TSCA §8-Reporting and Recordkeeping Requirements
| Author | Carolyne R. Hathaway/William K. Rawson/Ann Claassen/Julia A. Hatcher |
| Pages | 97-113 |
Page 97
Chapter X:
TSCA §8—Reporting and
Recordkeeping Requirements
TSCA §8 provides EPA with extensive
authority to require companies to maintain
records and report information concerning
chemical substa nces.1 EPA has actively used §8 to
assist the A gency in implementing virtually all of
its TSCA programs.
Four of t he six subsections of TSCA §8 (§8(a),
(c), (d), and (e)) t rigger reporting obligations for
regulated entities.2 Under the broad informa-
tion gathering authority of TSCA §8(a), EPA has
required manufacturers and processors of chemical
substances to report data on production quantities,
environmental and health eects, worker exposure,
and disposal practices for specied chemicals.3
TSCA §8(c) and its implementing regulations obli-
gate manufacturers and processors to keep records
of allegations concerning the adverse health and
environmental eects of the chemica l substances
they manufacture, process, or d istribute.4 TSCA
§8(d) requires manufactu rers and processors to
submit unpublished hea lth and safety studies per-
taining to specied chemica l substances.5 Addi-
tionally, TSCA §8(e) requires manufacturers,
processors, or distributors to le an immediate
report to EPA whenever they obta in information
“which reasonably supports the c onclusion that [a]
1. 15 U.S.C. §2607, ELR S. TSCA §8.
2. Id. §2607(b), ELR S. TSCA §8(b). TSCA §8(b) addresses
compilation and maintenance of the TSCA Inventory; EPA
has used its §8(a) authority to require periodic reporting of
production quantities, worker exposures, and processing and
use information as part of maintaining the Inventory. Section
8(b) is discussed primarily, supra Part III. e sixth subsection,
id. §2607(f), ELR S. TSCA §8(f), denes “manufacture” and
“process,” as used in §8, to mean “manufacturing or processing
for commercial purposes.”
3. 15 U.S.C. §2607(a), ELR S. TSCA §8(a).
4. Id. §2607(c), ELR S. TSCA §8(c).
5. Id. §2607(d), ELR S. TSCA §8(d).
substance or mixture presents a substantial risk of
injury to health or the environment. . . .”6
A. Section 8(a) Reporting
on Aspects of Chemical
Manufacture and Use
1. Statutory Language
TSCA §8(a) grants EPA broad authority to require
chemical substance manufacturers and proces-
sors to maintain records and provide detailed data
about all aspects of chemical manufacture and use,
including workplace exposure data and disposal-
related data. e statutory language illustrates the
potential breadth of the §8(a) requirements.
e Admini strator may require . . . maintenance
of records and reporting with respect to the fol-
lowing insofar as known to the person making
the report or insofar a s reasonably ascertainable:
(A) e common or trade name, the chemical
identity, and t he molecular struc ture of each
chemical substance or mixture for which such a
report is required.
(B) e categories or proposed categories of use of
each such substanc e or mixture.
(C) e total amount of each such substance and
mixture manufact ured or processed, reasonable
estimates of the total amount to be manufactured
or proce ssed, the amount manufact ured or pro -
cessed for each of its categories of use, and reason-
able estimates of t he amount to be manufactured
or processed for eac h of its categories of u se or
proposed categories of use.
6. Id. §2607(e), ELR S. TSCA §8(e).
Page 98 TSCA Deskbook
(D) A description of the byproducts resulting
from the manufacture, processing, use, or dis-
posal of each such subst ance or mixture.
(E) All existing data conce rning the environ-
mental and health eects of such substance or
mixture.
(F) e number of individual s exposed, and
reasonable estimates of the number who will be
exposed, to such subst ance or mixture in their
places of employment and the duration of such
exposure.
(G) [T]he ma nner or method of . . . disposal [of
the chemical subst ance or mixture].7
EPA has implemented §8(a) reporting require-
ments through promulgation of t hree separate sets
of rules, only two of which are currently eective:
the Comprehensive Assessment Information Rule
(CAIR)8; the Preliminary Assessment Information
Rule (PAIR), codied at 40 C.F.R. Part 712, Sub-
part B; and the Inventory Update Reporting (IUR)
rule, codied at 40 C.F.R. Part 710, Subpart s B
and C . Because it is tied to the TSCA Inventory,
the IUR rule is only briey su mmarized here and
is discussed in greater detail in Part III.F. EPA pro-
posed signicant amendments to the IUR rule on
August 13, 2010, with the stated intention of pro-
mulgating a nal rule prior to the next IUR report-
ing period in 20119; therefore, the information
below may be superseded to some extent.
2. Chemicals Covered
IUR. TSCA §8(b) required EPA to “compile, keep
current, and publish a list of each chemical sub-
stance which is manufactured or processed in t he
United States.”10 EPA published the initial TSCA
7. Id. §2607(a)(2), ELR S. TSCA §8(a)(2).
8. Comprehensive Assessment Information Rule, 53 Fed. Reg.
51698 (Dec. 22, 1988). EPA removed the CAIR regulations
from the Code of Federal Regulations in 1995. Chemical Sub-
stances, Deletion of Certain Chemical Regulations, Technical
Amendments to the Code of Federal Regulations, 60 Fed. Reg.
31917, 31917-18 (June 19, 1995).
9. TSCA Inventory Update Reporting Modications; Proposed
Rule, 75 Fed. Reg. 49656 (Aug. 13, 2010). See also U.S. EPA,
F S— P R: TSCA I U
R M (2010), available at http://www.
epa.gov/oppt/iur/pubs/Fact%20Sheet_IUR%20Modication-
NPRM_08-05-10.pdf.
10. 15 U.S.C. §2607(a), ELR STAT. TSCA §8(a). Pursuant to
its rulemaking authority in §8(a), in 1977, EPA promulgated
rules requiring chemical manufacturers (including impor ters)
to provide information regarding each chemical subs tance
manufactured for commercial purposes in the United states
during 1977. Inventory Reporting Regulations, 42 Fed. Reg.
64572 (Dec. 23, 1977); Inventory Reporting Regulations,
Inventory in July 197911 and has updated it con-
tinuously as it receives NOCs of new chemical
substances. In 1986, pursuant to TSCA §8(a), EPA
promulgated regulations requiring periodic updat-
ing of the TSCA Inventory.12 All chemicals that are
on the TSCA Inventory at the commencement of
the IUR reporting period are subject to the rule,
except for polymers, microorganisms, “naturally
occurring chemical substances,” and c ertain natu-
ral gas streams.13 Petroleum streams and certain
listed chemicals are partially exempt from the IUR
reporting requirements.14
PAIR. e PAIR is a generic rule that uses a
relatively simple, two-page reporting form. EPA
periodically adds chemicals to the list of substances
subject to PAIR reporting and requires qualifying
manufacturers to complete the PAIR form for those
chemicals. is reporting obligation is a “one-time
only” event; i f a company is not manufacturing
the chemical at t he time reporting is required, it is
not required to report even if it subsequently com-
mences manufacturing that chemical. Compare
§8(d) requirements discussed later in Part X.C.
EPA links the PAIR with the biannual recom-
mendations of chemicals for priority testing under
TSCA §4 made by the Interagency Testing Com-
mittee (ITC).15 Unless otherwise instructed by
the ITC, EPA generally adds the ITC list to t he
PAIR,16 and may also separately designate chemi-
cals subject to the PAIR. In this way, the Agency
ensures that it has on hand relevant production
and use information when ma king decisions on
potential testing of chemicals under §4. Lists of all
the chemicals added to the PAIR a nd the dates on
which they were added are set forth at 40 C.F.R.
Supplemental Clarication and Notice of Meetings, 43 Fed
Reg. 9254 (Mar. 6, 1978). EPA also permitted manufacturers
and processors to report substances manufactured, processed, or
used for commercial purposes between January 1, 1975 and July
1, 1979. Availability of TSCA Initial Inventory; Beginning of
210-Day Reporting Period for Revised Inventory, 44 Fed. Reg.
28558 (May 15, 1979); see also Availability of TSCA Revised
Inventory, 45 Fed. Reg. 50544 (July 29, 1980).
11. 44 Fed. Reg. at 28558; Oce of Pesticides and Toxic Substances;
Availability of a Supplement to TSCA Chemical Substances
Initial Inventory, 44 Fed. Reg. 65180 (Nov 9, 1979); see also
45 Fed. Reg. at 50544.
12. Partial Updating of TSCA Inventory Data Base; Production and
Site Reports, 51 Fed. Reg. 21438 (June 12, 1986).
13. 40 C.F.R. §710.45, .46.
14. Id. §710.46(b). Prior to the 2006 IUR, inorganic substances
were exempt from the IUR. See id. §710.26(a). During the
2006 IUR, inorganic substances were partially exempt, but are
to have no exemption going forward. Id. §710.46(b)(3).
15. e ITC and its recommendation process are discussed in detail,
supra Part VIII.C.1.
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