[Federal Register Volume 60, Number 60 (Wednesday, March 29, 1995)]
[Rules and Regulations]
[Pages 16316-16336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7712]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 723
[OPPTS-50594B; FRL-4929-8]
RIN 2070-AC14
Premanufacture Notification Exemptions; Revisions of Exemptions
for Polymers; Final Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is promulgating amendments to the polymer exemption rule
to expand the exemption criteria and exempt manufacturers of eligible
polymers from certain section 5 premanufacture notification (PMN)
requirements. EPA has determined that the manufacture, processing,
distribution in commerce, use, and disposal of new chemical substances
meeting the revised polymer exemption criteria will not present an
unreasonable risk of injury to human health or the environment under
terms of the exemption. These final amendments reflect criteria
developed and used by EPA to assess the hazards associated with new
polymeric substances over the past 15 years the New Chemicals Program
has been in place. EPA believes that these amendments will encourage
the manufacture of safer polymers by reducing industry's reporting
burden for this category of chemical substances.
DATES: This rule will become effective May 30, 1995. In accordance with
40 CFR 23.5 (50 FR 7271), this rule shall be promulgated for purposes
of judicial review at 1 p.m. eastern time on April 12, 1995.
FOR FURTHER INFORMATION CONTACT: James B. Willis, Acting Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460, Telephone: (202) 554-1404; TDD: (202) 554-0551.
SUPPLEMENTARY INFORMATION: The polymer exemption rule was originally
promulgated on November 21, 1984. The supporting rationale and
background for that exemption was published at 49 FR 46066 on November
21, 1984 and 46 FR 54688 on November 3, 1981. On February 8, 1993, EPA
proposed amendments to the 1984 polymer exemption rule (58 FR 7679).
Consult those documents for further information on the objectives,
rationale, and procedures for the rule and the basis for the finding
that polymers eligible for exemption will not present an unreasonable
risk of injury to human health and the environment under terms of the
exemption. The docket control number for this document is OPPTS-50594B.
The amended rule allows manufacture and distribution of polymers
meeting the exemption criteria without submission of a PMN or an
exemption notice prior to commencement of manufacture for a commercial
purpose under terms of the exemption. However, manufacturers of
exempted polymers are required to submit an annual report on exempted
polymers for which manufacture or importation commenced for the first
time under terms of the exemption during the preceding calendar year.
Recordkeeping requirements are retained as part of the rule to document
compliance with the exemption criteria. Overall, these amendments
constitute a substantial revision of the existing polymer exemption
rule.
I. Background
A. Statutory Authority
Section 5(a)(1) of TSCA requires that persons notify EPA at least
90 days before they manufacture or import a new chemical substance for
commercial purposes. A ``new chemical substance'' is any substance that
is not on the Inventory of Chemical Substances compiled by EPA under
section 8(b) of TSCA. Section 5(h)(4) of TSCA authorizes EPA, upon
application and by rule, to exempt the manufacturer or importer of any
new chemical substance from part or all of the provisions of section 5
if the Agency determines that the manufacture, processing, distribution
in commerce, use, or disposal of the new chemical substance will not
present an unreasonable risk of injury to human health or the
environment. In this preamble and under the rule, references to
``manufacture'' and ``manufacturer'' include ``import'' and
``importer'', respectively, as defined in TSCA section 3 and the PMN
rule.
B. History/Rationale
In 1984, the Agency published a TSCA section 5(h)(4) rule granting
an exemption for persons who manufacture or import certain polymers,
set forth at 40 CFR 723.250. Since promulgation of the 1984 polymer
exemption rule (the ``1984 exemption''), the Agency has reviewed over
2,000 polymers submitted as polymer exemption notices in the 21-day
review process in addition to over 10,000 polymers submitted as PMNs
since the initiation of the 90-day PMN review process in 1979. In the
course of performing hazard and risk assessments for these polymers,
the Agency has developed internal guidelines for identifying polymeric
substances that do not present an unreasonable risk of injury to human
health or the environment. These guidelines are based on (1) EPA's
ongoing review of the available literature on the toxicity of polymers,
(2) EPA's analyses of various samples of the PMN polymer data base, (3)
information provided to EPA by outside groups [[Page 16317]] during and
subsequent to development of the 1984 exemption, and (4) professional
judgment of EPA staff scientists. The final rule will bring the 1984
polymer exemption criteria into close alignment with the internal
criteria currently being used by EPA to assess hazards and risks of
polymers. The eligibility criteria in the final rule, which are based
on the 1984 polymer exemption criteria, have been refined and expanded
to allow more low-risk polymers to qualify for exemption. While
expanding the category of safer polymers, the exemption continues to
exclude or restrict those polymers that the Agency believes should be
reviewed under the 90-day PMN process.
Both the Agency and the polymer industry have had 10 years of
practical experience with the polymer exemption. Since the current
exemption criteria define what the Agency considers to be low-risk
polymers, eligible polymers generally receive only a cursory Agency
review to validate that the polymer meets the eligibility criteria.
Consequently, most polymers eligible for the exemption present no
issues and manufacture can commence when the 21-day review period
expires.
Based on the Agency's review and analysis of polymer exemption
applications submitted to date, EPA has determined that an overwhelming
number of submitters correctly determined the eligibility status of the
polymer. Consequently, the Agency believes that it is no longer
necessary for EPA to expend its limited resources to validate a
polymer's eligibility under the exemption. The Agency would like to
shift the resources currently expended on analytical screening of this
class of low-risk substances to the substantive review of substances
that present unknown or potentially higher risks. Moreover, the Agency
believes that industry has become sufficiently familiar with the
criteria over the past 10 years and is capable of correctly determining
the eligibility of a polymer under the exemption. Therefore, EPA has
decided to eliminate the requirement that a company submit an exemption
application prior to the manufacture or importation of an exempted
polymer under terms of the exemption. Instead, the final rule requires
submission of an annual report on polymers for which manufacture or
importation under terms of the exemption commenced for the first time
during the preceding calendar year. However, to increase the level of
assurance that polymers manufactured under the exemption meet the
eligibility criteria, EPA has prepared a draft technical guidance
document and will hold workshops on determining eligibility of exempted
polymers for polymer manufacturers. In addition, the final rule
requires that records documenting an exempted polymer's eligibility
under terms of the exemption be maintained at the manufacturing site.
The Agency believes that expanding the 1984 exemption criteria and
eliminating routine EPA review will increase the number of polymeric
substances eligible for exemption, encourage the manufacture of safer
polymers, and result in resource savings to industry and the EPA
without decreasing or compromising the level of risk reduction/
management afforded by a 21-day or 90-day review of these same
substances.
II. Final Amendments
A. Summary of Final Amendments
1. Definition of polymer. To be considered for exemption,
substances must meet the definition of polymer in the rule. EPA is
amending the definition of ``polymer'' to adopt the exact wording of
the internationally recognized definition of polymer which was
developed at the Organization of Economic Cooperation and Development
(OECD) Expert Group Meetings on Polymers held in Toronto, Canada
(January, 1990), Paris, France (October, 1991), and Tokyo, Japan
(April, 1993) and agreed upon in May, 1993 by the OECD Member
Countries. (Copies of the OECD Chairperson's reports are available in
the docket for this rulemaking.) The definition, which is based on the
Agency's 1984 polymer definition at 40 CFR 723.250, ensures that exempt
substances have the structural characteristics common to the category
of substances on which EPA has based its no unreasonable risk finding.
Minor revisions are included in the definition in response to comments.
2. Classes of polymers ineligible for exemption. Section 723.250(d)
of the 1984 exemption established certain classes of polymers that were
ineligible for exemption. As with the 1984 exemption, polymers that are
designed or reasonably anticipated to substantially degrade, decompose,
or depolymerize will remain ineligible for exemption in this final
rule. In addition, polymers that are prepared from monomers or other
reactants that are included in the polymer identity must be existing
chemical substances on the TSCA Inventory or otherwise excluded or
manufactured under terms of another TSCA section 5 exemption. The final
rule excludes from eligibility water-absorbing polymers with molecular
weights (MW) equal to or greater than 10,000 daltons; moreover, the
term ``water-absorbing'' has been re-defined to describe more
specifically the category of polymers that the Agency believes should
remain subject to the full PMN review process. The final rule also
amends certain restrictions contained in the 1984 exemption for
cationic polymers and polymers that contain certain elements.
Restriction on polymers that contain certain reactive functional groups
have been amended and are part of the eligibility criteria for polymers
with MW equal to or greater than 1,000 and less than 10,000 daltons
(Sec. 720.250(e)(1)).
3. Polymers eligible for the exemption. Polymers with number-
average MW greater than 1,000 daltons and polyesters that are made from
a specified list of reactants remain eligible for exemption. The final
rule sets limits on oligomer content and reactive functional groups for
polymers with number-average MW equal to or greater than 1,000 and less
than 10,000 daltons. In addition, polymers with number-average MW equal
to or greater than 10,000 daltons and restricted oligomer content are
also eligible for exemption. In the 1993 proposal, the Agency requested
comment on its proposal to impose certain restrictions relating to
potential inhalation exposure of respirable water-insoluble polymer
particles, along with several alternatives for dealing with potential
lung effects associated with the inhalation of water-insoluble
particles of respirable size. Based on comments and further analysis of
the available data, the Agency has removed the restrictions on water-
insoluble polymers with MW of 10,000 daltons or greater, with the
exception of water-absorbing polymers which are ineligible for
exemption.
Polyesters remain eligible as in the current exemption; however, in
response to comments that the Agency should expand the category of
polyester polymers eligible for exemption, the final rule includes a
number of additional substances in the list of acceptable polyester
reactants.
Finally, the following classes of polymers are now eligible for
exemption: (a) polymers that contain less than 32 percent carbon; (b)
biopolymers, their synthetic equivalents, and modifications and
derivatives of biopolymers; and (c) polymers made from reactants that
contain halogen atoms or cyano groups.
4. General provisions. In the 1993 proposal, manufacturers and
importers would have been required to submit an abbreviated notice
within 30 calendar days following the first manufacture or import of an
eligible polymer rather [[Page 16318]] than 21 days prior to
manufacture (import) as required in the 1984 exemption. However, the
final rule further modifies the notification provisions and now
requires only that manufacturers of exempt polymers submit an annual
report on all exempted polymers for which manufacture or importation
under terms of the exemption commenced for the first time during the
preceding calendar year. This annual report would provide the Agency
with information concerning use of the exemption. Manufacturers are
required to maintain specific records to document a polymer's
eligibility under the exemption rule.
With the elimination of the obligation to notify EPA in advance of
manufacture of an exempted polymer, the use of EPA Form 7710-25 will
not be required. However, the final rule requires that certain
information be maintained at the site of manufacture including chemical
identity and structure, records of production volume for the first 3
years of manufacture, date of commencement of manufacture or import,
certification that the polymer meets the conditions of the exemption,
and information that demonstrates compliance with the exemption,
including analytical data or other information that substantiates the
manufacturer's claim of eligibility under criteria established for
minimum number average MW and restricted oligomer content.
EPA proposed but is not requiring that polymer identity be
described by a Chemical Abstracts (CA) Index Name or CA Preferred Name,
since manufacturers are not required to submit an exemption notice to
the Agency under the final rule. Finally, the Agency has determined,
for the reasons outlined in the discussion below, that the revocation
provisions in the 1993 proposal are not necessary for the Agency to
make its determination that this category of substances will not
present unreasonable risk to human health and the environment and has
deleted these provisions in their entirety.
B. Discussion of the Amendments and Response to Comments
The final rule adopts many of the proposed amendments without
changes. However, as indicated above, certain provisions of the
proposed amendments have been revised in light of the Agency's
consideration of comments received. A discussion of the major comments,
the Agency's responses, and the amended provisions follow:
1. Definition of polymer. Under the proposal, EPA proposed to
revise the definition of polymer in the 1984 exemption to conform with
the international definition of polymer recently adopted by OECD Member
Countries, including the United States, Canada, Japan, and the member
nations of the European Union. The revised definition retains the
meaning and purpose of the 1984 exemption definition of polymer. For
purposes of this exemption, the term ``polymer'' means ``a chemical
substance consisting of molecules characterized by the sequence of one
or more types of monomer units and comprising a simple weight majority
of molecules containing at least 3 monomer units which are covalently
bound to at least one other monomer unit or other reactant and which
consists of less than a simple weight majority of molecules of the same
molecular weight. Such molecules must be distributed over a range of
molecular weights wherein differences in the molecular weight are
primarily attributable to differences in the number of monomer units.''
The term ``monomer unit,'' which replaces the non-standard term
``internal subunit'' used in the 1984 exemption, means the reacted form
of the monomer in a polymer, i.e., the monomer must have formed at
least one covalent bond with another like or unlike molecule under the
conditions of the relevant polymer-forming reaction. The fact that a
monomer must be capable of forming two or more such bonds is not a
requirement that it do so to be considered ``the reacted form;'' one is
sufficient. Consequently, ``polymer molecules,'' defined as containing
``at least 3 monomer units which are covalently bound to at least one
other monomer unit or other reactant,'' continue to require at least 4
precursor units, as in the 1984 definition. The difference is that,
under the proposal, at least 3 of the units must be in a ``sequence,''
and further, one of the groupings could come from an ``other reactant''
as well as from a monomer. The first change (``sequence'') is slightly
more restrictive and the second (``other reactant'') slightly less
restrictive than the present definition. The net effect of the change,
made to be consistent with protocols of the OECD, is expected to be
minimal. The term ``sequence'' is defined as part of the polymer
definition in the final rule. ``Monomer'' and ``reactant'' remain
consistent with the terms used for purposes of Inventory reporting and
premanufacture notification, wherein ``reactants'' include monomers,
chain transfer and cross-linking agents, monofunctional groups that act
as modifiers, and other end groups if incorporated into the polymer
molecule.
Comment. The Society of the Plastics Industry (SPI) commented that
the new polymer definition should be clear and complete. By using
wording that strays from the OECD definition, EPA has rendered its
definition unclear and made interpretation difficult. The definition of
``polymer molecule'' that uses the term ``monomer unit'' cannot be
equated with the earlier definition that used ``internal subunit''
because a ``monomer unit'' does not have to be internal. The term
``polymer molecule'' defined at Sec. 723.250(b), requiring at least two
internal monomer units, is in conflict with the statement in the
preamble that ``at least three of the units must be internal.''
Response. The polymer definition in the proposed rule represents a
version proposed before an OECD meeting held in April 1993 in which the
participants agreed upon an interpretation of the polymer definition.
(The definition of the term ``polymer molecule'', which is responsible
for some of the confusion, was introduced to assist in defining
``polyester,'' which is not relevant to the OECD definition of
polymer.) EPA has therefore made changes in the relevant provisions of
the rule.
Comment. SPI commented that the definition of ``reactant'' is
inconsistent with the definition of ``reactive functional group'' and
is problematic because of EPA's dependence on subjective intent; it
recommends that the language ``reasonably be anticipated'' and
``reasonably ascertainable'' be used instead of depending on intent.
Response. The Agency does not believe there is an inconsistency
between the definitions, nor any particular reason why they should be
consistent, since they are describing different things and addressing
different issues. Sodium hydroxide may be a reactant, but it can hardly
be a reactive functional group. Furthermore, many chemically reactive
substances are not ``reactants'' in this context because they are not
intended (or reasonably anticipated) to become chemically part of the
polymer.
2. Polymers ineligible for exemption-- (a) Exclusion of certain
polymers that are cationic or anticipated to become cationic in aquatic
environments. The Agency continues to have ecotoxicity concerns for
cationic polymers with specific characteristics but believes that
certain restrictions in the 1984 exemption can be modified as discussed
in the 1993 proposal. No comments were received on this provision.
Accordingly, under the final rule, the [[Page 16319]] current
restriction on cationic polymers at Sec. 723.250(d)(1) is amended to
provide that certain cationic polymers will be eligible for exemption
if:
(i) The polymer is a solid material that is not soluble or
dispersible in water and will be used only in the solid phase (e.g.,
polymers that will be used as ion exchange beads), or
(ii) The combined (total) functional group equivalent weight of
cationic groups (e.g., primary, secondary and tertiary amines,
quaternary ammonium, phosphonium, and sulfonium) in the polymer is
equal to or greater than 5,000. ``Equivalent weight'' of a functional
group means the ratio of the molecular weight to the number of
occurrences of that functional group in the molecule. It is the weight
of substance that contains one formula-weight of the functional group.
In addition, the definition of ``cationic polymer'' was rephrased in
the final rule to replace the term ``subunit,'' which as discussed
previously in this unit under Definition of Polymer is considered a
non-standard term.
(b) Exclusion of polymers with certain weight content of certain
elements. The rule continues to exclude from eligibility polymers
containing certain levels of particular elements from the exemption if
the elements are present as an integral part of the polymer structure,
or present as counterions in the polymer. However, as proposed, the
Agency is expanding the list of allowable elements set forth at
Secs. 723.250(d)(2)(ii)(B) and (C) to include chlorine, bromine, and
iodine as the monatomic counterions; and fluorine, chlorine, bromine,
and iodine as covalently bound to carbon. The Agency received no
comments on this specific provision.
(c) Exclusion of polymers that degrade, decompose, or depolymerize.
The rule continues the exclusion at Sec. 723.250(d)(3) for polymers
that are designed or reasonably anticipated to substantially degrade,
decompose, or depolymerize, including those polymers that could
substantially decompose after manufacture and use, even though they are
not actually intended to do so. A description of what the Agency
considers degradation, decomposition and depolymerization for purposes
of this exemption is contained in the final rule. No specific comments
were received on this provision.
(d) Exclusion of polymers that are prepared from monomers or other
reactants that are not already on the TSCA Inventory. As proposed,
polymers that are manufactured using monomers or other reactants that
are not on the TSCA Inventory, or that are not manufactured under an
applicable section 5 exemption are not eligible for exemption at
Sec. 723.250(d)(4). Some confusion surrounded the Agency's position on
the use of non-Inventory listed monomers or other reactants at levels
of 2 percent or less, as evidenced at the public hearing on the
proposed rule held in Washington, D.C. on April 26-27, 1993 and written
comments on this proposal. EPA is making clear that this provision
relates specifically to monomers or other reactants that would be
considered part of the polymer's identity, if the same substance was
reported in a PMN, i.e., those substances charged to the reaction
vessel or incorporated in the polymer at levels greater than 2 percent.
The provision will not restrict the use of non-Inventory listed
reactants that are not considered part of the polymer identity,
provided that those reactants do not introduce into the polymer
elements, properties, or functional groups that would render the
polymer ineligible for the exemption. In other words, the ``two percent
rule'' affects only the identity of the polymer, not its eligibility.
This is consistent with the 1984 exemption. However, in practice, the
use of non-Inventory listed monomers or reactants at 2 percent or less
may be applicable only to imported polymers since chemical substances
used as feedstocks in domestic manufacture must be on the Inventory or
otherwise excluded or exempted from the section 5 requirements. In a
separate rulemaking being published concurrently with this document
[Revisions of Premanufacture Notification Regulations], EPA amended the
``Two Percent Rule'' to allow submitters greater flexibility in
determining the amount of monomer or other reactant used in the
manufacture of a polymer. Please consult that rule for further
information.
As stated in the proposal, hazard concerns for polymers are often
based on a concern for residual monomers or other reactants in the
polymer. Since residual levels of monomers or other reactants are not
restricted under the exemption and EPA is not reviewing exempt
polymers, the Agency is restricting this exemption to those polymers
manufactured using only Inventory-listed (or otherwise excluded or
manufactured under an applicable section 5 exemption) constituent
monomers or other reactants that are part of the polymer's chemical
identity. This ensures that the Agency will review polymers that
contain new chemical monomers or other reactants through the full PMN
process and can regulate any new polymer that may cause concern as a
result of residual monomers or reactants that are new chemical
substances.
Comment. The Synthetic Organic Chemical Manufacturers Association
(SOCMA), The Dow Chemical Company (Dow), Monsanto Company, and SPI
commented that imported polymers should be treated as polymers produced
in the United States. That is, if the imported polymer meets the
polymer exemption criteria but contains a non-Inventory listed monomer
or reactant (at greater than 2 percent), that polymer should be
eligible for the polymer exemption as long as the residual monomer or
reactant level is kept below 1 percent (0.1 percent if a carcinogen).
The importer may have no reason to ever bring the monomer or other
reactant into the United States, and thus no PMN would be filed on that
material. This would reduce the burden on those companies importing
polymers that meet the exemption criteria since PMNs would not have to
be filed for the monomers that these polymers contain. The residual
monomer level limit would address any potential risk to health and the
environment.
Response. Imported polymers are being treated the same under this
exclusion as polymers manufactured in the United States. As stated
above, the Agency wants to be able to assess new monomers and reactants
if present as residuals. Further, the Agency has not considered setting
a specific level for residuals nor concluded that polymers made with
presently unknown monomers (i.e., chemicals not on the Inventory or
exempted) will not present an unreasonable risk to health or the
environment.
(e) Exclusion of water-absorbing polymers with number-average MW
equal to or greater than 10,000 daltons. The final rule excludes from
the exemption water-absorbing polymers having MW of 10,000 daltons or
greater (Sec. 723.250(d)(5)). In the proposal, EPA had defined a water-
absorbing polymer as a polymeric substance that, either in whole or in
part, increases its volume when in contact with water. Numerous
comments were received by the Agency concerning this definition and the
MW restriction. Commenters argued that this restriction represented a
very narrow approach by the Agency since it was based on the TSCA
section 8(e) study, designated 8(e)-1795 and FYI-470, on a water-
absorbing polyacrylate polymer with a MW in excess of 1 million
daltons. The section 8(e) data on the toxicity of the water-absorbing
polyacrylate polymer included a 1-year chronic inhalation study, a 2-
year chronic/oncogenicity study, and a [[Page 16320]] subchronic
inhalation study. As discussed in the 1993 proposal, preliminary data
from the 2-year chronic inhalation study reported squamous cell
carcinoma and bronchio-alveolar carcinomas. The exposure concentrations
were 0.05, 0.2, and 0.8 mg/m3. Preliminary pathology reports state
that cancer was observed in the two highest concentrations. Since the
1993 proposal, the final report on the 2-year chronic inhalation study
has been received and reviewed by the Agency. The final report confirms
the preliminary conclusions that under the conditions of the study, the
water-absorbing polyacrylate polymer was carcinogenic to F344 rats,
inducing lung tumors (bronchiolar/alveolar adenomas and
adenocarcinomas) in both males and females. Statistically significant
increased incidences of lung tumors were seen in both male and female
rats exposed to 0.8 mg/m3 of the polymer. The tumor incidences in
males and female rats also showed significant trends as analyzed using
the Logistic Regression Test. At the present time published Agency
guidelines state that cancer may be a non-threshold effect, i.e., that
dose is cumulative over a lifetime (see Guidelines for Carcinogen Risk
Assessment, 51 FR 33998, September 24, 1986 and Risk Assessment
Guidelines of 1986, Document No. EPA/600/8-87/045). Consequently, EPA
has excluded such polymers from the exemption and will review them in
the full PMN process to ensure that they do not present an unreasonable
risk of injury to human health or the environment. The subject polymer
evaluated in the study has no reactive functionalities and no residuals
below 1,000 daltons, conditions which might have excluded it from this
exemption, and, if present, could have played a role in the reported
carcinogenicity. In the absence of these factors, the Agency concluded
that the water-absorbing properties of the polymer may have played a
role in the reported carcinogenicity findings. The Agency intends to
keep abreast of the scientific findings related to the inhalation
toxicity of water-absorbing high MW polymers, which for purposes of
this rule means polymers with MW equal to or greater than 10,000
daltons, and will consider modifying these conclusions as the data so
warrant.
The Agency examined more closely its own databases to determine the
MW range for water-absorbing polymers and their water-absorbing
capabilities. The polymer that was the subject of the section 8(e)
report is a so-called ``super absorbent'' material of the type used
primarily in applications such as disposable diapers and paper towels.
It is the Agency's understanding that to be applicable for these types
of uses, the polymers must absorb at least 60 - 100 times their weight
of water. The Agency also has observed that these polymers have
molecular weights (MW) in the 1 million dalton range. The Agency
recognizes that although many other high MW polymers absorb water to
some extent, they do not belong to the class identified as ``super
absorbent.'' To the Agency's knowledge, data showing adverse lung
effects which include oncogenicity do not exist on other than the
single high MW ``super absorbent'' type polymer that was the subject of
this section 8(e) study. Based on the review of this polymer, the
Agency, at this time, is still unable to establish an exact MW limit
for water-absorbing polymers likely to cause effects similar to those
reported in the section 8(e) study, but believes that it is reasonable
to set the number-average MW exclusion for water-absorbing polymers at
10,000 daltons. Based on EPA's professional judgment, the Agency
believes that a MW of 10,000 daltons is a reasonable value where
absorption is slow enough that a compound can be considered to persist
in the lung. In addition, this MW is two orders of magnitude less than
the MW of the tested polymer. The Agency believes that polymers with a
number-average MW less than 10,000 daltons, in general, can be expected
to be absorbed by the lung and therefore have different detoxification
mechanisms available to mitigate potential health hazards.
In response to comments requesting a definition of ``water
absorbing'' that more accurately bounds the category of polymers of
concern, EPA has defined a ``water-absorbing polymer'' as a polymer
that is capable of absorbing its weight of water. Although the tested
polyacrylate polymer absorbs 100 times its weight of water, the Agency
lowered the threshold for exclusion in this rule to ``absorbing its
weight of water'', a threshold which is 2 orders of magnitude less than
that of the tested polymer. The hundredfold difference in water
absorption is believed to be appropriate based in part on the limited
data, duration of the studies, effects noted, dose levels at which
effects were seen, extrapolation from animal to humans, and the
professional judgment of EPA experts.
Comment. Monsanto comments that the definition of water-absorbing
is entirely too broad. Nearly all polymers will absorb some minute
amount of water which will alter its volume if the measurements are
precise enough. A better approach might be to exclude from the
exemption polymers that will absorb more than 20 percent of their
weight of water.
Response. The Agency agrees that the definition in the proposal,
which defined a water-absorbing polymer as any polymeric substance
that, either in whole or in part, increases its volume when in contact
with water, was too broad and has narrowed the definition.
Comment. 3M states that the water-absorbing exclusion is based on a
single section 8(e) report on a polyacrylate polymer with a MW of
greater than 1 million daltons. While 3M understands the Agency's
desire to develop an excluded class with an apparent safety factor in
terms of MW, the company asks EPA to better define water-absorbing and
review industry and scientific data to restrict the exclusion to water-
absorbing polymer classes and MW ranges of true concern.
Response. As discussed above, based on the limited data received by
EPA, the Agency was unable to establish an exact MW limit but believes
it is reasonable to set the MW exclusion at 10,000 daltons.
3. Elimination of specific exclusions contained in the 1984
exemption. No comments were received on the Agency's proposal to remove
three of the exclusion criteria present in the 1984 exemption including
(a) polymers containing less than 32 percent carbon, (b) biopolymers,
and (c) polymers manufactured from reactants containing halogen atoms
or cyano groups. Therefore, these restrictions have been deleted from
the final rule as proposed. Further discussion of this issue is
contained in the proposed rule.
4. Exemption criteria. The Agency is amending the exemption
criteria for polymers with MW of 1,000 daltons or greater by
establishing two MW ranges with restricted oligomer content. Section
723.250(e)(1) sets out exemption criteria for polymers with number-
average MW equal to or greater than 1,000 and less than 10,000 daltons,
while Sec. 723.250(e)(2) sets out criteria for polymers with number-
average MW equal to or greater than 10,000 daltons. The exemption
criteria for polyester polymers manufactured using certain specified
precursors have been retained and redesignated at Sec. 723.250(e)(3).
Under the final rule, polymers eligible for exemption include the
following:
a. Polymers with number-average MW equal to or greater than 1,000
and less than 10,000 daltons. Section 723.250 (e)(1) exempts polymers
with number average MW equal to or greater than 1,000 and less than
10,000 daltons (and oligomer content less than 10 percent below MW 500
and less than 25 percent below MW 1,000) provided the polymer
[[Page 16321]] also meets the following criterion: the polymer can not
contain reactive functional groups except as specified in paragraph
(e)(1)(ii).
i. Restrictions on number average MW and oligomer content. As
discussed in the proposal, a chemical must be absorbed by an organism
in order to cause an adverse health or ecological effect, other than
direct contact effects; further, the ability of a molecule to pass
through membranes and therefore be absorbed by organisms generally
decreases with increasing MW (size).
Based on these principles, the Agency concluded that low MW species
content provides an appropriate indication of the concerns that EPA has
for polymers, namely, the content of potentially absorbable low MW
compounds. As was proposed, the final rule includes restrictions on the
percentage of low MW components directly derived from the monomers or
other reactants for Sec. 723.250(e)(1) polymers. The criterion requires
that oligomer content be less than 10 percent below MW 500 and less
than 25 percent below MW 1,000.
Under the final rule, companies are free to manufacture any
exempted polymer with any residual reactant content desired, as long as
the percentages of low MW species do not exceed the levels specified in
the exemption criteria.
Comment. SPI commented that number-average MW is a poor criterion
for determining the amount of low MW oligomers present, and that the
weight percentages of material with MW below 500 and 1,000 daltons are
a better indicator of concern.
Response. While the Agency agrees that the number-average MW is by
itself a less than perfect measure of the amount of low MW species
present, a high statistical correlation of the two values was
established by EPA in the course of preparing the criteria for the 1984
exemption, and EPA's experience since then has reinforced the
correlation. In addition, the most frequently used method for
determining the number-average MW, size-exclusion chromatography, also
yields the percentages of material in given MW ranges. It should also
be noted that because the Agency has concerns for possible lung effects
associated with certain water-absorbing polymers with MW greater than
10,000 daltons, determination of number-average MW is needed for more
than one criterion.
ii. Allowable reactive functional groups. The final rule excludes
from eligibility under the Sec. 723.250(e)(1) criterion certain
polymers that contain reactive functional groups (groups that are
intended or can reasonably be anticipated to undergo further reaction).
The final rule also amends certain restrictions in the 1984 exemption.
As discussed in the proposal, polymers that contain reactive
functional groups may be capable of reacting with tissues or other
chemical constituents of living organisms. Absorption of polymers
containing reactive functional groups is also plausible since reactive
groups can cause sufficient irritation to disrupt normal cell membrane
barriers and facilitate penetration.
There are no restrictions on polymers containing certain reactive
functional groups that generally lack reactivity in biological
settings. Under Sec. 723.250(e)(1)(ii)(A), polymers containing only the
following reactive functional groups remain eligible for the exemption
without restrictions on equivalent weight: carboxylic acid groups,
aliphatic hydroxyl groups, unconjugated olefinic groups that are
considered ``ordinary'' (i.e., not specially activated either by being
part of a larger functional group, such as a vinyl ether, or by other
activating influences, for example, strongly electron-withdrawing
sulfone group with which the olefinic groups interact), butenedioic
acid groups, and conjugated olefinic groups in naturally-occurring
fats, oils, and carboxylic acids.
Certain other functional groups are also implicitly permitted.
Obviously, carboxylic esters, ethers, amides, urethanes, and sulfones
are among them, although not listed above, because polyesters, -ethers,
-amides, -urethanes, and -sulfones are among the types of polymers
allowed under the exemption. As long as these groups have not been
modified to enhance their reactivity (for example, dinitrophenyl esters
of carboxylic acids would be considered reactive; see also the related
discussion of ``ordinary'' above), they are assumed not to be reactive.
Please consult the draft technical guidance document for further
discussion of this issue.
Further, as discussed in the proposal, EPA believes that the
following groups generally lack or have low reactivity in biological
settings and has therefore included them in Sec. 723.250(e)(1)(ii)(A):
blocked isocyanates (including ketoxime-blocked isocyanates), thiols,
unconjugated nitrile groups, and halogens (except reactive halogen-
containing groups such as benzylic or allylic halides).
iii. Allowable equivalent weights for other reactive functional
groups. In the 1984 exemption, the Agency established equivalent weight
criteria which allowed low concentrations of reactive functional groups
to be present in the polymer molecules. At that time EPA believed that
a level of less than 1 gram-formula weight of reactive functional
groups in 10,000 grams of polymer was sufficient to ensure that the
reactive functional group was substantially diluted by polymeric
material. Based on the Agency's experience in reviewing polymers since
the 1984 exemption was promulgated, EPA now believes that the reactive
functional group equivalent weight can be lowered accordingly, because
of EPA's lower level of concern. For example, data generated by
companies through the PMN program (either as section 5(e) testing or
via voluntary programs) and reviewed by EPA now indicate that epoxy
resins with epoxide equivalent weights greater than 800 are negative in
the Ames assay; and numerous so-called ``engineering'' plastics
containing substantial concentrations of anhydride functional groups
derived from maleic anhydride are essentially inert to water and other
reagents that might ordinarily react with them by virtue of the overall
insolubility and hydrophobicity of the polymer. The final rule
establishes equivalent weights of 1,000 and 5,000 daltons for specific
reactive functional groups, as discussed below.
Section 723.250(e)(1)(ii)(B) sets forth allowable equivalent
weights at 1,000 for the combined weight of certain polymer reactive
functional groups (other than those of lower concern identified in
Sec. 723.250(e)(1)(ii)(A), which are not restricted), based on the
Agency's lower level of concern for these reactive groups. These groups
will include the following: acid halides; acid anhydrides; aldehydes;
hemiacetals; methylolamides, -amines or -ureas; alkoxysilanes with
alkoxy greater than C2; allyl ethers, conjugated olefins;
cyanates; epoxides; imines; and unsubstituted positions ortho or para
to phenolic hydroxyl.
All other reactive functional groups (except those that are
unrestricted) are required at Sec. 723.250(e)(1)(ii)(C) to have a
combined equivalent weight of 5,000 daltons or greater, including
pendant acrylates and methacrylates, aziridines, carbodiimides,
halosilanes, hydrosilanes, hydrazines, isocyanates, isothiocyanates,
alpha or beta lactones, methoxy or ethoxy silanes, vinyl sulfones or
analogous compounds, and any other reactive functional group not listed
at Secs. 723.250(e)(1)(ii)(A) or (B).
EPA requested comment on the complexity of this specific provision
and was concerned that smaller businesses or those with limited
technical resources would have trouble interpreting the exemption
criteria for reactive functional groups, if the groups
[[Page 16322]] are complicated, and might choose not to use the
exemption for eligible polymers. Such persons would, of course, have
the option of using 5,000 as the equivalent weight if they are
uncertain whether a particular reactive functional group is listed
under Secs. 723.250(e)(1)(ii)(A) and (B). No adverse comments were
received on the Agency's specific approach. Therefore, the final rule
includes this provision as proposed.
EPA believes that restrictions on reactive functional groups are
not necessary for polymers with a number-average MW equal to or greater
than 10,000 because, as stated in the proposed rule, polymers of this
size are not expected to be absorbed by biological systems.
b. Polymers with number-average MW equal to 10,000 daltons or
greater. Section 723.250(e)(2) exempts polymers with number average MW
equal to 10,000 daltons or greater (and oligomer content less than 2
percent below MW 500 and less than 5 percent below MW 1,000). The
Agency established this separate category for polymers with number-
average MW equal to or greater than 10,000 daltons because high MW
polymers are not expected to be readily absorbable by any route of
exposure because of their molecular size. As stated earlier in this
unit, polymers with a number-average MW of less than 10,000 daltons, in
general, can be expected to be absorbed by the lung and therefore have
different detoxification mechanisms available to mitigate potential
health hazards.
In the 1993 proposal, EPA proposed as a condition of the exemption
that the submitter evaluate the potential for inhalation exposure to
respirable particles of water-insoluble polymers and, if warranted,
provide adequate notification and appropriate protective measures to
exposed workers. At that time, EPA had expressed concern for potential
health effects that may be caused by inhalation of respirable particles
of water-insoluble high MW polymers of 10,000 daltons or greater based
on section 8(e) data which are discussed below. In the 1984 exemption,
the Agency also discussed a similar concern for potential health risks
but in the preamble to the 1984 final polymer exemption rule, EPA
concluded that such exposure to polymer particulates was generally
limited and expected to be of low risk [49 FR 46082, November 21,
1984]. Following publication of the 1993 proposal, the Agency received
numerous adverse comments regarding EPA's proposed conditions on this
category of high MW polymers which, as a class in general, is
considered to be one of the safest categories of chemicals in commerce.
To address these comments, the Agency reviewed in detail its
experience with polymers in the New Chemicals Program and in particular
re-examined its database of polymers submitted under the 1984 polymer
exemption rule to determine what percentage of these polymers afforded
the potential for inhalation exposure. In particular, the Agency
examined 553 polymer exemption notices received since 1991 and found
that of the 18 polymers that fit the proposed exemption criteria for
water-insoluble polymers, only 1 polymer presented a possible
inhalation risk based on particle size and use considerations. The
exemption application for this polymer was converted to a PMN to allow
a full review in the 90-day PMN review process. The Agency's review did
not result in a finding that the manufacture, processing, use, or
disposal of the polymer ``may present'' an unreasonable risk to human
health and the polymer was dropped from further review. In view of the
Agency's experience over the last 3 years and its judgment that
exposure patterns will not change appreciably, the Agency has concluded
that there is an exceedingly low probability that potential exposure to
high MW water-insoluble polymers, as a class, will result in
unreasonable risk of injury to human health or the environment. In the
1993 proposal, EPA stated that it received TSCA section 8(e) data,
designated 8(e)-0668, reporting irreversible lung damage linked with
inhalation of respirable particles of water-insoluble polymers with MW
of 70,000 daltons or greater. Of these data, the central study was
contained in section 8(e)-0668. The subject chemical was a toner used
in copy machines. This submission included chronic inhalation studies
in both rats and hamsters and concluded that both species suffered
similar lung damage when respirable dusts were inhaled at levels that
also produced ``lung overloading.'' In addition, studies were performed
on clearance rates that demonstrated that impaired clearance occurred
without regard to particle concentration once overloading had taken
place. Other section 8(e) data on water-insoluble high MW polymers did
not include chronic studies, but were shorter term studies that
resulted in a similar type of lung damage. The 1993 proposal contains a
full discussion concerning these data and the issues the data raised
for the Agency.
In the 1993 proposal, EPA proposed an exposure level for respirable
polymer dust of 0.5 mg/m3 as an 8-hour time weighted average to
provide an adequate margin of safety given the Agency's interpretation
of the section 8(e) data and believed that this level was
technologically feasible. EPA assumed that most companies would be in
compliance with the Occupational and Safety and Health Administration's
(OSHA) existing Permissible Exposure Limit (PEL) for respirable
Particulates Not Otherwise Regulated (PNOR), as an 8-hour time weighted
average of 5 mg/m3 and that EPA's proposed lower limit of 0.5 mg/
m3 could be attained through additional engineering controls, work
practices, good housekeeping practices, or different respiratory
protection. While EPA is not imposing conditions on this category of
high MW polymers as part of the final rule, the Agency believes that
manufacturers and users of polymers and chemical substances, in
general, where feasible should take appropriate action to mitigate
exposure to all respirable particles. In addition, EPA has raised the
general issue of particulate inhalation exposure to the attention of
the ``ONE'' Committee, which is an intra-agency committee of OSHA,
National Institute for Occupational Safety and Health, the Mine Safety
and Health Administration, and EPA representatives, formed in 1988 as a
focal point for coordination and information exchange related to
occupational issues. When further research is conducted in the area of
particulate inhalation exposure and the data gaps are addressed (see
``Inhalation Toxicity of High Molecular Weight Polymers, Workshop
Proceedings, by Technical Resources, Inc., 1993), EPA may refine the
eligibility criteria further for the polymer exemption or may impose
new restrictions, if necessary.
Comment. The American Fiber Manufacturers Association (AFMA)
comments that it was unwarranted to impose restrictive evaluation
criteria for products based on the limited data available. AFMA stated
that since EPA has already restricted the introduction of polymers
containing chemically reactive groups and water-absorbing polymers, the
remaining polymers should not present any special hazard dependent
solely upon MW. This restriction should be eliminated.
Response. As stated previously, EPA has concluded that there is an
exceedingly low probability that potential exposure to high MW water-
insoluble polymers as a class will result in unreasonable risk of
injury to human health or the environment. Consequently, the final rule
does not impose restrictive evaluation criteria on this class of
polymers. [[Page 16323]]
Comment. AFMA commented that the 1991 EPA workshop on Inhalation
Toxicity of High MW Polymers recommended against using MW as a
predictor of inhalation toxicity, stating that the workshop concluded
that knowledge of MW alone does not provide enough information about
the material for use in predicting inhalation toxicity and that lung
toxicity seen in animals with excessive lung burdens of high MW
polymers is likely the result of a particle overload mechanism. The
Workshop did not believe there is a relationship between MW and
particle overloading that would justify use of MW for the proposed
criteria determinant.
Response. The Workshop was advisory in nature and the opinions of
the participants are not necessarily those of EPA. Nevertheless, EPA
has reconsidered its own experience with such polymers and the
available data for water-insoluble polymers and concluded that the
proposed MW criteria were unduly limited and its reliance on MW as a
restricting factor is unnecessary. Therefore, the limitation on water-
insoluble polymers has been removed.
Comment. AFMA cited a report (attached to AFMA's comments) where
polypropylene fibers were tested in subchronic inhalation studies.
Under the conditions of the study, these high MW water-insoluble
polymers are not fibrogenic, yet would be needlessly and improperly
regulated by EPA as proposed.
Response. The report cited by AFMA is a 90-day inhalation study of
polypropylene fibers, not respirable particulate dust. The toxicity of
fibers involves factors such as length and diameter which are unique to
fibers and not applicable to respirable dust. The study therefore, has
limited relevancy to the polymer exemption criteria.
Comment. AFMA states that data filed under TSCA section 8(e) HQ-
0487-0668 and section 8(e) HQ-0983-0492 S both involve polymers which
fall below the proposed 10,000 MW cut-off. Both polymers appear to be
biologically-active (acutely toxic) with reactive functional groups
associated with them, rendering each ineligible for PMN exemption
regardless of their MW. In both cases, MW would be an inappropriate
primary determinant of toxicity.
Response. EPA agrees that these polymers would not be eligible for
the exemption under the criterion which restricts reactive functional
groups. Further, these studies were not used by the Agency in assessing
concerns for high MW water-insoluable polymer.
Comment. AFMA stated that data on the pulmonary toxicity of
xerographic toner, as filed in TSCA section 8(e)HQ-0487-0668, should
not be used in determining polymer toxicity criteria. The ``toner''
tested was a mixture of materials, not a single polymer. Approximately
10 percent of this mixture is reported to be carbon black. EPA should
defend its rationale for including this mixture in the database for
water-insoluble polymers. AFMA contends it is inappropriate for EPA to
restrict use of an entire class of polymers based on extrapolation of
the results of a toxicity study on a mixture.
Response. It is EPA's understanding that the carbon black was
encased in the polymer and therefore not bioavailable. Only the polymer
was available for contact with the experimental animal. Thus EPA does
not consider the carbon black to be a factor in the toxicity described
in TSCA 8(e)HQ487-0668. As discussed previously in this unit and in the
preamble to the proposed rule, EPA did not rely solely on this
particular study but also considered other data albeit shorter term
studies. Based on EPA's experience in evaluating polymers as discussed
above, EPA has decided to proceed as described in this rulemaking.
Comment. AFMA states that the inhalation data on super-absorbent
polymers are inappropriate for use in determining exemption criteria in
the water-insoluble polymer section of the proposed rule. It appears
that TSCA section 8(e) filings reporting pulmonary toxicity [as
reported hazardous in 8(e)HQ-0382-0438 S, section, 8(e)HQ-0683-0484 S,
8(e)HZ-1291-1795, and FYI-OTS-1285- 0470] were used by EPA to propose
conditions on water-insoluble polymers as part of the exemption.
However, EPA has not provided relevant data to show that similar
pulmonary toxicity would occur in water-insoluble and water-absorbent
polymers. Accordingly, AFMA believes it inappropriate for EPA to use
toxicity data obtained from water-absorbent polymers in a manner that
affects the exemption eligibility of water-insoluble polymers. AFMA
believes that in the absence of adequate supporting data, these
polymers should be treated as nuisance particulates.
Response. EPA agrees that use of the data on super-absorbent
polymers are not appropriate for use in determining exemption criteria
for water-insoluble polymers. Further, in its proposal, EPA did not use
the data on super-absorbent polymers in determining exemption criteria
of water-insoluble polymers.
Comment. Elf Atochem commented that by setting a 0.5 mg/m3
dust concentration level (a factor of 10 less than OSHA's PEL of 5 mg/
m3), the acceptability of new polymers would be greatly reduced.
To maintain consistency between Federal agencies, EPA should raise its
workplace exposure level to be consistent with the OSHA standard. In
addition, Exxon commented that the imposition of inhalation standards
that are inconsistent not only with OSHA PEL levels but with existing
polymers creates yet another disincentive for pursuing polymer
exemptions.
Response. EPA agrees that consistency among Federal regulations
regarding workplace exposure is desirable. EPA has elected not to
establish an exposure limit for respirable particles at this time for
reasons given above. However, TSCA provides authority to ``protect
human health and the environment'' and authorizes EPA to establish
limits on worker exposure for new chemical substances where such
exposure may present an unreasonable risk of injury to human health.
EPA has removed the proposed limitations on water-insoluble polymers
for the reasons stated above. However, the Agency believes that
manufacturers and users of polymers and other chemical substances
should take appropriate actions to mitigate exposure to all respirable
particles as part of good industrial hygiene practices.
c. Polyester polymers manufactured solely from reactants listed at
Sec. 723.250(e)(3). The Agency has had sufficient experience in
reviewing polymer exemption notices for polyester polymers that are
prepared using reactants specified in the 1984 exemption rule that the
Agency does not believe such polymers present an unreasonable risk of
injury to human health or the environment. Accordingly, these polyester
polymers continue to be eligible for exemption. As discussed in the
1993 proposal, EPA is deleting footnote No. 2 in Sec. 723.250(e)(3),
which is no longer applicable, because under the final rule all
monomers and reactants used to manufacture the polymer must be on the
TSCA Inventory.
There are many polyester polymer reactants that are not included in
the 1984 polyester exemption list, and the Agency requested comments on
expanding the list of potential polyester reactants. Several companies
identified reactants for Agency review. Agency scientists, using
structure-activity relationships and their expert judgment, evaluated
the candidate reactants and identified no health or ecological concerns
for these reactants. Based on [[Page 16324]] the Agency's evaluation,
the following substances have been added to Table 1 of this regulation:
canola oil; castor oil fatty acids; dehydrated castor-oil fatty acids;
C16-18 and C18-unsatd. fatty acids; C18-unsatd. fatty
acids, dimers; oxidized linseed oil; conjugated sunflower oil fatty
acid; C16-18 and C18-unsatd. glycerides; butanedioic acid,
dimethyl ester; butanedioic acid, diethyl ester; pentanedioic acid,
dimethyl ester; pentanedioic acid, diethyl ester; hexanedioic acid,
dimethyl ester; hexanedioic acid, diethyl ester; heptanedioic acid;
heptanedioic acid, dimethyl ester; octanedioic acid; octanedioic acid,
dimethyl ester; nonanedioic acid, dimethyl ester; nonanedioic acid,
diethyl ester; decanedioic acid, dimethyl ester; undecanedioic acid;
dodecanedioic acid; diethyl terephthalate; dimethyl terephthalate;
dimethyl isophthalate; 2-methyl-1,3-propanediol; diethylene glycol.
One reactant, terephthaloyl chloride [CASRN: 100-20-9], was not
approved for inclusion in the list of reactants because the Agency does
not believe it has had sufficient experience with the reactant or ones
of this type. The Agency has decided not to include the following
substances in the list of eligible reactants for polyester because they
are not on the TSCA Inventory: heptanedioic acid, diethyl ester [CASRN:
2050-20-6]; octanedioic acid, diethyl ester [CASRN: 2050-23-9];
undecanedioic acid, dimethyl ester [CASRN: 4567-98-0]; undecanedioic
acid, diethyl ester [CASRN: 22543-29-9]; dodecane-dioic acid, dimethyl
ester [CASRN: 1731-79-9]; dodecanedioic acid, diethyl ester [CASRN:
10471-28-0].
Comment. CMA commented that the list of eligible reactants for
polyester polymers under the 1984 rule is extremely limited, that many
analogous polyols and acids on the Inventory are worthy of inclusion,
and that in practice polyesters are often made from esters rather than
acids. CMA, Arco, and Eastman proposed expanding the list to include a
number of additional substances. CMA, Arco, Dow, Quantum, and Rohm Haas
recommended that EPA develop and publish procedures for periodic
updating of the ``approved'' reactants list.
Response. The Agency agrees with the general tenor of the comments
and notes that the original ``approved'' reactants list was compiled
from suggestions submitted by manufacturers, after review by Agency
scientists. The Agency believes that it would be appropriate in the
future to propose amendments to this section to allow expansion of the
list of eligible precursors, when additional candidates have been
identified. To support requests for additional reactants, petitioners
should provide health and environmental effects information on the
candidate reactants, which must be already on the Inventory.
5. Determination of eligibility. The Agency believes that, when a
polymer is manufactured under the terms of the exemption, it is
reasonable for the manufacturer to take on a greater burden to
demonstrate eligibility than under the 1984 exemption because EPA is
eliminating its premanufacture review of these polymers. Under the 1984
exemption, the Agency did not require that submitters perform
analytical measurements of the physical and chemical properties of
polymers, but allowed manufacturers to determine compliance with the
exemption conditions on whatever basis the manufacturer deemed
appropriate. These included using past experience by correlating
observed or measured values of the properties of similar polymers to
the polymer in question, using stoichiometric relationships based on
knowledge of the starting materials and expected reactions, or using
knowledge of process and purification steps.
Under the final rule, the Agency will no longer receive and review
exemption notices prior to manufacture or import of exempted polymers
nor verify a polymer's eligibility under terms of the exemption.
Consequently, the manufacturer must take the steps necessary to ensure
that a chemical substance is eligible for exemption. Therefore, the
Agency is requiring that a manufacturer generate appropriate records
and data to demonstrate that a substance meets the eligibility criteria
set forth at Sec. 723.250(e) to ensure compliance with the exemption.
The final rule requires manufacturers of exempt substances at
Sec. 723.250(e)(1) and (e)(2) to generate appropriate analytical data,
if applicable, or theoretical calculations if it can be documented that
an analytical determination can not be made or is not necessary, to
demonstrate that the polymer meets the minimum number average MW and
corresponding restrictions on oligomer content. The Agency has not
specified a particular analytical method to demonstrate compliance with
the eligibility criteria, but allows the manufacturer to use an
appropriate method of analysis that generates the data to verify
compliance with the criteria, such as gel permeation chromatography or
vapor pressure osmometry. Performance of such analysis is required
prior to commencement of manufacture or import in accordance with the
exemption. A number of commenters stated that manufacturers were
concerned about the requirement to generate updated analyses and
documentation to demonstrate that a given polymer continues to qualify
for the exemption whenever a manufacturing process change occurs that
could possibly cause the polymer to not meet the exemption criteria.
Although the manufacturer is not required to generate updated
analytical data on the exempted polymer under the final rule, EPA
expects that if conditions, such as reaction temperature or sources for
feedstock change, manufacturers will take steps to determine the effect
of such a change so as to ensure continued compliance with the
exemption. Obviously, if a new chemical substance is generated during
subsequent manufacture, the manufacturer would be required to be in
compliance with all the section 5 provisions.
Manufacturers are expected to follow the provisions of the
exemption for research and development (R&D) activities during the
period of evaluation of eligibility of a substance under the exemption
criteria prior to actual manufacture under the exemption provisions.
Such R&D activities will be subject to the R&D procedural and
recordkeeping provisions in the PMN rule at 40 CFR 720.36 and 720.78,
respectively. To enhance compliance with the criteria, EPA is
publishing a draft technical guidance document for this rule and will
hold a series of workshops on these criteria to facilitate
understanding and compliance with this exemption.
6. Reporting requirements. The proposed rule would have required
that a notice be filed with EPA within 30 days after manufacture or
importation for commercial purposes instead of 21 days prior to
manufacture of an eligible polymer as under the current exemption. The
Agency also solicited comment on a ``no reporting'' option for this
category of substances. In light of the Agency's determination that
this class of polymeric substances will not present an unreasonable
risk of injury to human health or the environment if manufactured under
the criteria specified in this rule, and in the interests of reducing
the reporting burdens for both industry and EPA, the final rule will
require only annual reporting on polymers for which manufacture or
importation under terms of the exemption has commenced for the first
time during the preceding [[Page 16325]] calendar year. This reporting
requirement will allow EPA inspectors to determine which companies have
manufactured polymers under the exemption thereby allowing them to
ensure compliance with the provisions of this rule during site
inspections. The final rule requires that a company file a polymer
exemption report to EPA, postmarked by January 31, that includes all
chemical substances for which manufacture or importation commenced
under the terms of the exemption during the preceding year
[Sec. 723.250(f)]. Such report must include submitter identity
information including company name and address, a technical contact (a
person available in the United States) and telephone number, and the
number of eligible substances for which manufacture commenced under the
terms of the exemption during the previous calendar year.
A company may decide to report by plant site instead of submitting
a single company report which consolidates reporting on the number of
polymers manufactured for the first time under terms of the exemption;
however, reporting on the number of polymers manufactured under the
exemption should not be duplicated. EPA believes that an annual report
on the number of polymers being manufactured for the first time under
terms of the exemption will alleviate industry's reporting burden by
reducing the information submission requirements while providing EPA
with a direct mechanism for monitoring compliance. This type of
reporting will also provide a useful measure of the utility of the
polymer exemption.
7. Chemical identity information. As discussed above, an exemption
notice is no longer required under the final rule. However,
manufacturers of polymers under terms of the exemption are required to
maintain certain information at the site of manufacture, including
chemical identity and a structural diagram, to the extent known or
reasonably ascertainable, as specified at Sec. 723.250(g). The 1993
proposal, if adopted, would have required a Chemical Abstracts (CA)
Index Name or CA Preferred Name, CAS Registry number (or EPA Inventory
accession or PMN number) for each reactant used at greater than 2
percent (by weight) to manufacture the polymer, or alternatively,
incorporated at greater than 2 percent (by weight) in the polymer.
Although the Agency encourages the use of CA nomenclature, the final
rule does not require CA nomenclature since polymers manufactured under
terms of the exemption will not be placed on the TSCA Inventory. For
purposes of determining chemical identity, the manufacturer may
determine whether a reactant is used or incorporated at greater than 2
percent (by weight). However, as discussed earlier in unit II B.2(d) of
this preamble, reactants that introduce into the polymer elements,
properties, or functional groups that would render the polymer
ineligible for the exemption are not allowed. The ``two percent rule''
affects only the polymer's identity, not its eligibility under the
exemption criteria.
Under the final polymer exemption rule, the manufacturer is
required to maintain appropriate analytical data or other supporting
information to demonstrate that the exempted polymer meets the specific
number-average MW and restricted oligomer content criteria at
Sec. 723.250(e)(1) or (e)(2), as discussed under unit II.B.5 of this
preamble. The final rule allows the company to make the polymer with MW
ranges, or residual reactant concentrations, etc., as the company
desires, provided that these values fall within the exemption criteria.
8. Certification. The final rule retains provisions that require
that the manufacturer of an exempt polymer, as of the date of first
manufacture, certify that the polymer meets the definition of a
polymer, is not specifically excluded from the exemption, and meets the
conditions of the exemption [Sec. 723.250(h)(3)]. Certification
statements must be retained with the other required records at the
manufacturing or import site.
9. Recordkeeping. EPA believes that recordkeeping requirements are
an essential component of an effective exemption enforcement program
and has retained this provision in the final rule at Sec. 723.250(j),
while including some additional provisions proposed in 1993 since EPA
will no longer receive exemption notices. These additional provisions
include certification statements, chemical identity information, and
analytical data, as discussed in this unit. Documentation of
information would be used by enforcement personnel to determine
compliance with the rule. The recordkeeping requirements have been
amended to require that the manufacturer maintain certain information
at the site of manufacture or the site of import.
Comment. Some commenters suggested that the present recordkeeping
requirements for the polymer exemption would be adequate to ensure
industry compliance.
Response. Since the Agency will not conduct any premanufacturing
review of exempted polymers, EPA believes that it is important for
manufacturers to develop and maintain more detailed and comprehensive
records than are required by the current polymer exemption. EPA
believes that the recordkeeping requirements are necessary to ensure
that manufacturers are able to demonstrate compliance by documenting
that the exempted polymers meet the eligibility criteria.
10. Inspections. The Agency will continue to periodically inspect
companies to ensure compliance with TSCA section 5. Those companies
with past violations may be inspected more frequently. To determine
compliance with the polymer exemption, the EPA inspector will focus on
the information in the company's records, including the analytical data
documenting the substance's eligibility under the exemption.
11. Deletion of proposed revocation provisions. The 1993 proposal
contained provisions to allow EPA to revoke the exemption for an
exempted polymer and require a full PMN review if EPA obtains
information indicating that a particular polymer or category of
polymers may present an unreasonable risk of injury to human health or
the environment.
The Agency has determined, for the reasons outlined below, to
delete the proposed revocation provision in its entirety. When the
Agency proposed amendments to the polymer rule in 1993, development of
the revocation provisions was predicated on EPA's evaluation of the
section 8(e) data on certain high MW water-insoluble polymers
previously discussed in this unit. EPA believed it was prudent, given
its evaluation of the data at the time of the proposal, to ensure it
had a mechanism in place to identify eligible polymers which may pose
an unreasonable risk of injury to human health or the environment.
Specifically, the Agency was concerned that additional section 8(e)
data or other adverse data would be received which might compromise the
ability of the Agency to prevent unreasonable risk of injury to human
health or the environment in a timely fashion.
The Agency received numerous comments reflecting general
dissatisfaction with the proposed revocation provisions. Specifically,
the comments received by the Agency, both in writing and in conjunction
with the public hearing on the proposed rule, were as follows:
(1) The provisions do not provide recourse for the submitter and
allow insufficient time for objections to be lodged with the Agency;
[[Page 16326]]
(2) The provisions will discourage many companies from developing
new products;
(3) Specialty chemical companies in particular would not be as
willing to develop new products under the threat that they would be
banned from the marketplace;
(4) The revocation provisions of the proposal reduce the commercial
acceptability of the exemption process and business managers will
prefer the stability and certainty of clearance through submission of a
PMN, rather than risk potential business interruptions under the terms
of the proposed exemption; and
(5) The provision will threaten the utility of the entire exemption
procedure as a vehicle for reducing the number of PMNs that are filed
for substances that pose no reasonable likelihood of harm to health or
the environment.
Based on consideration of these adverse comments and in light of
the Agency's conclusion that the likelihood of eligible polymers posing
an unreasonable risk is low, the Agency has determined that these
provisions are not necessary to support the Agency's statutory finding
that polymers manufactured under terms of the exemption will not
present an unreasonable risk of injury to human health and the
environment. Should evidence be received by the Agency that casts
reasonable doubt on the appropriateness of a criterion or set of
criteria, the Agency has other regulatory options available, such as
publication of a proposed amendment to the polymer exemption rule to
either refine the criteria or impose new restrictions, similar to EPA's
treatment of water-absorbing high MW polymers in this rulemaking.
Specifically, EPA proposed an amendment to the 1984 exemption that
would exclude this category of polymers from eligibility for the
exemption based on the Agency's evaluation of certain section 8(e) data
as discussed in unit II.B.2(e) of this preamble. After publishing its
1993 proposal and providing an opportunity for public comment, the
Agency amended the 1984 exemption in this rulemaking to exclude high MW
water-absorbing polymers from eligibility. Similarly, any future
proposed revisions would also be subject to notice in the Federal
Register and comment in accordance with the Administrative Procedure
Act.
12. Inventory status of exempted polymer. Polymers that were
reviewed under the terms of the 1984 polymer exemption rule and
included on the Inventory will remain on the Inventory, with the
restrictions concerning low MW species content and maximum residual
amounts of reactants specified for each exempted polymer still in
force. Polymers manufactured under the amended exemption will not be
included on the Inventory. A number of commenters argued that exempt
polymers warrant inclusion on the TSCA Inventory, since customers rely
on Inventory listings to confirm a product's regulatory compliance.
Since the Agency will not be receiving information on the chemical
identity of the exempted polymer as part of the reporting requirement,
the Agency will not have a mechanism for including exempted polymers on
the Inventory. However, the Agency recognizes that it is essential that
manufacturers have an adequate method to assure their customers that
their products are in compliance with TSCA regulations and agrees that
an Inventory listing of the substance would simplify this process.
Under the final rule, an exempted polymer remains a new chemical
substance (although legitimately manufactured under terms of the
exemption) until a PMN has been submitted for the substance and has
completed the PMN review period, followed by manufacture for non-exempt
commercial purpose and subsequent NOC. Nonetheless, it is current
practice that manufacturers employ a variety of methods to assure
customers that a chemical substance is in compliance, particularly in
situations where the Agency does not include an exempted substance on
the Inventory, as is the case for low volume, test marketing, and R&D
substances. Since the Agency will neither be receiving notices for
exempted polymers nor providing receipt numbers (similar to the status
of R&D substances), manufacturers who use this exemption should rely on
practices similar to ones currently used for R&D substances. These
include appropriate labeling and reference to the polymer exemption
rule at 40 CFR 723.250 and this Federal Register document. A company
might also consider setting up a system for identifying exempted
polymers which relates back to the exemption and use this
identification code to identify polymers in any commercial activity or
Material Safety Data Sheet (MSDS).
The Agency believes that use of the polymer exemption provides
significant benefits to polymer manufacturers for a number of reasons
discussed in this document. Moreover, polymers manufactured under this
exemption have been identified by EPA as some of the least hazardous
substances in commerce. In light of pollution prevention and product
stewardship initiatives undertaken by the regulated community, the
Agency believes that the marketing of safer chemical substances should
enhance the commercial viability of these substances.
Comment. CMA states that customers rely on TSCA Inventory listings
to confirm a product's regulatory compliance. Elf Atochem argues that
inclusion on a separate list leaves the regulatory status of exempt
polymers rather ambiguous.
Response. As discussed above, the Agency believes that
manufacturers who use the exemption will be able to develop adequate
methods of assuring their customers that these polymers are not only in
compliance with TSCA regulations but meet the Agency's low-risk
criteria.
13. Transition period until final rule becomes effective. The
Agency will continue to accept and review polymer exemption
applications under the terms of the 1984 exemption at 40 CFR 723.250
until the effective date of this final rule. No new exemption
applications will be accepted after the effective date of this rule.
If a manufacturer who submitted a polymer exemption application
under the 1984 exemption rule but has not yet submitted a NOC wishes to
add its polymer to the Inventory, the person may submit the NOC in
accordance with 40 CFR 720.102. The exempt polymer will then be listed
on the Inventory with the applicable 1984 polymer exemption criteria
and exemption category restrictions on residual monomers/reactants and
low MW species content. The manufacturer may instead choose to
manufacture under the terms of the new exemption.
III. Response to Other Alternatives Considered
EPA requested comments and data on all aspects of the 1993
proposal, including the following specific issues discussed below:
Other Polymers Considered for Exemption
1. Polymer salts. The Agency has also considered a proposal to
exempt certain salts of polymers that are listed on the TSCA inventory
but was unable to make the determination that, as a class, all of these
polymers will not present an unreasonable risk of injury to human
health or the environment. However, EPA believes that many individual
polymer salts will be eligible for exemption under the amended
criteria. [[Page 16327]]
2. Polymers containing high cationic functional group. The Agency
considered allowing, under the exemption, polymers which contain high
percentages of amine (low amine equivalent weight) in their structures
but decided against this approach. Accordingly, polymers with high
cationic functional groups continue to be subject to the restrictions
under Sec. 723.250(d)(1) for the following reason. In the past, the
main concern for cationic polymers was for ecotoxicity, specifically,
aquatic toxicity. There has been a significant amount of data generated
by industry in response to section 5(e) consent orders or on a
voluntary basis, which after EPA review, was concluded to demonstrate
that for the category of polymers with a high amine or cationic
content, equivalent weight of 425 daltons or less, there is sufficient
mitigation of the risk, through the mechanism of dissolved-organic-
carbon (DOC), to render this polymer class of low risk for ecotoxicity
if used according to current standard practices. The Agency believes
that these data sufficiently support the conclusion that high amine
content polymers, as specified above, will not pose an unreasonable
risk of injury for aquatic toxicity.
However, as discussed in the 1993 proposal, EPA received section
8(e) data on a polymer with high cationic functional group content in
which test results demonstrated lethality in standard eye irritation
tests in rabbits. This study has resulted in high concerns for acute
lethality as demonstrated by this polymer. The polymer used in the
study met all provisions of the proposed polymer exemption and would
have qualified for exemption if the low cationic functional group
equivalent weight (high cationic content) provision was incorporated as
part of the exemption criteria. It is for this reason that EPA believes
that it would be inappropriate to include the high cationic functional
group content allowance in the final rule at this time and will
continue to restrict these polymers under the final rule.
Comment. One commenter stated that the exclusion of the polymers
with high cationic functional group content is based upon the
assumption that all high cationic charge polymers have similar
physical-chemical, steric, structural and toxicological properties and
that the concern should be more focused on the class of polymers that
cause the adverse effect.
Response. The Agency agrees that it may be more appropriate to use
the definition of the class of cationic polymers to exclude the
polymers of concern from the exemption in lieu of the broader-based
exclusion. However, this preliminary assessment is based on section
8(e) data that are claimed as CBI. (At the time of the proposal, EPA
believed that it would be able to resolve the CBI claim in a way that
would allow the public an opportunity to comment on the data.) To date,
the submitter of the 8(e) data has declined to rescind the CBI claim on
the chemical structure despite repeated requests. Nor were publicly
accessible data received during the comment period that support
narrowing the category of polymers excluded from the exemption.
Therefore, because the public has not had an opportunity to comment on
the basis for such an exemption and in order not to delay issuance of
this final rule until the CBI issues can be resolved, the Agency has
elected not to include a more narrow category in this rulemaking. The
Agency may continue discussions with the submitter of the section 8(e)
data and amend this section as appropriate in the future.
IV. Regulatory Analysis
A. Summary of Risk Assessment
1. Introduction. The Agency has determined that polymers defined by
the exemption criteria set forth in this rule are of low concern due to
their lack of reactivity and their molecular size. These criteria have
been developed based on the Agency's review of over 5,000 polymer
submissions since the original polymer exemption rule in 1984 (49 FR
46066). The Agency believes that polymers eligible for this exemption
are generally of low risk and that sufficient information exists on the
potential risks of other polymers with certain characteristics to make
them ineligible for the exemption.
2. Approach to risk analysis. The Agency based its risk analysis on
(a) the effect MW has on the overall risk a polymer poses, (b) the
specific concerns the Agency has had in the past for polymers submitted
as PMNs, (c) toxicological data available on particular polymers, (d)
an analysis of the Agency's database on over 500 polymers received in
the last 3 years under the current polymer exemption to determine the
potential for exposure to respirable particles of insoluble high MW
polymers, and (e) an analysis of the Agency's experience to date in
assessing potential risks of new polymers submitted as PMNs or
exemption applications. The 1993 proposal contains an extensive
discussion of the Agency's approach and limitations to that approach.
The proposal also details EPA's extensive evaluation of ecotoxicity
considerations for polymers. The discussion below is limited to an
analysis of the inhalation toxicity concerns associated with exposure
to respirable polymeric particles.
3. Inhalation toxicity. As discussed in the 1993 proposal, health
concerns exist for certain types of polymers that have been found to
produce lung toxicity if inhaled. Based on section 8(e) data on a
water-absorbing polyacrylate polymer with a MW in excess of 1 million
daltons that indicated a potential oncogenic (cancer) concern for this
type of high MW water-absorbing polymer, the Agency has excluded water-
absorbing polymers of MW equal to or greater than 10,000 daltons from
the exemption. Other section 8(e) data on high MW water-insoluble
polymers were indicative of a lung-overload phenomenon and did not
demonstrate any carcingenic response under conditions of the studies.
Please consult units II.B.4(b) and IV.C of this preamble and the
preamble to the proposed rule for a full discussion of this issue.
The final rule does not impose a condition in the exemption on high
MW water-insoluble polymers linked to the evaluation of the potential
for inhalation exposure to respirable particles as was contemplated in
the 1993 proposal. Based on numerous comments received on these
proposed limitations on high MW water-insoluble polymers, the Agency
reevaluated the existing scientific data and its own experience in
reviewing the potential for inhalation exposure to such polymers
submitted under the current polymer exemption. Based on these analyses,
EPA has determined that there is an exceedingly low probability that
potential inhalation exposure to high MW water-insoluble polymers, as a
class, will result in unreasonable risk of injury to human health or
the environment. This conclusion reaffirms EPA's finding at the time of
promulgation of the 1984 exemption that exposure to polymer
particulates was generally limited and expected to be of low risk.
Based on over 15 years experience with polymers, EPA considers that
the criteria set forth in this exemption define polymers of low-concern
and that the potential risk from respirable particles of high MW water-
insoluble polymers is low. Therefore, the Agency has not retained in
this rulemaking the requirement that companies evaluate the potential
for inhalation exposure to respirable particles for this specific
category. However, EPA believes that as part of responsible health and
safety and product stewardship programs in general, manufacturers and
their customers should be aware of the [[Page 16328]] potential for
toxicity from any respirable particle and when producing or using such
materials take measures to keep their workplace free of respirable
dusts of any type.
B. Summary of Regulatory Impact Analysis
EPA has evaluated the potential costs of the final amendments for
potential manufacturers of exempt polymers. The Agency's complete
economic analysis is available in the public record for this rule
(OPPTS-50594B).
The regulatory impact analysis estimates the costs and benefits
attributable to the final regulation. In this case, the analysis also
contains estimates for the three additional final amendments to section
5 regulations that are published elsewhere in this Federal Register.
These rules amend the PMN regulations, the Low Volume Exemption Rule,
and the Expedited Process for Issuing Significant New Use Rules.
Because these final regulations are amendments to current regulations,
the costs and benefits are incremental and estimate the effect of the
final rule with respect to the current regulations.
The costs and benefits associated with the polymer exemption
amendments are partially quantified; many of the benefits are
unquantified but are expected to be of significant importance as
discussed later in this unit. Considering only the quantified costs and
benefits, there is a cost saving. Since the number of section 5
submissions received by the Agency varies, this analysis used three
scenarios, assuming either 1,000, 2,000, or 3,000 annual submissions,
to reflect the expected range of submissions. The savings as compared
to the current regulation are estimated to be:
------------------------------------------------------------------------
Annual Cost Savings ($ Million)
Annual Number of ------------------------------------------------
Submissions Industry Government
------------------------------------------------------------------------
1,000.................. 4.7 - 6.8 0.2 - 0.4
2,000.................. 9.4 - 13.5 0.4 - 0.8
3,000.................. 14.2 - 20.3 0.6 - 1.2
------------------------------------------------------------------------
The industry costs associated with these amendments are labor
requirements for preparation of an annual report and recordkeeping
costs. Reporting and delay costs are eliminated due to the elimination
of submission requirements. The user fee is no longer applicable since
exemption notices will not be required. Moreover, the amendment makes a
larger number of polymers eligible for the exemption, further reducing
the reporting and delay costs for those substances.
The unquantified benefits include increased flexibility for
industry due to the expanded exemption criteria. In addition, Agency
resources will be focused on those substances more likely to pose an
unreasonable risk.
C. EPA's Approach to Making the No Unreasonable Risk Finding
1. Statutory background. Pursuant to section 5(h)(4) of TSCA, EPA
is authorized to exempt the manufacturer of any new chemical substance
from all or part of the requirements of section 5 if EPA determines
that the manufacture, processing, distribution in commerce, use, or
disposal of the substance, or any combination of such activities, will
not present an unreasonable risk of injury to human health or the
environment. Section 26(c) of TSCA provides that any action authorized
under TSCA for an individual chemical may be taken for a category of
such substances.
While TSCA does not contain a definition of ``unreasonable risk,''
the legislative history indicates that the determination of
unreasonable risk requires a balancing of the considerations of both
the severity and the probability that harm will occur against the
effect of the final regulatory action on the availability to society of
the benefits of the chemical substance [House Report 1341, 94th Cong.,
2nd Session, 14 (1976)]. This analysis can include an estimate of
factors such as market potential, the effect of the regulation on
promoting or hindering the economic appeal of a substance,
environmental effects, and many other factors which are difficult to
define and quantify precisely. EPA may rely not only on data available
to it, but also on its professional judgment. Congress recognized that
the implementation of the unreasonable risk standard ``will vary on the
specific regulatory authority which the Administrator seeks to
exercise'' [Ibid.]
2. EPA's approach. In determining whether the category of polymeric
substances being considered for exemption presents an unreasonable risk
of injury to human health or the environment, the Agency considers more
than just the inherent risks presented by the overall category of
polymers. The Agency also considers how the criteria of the exemption
maintain full regulatory oversight on higher risk polymers while
promoting the manufacture of low-risk polymers by providing regulatory
relief for them.
The amended polymer exemption modifies the requirements for
eligible polymers from the current polymer exemption requirements and
the general PMN requirements. EPA therefore compares the risks posed by
the substances being considered for an amended exemption with the risks
which would have resulted from the same category of substances, if that
category of substances had been subject to full notice submission
requirements and 90-day EPA review or, where applicable, the reporting
requirements of the current polymer exemption and the abbreviated 21-
day review. Certainly it is not possible to eliminate all risks
associated with the manufacture, processing, distribution in commerce,
use, and disposal of any new chemical substance nor was this Congress'
intent. The standard embodied by a section 5(h)(4) exemption does not
require the Agency to ensure absolute safety from the activities
associated with an exempted substance.
3. Application of no unreasonable risk factors. The following is an
explanation of the factors and their analysis relevant to the no
unreasonable risk finding. The design of the final polymer exemption
together with intrinsic properties of polymers significantly limit the
risks of injury to human health or the environment that exempt polymers
may present. Polymers as a general class are relatively unreactive and,
at or above a MW of 10,000, are not easily absorbed by body tissue
because they do not easily transport across human membranes. As
originally discussed in the Agency's 1984 polymer exemption rule:
...for a chemical to elicit a toxic response within an organism,
it must come into direct contact with the biological cells from
which it elicits the response. Because all organisms are encased in
protective membranes, a chemical must usually penetrate these
membranes and be translocated to various parts of the organism to
gain access to target sites. Therefore, it can be reasoned that if a
chemical cannot penetrate the protective membranes to gain access to
a target site, it usually cannot elicit a response in the organism
no matter what inherent potential it may have to do so. It can be
further reasoned that if a chemical cannot elicit a response, it
will generally not present a risk. [49 FR 46081 (November 21, 1984].
EPA's conclusions regarding low risk potential for polymers that
meet the eligibility criteria are supported by the available data as
well as EPA's scientific professional judgment based on 15 years
experience reviewing polymers under the PMN and current polymer
exemption requirements. Pursuant to the final rule, certain polymers
will be automatically ineligible for the polymer exemption. EPA has
excluded those polymers for which: (a) The Agency still has
insufficient data and review [[Page 16329]] experience to find that
they will not present an unreasonable risk of injury, or (b) the Agency
has found that, under certain conditions, based on data on the polymers
in question, a polymer, or subset of polymers, may present an
unreasonable risk, thereby requiring a closer examination of the
conditions of manufacturing, processing, distribution in commerce, use,
and disposal during a full 90-day PMN review. This level of analysis
would be necessary to make an appropriate determination about risk.
In 1982, when the Risk Analysis and Evaluation of PMN Regulatory
Decisions for Polymers was performed for the original polymer rule, the
Agency determined that high MW polymers containing small amounts of low
MW species were not considered an unreasonable risk to humans or the
environment. Extensive discussion on this topic can be found in the
1982 proposed polymer exemption rule and the preamble to the final rule
promulgated in 1984. The Agency has assumed that monomers would be of
greater concern than oligomers, and that oligomers would be of greater
concern than polymers based on the probability that the monomer would
be more readily absorbed and, on a weight basis, be more reactive than
the resulting oligomer or polymer. In its 1982 proposal, the Agency
proposed to allow polymers with MW greater than 20,000 daltons to be
manufactured without any premanufacture review by EPA but determined in
the final rule that an abbreviated review period was necessary due to
concerns for unreacted monomers and low MW species. The Agency is now
modifying this approach, based on the review and hazard assessment of
polymers reviewed as PMNs or polymer exemptions since the 1984 polymer
exemption was promulgated. The Agency now believes that it has
sufficient experience with high MW polymers such that a ``no
unreasonable risk'' finding may be made for a broader class of these
substances without EPA premanufacture review.
Over the past 15 years, the Agency has reviewed over 10,000
polymers in the New Chemicals Program (over approximately 50 percent of
all PMNs are polymers). Of these 10,000, the polymers that would have
qualified for the final polymer exemption rule have consistently been
characterized as posing low concern for both adverse health and
environmental risks by the Agency during the course of PMN review. The
characteristics of a significant number of polymers (i.e., their MW
and/or physical/chemical properties), are such that they are neither
absorbed by biological systems nor do they interact with biological
systems, as described above. (A more detailed discussion is provided in
the preambles to the 1984 polymer exemption and the 1993 proposal.)
Furthermore, these polymers do not degrade to toxic species in the
environment.
The Agency has developed specific criteria which define low-risk
polymeric substances. Such criteria include limitations on low MW
species, reactive functional groups, and cationic polymers. Many of
these criteria are outgrowths of the criteria used to determine
eligibility under the current polymer exemption that has been in effect
since 1984. Further, the Agency uses these same criteria to identify
low-risk polymers in its PMN review process. The 1984 polymer
exemption, which uses the same types of criteria as these final
exemption criteria to determine eligibility, required a 21-day
premanufacture review period. The Agency believes that this review
period for polymers that meet the final exemption criteria is
unnecessary based on EPA's finding that these exemption criteria place
sufficient constraints on risk, such that EPA review of these eligible
polymers would not result in any additional protection. Accordingly,
exempting polymers that meet the low-risk eligibility criteria will
allow the Agency to refocus its limited resources on those non-exempt
substances which, by comparison, may pose a considerable risk to
society.
In its 1993 proposal, the Agency expressed concern for potential
lung toxicity due to inhalation of respirable high MW polymers.
Toxicity studies, in the form of section 8(e) submissions on a water-
absorbing high MW polymer and certain water-insoluble high MW polymers,
indicated two areas of potential concern with high MW polymers.
The data set on the water-absorbing polymer, which is discussed in
detail in unit II.B.2(e) of this preamble, included a 2-year chronic
inhalation study reporting squamous cell carcinoma and bronchio-
alveolar carcinomas at concentrations of 0.2 mg/m3 and 0.8 mg/
m3 for the tested polymer, which was a water-absorbing
polyacrylate polymer having a MW of greater than 1 million daltons. The
tested polymer lacked both reactive functionalities and low MW species
(below a MW of 1,000 daltons), factors that could have played a role in
the reported carcinogenicity. In the absence of these factors, the
Agency concluded that the water-absorbing properties of the polymer may
have played a role in the reported carcinogenicity findings. Although
the Agency was unable to establish a link between MW and toxicity for
water-absorbing polymers, the Agency set the number average MW
exclusion at 10,000 daltons which the Agency believes is a reasonable
value at which absorption is a sufficiently slow process that a
substance can persist in the lung. This MW level is also two orders of
magnitude below that of the tested polymer. At 10,000 daltons and
greater, these water-absorbing polymers are not likely to be absorbed,
so mechanisms for detoxification which are available for lower MW
polymers may not be available. Thus the respirable particles are
expected to remain in the lung for extended periods. As stated earlier
in unit II of this preamble, EPA believes that polymers with MW less
than 10,000 daltons can be expected to be absorbed by the lung and
therefore have different detoxification mechanisms available to
mitigate potential health hazards. Based on these findings, the Agency
has determined that exposure to respirable fractions of these polymers
might present an unreasonable risk to human health and has excluded
water-absorbing polymers with MW of 10,000 daltons or greater from the
exemption eligibility.
Moreover, in response to comments requesting a definition of
``water-absorbing'' that more accurately defines this parameter for
polymers of concern and based on further evaluation of the 2-year
inhalation study on the polyacrylate polymer, the final rule defines a
``water-absorbing polymer'' as a polymer capable of absorbing its
weight of water. Although the subject polyacrylate polymer absorbs
approximately 100 times its weight of water, the Agency lowered the
threshold for exclusion in this rule to absorbing its weight of water
by using a hundredfold factor. This definition more accurately bounds
the category of polymers that the Agency believes should be subject to
the full PMN review process, pending the development of data that would
mitigate the Agency's concern. These two limitations allow the Agency
to conclude that the non-excluded water-absorbing polymers will not
present an unreasonable risk of injury to human health. Accordingly,
the final rule defines the term ``water-absorbing'' and excludes such
polymers with MW of 10,000 or greater from the exemption.
The section 8(e) data on high MW water-insoluble polymers, which
are discussed in detail in the 1993 proposal, indicated that inhalation
of respirable particles of certain high MW water-insoluble polymers
resulted in irreversible lung damage (fibrosis) but, under the
conditions of the study, no [[Page 16330]] carcinogenic response to
experimental animals. Numerous comments received on this issue
questioned the Agency's use of a limited set of data to impose
restrictions on an entire class of water-insoluble high MW polymers
that are generally recognized as polymers of low-concern. In the
proposed rule, the Agency itself recognized that imposing conditions
under the exemption on high MW water-insoluble polymers may not have
been appropriate and had requested comments on the alternative of
imposing no limitations on the exemption eligibility of this category
of polymers. In light of this and in response to numerous comments, the
Agency re-examined its proposal to impose conditions on this category
of high MW water-insoluble polymers. Please consult unit II.B of this
preamble for an extensive discussion of this issue.
Based on its evaluation of 553 polymers that were the subject of
polymer exemption applications during the past 3 years, as previously
discussed in unit II.B.4(b) of this preamble, EPA concluded that there
is an exceedingly low probability that potential exposure to high MW
water-insoluble polymers, as a class, would result in an unreasonable
risk of injury to human health or the environment. EPA reached a
similar conclusion during promulgation of the 1984 exemption that
exposure to polymer particulates was generally limited and expected to
be of low risk. In its 1984 rule, EPA had recognized that particulate
inhalation exposure was a potential source of toxicity which was not
explained by MW, stating then that the review experience developed in
the PMN program had demonstrated that exposure to polymer particulates
was generally limited and therefore expected to be of low concern. 49
FR 46082 (November 21, 1984).
Further, EPA reviewed the section 8(e) data that were the basis of
the Agency's concern regarding potential inhalation toxicity of high MW
water-insoluble polymers. The studies on a toner for copy machines that
was a water-insoluble polymer with a MW of 70,000 daltons included
chronic inhalation studies in both rats and hamsters. These studies
indicated that both species suffered similar lung damage when
respirable dusts were inhaled at levels that also produced lung
overloading. Other studies were performed on clearance rates that
demonstrated that impaired clearance occurred without regard to
particle concentration in the air once overloading had taken place.
Other section 8(e) data on water-insoluble high MW polymers did not
include chronic studies, but were shorter term studies that resulted in
lung damage consistent with the damage seen when ``lung overloading''
occurred on a chronic basis.
Based on the above mentioned limited data and uncertainty as to all
the factors contributing to the identified effects, the Agency
determined that it could not draw any broad scientific conclusions in
which lung toxicity is linked affirmatively with any specific chemical
class or category of high MW water-insoluble polymers. In addition, it
should be recognized that the chronic toxicity endpoint being
addresssed for water-insoluble polymers was only seen under conditions
of lung overload (which suggests the presence of a threshold for this
type of toxicity). In the case of the water-absorbing polymers, which
exhibit a cancer endpoint, the exemption criteria reflect the more
conservative approach which the Agency has historically adopted for
oncogenicity concerns. Further, it is clear from the Agency's
experience in assessing high MW water-insoluble polymers that members
of this class of polymers have rarely been subject to control action as
a result of PMN review.
In the present rulemaking, based on numerous comments on this issue
and the Agency's finding that exposure to respirable particles of high
MW water-insoluble particles is expected to be limited, the Agency has
concluded that it can make its statutory finding that polymers meeting
the eligibility criteria will not present an unreasonable risk of
injury to human health or the environment. The Agency believes that the
criteria set forth in this exemption are sufficient to mitigate risk,
particularly when compared to the benefits, in toto, of encouraging
further development of comparatively lower risk classes of chemicals,
such as polymers. Furthermore, the expedited manufacture of eligible
new polymers will provide essential benefits to industry and to the
public, which comprise an important element in the finding of no
unreasonable risk.
4. Benefits. The following discussion describes the benefits of
this rule in a qualitative manner; for a more quantitative approach,
see the economic analysis discussion in unit V.B of this preamble. It
is reasonable to assume that a newly developed polymer will either
possess a new function or serve an existing function more efficiently
or less expensively. The reduction in delay for that polymer to be
introduced into commerce is a benefit to both manufacturers and the
general public, who will have access to the substance in a more timely
manner.
The benefits analyzed encompass more than the costs associated with
submitting the polymer for review in a full PMN. Rather, EPA's benefit
analysis included a consideration of the broader benefits of reduction
of costs to society by providing a less burdensome alternative for
polymer manufacturers, including a reduction in the burden associated
with both full PMN and current polymer exemption requirements. EPA's
unreasonable risk determination is based on broader benefits to society
as well as those benefits attributable to the substance itself.
Some of the costs directly attributable to the substance include
the preparation of the PMN or polymer exemption form as well as the
delay in the commercial market introduction of the new chemical
substance. On the other hand, there are broad societal benefits that
can not be directly attributed to any one chemical substance or
category of substances. Such benefits include a reduction in Agency
review resources being dedicated to a category of compounds determined
to be of low risk, and a concomitant shift in those resources to the
review of substances of greater known concern. While factors such as
these are generally not of the type that EPA would take into account
when making an individual control decision on a new chemical substance,
they have a significant effect on society which is directly linked to
EPA's exercise of its exemption authority, and are therefore
appropriately considered in a section 5(h)(4) unreasonable risk finding
for a category of substances. The costs of reporting requirements will
also be eliminated since companies will be able to manufacture polymers
under terms of the exemption without submitting PMNs or exemption
notices. These savings are detailed in the Regulatory Impact Analysis
report which is available in the public docket for this rulemaking
(docket control number OPPTS-50594B).
Manufacturers of polymers for which there is little concern bear a
significant regulatory burden. By incorporating into the exemption
those criteria that the EPA uses internally to judge the risks posed by
polymers, the Agency removes the regulatory impediments to the design,
manufacture, and commercialization of this large class of chemical
substances and substantially reduces costs associated with industry's
reporting burden for polymers meeting these low-risk criteria.
In addition, if the exemption is used to its greatest advantage,
more than 31 [[Page 16331]] percent of the resources allocated to the
PMN program by EPA could be shifted from this category of low concern
to those chemicals considered to pose a considerably greater risk to
society. Finally, manufacturers of these polymeric substances will be
given greater flexibility provided they meet the terms of the criteria
of the exemption.
One of the benefits of the rule is that it incorporates exactly
those criteria that delineate the areas of concern to EPA. By including
this level of specificity in the rule, EPA provides industry with an
understanding of which specific chemicals and chemical properties
within the general class of polymers are considered to be hazards and
which are considered relatively innocuous. Industry can use this
information to design future polymeric products or classes of polymers
that can supply the function that is desired while minimizing or
eliminating any hazard. Supplying this information as criteria in the
rule allows industry to engage in up-front risk-reduction activities by
designing new products that conform with the provisions of the polymer
exemption while reducing regulatory compliance costs.
Further, this rule provides pollution prevention benefits as well
in three areas: the functional group equivalent weight specifications,
the acceptable monomers list, and the water absorbability criteria.
Pollution prevention principles have the goal of reducing or
eliminating the use or generation of hazardous feedstocks, by-products,
or products. By adherence to the lists of feedstocks and reactants of
low concern contained in this rule, companies will be able to
accomplish these pollution prevention goals while minimizing their
regulatory compliance costs.
In view of the extensive and continually increasing use of polymers
in commerce, encouraging industry to expand the use of low risk
polymers can result in significant benefits to society. In general,
such low risk polymers can, and often do, function as replacements for
heavy metals, many of which can cause detrimental human health effects
to multiple organ systems as well as permanently contaminating the
ecosystem with subsequent damage to the flora and fauna. The benefits
of encouraging the development of new chemical substances of low
concern in place of those existing substances with known hazards touch
on all aspects of human activity and the environment including less
hazardous work place environments, safer products available for the
consumer, and materials that will not decompose to toxic products in
the disposal sites.
5. Risk/benefit balance. Determining the presence or absence of an
unreasonable risk requires balancing of the benefits and risks posed by
a regulatory action. EPA has determined that the risks are low based on
the inherent properties of this class of substances and the additional
safeguards provided by the risk-based ineligibility provisions.
EPA believes that the benefits of this action are quite
significant. Promoting the development of this category of polymeric
substances by reducing the regulatory burden in both reporting
requirements and in eliminating the delay of these products into
commerce will have discernible benefits to society. The added benefit
of concentrating limited EPA resources on regulation of substances
which have a greater potential to present significant risks, rather
than a category such as polymers, which have a minimal potential for
significant risk, is difficult to quantify, but is considered
substantial nonetheless.
Given the above analysis, EPA concludes that the polymers covered
by the scope of this final rule will not present an unreasonable risk
of injury to human health or the environment when manufactured under
the conditions of this exemption.
V. Rulemaking Record
EPA has established a record for this rulemaking (docket control
number OPPTS-50594B). The record includes basic information considered
by the Agency in developing this final rule. A public version of the
record without any confidential business information is available in
the TSCA Nonconfidential Information Center (also known as the TSCA
Public Docket Office) from 12 noon to 4 p.m., Monday through Friday,
except legal holidays. The TSCA Nonconfidential Information Center is
located at EPA Headquarters in Rm. NE-B307, 401 M St., SW., Washington,
DC.
VI. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51835, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the Order defines a ``significant regulatory action'' as an action that
is likely to (1) have an annual effect on the economy of $100 million
or more, or adversely and materially affect a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as ``economically significant'') (2) create serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially alter the budgetary impacts of
entitlement, grants, user fees, or load programs or the rights and
obligations of recipients thereof; or (4) raise novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in this Executive Order.
Pursuant to the terms of this Executive Order, it has been
determined that this rule is not a ``significant regulatory action''
under section 3(f) of the Order. This action is therefore not subject
to OMB review.
B. Regulatory Flexibility Act
Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.),
the Agency has determined that this regulatory action will not impose
any adverse economic impacts on small entities. EPA believes that, even
if all of the polymer exemption notice submitters were small firms, the
number of small businesses affected by this action will not be
substantial. In addition, since this action will generally reduce the
existing burden and cost imposed on PMN submitters, the impact of this
action on small entities should be an overall positive one.
C. Paperwork Reduction Act
The information collection requirements in this rule have been
approved under the provisions of the Paperwork Reduction Act, 44 U.S.C.
3502 et. seq. and have been assigned OMB control number 2070-0012. The
public reporting burden for this exemption has been eliminated. The
public reporting burden for a PMN submission is estimated to vary from
95 to 110 hours; the burden for the 1984 polymer exemption is estimated
to vary from 29.5 to 40 hours.
List of Subjects in 40 CFR Part 723
Chemicals, Environmental protection, Hazardous materials,
Premanufacture notification, Reporting and recordkeeping requirements.
Dated: March 21, 1995.
Carol M. Browner,
Administrator.
Therefore, 40 CFR chapter I, subchapter R, part 723 is amended as
follows: [[Page 16332]]
PART 723--[AMENDED]
1. The authority citation for part 723 continues to read as
follows:
Authority: 15 U.S.C. 2604
2. By revising Sec. 723.250 to read as follows:
Sec. 723.250 Polymers.
(a) Purpose and scope. (1) This section grants an exemption from
certain of the premanufacture notice requirements of section 5(a)(1)(A)
of the Toxic Substances Control Act (15 U.S.C. 2604(a)(1)(A)) for the
manufacture of certain polymers.
(2) To manufacture a new chemical substance under the terms of this
section, a manufacturer must:
(i) Determine that the substance meets the definition of polymer in
paragraph (b) of this section.
(ii) Determine that the substance is not specifically excluded by
paragraph (d) of this section.
(iii) Ensure that the substance meets the exemption criteria of
paragraph (e) of this section.
(iv) Submit a report as required under paragraph (f) of this
section.
(v) Comply with the recordkeeping requirements of paragraph (j) of
this section.
(b) Definitions. In addition to the definitions under section 3 of
the Act, 15 U.S.C. 2602, the following definitions apply to this part.
Act means the Toxic Substances Control Act (15 U.S.C. 2601 et
seq.).
Biopolymer means a polymer directly produced by living or once-
living cells or cellular components.
Category of chemical substances has the same meaning as in section
26(c)(2) of the Act (15 U.S.C. 2625).
Cationic polymer means a polymer that contains a net positively
charged atom(s) or associated groups of atoms covalently linked to its
polymer molecule.
Chemical substance, Director, EPA, importer, impurity, Inventory,
known to or reasonably ascertainable, manufacture, manufacturer,
mixture, new chemical, person, possession or control, process and test
data have the same meanings as in Sec. 720.3 of this chapter.
Equivalent weight of a functional group means the ratio of the
molecular weight to the number of occurrences of that functional group
in the molecule. It is the weight of substance that contains one
formula-weight of the functional group.
Internal monomer unit means a monomer unit that is covalently
bonded to at least two other molecules. Internal monomer units of
polymer molecules are chemically derived from monomer molecules that
have formed covalent bonds between two or more other monomer molecules
or other reactants.
Monomer means a chemical substance that is capable of forming
covalent bonds with two or more like or unlike molecules under the
conditions of the relevant polymer-forming reaction used for the
particular process.
Monomer Unit means the reacted form of the monomer in a polymer.
Number-average molecular weight means the arithmetic average (mean)
of the molecular weight of all molecules in a polymer.
Oligomer means a polymer molecule consisting of only a few monomer
units (dimer, trimer, tetramer)
Other reactant means a molecule linked to one or more sequences of
monomer units but which, under the relevant reaction conditions used
for the particular process, cannot become a repeating unit in the
polymer structure.
Polyester means a chemical substance that meets the definition of
polymer and whose polymer molecules contain at least two carboxylic
acid ester linkages, at least one of which links internal monomer units
together.
Polymer means a chemical substance consisting of molecules
characterized by the sequence of one or more types of monomer units and
comprising a simple weight majority of molecules containing at least 3
monomer units which are covalently bound to at least one other monomer
unit or other reactant and which consists of less than a simple weight
majority of molecules of the same molecular weight. Such molecules must
be distributed over a range of molecular weights wherein differences in
the molecular weight are primarily attributable to differences in the
number of monomer units. In the context of this definition, sequence
means that the monomer units under consideration are covalently bound
to one another and form a continuous string within the molecule,
uninterrupted by units other than monomer units.
Polymer molecule means a molecule which contains a sequence of at
least 3 monomer units which are covalently bound to at least one other
monomer unit or other reactant.
Reactant means a chemical substance that is used intentionally in
the manufacture of a polymer to become chemically a part of the polymer
composition.
Reactive functional group means an atom or associated group of
atoms in a chemical substance that is intended or can reasonably be
anticipated to undergo further chemical reaction.
Reasonably anticipated means that a knowledgeable person would
expect a given physical or chemical composition or characteristic to
occur based on such factors as the nature of the precursors used to
manufacture the polymer, the type of reaction, the type of
manufacturing process, the products produced in polymerization, the
intended uses of the substance, or associated use conditions.
(c) Applicability. This section applies to manufacturers of new
chemical substances that otherwise must submit a premanufacture notice
to EPA under Sec. 720.22 of this chapter. New substances are eligible
for exemption under this section if they meet the definition of
``polymer'' in paragraph (b) of this section, and the criteria in
paragraph (e) of this section, and if they are not excluded from the
exemption under paragraph (d) of this section.
(d) Polymers that cannot be manufactured under this section-- (1)
Cationic polymers. A polymer cannot be manufactured under this section
if the polymer is a cationic polymer as defined under paragraph (b) of
this section or if the polymer is reasonably anticipated to become a
cationic polymer in a natural aquatic environment (e.g., rivers, lakes)
unless:
(i) The polymer is a solid material that is not soluble or
dispersible in water and will be used only in the solid phase (e.g.,
polymers that will be used as ion exchange beads), or
(ii) The combined (total) functional group equivalent weight of
cationic groups in the polymer is equal to or greater than 5,000.
(2) Elemental limitations. (i) A polymer manufactured under this
section must contain as an integral part of its composition at least
two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon,
and sulfur.
(ii) A polymer cannot be manufactured under this section if it
contains as an integral part of its composition, except as impurities,
any elements other than the following:
(A) The elements listed in paragraph (d)(2)(i) of this section.
(B) Sodium, magnesium, aluminum, potassium, calcium, chlorine,
bromine, and iodine as the monatomic counterions Na+, Mg+2,
Al+3, K+, Ca+2, Cl-, Br-, or I-.
(C) Fluorine, chlorine, bromine, and iodine covalently bound to
carbon.
(D) Less than 0.20 weight percent of any combination of the atomic
elements lithium, boron, phosphorus, titanium, manganese, iron, nickel,
copper, zinc, tin, and zirconium.
(3) Polymers which degrade, decompose, or depolymerize. A polymer
[[Page 16333]] cannot be manufactured under this section if the polymer
is designed or is reasonably anticipated to substantially degrade,
decompose, or depolymerize, including those polymers that could
substantially decompose after manufacture and use, even though they are
not actually intended to do so. For the purposes of this section,
degradation, decomposition, or depolymerization mean those types of
chemical change that convert a polymeric substance into simpler,
smaller substances, through processes including but not limited to
oxidation, hydrolysis, attack by solvents, heat, light, or microbial
action.
(4) Polymers manufactured or imported from monomers and reactants
not on the TSCA Chemical Substance Inventory. A polymer cannot be
manufactured under this section if the polymer being manufactured or
imported is prepared from monomers and/or other reactants (that are
either charged to the reaction vessel or incorporated in the polymer at
levels of greater than 2 weight percent) that are not already included
on the TSCA Chemical Substance Inventory or manufactured under an
applicable TSCA section 5 exemption.
(5) Water absorbing polymers with number average molecular weight
(MW) 10,000 and greater. A polymer cannot be manufactured under this
section if the polymer being manufactured or imported is a water
absorbing polymer and has a number average MW greater than or equal to
10,000 daltons. For purposes of this section, a water-absorbing polymer
is a polymeric substance that is capable of absorbing its weight of
water.
(e) Exemption criteria. To be manufactured under this section, the
polymer must meet one of the following criteria:
(1) Polymers with number average MW greater than or equal to 1,000
and less than 10,000 daltons (and oligomer content less than 10 percent
below MW 500 and less than 25 percent below MW 1,000). (i) The polymer
must have a number average MW greater than or equal to 1,000 and less
than 10,000 daltons and contain less than 10 percent oligomeric
material below MW 500 and less than 25 percent oligomeric material
below MW 1,000.
(ii) The polymer cannot contain reactive functional groups unless
it meets one of the following criteria:
(A) The polymer contains only the following reactive functional
groups: carboxylic acid groups, aliphatic hydroxyl groups,unconjugated
olefinic groups that are considered ``ordinary,''(i.e., not specially
activated either by being part of a larger functional group, such as a
vinyl ether, or by other activating influences, e.g., strongly
electron-withdrawing sulfone group with which the olefinic groups
interact), butenedioic acid groups, those conjugated olefinic groups
contained in naturally-occurring fats, oils, and carboxylic acids,
blocked isocyanates (including ketoxime-blocked isocyanates), thiols,
unconjugated nitrile groups, and halogens (except that reactive
halogen-containing groups such as benzylic or allylichalides cannot be
included).
(B) The polymer has a combined (total) reactive group equivalent
weight greater than or equal to 1,000 for the following reactive
functional groups: acidhalides; acid anhydrides; aldehydes,
hemiacetals; methylolamides,- amines or,- ureas; alkoxysilanes with
alkoxy greater than C2-alkoxysilanes; allyl ethers; conjugated
olefins;cyanates; epoxides; imines; or unsubstituted positions ortho or
para to phenolic hydroxyl; or
(C) If any reactive functional groups not included in paragraph
(e)(1)(ii)(A) and (B) of this section are present, the combined (total)
reactive group equivalent weight, including any groups listed in
paragraph (e)(1)(ii)(B), is greater than or equal to 5,000.
(2) Polymers with number average MW greater than or equal to 10,000
(and oligomer content less than 2 percent below MW 500 and less than 5
percent below MW 1,000) . The polymer must have a number average MW
greater than or equal to 10,000 daltons and contain less than 2 percent
oligomeric material below MW 500 and less than 5 percent oligomeric
material below MW 1000.
(3) Polyester polymers. The polymer is a polyester as defined in
paragraph (b) of this section and is manufactured solely from one or
more of the reactants in the following Table 1:
Table 1.-- List of Reactants From Which Polyester May be Made
------------------------------------------------------------------------
Reactant CAS No.
------------------------------------------------------------------------
Monobasic Acids and Natural Oils
Benzoic acid............................. 65-85-0
Canola oil............................... 120962-03-0
Coconut oil.............................. 8001-31-8*
Corn oil................................. 8001-30-7*
Cottonseed oil........................... 8001-29-4*
Dodecanoic acid.......................... 143-07-7
Fats and glyceridic oils, anchovy........ 128952-11-4*
Fats and glyceridic oils, babassu........ 91078-92-1*
Fats and glyceridic oils, herring........ 68153-06-0*
Fats and glyceridic oils, menhaden....... 8002-50-4*
Fats and glyceridic oils, sardine........ 93334-41-9*
Fats and glyceridic oils, oiticica....... 8016-35-1*
Fatty acids,C16-18 and C18-unsatd........ 67701-08-0*
Fatty acids, castor-oil.................. 61789-44-4*
Fatty acids, coco........................ 61788-47-4*
Fatty acids, dehydrated castor-oil....... 61789-45-5*
Fatty acids, linseed oil................. 68424-45-3*
Fatty acids, safflower oil...............
Fatty acids, soya........................ 68308-53-2*
Fatty acids, sunflower oil............... 84625-38-7*
Fatty acids, sunflower-oil, conjugated... 68953-27-5*
Fatty acids, tall-oil.................... 61790-12-3*
Fatty acids, tall-oil, conjugated*.......
Fatty acids, vegetable oil............... 61788-66-7*
Glycerides, C16-18 and C18-unsatd........ 67701-30-8*
Heptanoic acid........................... 111-14-8
[[Page 16334]]
Hexanoic acid............................ 142-62-1
Hexanoic acid, 3,3,5-trimethyl-.......... 3302-10-1
Linseed oil.............................. 8001-26-1*
Linseed oil, oxidized.................... 68649-95-6*
Nonanoic acid............................ 112-05-0
Oils, Cannabis*..........................
Oils, palm kernel........................ 8023-79-8*
Oils, perilla............................ 68132-21-8*
Oils, walnut............................. 8024-09-7
Safflower oil............................ 8001-23-8*
Soybean oil.............................. 8001-22-7*
Sunflower oil............................ 8001-21-6*
Tung oil................................. 8001-20-5*
Di and Tri Basic Acids:....................
1,2-Benzenedicarboxylic acid............. 88-99-3
1,3-Benzenedicarboxylic acid............. 121-91-5
1,3-Benzenedicarboxylic acid, dimethyl 1459-93-4
ester.
1,4-Benzenedicarboxylic acid............. 100-21-0
1,4-Benzenedicarboxylic acid, diethyl 636-09-9
ester.
1,4-Benzenedicarboxylic acid, dimethyl 120-61-6
ester.
1,2,4-Benzenetricarboxylic acid.......... 528-44-9
Butanedioic acid......................... 110-15-6
Butanedioic acid, diethyl ester.......... 123-25-1
Butanedioic acid, dimethyl ester......... 106-65-0
2-Butenedioic acid (E)-.................. 110-17-8
Decanedioic acid......................... 111-20-6
Decanedioic acid, diethyl ester.......... 110-40-7
Decanedioic acid, dimethyl ester......... 106-79-6
Dodecanedioic acid....................... 693-23-2
Fatty acids, C18-unsatd., dimers......... 61788-89-4*
Heptanedioic acid........................ 111-16-0
Heptanedioic acid, dimethyl ester........ 1732-08-7
Hexanedioic acid......................... 124-04-9
Hexanedioic acid, dimethyl ester......... 627-93-0
Hexanedioic acid, diethyl ester.......... 141-28-6
Nonanedioic acid......................... 123-99-9
Nonanedioic acid, dimethyl ester......... 1732-10-1
Nonanedioic acid, diethyl ester.......... 624-17-9
Octanedioic acid......................... (505-48-6)
Octanedioic acid, dimethyl ester......... 1732-09-8
Pentanedioic acid........................ (110-94-1)
Pentanedioic acid, dimethyl ester........ 1119-40-0
Pentanedioic acid, diethyl ester......... 818-38-2
Undecanedioic acid....................... 1852-04-6
Polyols
1,3-Butanediol........................... 107-88-0
1,4-Butanediol........................... 110-63-4
1,4-Cyclohexanedimethanol................ 105-08-8
1,2-Ethanediol........................... 107-21-1
Ethanol, 2,2'-oxybis-.................... 111-46-6
1,6-Hexanediol........................... 629-11-8
1,3-Pentanediol, 2,2,4-trimethyl-........ 144-19-4
1,2-Propanediol,......................... 57-55-6
1,3-Propanediol, 2,2-bis(hydroxymethyl)-. 115-77-5
1,3-Propanediol, 2,2-dimethyl-........... 126-30-7
1,3-Propanediol, 2-ethyl-2- 77-99-6
(hydroxymethyl)-.
1,3-Propanediol, 2-(hydroxymethyl)-2- 77-85-0
methyl-.
1,3-propanediol, 2-methyl................ 2163-42-0
1,2,3-Propanetriol....................... 56-81-5
1,2,3-Propanetriol, homopolymer.......... 25618-55-7
2-Propen-1-ol, polymer with 25119-62-4
ethenylbenzene.
Modifiers
Acetic acid, 2,2'-oxybis-................ 110-99-6
1-Butanol................................ 71-36-3**
Cyclohexanol............................. 108-93-0
Cyclohexanol, 4,4'-(1- 80-04-6
methylethylidene)bis-.
Ethanol, 2-(2-butoxyethoxy)-............. 112-34-5
1-Hexanol................................ 111-27-3
Methanol, hydrolysis products with 72318-84-4*
trichlorohexylsilane and
trichlorophenylsilane.
1-Phenanthrenemethanol, tetradecahydro- 13393-93-6
1,4a-dimethyl-7-(1-methylethyl)-.
[[Page 16335]]
Phenol, 4,4'-(1-methylethylidene)bis-, 25036-25-3
polymer with 2,2'- [(1-
methylethylidene)bis(4,1-
phenyleneoxymethylene)] bis[oxirane].
Siloxanes and Silicones, di-Me, di-Ph, 68440-65-3*
polymers with Ph silsesquioxanes,
methoxy-terminated.
Siloxanes and Silicones, di-Me, methoxy 68957-04-0*
Ph, polymers with Ph silsesquioxanes,
methoxy-terminated.
Siloxanes and Silicones, Me Ph, methoxy \1\68957-06-2*
Ph, polymers with Ph silsesquioxanes,
methoxy- and Ph-terminated.
Silsesquioxanes, Ph Pr................... \1\68037-90-1*
------------------------------------------------------------------------
* Chemical substance of unknown or variable composition,complex reaction
products, and biological materials (UVCB). The CAS Registry Numbers
for UVCB substances are not used in CHEMICAL ABSTRACTS and its
indexes.
** These substances may not be used in a substance manufactured from
fumaric or maleic acid because of potential risks associated with
esters, which may be formed by reaction of these reactants.
(f) Exemption report for polymers manufactured under the terms of
this section. For substances exempt under paragraphs (e)(1), (e)(2),
and (e)(3) of this section a report of manufacture or import must be
submitted (postmarked) by January 31 of the year subsequent to initial
manufacture. The notice must include:
(1) Manufacturer's name. This includes the name and address of the
manufacturer and the name and telephone number of a technical contact.
(2) Number of substances manufactured. Number of substances
manufactured. The manufacturer must identify the number of polymers
manufactured under terms of the exemption for the first time in the
year preceding the notice.
(g) Chemical identity information. For substances exempt under
paragraph (e) of this section the manufacturer must to the extent known
to or reasonably ascertainable by the manufacturer identify the
following and maintain the records in accordance with paragraph (j) of
this section:
(1) A specific chemical name and CAS Registry Number (or EPA
assigned Accession Number) for each ``reactant,'' as that term is
defined in paragraph (b) of this section, used at any weight in the
manufacture of the polymer. For purposes of determining chemical
identity, the manufacturer may determine whether a reactant is used at
greater than two weight percent according to either the weight of the
reactant charged to the reaction vessel or the weight of the chemically
combined (incorporated) reactant in the polymer. Manufacturers who
choose the ``incorporated'' method must have analytical data, or
theoretical calculations (if it can be documented that an analytical
determination cannot be made or is not necessary), to demonstrate
compliance with this paragraph. Reactants that introduce into the
polymer elements, properties, or functional groups that would render
the polymer ineligible for the exemption are not allowed at any level.
(2) A representative structural diagram, if possible.
(h) Certification. To manufacture a substance under the terms of
this section, a manufacturer must as of the date of first manufacture,
make the following certification statements and maintain them in
accordance with paragraph (j) of this section:
(1) The substance is manufactured or imported for a commercial
purpose other than for research and development.
(2) All information in the certification is truthful.
(3) The new chemical substance meets the definition of a polymer,
is not specifically excluded from the exemption in paragraph (d) of
this section, and meets the conditions of the exemption in paragraph
(e) of this section.
(i) Exemptions granted under superseded regulations. Manufacturers
granted exemptions under the superseded requirements of Sec. 723.250
(as in effect on May 26, 1995) shall either continue to comply with
those requirements or follow all procedural and recordkeeping
requirements pursuant to this section. If an exemption holder continues
to follow the superseded regulations, the Notice of Commencement
requirements apply and the exempt polymer will continue to be listed on
the Inventory with exclusion criteria and exemption category
restrictions on residual monomer/reactant and low molecular weight
species content limitations.
(j) Recordkeeping. (1) A manufacturer of a new polymer under
paragraphs (e) of this section, must retain the records described in
this paragraph at the manufacturing site for a period of 5 years from
the date of commencement of manufacture or import.
(2) The records must include the following to demonstrate
compliance with the terms of this section:
(i) Chemical identity information as required in paragraph (g) of
this section.
(ii) Information to demonstrate that the new polymer is not
specifically excluded from the exemption.
(iii) Records of production volume for the first 3 years of
manufacture and the date of commencement of manufacture.
(iv) Information to demonstrate that the new polymer meets the
exemption criteria in paragraphs (e)(1), (e)(2), or (e)(3) of this
section.
(v) Analytical data, or theoretical calculations (if it can be
documented that an analytical determination cannot be made or is not
necessary), to demonstrate that the polymer meets the number-average MW
exemption criteria in paragraphs (e)(1) or (e)(2) of this section.The
analytical tests may include gel permeation chromatography (GPC).vapor
pressure osmometry (VPO), or other such tests which will demonstrate
that the polymer meets the number-average MW criterion.
(vi) Analytical data, or theoretical calculations (if it can be
documented that an analytical determination cannot be made or is not
necessary), to demonstrate that the polymer meets the criteria in
paragraphs (e)(1) or (e)(2) of this section, meets the low MW content
criteria in paragraphs (e)(1) or (e)(2) of this section.
(vii) If applicable, analytical data, or theoretical calculations
(if it can be documented that an analytical determination cannot be
made or is not necessary) required in paragraph (g) of this section for
determining monomers or reactants charged to the reaction vessel at
greater than 2 weight percent but incorporated at 2 weight percent or
less in the manufactured polymer.
(viii) The certification statements as required under paragraph (h)
of this section.
(3) The manufacturer must submit the records listed in paragraph
(j)(2) of this section to EPA upon written request by EPA. The
manufacturer must provide these records within 15 working days of
receipt of this request. In addition, any person who manufactures a new
chemical substance under the terms of this section, upon request of
EPA, must [[Page 16336]] permit such person at all reasonable times to
have access to and to copy these records.
(k) Submission of information. Information submitted to EPA under
this section must be sent in writing to: TSCA Document Control Officer,
(7407), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.
(l) Compliance. (1) A person who manufactures or imports a new
chemical substance and fails to comply with any provision of this
section is in violation of section 15 of the Act (15 U.S.C. 2614).
(2) Using for commercial purposes a chemical substance or mixture
which a person knew or had reason to know was manufactured, processed,
or distributed in commerce in violation of section 5 of the Act is a
violation of section 15 of the Act (15 U.S.C. 2614).
(3) Failure or refusal to establish and maintain records or to
permit access to or copying of records, as required by this section and
section 11 of the Act, is a violation of section 15 of the Act (15
U.S.C. 2614).
(4) Failure or refusal to permit entry or inspection as required by
section 11 of the Act is a violation of section 15 of the Act (15
U.S.C. 2614).
(5) Violators may be subject to the civil and criminal penalties
insection 16 of the Act (15 U.S.C. 2615) for each violation. Persons
who submit materially misleading or false information in connection
with the requirements of any provision of this section may be subject
to penalties calculated as if they never filed their notices.
(6) EPA may seek to enjoin the manufacture or processing of a
chemical substance in violation of this section or act to seize any
chemical substance manufactured or processed in violation of this
section or take other actions under the authority of section 7 of the
Act (15 U.S.C. 2606) or section 17 of the Act (15 U.S.C. 2616).
(m) Inspections. EPA will conduct inspections under section 11
ofthe Act to assure compliance with section 5 and this section, to
verify that information submitted to EPA under this section is true and
correct, and to audit data submitted to EPA under this section.
(n) Confidentiality. If a manufacturer submits information to EPA
under this section which the manufacturer claims to be confidential
business information, the manufacturer must clearly identify the
information at the time of submission to EPA by bracketing, circling,
or underlining it and stamping it with ``CONFIDENTIAL'' or some other
appropriate designation. Any information so identified will be treated
in accordance with the procedures in 40 CFR part 2. Any information not
claimed confidential at the time of submission may be made available to
the public without further notice.
[FR Doc. 95-7712 Filed 3-24-95; 3:32 pm]
BILLING CODE 6560-50-F
