U.S. EPA, Questions and Answers Concerning the TSCA Section 8(c) Rule, Questions Received at: Seminar on TSCA Section 8(c) Recordkeeping and Reporting Allegations of Adverse Reactions, Nov. 10, 1983, at 38, question 1 (1984) (ELR Order No. AD-487)
| Author | Carolyne R. Hathaway/William K. Rawson/Ann Claassen/Julia A. Hatcher |
| Pages | 271-286 |
Questions and Answers Concerning the TSCA §8(c) Rule Page 271
Questions and Answers Concerning
the TSCA Section 8(c) Rule,
Questions Received at: Seminar on
Toxic Substances Control Act Section
8(c) Recordkeeping and Reporting
Allegations of Adverse Reactions,
November 10, 1983
U.S. Environmental Protection Agency
Office of Toxic Substances 401 M
Street S.W. Washington, D.C. 20460
July 1984
Table Of Contents
Allega tions Subject to the Rule
Respons ibility for Recordkee ping
EPA Use o f Rep orted Informati on
Report ing Pro cedures
Report ing Und er Ot her L aws
Report ing Re quirements
Recordi ng Proc edures
Public Access to 8(c) Records
Multi-Si ted C orporation s
Defini tions
Lawsui ts an d Leg al Act ions
The Relation ship Between Section 8(c) and Sectio n 8(e )
Rules.
Oral Allega tions
Self-In itiated Investig ations.
Passback of Allega tions
Employe e/Public Awareness
November 21, 1983 Effect ive D ate
Substan ces C overed
FIFR A/FDA Covered Product s
Extrac tive I ndustry Exempti on
Researc h and Deve lopment Chemica ls
Toxicology Labor atories
Miscell aneous SIC 28/2911 Covera ge Iss ues
Known Effect s Excl usions
Allegations Subject To The Rule
1. Is it necessar y for us to keep all alle gations, or
must we verif y that the allegation mee ts the deni-
tion contained i n the rule? Who determ ines what
constitutes a si gnicant adverse reac tion? Do cus-
tomer incidents involvi ng human and environmen-
tal exposu re, even if they are unr emarkable, need to
be kept? In the ca se of a human reaction, is a doc-
tor’s report required?
Answer:
You are only required to keep those alleg ations that
have been determined to meet the de nitions, includ-
ing a signica nt adverse reaction, that are c ontained
in the rule. is det ermination is made by the person
subject to the rule. Consumer a llegations involving
human or environmental rea ctions are recordable.
Again, compan ies have the right to compare the stated
reaction to the denitions in t he rule. No doctor’s
report is required, and, i n general, no proof or evidence
is required to be included in an a llegation for it to be
recordable.
2. May severa l identical or very simila r allegations
received over a short per iod of time (i.e., a week or
two) be recorded as a si ngle allegation?
Answer:
You must record and le allegations ind ividually.
3. If allega tions are made as a result of unu sual
circumst ances, for example, misu se, spills, and acci-
dents, are the se recordable?
Answer:
In such cases, t he known eects exemptions may apply.
If the allegat ions indicate that the re action occurred as
a result of exposure from us e not in accordance with
the labeling, t hen this may be an exempt allegation.
(See 40 CFR 717.3(c)). If the environmental reaction
can be attributed di rectly to an incident of contamina-
tion already reported, t hen this may not be a record-
able allegation (See 40 CFR 717.12(d)).
4. In a situation whe re a company receives an alle -
gation nami ng a specic material or proce ss, but
there is no evidenc e that the material ca n cause
the signic ant adverse reaction, is the a llegation
recordable?
Answer:
Yes. In general, proof or evidence that a materia l can
cause a signic ant adverse reaction is not required.
5. Are alle gations which do not cite a specic sub-
stance, ma terial, process, or euent requi red to be
recorded? Somet imes plant neighbors provide very
vague and ge neral complaints, such as : the plant
fumes burn my e yes and throat; the pla nt emissions
smell terrible; I’m afr aid to drink my well water; or,
the plant odors ag gravate my sinuses, alle rgies, or
asthma . Are these types of a llegations recordable?
Answer:
Some link between t he signicant adverse reaction and
a company’s product must be made. Allegat ions must
implicate the product by namin g a specic substance,
Page 272 TSCA Deskbook
or an article or mix ture containing a substance, by
naming a proces s or operation in which substanc es are
involved, or by identifying a n euent, emission, or
other discharge f rom a site of manufacturi ng, process-
ing, or distribution of a substa nce or mixture. Several
of the above examples relati ng to plant euents could
be recordable because the y indicate the plant’s air emis-
sions and cite a reaction that impa irs normal activities.
6. Are al legations which incorrect ly identify the
cause requi red to be recorded?
Answer:
Allegations must b e recorded based upon their con-
tents. Once led, you may not remove an alleg ation
from the le as a result of f urther investigation. e
results of the subsequent investig ation (e.g., that the
company believes the cau se was incorrectly identied)
may be placed in the al legation le.
7. Are unsigned union gr ievances relating to a spe -
cic substa nce recordable?
Answer:
No. Companies are not required to le a n unsigned
written allegat ion.
8. If an employee says “t he normal chemicals don’t
bother me, but, boy the f umes from that one pro-
cess do,” is this a re cordable/reportable allegat ion?
What if he is a hea vy smoker with known respi ra-
tory impai rment?
Answer:
First, an alleg ation citing a process is potentially
recordable. e fact that t he alleger is a heav y smoker
is not relevant to whether the stated re action is
recordable.
9. If an employee of a user of a chemic al makes
an alleg ation, is the allegation subje ct to
recordkeepin g?
Answer:
Yes. is is a potentially recordable a llegation. Any
person may make an a llegation.
10. If an employee alleg ation implicates a propri-
etary m ixture made by another c ompany and the
mixtu re contains a material ma de by your com-
pany, is the alleg ation recordable?
Answer:
is is potentially a rec ordable allegation, and should
certainly b e reviewed by the receiving company as
such. Generally, an alleg ation of this type should be
sent to the manufactu rer of the mixture. Howe ver, if
the alleger speci cally implicates the mixtu re compo-
nent made by your company as the caus e of the signi-
cant adverse reaction, you should keep t he allegation.
11. When one of our employees make s a statement
allegin g a health eect durin g the course of a medi-
cal exa mination, is this an 8(c) alleg ation or is it
protected as c ondential medical in formation, or
both?
Answer:
Provided the employee statement meets all of the cr ite-
ria for a recordable allegat ion as stated in the ru le, this
type of statement is potentia lly recordable. In so far
as the condential ity of medical rec ords is concerned,
when reporting is required t he alleger’s identity will
most likely not be part of the a bstract of the allegation
that would be reported to EPA.
12. If early sig ns of a health eect (such as ele vated
protein in the ur ine) are found during a medica l
surveil lance program, must thi s be recorded as-an
allegat ion?
Answer:
Isolated medical dat a are not inherently allegations. If
a doctor were to make an al legation (i.e., a statement
or assertion) on behalf of a pat ient, such data could be
cited as the signic ant adverse reaction.
13. In cases wher e a medical eect is identi-
ed without the employee’s knowled ge, can the
employer make an a llegation on behalf of an
employee?
Answer:
Employers can make a llegations on behalf of employ-
ees. However, consciously depriving an employee of
information of a potentially rec ordable signica nt
adverse reaction could exp ose an employer to legal
liability.
14. A 75 year old retiree (30 yea rs company service)
writes a lette r to the company that he has lung c an-
cer and his doc tor says it is due so his past asbes tos
exposure as a pl ant mechanic engaged i n asbestos
insulation re moval. Is this recordable unde r section
8(c)?
Answer:
Unless the company is also the producer of the asbestos
material in question, that employer would not be the
person required to keep the allegation under section 8(c).
15. Does an alle gation of an adverse react ion
where a mixt ure of standard chemica ls is identied
require record ing under section 8(c)?
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