[Code of Federal Regulations]
[Title 40, Volume 29]
[Revised as of July 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR723.250]
[Page 482-488]
TITLE 40--PROTECTION OF ENVIRONMENT
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
PART 723_PREMANUFACTURE NOTIFICATION EXEMPTIONS--Table of Contents
Subpart B_Specific Exemptions
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. This section does not apply to
microorganisms subject to part 725 of this chapter.
(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
[[Page 483]]
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
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)
[[Page 484]]
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*
[[Page 485]]
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
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)-.
[[Page 486]]
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)-.
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
[[Page 487]]
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 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, 1200 Pennsylvania Ave., NW., 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
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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 in
section 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 of
the 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.
[60 FR 16332, Mar. 29, 1995, as amended at 62 FR 17932, April 11, 1997]