LeBeau. But if there's reason to suspect a cause-and-effect relationship between a substance and a threat to human health, Dow reports it, he adds.
KEN STERNBERG
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. \|ijux-ii oy llit` uiw, ttJA this detail..
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n -actions )o liumon beuJlh or I hr environ
tm nl, .is follows:
Significant adverse reactions <m> reactions Hull may indicate substantial imf>airment ol normal activities or long-lasting or irreversible damage to health or the environ merit.
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Examples of significant adverse reactions to human health include:
Long lasting or irreversible damage, such as cancer or birth delects.
Partial or complex impairment ol bodily iunclions, such as blood, reproductive, or neurological disorders.
An impairment ol normal activities, which is experienced by all or most of Ibe persons exposed at one lime.
An impairment ol normal activities, which is experienced each time dn individual is exposed.
Examples ol significant adverse reactions to the environment include:
Gradual or sudden changes in the com position ol animal or plant life in an area.
An abnormal number ol deaths of organisms (e.g., fish kills).
A reduction ol the reproductive success or vigor of a species.
A reduction in agricultural productivity, whether crops or livestock.
Alterations in the behavior or distribution ol a species.
l.ong lasting or irreversiblecontamination ol eamfxjrienlr; ol the physical environment ,in h . ir. i |ii nimivy. Her or soil.
The Toxic Subslantx's Control Act (TSCA) w^. signet! into law m October 1976. The purpose ol I'SCA is to ensure that chemical substances and mixtures are regulated in a manner that {insures that they do nut present an unreasonable risk of injury to health or the environment.
This brochure provides a summary of the major provisions of EPA's TSCA Sedion 8(c) linal rule, 40 CFR 717, which was published in its entirety in the August 22, 1983 Federal Register, Volume 48, Page 38178, and became ellective on November 21, 1983.
It was the intent ol Congress when it passed the Toxic Substances Control Ad (TSCA) that the public be made aware of potential hazards to human health and the environment, and of the action to take il exposure lakes place. This brochure has been developed to help inform you about this new TSCA 8(c) rule.
If you have questions beyond those covered here, please contact the TSCA Assistance Office:
Long Distance: (800) 424 9(135 Washington. DC: (202) 554 1404
Answers to Your Questions
About the TSCA Section 8(c) Rule
Olluo ol Ibxtc Substances Hnviiomtieutnl I'rolrelion Agency
About the 8(c) Rule
nv\ has issued a regulation that will, leu the lirst
1 uti*. e-gum- the chemical industry to keep records I - IHig< -d "significant adverse nactions" 1o chemical *11'.I.in- <;* ;md mixtures. This is being done under Mi- authority ol Section 8(c) ol the Toxir Substances Control Act (TSCA).
The Rule requires the chemical industry to keep those allegations on record lor thirty (30) years in the rase ol employee health, and (or (ive (5) years in all other cases. EPA can inspect such records and ntrqum? lli-it the industry report the information contained in such records to the Agency.
What Is an Allegation?
A worker on a new chemical process line lulls his sujn>rviKor tluit he is experiencing spells ol hand tremors and blurred vision while on the job. He thinks the problem is caused by the vapors tie breathes in while refilling a mixing tank. His supervisor asks him to lill out and sign a brie! form describing Ins prob lern. The worker does so. This is an 8(c) allegation.
Briefly, an allegation is a statement ol an individual's helii-l that a chemical subslam'e, mixture, etc., has mused harm to him, another person, or to the environ merit. But he is not required to provide prool or evidence ol the adverse reaction.
The TSCA Section 8(c) rule defines an allegation .is .) "statement made without formal prool or regard lor evidenee, that a chemical substance or mixture caused a significant adverse reaction to human health or the environment"
Who Can Make an Allegation?
Any person con make an allegation.
This includes anyone who has oxjx-noneed or witnessed a "significant adverse reaction to human health or the environment."
In addition to individual company employees, consumers, or plant neighbors, allegations can be submitted by one fjerson or a group on behalf of another person or group. For example, a person could make an allegation on behalf of an injured or de ceased relative, or a union representative could make an allegation on behalf of one or more members.
What Allegations Are Recordable?
The T3CA Section 8(c) rule is in no way attempting to limit or dictate the kinds of complaints or the content of allegations that a worker or any other citizen may make. Some companies may, as a matter of policy, keep every allegation they receive. But persons who submit allegations should be aware that under the 8(c) rule, industry is only required 1$' record allegations that meet certain criteria. With this in mind, here are some basic suggestions for structuring an allegation.
Sign Any Written Allegation Companies subject to the rule are not required to record unsigned written allegations. Companies must also deal with oral allegations, but rnay do so in one ol two ways either by transcribing the allega tion as orally presented to them, or by requesting Ilia! the ulleger submit it in writing.
Link Cause with Effect.
I he allegation must mail' a link l-lwi-en a p.r ticular company s pnxluct, process, or effluent and ll . human li allh or nvironrnentul el led.
Clearly State What Caused the Reaction
II is very unportan. that the cause of the n-n- ii..n be clearly identilir J. This is important because companies will bo ang such allegations by the? chemical or other . ubslanee reported as a cause of the reaction. Jut, you don't have to know tin- exact chemical idr nlily ol the causative agent. You can ule a cause by:
Naming the specific sibslance;
Naming a mixture that contains a specific substance (e.g., a product brand name);
Naming an article that contains a specific subs! .nco;
Naming a company piocess or operation in which substances a*e involved; or
Identifying an diluent emission, or other discharge irorn a site of manufacturing, processing, ordistribu.ionofa substance.
Fully Describe the Advene Reaction
The nature of Hi 1 adverse reaction should lexplained. If the reaction n a health ellcci, it would be helplul to explain how you discover'd it and how you feel you were exj>osed. If the adverse n-action is an environmental effect, ide nlify as best you c.m iIk affee-led plants, animals, or the contaminated | >arl ol the environment as well as tie kind ol reaction yon observe -d.
Significant Adverse React ons
Finally, the industry is a.ily rcgmr-M l- '-..-id "significant adverse reaelinn-C
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