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§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 §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 §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) 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 C (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: (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 §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 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]
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,C[INF]16-18[/INF] and 67701-08-0*
C[INF]18[/INF]-unsatd..
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, C[INF]16-18[/INF] and 67701-30-8*
C[INF]18[/INF]-unsatd..
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*
1 1 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, C[INF]18[/INF]-unsatd., 61788-89-4*
dimers.
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[prime]-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[prime]-oxybis-.......... 110-99-6
1-Butanol................................ 71-36-3**
Cyclohexanol............................. 108-93-0
Cyclohexanol, 4,4[prime]-(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[prime]-(1- 25036-25-3
methylethylidene)bis-, polymer with
2,2[prime]- [(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*
------------------------------------------------------------------------
[SU]*[/SU] 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.
[SU]**[/SU] 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.
