( iii) Work practices. Work practices and operating procedures must be designed to limit exposure to any new chemical substance contained in wet mixtures. Any spills or unanticipated releases of a wet mixture must be controlled by trained personnel wearing appropriate protective clothing or equipment such as gloves, eye protection, and, where necessary, respirators or chemically imprevious clothing.

( 3) Personal protection devices. All workers engaged in the processing of a wet mixture containing a new chemical substance must wear suitable protective clothing or equipment such as coveralls, protective eyewear, respirators, and gloves.

( g) Incorporation of photographic articles into instant photographic and peel apart film articles. A photographic article may be incorporated into the instant photographic or peel apart film article outside the special production area. The manufacturer must take measures to limit worker and environmental exposure to new chemical substances during these operations using engineering controls, training, hygiene, work practices, and personal protective devices.

( h) Environmental release and waste treatment  ( 1) Release to land. Process waste from May 10, 2004 manufacturing and processing operations in the special production area that contain a new chemical substance are considered to be hazardous waste and must be handled in accordance with the requirements of parts 262 through 267 and parts 122 and 124 of this chapter.

( 2) Release to water. All wastewater or discharge which contain the new chemcial subtance must be appropriately pretreated before release to a Publicly Owned Treatment Works ( POTW) or other receiving body of water. In the case of release to a POTW, the pretreatment must prevent structural damage to, obstruction of, or interference with the operation of the POTW. The treatment of direct release to a receiving body of water must be appropriate for the new chemical substance's physical chemical properties and potential toxicity.

( 3) Release to air. All process emissions released to the air which contain the new chemical substance must be vented through control devices appropriate for the new chemical substance's physical chemical properties and potential toxicity.

( i) Exemption notice. An exemption notices must be submitted to EPA when manufacture of the new chemical substance begins.

( 1) Contents of exemption notice. The exemption notice must include the following information:

( i) Manufacturer and sites. The notice must identify the manufacturer and the sites and locations where the new chemical substance and the instant photographic or peel apart film articles will be manufactured and processed.

( ii) Chemical identification. The notice must identify the new chemical substance as follows:

( A) Class 1 substances. For chemical substances whose composition can be represented by a definite structural diagram ( Class 1 substances), the notice must provide the chemical name ( preferably CAS or IUPAC nomenclature), the molecular formula, CAS Registry Number ( if available), known synonyms ( including trade names), and a structural diagram.

( B) Class 2 substances. For chemical substances that cannot be fully represented by a structural diagram, ( Class 2 substances), the notice must provide the chemical name, the molecular formula, the CAS Registry Number ( if available), and known synonyms ( including trade names). The notice must identify the immediate precursors and reactants by name and CAS Registry Number ( if available). The notice must include a partial or incomplete structural diagram, if available.

( C) Polymers. For a polymer, the notice must indentify monomers and other reactants used in the manufacture of the polymer by chemical name and CAS Registry Number. The notice must indicate the amount of each monomer used ( by weight percent of total monomer); the maximum residual of each monomer present in the polymer; and a partial or incomplete structural diagram, if available. The notice must indicate the number average molecular weight of the polymer and characterize the anticipated low molecular weight species. The notice must include this information for each typical average molecular weight composition of the polymer to be manufactured.

( iii) Impurities. The notice must identify the impurities that can be reasonably anticipated to be May 10, 2004 present in the new chemical substance when manufactured under the exemption by name and CAS Registry Number, by class of substances, or by process or source. The notice also must estimate the maximum percent ( by weight) of each impurity in the new chemical substance and the percent of unknown impurities present.

( iv) Physical chemical properties. The notice must describe the physical chemical properties of the new chemical substance. Where specific physical chemical data are not available, reasonable estimates and the techniques used to develop these estimates must be provided.

( v) Byproducts. The notice must identify the name, CAS Registry number ( if available), and the volume of each byproduct that would be manufactured during manufacture of the new chemical substance.

( vi) Production volume. The notice must include an estimate of the anticipated maximum annual production volume.

( vii) Test data. The notice must include all information and test data on the new chemical substance's health and environmental effects that are known to or reasonably ascertainable by the manufacturer.

( viii) Identity of the article. The notice must identify and describe the instant photographic film article( s) or peel apart film article( s) that will contain the new chemical substance.

( ix) Release to water. The notice must include a description of the methods used to control and treat wastewater or discharge released to a POTW or other receiving body of water. The notice must also identify the POTW or receiving body of water.

( x) Certification. The manufacturer must certify in the notice that it is familiar with the terms of the exemption and that the manufacture, processing, distribution, use, and disposal of the new chemical substance will comply with those terms.

( 2) Duplication of information in premanufacture notice. If a manufacturer who submits an exemption notice under this paragraph has already submitted, or simultaneously submits, a premanufacture notice under section 5( a)( 1)( A) of the Act for the new chemical substance, it may, in lieu of submitting the information required by this paragraph, reference the required information to the extent it is included in the premanufacture notice. At a minimum, the exemption notice must identify the manufacturer and the new chemical substance, and contain the certification required by paragraph ( i)( 1)( x) of this section.

( 3) Address. The exemption notice must be addressed to the Document Control Office ( 7407), Office of Pollution Prevention and Toxics, U. S. Environmental Protection Agency, Room G 099, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

( j) Recordkeeping. ( 1) Manufacturers of a new chemical substance under this exemption must keep the following records for 30 years from the final date of manufacture. ( i) Production records. Each manufacturer must maintain records of the annual production volume of each new chemical substance manufactured under the terms of the exemption. This May 10, 2004 record must indicate when manufacture of the new chemical substance began. ( ii) Exposure monitoring records. Manufacturers must maintain an accurate record of all monitoring required by this section. Monitoring records may be adapted to the individual circumstances of the manufacturer but, at a minimum, must contain the following information: The chemical identity of the new chemical substance, date of the monitoring, the actual monitoring data for each monitoring location and sampling, and a reference to or description of the collection and analytic techniques. If the manufacturer does not monitor, the manufacturer must maintain a record of the reasons for not monitoring and the methods used to determine compliance with the exposure limits of paragraph ( e)( 1) of this section. ( iii) Training and exposure records. For each employee engaged in the manufacture or processing of a new chemical substance, the company must develop and maintain a record of the worker's participation in required training. This record must also demonstrate the regular use of personal exposure safeguards, including the results of any personal exposure monitoring, the results of the quantitative fit test for the worker's personal respirator, and any additional information related to the worker's occupational exposure. ( iv) Treatment records. Manufacturers who release treated wastewater or discharge containing a new chemical substance to a POTW or other receiving body of water must maintain records of the method of treatment.

( 2) The manufacturer must make the records listed in paragraph ( j)( 1) of this section available to EPA upon written request by the Director of the Office of Pollution Prevention and Toxics. The manufacturer must provide these records within 15 working days of receipt of this request.

( k) Confidentiality. If the manufacturer submits information under paragraph ( i) or ( j) of this section which it claims to be confidential business information, the manufacturer must clearly identify the information at the time of submission to the Agency 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 part 2 of this chapter. Any information not claimed confidential at the time of submission will be made available to the public without further notice to the submitter.

( l) Amendment and repeal. ( 1) EPA may amend or repeal any term of this exemption if it determines that the manufacture, processing, distribution, use, and disposal of new chemical substances under the terms of the exemption may present an unreasonable risk of injury to health or the environment. EPA also may amend this exemption to enlarge the exemption category or to reduce the restrictions or conditions of the exemption.

( 2) As required by section 5( h)( 4) of the Act, EPA will amend or repeal the substantive terms of an exemption granted under this part only by the formal rulemaking procedures described in section 6( c)( 2) and ( 3) of the Act ( 15 U. S. C. 2605( c)).

( m) Prohibition of use of the exemption. The Director of the Office of Pollution Prevention and Toxics may prohibit the manufacture, processing, distribution, use, or disposal of any new chemical substance under the terms of this exemption if he or she determines that the manufacture, processing, distribution in commerce, use, or disposal of the new chemical substance may present an unreasonable risk of injury to health or the environment. May 10, 2004 ( n) Enforcement. ( 1) A failure to comply with any provision of this part is a violation of section 15 of the Act ( 15 U. S. C. 2614).

( 2) Submitting materially misleading or false information in connection with the requirements of any provision of this part is a violation of this regulation and therefore a violation of section 15 of the Act ( 15 U. S. C. 2614).

( 3) Violators may be subject to the civil and criminal penalties in section 16 of the Act ( 15 U. S. C. 2615) for each violation.

( 4) EPA may seek to enjoin the manufacture of a new chemical substance in violation of this exemption or act to seize any chemical substances manufactured in violation of the exemption under the authority of section 17 of the Act ( 15 U. S. C. 2616).

[ 47 FR 24317, June 4, 1982, as amended at 53 FR 12523, Apr. 15, 1988; 60 FR 34465, July 3, 1995; 62 FR 17932, April 11, 1997; 68 FR 906, Jan. 7, 2003]

§ 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 May 10, 2004 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. May 10, 2004 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. May 10, 2004 ( 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 May 10, 2004 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, 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 May 10, 2004 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, 1459 93 4 diethyl ester. 1,4 Benzenedicarboxylic acid............ 100 21 0 1,4 Benzenedicarboxylic acid, 636 09 9 diethyl ester. 1,4 Benzenedicarboxylic acid, 120 61 6 dimethyl 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........................ ....... 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 May 10, 2004 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 May 10, 2004 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 § 723.250 ( as in effect on May 26, 1995) shall either continue to comply with those requirements or follow all procedural and recordkeeping requirements May 10, 2004 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). May 10, 2004 ( 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] May 10, 2004 Attachment F 40 CFR Part 725 May 10, 2004 40 CFR Protection of Environment CHAPTER I ENVIRONMENTAL PROTECTION AGENCY ( CONTINUED)

SUBCHAPTER R  TOXIC SUBSTANCES CONTROL ACT PART 725  REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS Subpart A  General Provisions and Applicability Sec. 725.1 Scope and purpose. 725.3 Definitions. 725.8 Coverage of this part. 725.12 Identification of microorganisms for Inventory and other listing purposes. 725.15 Determining applicability when microorganism identity or use is confidential or uncertain. 725.17 Consultation with EPA.

Subpart B  Administrative Procedures 725.20 Scope and purpose. 725.25 General administrative requirements. 725.27 Submissions. 725.28 Notice that submission is not required. 725.29 EPA acknowledgement of receipt of submission. 725.32 Errors in the submission. 725.33 Incomplete submissions. 725.36 New information. 725.40 Notice in the FEDERAL REGISTER. 725.50 EPA review. 725.54 Suspension of the review period. 725.56 Extension of the review period. 725.60 Withdrawal of submission by the submitter. 725.65 Recordkeeping. 725.67 Applications to exempt new microorganisms from this part. 725.70 Compliance. 725.75 Inspections.

Subpart C  Confidentiality and Public Access to Information 725.80 General provisions for confidentiality claims. 725.85 Microorganism identity. 725.88 Uses of a microorganism. 725.92 Data from health and safety studies of microorganisms. 725.94 Substantiation requirements. May 10, 2004 725.95 Public file.

Subpart D  Microbial Commercial Activities Notification Requirements 725.100 Scope and purpose. 725.105 Persons who must report. 725.110 Persons not subject to this subpart. 725.150 Procedural requirements for this subpart. 725.155 Information to be included in the MCAN. 725.160 Submission of health and environmental effects data. 725.170 EPA review of the MCAN. 725.190 Notice of commencement of manufacture or import.

Subpart E  Exemptions for Research and Development Activities 725.200 Scope and purpose. 725.205 Persons who may report under this subpart. 725.232 Activities subject to the jurisdiction of other Federal programs or agencies. 725.234 Activities conducted inside a structure. 725.235 Conditions of exemption for activities conducted inside a structure. 725.238 Activities conducted outside a structure. 725.239 Use of specific microorganisms in activities conducted outside a structure. 725.250 Procedural requirements for the TERA. 725.255 Information to be included in the TERA. 725.260 Submission of health and environmental effects data. 725.270 EPA review of the TERA. 725.288 Revocation or modification of TERA approval.

Subpart F  Exemptions for Test Marketing 725.300 Scope and purpose. 725.305 Persons who may apply under this subpart. 725.350 Procedural requirements for this subpart. 725.355 Information to be included in the TME application. 725.370 EPA review of the TME application.

Subpart G  General Exemptions for New Microorganisms 725.400 Scope and purpose. 725.420 Recipient microorganisms. 725.421 Introduced genetic material. 725.422 Physical containment and control technologies. 725.424 Requirements for the Tier I exemption. 725.426 Applicability of the Tier I exemption. 725.428 Requirements for the Tier II exemption. 725.450 Procedural requirements for the Tier II exemption. 725.455 Information to be included in the Tier II exemption request. May 10, 2004 725.470 EPA review of the Tier II exemption request.

Subparts H K [ Reserved]

Subpart L  Additional Procedures for Reporting on Significant New Uses of Microorganisms 725.900 Scope and purpose. 725.910 Persons excluded from reporting significant new uses. 725.912 Exemptions. 725.920 Exports and imports. 725.950 Additional recordkeeping requirements. 725.975 EPA approval of alternative control measures. 725.980 Expedited procedures for issuing significant new use rules for microorganisms subject to section 5( e) orders. 725.984 Modification or revocation of certain notification requirements.

Subpart M  Significant New Uses for Specific Microorganisms 725.1000 Scope. 725.1075 Burkholderia cepacia complex.

Authority: 15 U. S. C. 2604, 2607, 2613, and 2625.

Source: 62 FR 17932, April 11, 1997, unless otherwise noted.

Subpart A  General Provisions and Applicability § 725.1 Scope and purpose.

( a) This part establishes all reporting requirements under section 5 of TSCA for manufacturers, importers, and processors of microorganisms subject to TSCA jurisdiction for commercial purposes, including research and development for commercial purposes. New microorganisms for which manufacturers and importers are required to report under section 5( a)( 1)( A) of TSCA are those that are intergeneric. In addition, under section 5( a)( 1)( B) of TSCA, manufacturers, importers, and processors may be required to report for any microorganism that EPA determines by rule is being manufactured, imported, or processed for a significant new use.

( b) Any manufacturer, importer, or processor required to report under section 5 of TSCA ( see § 725.100 for new microorganisms and § 725.900 for significant new uses) must file a Microbial Commercial Activity Notice ( MCAN) with EPA, unless the activity is eligible for a specific exemption as described in this part. The general procedures for filing MCANs are described in subpart D of this part. The exemptions from the requirement to file a MCAN are for certain kinds of contained activities ( see § § 725.424 and 725.428), test marketing activities ( see § 725.300), and research and development activities described in paragraph ( c) of this section.

( c) Any manufacturer, importer, or processor required to file a MCAN for research and May 10, 2004 development ( R& D) activities may instead file a TSCA Experimental Release Application ( TERA) for a specific test ( see § 725.250). A TERA is not required for certain R& D activities; however a TERA exemption does not extend beyond the research and development stage, to general commercial use of the microorganism, for which compliance with MCAN requirements is required. The TERA exemptions are for R& D activities subject to other Federal agencies or programs ( see § 725.232), certain kinds of contained R& D activities ( see § 725.234), and R& D activities using certain listed microorganisms ( see § 725.238).

( d) New microorganisms will be added to the Inventory established under section 8 of TSCA once a MCAN has been received, the MCAN review period has expired, and EPA receives a Notice of Commencement ( NOC) indicating that manufacture or importation has actually begun. New microorganisms approved for use under a TERA will not be added to the Inventory until a MCAN has been received, the MCAN review period has expired, and EPA has received an NOC.

§ 725.3 Definitions.

Definitions in section 3 of the Act ( 15 U. S. C. 2602), as well as definitions contained in § § 704.3, 720.3, and 721.3 of this chapter, apply to this part unless otherwise specified in this section. In addition, the following definitions apply to this part:

Consolidated microbial commercial activity notice or consolidated MCAN means any MCAN submitted to EPA that covers more than one microorganism ( each being assigned a separate MCAN number by EPA) as a result of a prenotice agreement with EPA.

Containment and/ or inactivation controls means any combination of engineering, mechanical, procedural, or biological controls designed and operated to restrict environmental release of viable microorganisms from a structure.

Director means the Director of the EPA Office of Pollution Prevention and Toxics.

Exemption request means any application submitted to EPA under subparts E, F, or G of this part. General commercial use means use for commercial purposes other than research and development.

Genome means the sum total of chromosomal and extrachromosomal genetic material of an isolate and any descendants derived under pure culture conditions from that isolate.

Health and safety study of a microorganism or health and safety study means any study of any effect of a microorganism or microbial mixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a microorganism or microbial mixture, toxicological, clinical, and ecological, or other studies of a microorganism or microbial mixture, and any test performed under the Act. Microorganism identity is always part of a health and safety study of a microorganism.

( 1) It is intended that the term " health and safety study of a microorganism" be interpreted broadly. Not only is information which arises as a result of a formal, disciplined study included, but other information relating to the effects of a microorganism or microbial mixture on health or May 10, 2004 the environment is also included. Any data that bear on the effects of a microorganism on health or the environment would be included.

( 2) Examples include:

( i) Tests for ecological or other environmental effects on invertebrates, fish, or other animals, and plants, including: Acute toxicity tests, chronic toxicity tests, critical life stage tests, behavioral tests, algal growth tests, seed germination tests, plant growth or damage tests, microbial function tests, bioconcentration or bioaccumulation tests, and model ecosystem ( microcosm) studies. ( ii) Long and short term tests of mutagenicity, carcinogenicity, or teratogenicity; dermatoxicity; cumulative, additive, and synergistic effects; and acute, subchronic, and chronic effects. ( iii) Assessments of human and environmental exposure, including workplace exposure, and impacts of a particular microorganism or microbial mixture on the environment, including surveys, tests, and studies of: Survival and transport in air, water, and soil; ability to exchange genetic material with other microorganisms, ability to colonize human or animal guts, and ability to colonize plants. ( iv) Monitoring data, when they have been aggregated and analyzed to measure the exposure of humans or the environment to a microorganism. ( v) Any assessments of risk to health and the environment resulting from the manufacture, processing, distribution in commerce, use, or disposal of the microorganism.

Inactivation means that living microorganisms are rendered nonviable.

Institutional Biosafety Committee means the committees described in the NIH Guidelines in section IV. B. 2.

Intergeneric microorganism means a microorganism that is formed by the deliberate combination of genetic material originally isolated from organisms of different taxonomic genera.

( 1) The term " intergeneric microorganism" includes a microorganism which contains a mobile genetic element which was first identified in a microorganism in a genus different from the recipient microorganism.

( 2) The term " intergeneric microorganism" does not include a microorganism which contains introduced genetic material consisting of only well characterized, non coding regulatory regions from another genus.

Introduced genetic material means genetic material that is added to, and remains as a component of, the genome of the recipient.

Manufacture, import, or process for commercial purposes means:

( 1) To import, produce, manufacture, or process with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer, importer, or processor, and includes, among other things, " manufacture" or " processing" of any amount of a microorganism or microbial mixture: May 10, 2004 ( i) For commercial distribution, including for test marketing. ( ii) For use by the manufacturer, including use for product research and development or as an intermediate.

( 2) The term also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another microorganism or microbial mixture, including byproducts that are separated from that other microorganism or microbial mixture and impurities that remain in that microorganism or microbial mixture. Byproducts and impurities without separate commercial value are nonetheless produced for the purpose of obtaining a commercial advantage, since they are part of the manufacture or processing of a microorganism for commercial purposes.

Microbial commercial activity notice or MCAN means a notice for microorganisms submitted to EPA pursuant to section 5( a)( 1) of the Act in accordance with subpart D of this part.

Microbial mixture means any combination of microorganisms or microorganisms and other chemical substances, if the combination does not occur in nature and is not an article.

Microorganism means an organism classified, using the 5 kingdom classification system of Whittacker, in the kingdoms Monera ( or Procaryotae), Protista, Fungi, and the Chlorophyta and the Rhodophyta of the Plantae, and a virus or virus like particle.

Mobile genetic element or MGE means an element of genetic material that has the ability to move genetic material within and between organisms. " Mobile genetic elements" include all plasmids, viruses, transposons, insertion sequences, and other classes of elements with these general properties.

New microorganism means a microorganism not included on the Inventory.

NIH Guidelines means the National Institutes of Health ( NIH) " Guidelines for Research Involving Recombinant DNA Molecules" ( July 5, 1994).

Non coding regulatory region means a segment of introduced genetic material for which:

( 1) The regulatory region and any inserted flanking nucleotides do not code for protein, peptide, or functional ribonucleic acid molecules.

( 2) The regulatory region solely controls the activity of other regions that code for protein or peptide molecules or act as recognition sites for the initiation of nucleic acid or protein synthesis.

Small quantities solely for research and development ( or " small quantities solely for purposes of scientific experimentation or analysis or research on, or analysis of, such substance or another substance, including such research or analysis for development of a product") means quantities of a microorganism manufactured, imported, or processed or proposed to be manufactured, imported or processed solely for research and development that meet the requirements of § 725.234. May 10, 2004 Structure means a building or vessel which effectively surrounds and encloses the microorganism and includes features designed to restrict the microorganism from leaving.

Submission means any MCAN or exemption request submitted to EPA under this part.

Technically qualified individual means a person or persons:

( 1) Who, because of education, training, or experience, or a combination of these factors, is capable of understanding the health and environmental risks associated with the microorganism which is used under his or her supervision,

( 2) Who is responsible for enforcing appropriate methods of conducting scientific experimentation, analysis, or microbiological research to minimize such risks, and ( 3) Who is responsible for the safety assessments and clearances related to the procurement, storage, use, and disposal of the microorganism as may be appropriate or required within the scope of conducting a research and development activity.

TSCA Experimental Release Application or TERA means an exemption request for a research and development activity, which is not eligible for a full exemption from reporting under § 725.232, 725.234, or 725.238, submitted to EPA in accordance with subpart E of this part.

Well characterized for introduced genetic material means that the following have been determined:

( 1) The function of all of the products expressed from the structural gene( s). ( 2) The function of sequences that participate in the regulation of expression of the structural gene( s). ( 3) The presence or absence of associated nucleotide sequences and their associated functions, where associated nucleotide sequences are those sequences needed to move genetic material including linkers, homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites.

§ 725.8 Coverage of this part.

( a) Microorganisms subject to this part. Only microorganisms which are manufactured, imported, or processed for commercial purposes, as defined in § 725.3, are subject to the requirements of this part.

( b) Microorganisms automatically included on the Inventory. Microorganisms that are not intergeneric are automatically included on the Inventory.

( c) Microorganisms not subject to this part. The following microorganisms are not subject to this part, either because they are not subject to jurisdiction under the Act or are not subject to reporting under section 5 of the Act. May 10, 2004 ( 1) Any microorganism which would be excluded from the definition of " chemical substance" in section 3 of the Act and § 720.3( e) of this chapter.

( 2) Any microbial mixture as defined in § 725.3. This exclusion applies only to a microbial mixture as a whole and not to any microorganisms and other chemical substances which are part of the microbial mixture.

( 3) Any microorganism that is manufactured and processed solely for export if the following conditions are met:

( i) The microorganism is labeled in accordance with section 12( a)( 1)( B) of the Act, when the microorganism is distributed in commerce.

( ii) The manufacturer and processor can document at the commencement of manufacturing or processing that the person to whom the microorganism will be distributed intends to export it or process it solely for export as defined in § 721.3 of this chapter.

§ 725.12 Identification of microorganisms for Inventory and other listing purposes.

To identify and list microorganisms on the Inventory, both taxonomic designations and supplemental information will be used. The supplemental information required in paragraph ( b) of this section will be used to specifically describe an individual microorganism on the Inventory. Submitters must provide the supplemental information required by paragraph ( b) of this section to the extent necessary to enable a microorganism to be accurately and unambiguously identified on the Inventory.

( a) Taxonomic designation. The taxonomic designation of a microorganism must be provided for the donor organism and the recipient microorganism to the level of strain, as appropriate. These designations must be substantiated by a letter from a culture collection, literature references, or the results of tests conducted for the purpose of taxonomic classification. Upon EPA's request to the submitter, data supporting the taxonomic designation must be provided to EPA. The genetic history of the recipient microorganism should be documented back to the isolate from which it was derived.

( b) Supplemental information. The supplemental information described in paragraphs ( b)( 1) and ( b)( 2) of this section is required to the extent that it enables a microorganism to be accurately and unambiguously identified.

( 1) Phenotypic information. Phenotypic information means pertinent traits that result from the interaction of a microorganism's genotype and the environment in which it is intended to be used and may include intentionally added biochemical and physiological traits.

( 2) Genotypic information. Genotypic information means the pertinent and distinguishing genotypic characteristics of a microorganism, such as the identity of the introduced genetic material and the methods used to construct the reported microorganism. This also may include information on the vector construct, the cellular location, and the number of copies of the May 10, 2004 introduced genetic material.

§ 725.15 Determining applicability when microorganism identity or use is confidential or uncertain.

( a) Consulting EPA. Persons intending to conduct activities involving microorganisms may determine their obligations under this part by consulting the Inventory or the microorganisms and uses specified in § 725.239 or in subpart M of this part. This section establishes procedures for EPA to assist persons in determining whether the microorganism or the use is listed on the Inventory, in § 725.239 or in subpart M of this part.

( 1) Confidential identity or use. In some cases it may not be possible to directly determine if a specific microorganism is listed, because portions of that entry may contain generic information to protect confidential business information ( CBI). If any portion of the microorganism's identity or use has been claimed as CBI, that portion does not appear on the public version of the Inventory, in § 725.239 or in subpart M of this part. Instead, it is contained in a confidential version held in EPA's Confidential Business Information Center ( CBIC). The public versions contain generic information which masks the confidential business information. A person who intends to conduct an activity involving a microorganism or use whose entry is described with generic information will need to inquire of EPA whether the unreported microorganism or use is on the confidential version.

( 2) Uncertain microorganism identity. The current state of scientific knowledge leads to some imprecision in describing a microorganism. As the state of knowledge increases, EPA will be developing policies to determine whether one microorganism is equivalent to another. Persons intending to conduct activities involving microorganisms may inquire of EPA whether the microorganisms they intend to manufacture, import, or process are equivalent to specific microorganisms described on the Inventory, in § 725.239, or in subpart M of this part.

( b) Requirement of bona fide intent. ( 1) EPA will answer the inquiries described in paragraph ( a) of this section only if the Agency determines that the person has a bona fide intent to conduct the activity for which reporting is required or for which any exemption may apply.

( 2) To establish a bona fide intent to manufacture, import, or process a microorganism, the person who intends to manufacture, import, or process the microorganism must submit the following information in writing to the Office of Pollution Prevention and Toxics, Document Control Officer, 7407, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: BIOTECH bona fide submission.

( i) Taxonomic designations and supplemental information required by § 725.12. ( ii) A signed statement certifying that the submitter intends to manufacture, import, or process the microorganism for commercial purposes. ( iii) A description of research and development activities conducted with the microorganism to date, demonstration of the submitter's ability to produce or obtain the microorganism from a foreign manufacturer, and the purpose for which the person will manufacture, import, or process the microorganism. ( iv) An indication of whether a related microorganism was previously reviewed by EPA to the May 10, 2004 extent known by the submitter. ( v) A specific description of the major intended application or use of the microorganism.

( c) If an importer or processor cannot provide all the information required by paragraph ( b) of this section, because it is claimed as confidential business information by its foreign manufacturer or supplier, the foreign manufacturer or supplier may supply the information directly to EPA.

( d) EPA will review the information submitted by the manufacturer, importer, or processor under this paragraph to determine whether that person has shown a bona fide intent to manufacture, import, or process the microorganism. If necessary, EPA will compare this information to the information requested for the confidential microorganism under § 725.85( b)( 3)( iii).

( e) In order for EPA to make a conclusive determination of the microorganism's status, the proposed manufacturer, importer, or processor must show a bona fide intent to manufacture, import, or process the microorganism and must provide sufficient information to establish identity unambiguously. After sufficient information has been provided, EPA will inform the manufacturer, importer, or processor whether the microorganism is subject to this part and if so, which sections of this part apply.

( f) If the microorganism is found on the confidential version of the Inventory, in § 725.239 or in subpart M of this part, EPA will notify the person( s) who originally reported the microorganism that another person ( whose identity will remain confidential, if so requested) has demonstrated a bona fide intent to manufacture, import, or process the microorganism and therefore was told that the microorganism is on the Inventory, in § 725.239, or in subpart M of this part.

( g) A disclosure to a person with a bona fide intent to manufacture, import, or process a particular microorganism that the microorganism is on the Inventory, in § 725.239, or in subpart M of this part will not be considered a public disclosure of confidential business information under section 14 of the Act.

( h) EPA will answer an inquiry on whether a particular microorganism is subject to this part within 30 days after receipt of a complete submission under paragraph ( b) of this section.

§ 725.17 Consultation with EPA.

Persons may consult with EPA, either in writing or by telephone, about their obligations under this part. Written consultation is preferred. Written inquiries should be sent to the following address: Environmental Assistance Division ( 7408), Office of Pollution Prevention and Toxics, U. S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: Biotechnology Notice Consultation. Persons wishing to consult with EPA by telephone should call ( 202) 554 1404; hearing impaired TDD ( 202) 554 0551 or e mail: TSCA Hotline@ epamail. epa. gov.

Subpart B  Administrative Procedures § 725.20 Scope and purpose. May 10, 2004 This subpart describes general administrative procedures applicable to all persons who submit MCANs and exemption requests to EPA under section 5 of the Act for microorganisms.

§ 725.25 General administrative requirements.

( a) General. ( 1) Each person who is subject to the notification provisions of this part must complete, sign, and submit a MCAN or exemption request containing the information as required for the appropriate submission under this part. Except as otherwise provided, each submission must include all referenced attachments. All information in the submission ( unless certain attachments appear in the open scientific literature) must be in English. All information submitted must be true and correct.

( 2) In addition to specific information required, the submitter should submit all information known to or reasonably ascertainable by the submitter that would permit EPA to make a reasoned evaluation of the human health and environmental effects of the microorganism and any microbial mixture or article that may contain the microorganism.

( b) Certification. Persons submitting MCANs and exemption requests to EPA under this part, and material related to their reporting obligations under this part, must attach the following statement to any information submitted to EPA. This statement must be signed and dated by an authorized official of the submitter:

I certify that to the best of my knowledge and belief: The company named in this submission intends to manufacture, import, or process for a commercial purpose, other than in small quantities solely for research and development, the microorganism identified in this submission. All information provided in this submission is complete and truthful as of the date of submission. I am including with this submission all test data in my possession or control and a description of all other data known to or reasonably ascertainable by me as required by 40 CFR 725.160 or 725.260.

( c) Where to submit information under this part. Persons submitting MCANs and exemption requests to EPA under this part, and material related to their reporting obligations under this part, must send them to: TSCA Document Processing Center ( 7407), Rm. L 100, Office of Pollution Prevention and Toxics, U. S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

( d) General requirements for submission of data. ( 1) Submissions under this part must include the information described in § 725.155, 725.255, 725.355, or 725.455, as appropriate, to the extent such information is known to or reasonably ascertainable by the submitter.

( 2) In accordance with § 725.160 or 725.260, as appropriate, the submission must also include any test data in the submitter's possession or control and descriptions of other data which are known to or reasonably ascertainable by the submitter and which concern the health and environmental effects of the microorganism.

( e) Agency or joint submissions. ( 1) A manufacturer or importer may designate an agent to submit the MCAN or exemption request. Both the manufacturer or importer and the agent must sign the May 10, 2004 certification required in paragraph ( b) of this section.

( 2) A manufacturer or importer may authorize another person ( e. g., a foreign manufacturer or supplier, or a toll manufacturer) to report some of the information required in the MCAN or exemption request to EPA on its behalf. If separate portions of a joint submission are not submitted together, the submitter must indicate which information will be supplied by another person and identify that person. The manufacturer or importer and any other person supplying the information must sign the certification required by paragraph ( b) of this section.

( 3) If EPA receives a submission which does not include the information required, which the submitter indicates that it has authorized another person to provide, the review period will not begin until EPA receives all of the required information.

( f) Microorganisms subject to a section 4 test rule. ( 1) Except as provided in paragraph ( f)( 3) of this section, if a person intends to manufacture or import a new microorganism which is subject to the notification requirements of this part, and the microorganism is subject to a test rule promulgated under section 4 of the Act before the notice is submitted, section 5( b)( 1) of the Act requires the person to submit the test data required by the testing rule with the notice. The person must submit the data in the form and manner specified in the test rule and in accordance with § 725.160. If the person does not submit the test data, the submission is incomplete and EPA will follow the procedures in § 725.33.

( 2) If EPA has granted the submitter an exemption under section 4( c) of the Act from the requirement to conduct tests and submit data, the person may not file a MCAN or TERA until EPA receives the test data.

( 3) If EPA has granted the submitter an exemption under section 4( c) of the Act and if another person previously has submitted the test data to EPA, the exempted person may either submit the test data or provide the following information as part of the notice:

( i) The name, title, and address of the person who submitted the test data to EPA. ( ii) The date the test data were submitted to EPA. ( iii) A citation for the test rule. ( iv) A description of the exemption and a reference identifying it.

( g) Microorganisms subject to a section 5( b)( 4) rule. ( 1) If a person:

( i) Intends to manufacture or import a microorganism which is subject to the notification requirements of this part and which is subject to a rule issued under section 5( b)( 4) of the Act; and ( ii) Is not required by a rule issued under section 4 of the Act to submit test data for the microorganism before the filing of a submission, the person must submit to EPA data described in paragraph ( g)( 2) of this section at the time the submission is filed.

( 2) Data submitted under paragraph ( g)( 1) of this section must be data which the person submitting the notice believes show that the manufacture, processing, distribution in commerce, use, and disposal of the microorganism, or any combination of such activities, will not present an May 10, 2004 unreasonable risk of injury to health or the environment.

( h) Data that need not be submitted. Specific data requirements are listed in subparts D, E, F, G, and L of this part. The following is a list of data that need not be submitted under this part:

( 1) Data previously submitted to EPA. ( i) A person need not submit any data previously submitted to EPA with no claims of confidentiality if the new submission includes: the office or person to whom the data were submitted; the date of submission; and, if appropriate, a standard literature citation as specified in § 725.160( a)( 3)( ii). ( ii) For data previously submitted to EPA with a claim of confidentiality, the person must resubmit the data with the new submission and any claim of confidentiality, under § 725.80.

( 2) Efficacy data. This part does not require submission of any data related solely to product efficacy. However, including efficacy data will improve EPA's ability to assess the benefits of the use of the microorganism. This does not exempt a person from submitting any of the data specified in § 725.160 or 725.260.

( 3) Non U. S. exposure data. This part does not require submission of any data which relates only to exposure of humans or the environment outside the United States. This does not exclude nonexposure data such as data on health effects ( including epidemiological studies), ecological effects, physical and chemical properties, or environmental fate characteristics.

§ 725.27 Submissions.

Each person who is required to submit information under this part must submit the information in the form and manner set forth in the appropriate subpart.

( a) Requirements specific to MCANs are described in § § 725.150 through 725.160. ( b) Requirements specific to TERAs are described in § § 725.250 through 725.260. ( c) Requirements specific to test marketing exemptions ( TMEs) are described in § § 725.350 and 725.355. ( d) Requirements specific to Tier I and Tier II exemptions for certain general commercial uses are described in § § 725.424 through 725.470. ( e) Additional requirements specific to significant new uses for microorganisms are described at § 725.950.

§ 725.28 Notice that submission is not required.

When EPA receives a MCAN or exemption request, EPA will review it to determine whether the microorganism is subject to the requirements of this part. If EPA determines that the microorganism is not subject to these requirements, EPA will notify the submitter that section 5 of the Act does not prevent the manufacture, import, or processing of the microorganism and that the submission is not needed.

§ 725.29 EPA acknowledgement of receipt of submission.

( a) EPA will acknowledge receipt of each submission by sending the submitter a letter that May 10, 2004 identifies the number assigned to each MCAN or exemption request and the date on which the review period begins. The review period will begin on the date the MCAN or exemption request is received by the Office of Pollution Prevention and Toxics Document Control Officer.

( b) The acknowledgement does not constitute a finding by EPA that the submission is in compliance with this part.

§ 725.32 Errors in the submission.

( a) Within 30 days of receipt of the submission, EPA may request that the submitter remedy errors in the submission. The following are examples of such errors:

( 1) Failure to date the submission. ( 2) Typographical errors that cause data to be misleading or answers to any questions to be unclear. ( 3) Contradictory information. ( 4) Ambiguous statements or information.

( b) In the request to correct the submission, EPA will explain the action which the submitter must take to correct the submission.

( c) If the submitter fails to correct the submission within 15 days of receipt of the request, EPA may extend the review period.

§ 725.33 Incomplete submissions.

( a) A submission under this part is not complete, and the review period does not begin, if: ( 1) The wrong person files the submission. ( 2) The submitter does not attach and sign the certification statement as required by § 725.25( b). ( 3) Some or all of the information in the submission or any attachments are not in English, except for published scientific literature. ( 4) The submitter does not provide information that is required by sections 5( d)( 1)( B) and ( C) of the Act and § 725.160 or 725.260, as appropriate. ( 5) The submitter does not provide information required by § 725.25, 725.155, 725.255, 725.355, or 725.455, as appropriate, or indicate that it is not known to or reasonably ascertainable by the submitter. ( 6) The submitter has asserted confidentiality claims and has failed to: ( i) Submit a second copy of the submission with all confidential information deleted for the public file, as required by § 725.80( b)( 2). ( ii) Comply with the substantiation requirements as described in § 725.94. ( 7) The submitter does not include any information required by section 5( b)( 1) of the Act and pursuant to a rule promulgated under section 4 of the Act, as required by § 725.25( f). ( 8) The submitter does not submit data which the submitter believes show that the microorganism will not present an unreasonable risk of injury to health or the environment, if EPA has listed the microorganism under section 5( b)( 4) of the Act, as required in § 725.25( g). ( 9) For MCANs, the submitter does not remit the fees required by § 700.45( b)( 1) or ( b)( 2)( vi) of this chapter. May 10, 2004 ( b)( 1) If EPA receives an incomplete submission under this part, the Director, or a designee, will notify the submitter within 30 days of receipt that the submission is incomplete and that the review period will not begin until EPA receives a complete submission. ( 2) If EPA obtains additional information during the review period for any submission that indicates the original submission was incomplete, the Director, or a designee, may declare the submission incomplete within 30 days after EPA obtains the additional information and so notify the submitter.

( c) The notification that a submission is incomplete under paragraph ( b) of this section will include: ( 1) A statement of the basis of EPA's determination that the submission is incomplete. ( 2) The requirements for correcting the incomplete submission. ( 3) Information on procedures under paragraph ( d) of this section for filing objections to the determination or requesting modification of the requirements for completing the submission.

( d) Within 10 days after receipt of notification by EPA that a submission is incomplete, the submitter may file written objections requesting that EPA accept the submission as complete or modify the requirements necessary to complete the submission.

( e)( 1) EPA will consider the objections filed by the submitter. The Director, or a designee, will determine whether the submission was complete or incomplete, or whether to modify the requirements for completing the submission. EPA will notify the submitter in writing of EPA's response within 10 days of receiving the objections. ( 2) If the Director, or a designee, determines, in response to the objection, that the submission was complete, the review period will be deemed suspended on the date EPA declared the submission incomplete, and will resume on the date that the submission is declared complete. The submitter need not correct the submission as EPA originally requested. If EPA can complete its review within the review period beginning on the date of the submission, the Director, or a designee, may inform the submitter that the running of the review period will resume on the date EPA originally declared it incomplete. ( 3) If the Director, or a designee, modifies the requirements for completing the submission or concurs with EPA's original determination, the review period will begin when EPA receives a complete submission.

( f) If EPA discovers at any time that a person submitted materially false or misleading statements in information submitted under this part, EPA may find that the submission was incomplete from the date it was submitted, and take any other appropriate action.

§ 725.36 New information.

( a) During the review period, if a submitter possesses, controls, or knows of new information that materially adds to, changes, or otherwise makes significantly more complete the information included in the MCAN or exemption request, the submitter must send that information to the address listed in § 725.25( c) within 10 days of receiving the new information, but no later than 5 days before the end of the review period.

( b) The new submission must clearly identify the submitter, the MCAN or exemption request to May 10, 2004 which the new information is related, and the number assigned to that submission by EPA, if known to the submitter.

( c) If the new information becomes available during the last 5 days of the review period, the submitter must immediately inform the EPA contact for that submission by telephone of the new information.

§ 725.40 Notice in the Federal Register.

( a) Filing of FEDERAL REGISTER notice. After EPA receives a MCAN or an exemption request under this part, EPA will issue a notice in the FEDERAL REGISTER including the information specified in paragraph ( b) of this section.

( b) Contents of notice. ( 1) In the public interest, the specific microorganism identity listed in the submission will be published in the FEDERAL REGISTER unless the submitter has claimed the microorganism identity confidential. If the submitter claims confidentiality, a generic name will be published in accordance with § 725.85.

( 2) The categories of use of the microorganism will be published as reported in the submission unless this information is claimed confidential. If confidentiality is claimed, the generic information which is submitted under § 725.88 will be published. ( 3) A list of information submitted in accordance with § 725.160( a), 725.255, 725.260, 725.355, or 725.455, as appropriate, will be published. ( 4) The submitter's identity will be published, unless the submitter has claimed it confidential.

( c) Publication of exemption decisions. Following the expiration of the appropriate review period for the exemption request, EPA will issue a notice in the FEDERAL REGISTER indicating whether the request has been approved or denied and the reasons for the decision.

§ 725.50 EPA review.

( a) MCANs. The review period specified in section 5( a) of the Act for MCANs runs for 90 days from the date the Document Control Officer receives a complete submission, or the date EPA determines the submission is complete under § 725.33, unless the Agency extends the review period under section 5( c) of the Act and § 725.56.

( b) Exemption requests. The review period starts on the date the Document Control Officer receives a complete exemption request, or the date EPA determines the request is complete under § 725.33, unless the Agency extends the review period under § 725.56. The review periods for exemption requests run as follows: ( 1) TERAs. The review period for TERAs is 60 days. ( 2) TMEs. The review period for TMEs is 45 days. ( 3) Tier II exemption requests. The review period for Tier II exemption requests is 45 days.

§ 725.54 Suspension of the review period.

( a) A submitter may voluntarily suspend the running of the review period if the Director, or a May 10, 2004 designee, agrees. If the Director does not agree, the review period will continue to run, and EPA will notify the submitter. A submitter may request a suspension at any time during the review period. The suspension must be for a specified period of time.

( b) A request for suspension may be made in writing to the address listed in § 725.25( c). The suspension also may be made orally, including by telephone, to the submitter's EPA contact for that submission. EPA will send the submitter a written confirmation that the suspension has been granted. ( 1) An oral request may be granted for no longer than 15 days. To obtain a longer suspension, the Document Control Officer for the Office of Pollution Prevention and Toxics must receive written confirmation of the oral request. The review period is suspended as of the date of the oral request. ( 2) If the submitter has not made a previous oral request, the running of the review period is suspended as of the date of receipt of the written request by the Document Control Officer for the Office of Pollution Prevention and Toxics.

§ 725.56 Extension of the review period.

( a) At any time during the review period, EPA may unilaterally determine that good cause exists to extend the review period specified for MCANs, or the exemption requests.

( b) If EPA makes such a determination, EPA: ( 1) Will notify the submitter that EPA is extending the review period for a specified length of time and state the reasons for the extension. ( 2) For MCANs, EPA may issue a notice for publication in the FEDERAL REGISTER which states that EPA is extending the review period and gives the reasons for the extension.

( c) The total period of the extension may be for a period of up to the same length of time as specified for each type of submission in § 725.50. If the initial extension is for less than the total time allowed, EPA may make additional extensions. However, the sum of the extensions may not exceed the total allowed.

( d) The following are examples of situations in which EPA may find that good cause exists for extending the review period:

( 1) EPA has reviewed the submission and is seeking additional information. ( 2) EPA has received significant additional information during the review period. ( 3) The submitter has failed to correct a submission after receiving EPA's request under § 725.32. ( 4) EPA has reviewed the submission and determined that there is a significant possibility that the microorganism will be regulated under section 5( e) or section 5( f) of the Act, but EPA is unable to initiate regulatory action within the initial review period.

§ 725.60 Withdrawal of submission by the submitter.

( a) A submitter may withdraw a submission during the review period. A statement of withdrawal must be made in writing to the address listed in § 725.25( c). The withdrawal is effective upon receipt of the statement by the Document Control Officer. May 10, 2004 ( b) If a manufacturer, importer, or processor who withdrew a submission later resubmits a submission for the same microorganism, a new review period begins.

§ 725.65 Recordkeeping.

( a) General provisions. ( 1) Any person who submits a notice under this part must retain documentation of information in the submission, including: ( i) Any data in the submitter's possession or control; and ( ii) Records of production volume for the first 3 years of manufacture, import, or processing.

( 2) Any person who submits a notice under this part must retain documentation of the date of commencement of testing, manufacture, import, or processing.

( 3) Any person who is exempt from some or all of the reporting requirements of this part must retain documentation that supports the exemption.

( 4) All information required by this section must be retained for 3 years from the date of commencement of each activity for which records are required under this part.

( b) Specific requirements. In addition to the requirements of paragraph ( a) of this section, specific recordkeeping requirements included in certain subparts must also be followed.

( 1) Additional recordkeeping requirements for activities conducted inside a structure are set forth in § 725.235( h). ( 2) Additional recordkeeping requirements for TERAs are set forth in § 725.250( f). ( 3) Additional recordkeeping requirements for TMEs are set forth in § 725.350( c). ( 4) Additional recordkeeping requirements for Tier I exemptions under subpart G of this part are set forth in § 725.424( a)( 5). ( 5) Additional recordkeeping requirements for Tier II exemptions under subpart G of this part are set forth in § 725.450( d). ( 6) Additional recordkeeping requirements for significant new uses of microorganisms reported under subpart L of this part are set forth in § 725.850. Recordkeeping requirements may also be included when a microorganism and significant new use are added to subpart M of this part.

§ 725.67 Applications to exempt new microorganisms from this part.

( a) Submission. ( 1) Any manufacturer or importer of a new microorganism may request, under section 5( h)( 4) of the Act, an exemption, in whole or in part, from this part by sending a Letter of Application to the Chief, New Chemicals Branch, Chemical Control Division, Office of Pollution Prevention and Toxics, U. S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

( 2) General provisions. The Letter of Application should provide information to show that any activities affected by the requested exemption will not present an unreasonable risk of injury to health or the environment. This information should include data described in the following paragraphs. May 10, 2004 ( i) The effects of the new microorganism on health and the environment. ( ii) The magnitude of exposure of human beings and the environment to the new microorganism. ( iii) The benefits of the new microorganism for various uses and the availability of substitutes for such uses. ( iv) The reasonably ascertainable economic consequences of granting or denying the exemption, including effects on the national economy, small business, and technological innovation.

( 3) Specific requirements. In addition to the requirements of paragraph ( a)( 2) of this section, the specific information requirements of the relevant subpart under which the exemption is sought should be met. ( i) Exemption from MCAN reporting under subpart D. Information requirements are set forth in § § 725.155 and 725.160.

( ii) Exemption from TERA reporting under subpart E. Information requirements are set forth in § § 725.255 and 725.260. ( iii) Listing a recipient microorganism as eligible for exemption under subpart G. Information regarding the following criteria should be addressed in an application to list a recipient microorganism under § 725.420:

( A) Identification and classification of the microorganism using available genotypic and phenotypic information; ( B) Information to evaluate the relationship of the microorganism to any other closely related microorganisms which have a potential for adverse effects on health or the environment; ( C) A history of safe commercial use for the microorganism; ( D) Commercial uses indicating that the microorganism products might be subject to TSCA; ( E) Studies which indicate the potential for the microorganism to cause adverse effects to health or the environment; and ( F) Studies which indicate the survival characteristics of the microorganism in the environment.

( b) Processing of the Letter of Application by EPA  ( 1) Grant of the Application. If, after consideration of the Letter of Application and any other relevant information available to EPA, the Assistant Administrator for Prevention, Pesticides and Toxic Substances makes a preliminary determination that the new microorganism will not present an unreasonable risk of injury to health or the environment, the Assistant Administrator will propose a rule to grant the exemption using the applicable procedures in part 750 of this chapter. ( 2) Denial of the application. If the Assistant Administrator decides that the preliminary determination described in paragraph ( b)( 1) of this section cannot be made, the application will be denied by sending the applicant a written statement with the Assistant Administrator's reasons for denial.

( c) Processing of the exemption  ( 1) Unreasonable risk standard. Granting a section 5( h)( 4) exemption requires a determination that the activities will not present an unreasonable risk of injury to health or the environment.

( i) An unreasonable risk determination under the Act is an administrative judgment that requires balancing of the harm to health or the environment that a chemical substance may cause and the magnitude and severity of that harm, against the social and economic effects on society of EPA May 10, 2004 action to reduce that harm.

( ii) A determination of unreasonable risk under section 5( h)( 4) of the Act will examine the reasonably ascertainable economic and social consequences of granting or denying the exemption after consideration of the effect on the national economy, small business, technological innovation, the environment, and public health.

( 2) Grant of the exemption. The exemption will be granted if the Assistant Administrator determines, after consideration of all relevant evidence presented in the rulemaking proceeding described in paragraph ( b)( 1) of this section, that the new microorganism will not present an unreasonable risk of injury to health or the environment.

( 3) Denial of the exemption. The exemption will be denied if the Assistant Administrator determines, after consideration of all relevant evidence presented in the rulemaking proceeding described in paragraph ( b)( 1) of this section, that the determination described in paragraph ( c)( 2) of this section cannot be made. A final decision terminating the rulemaking proceeding will be published in the FEDERAL REGISTER.

§ 725.70 Compliance.

( a) Failure to comply with any provision of this part is a violation of section 15 of the Act ( 15 U. S. C. 2614).

( b) A person who manufactures or imports a microorganism before a MCAN is submitted and the MCAN review period expires is in violation of section 15 of the Act even if that person was not required to submit the MCAN under § 725.105.

( c) Using a microorganism which a person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of section 5 of the Act or this part is a violation of section 15 of the Act ( 15 U. S. C. 2614).

( d) Failure or refusal to establish and maintain records or to permit access to or copying of records, as required by the Act, is a violation of section 15 of the Act ( 15 U. S. C. 2614).

( e) 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).

( f) 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 part may be subject to penalties calculated as if they never filed their submissions.

( g) EPA may seek to enjoin the manufacture or processing of a microorganism in violation of this part or act to seize any microorganism manufactured or processed in violation of this part 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). May 10, 2004 § 725.75 Inspections.

EPA will conduct inspections under section 11 of the Act to assure compliance with section 5 of the Act and this part, to verify that information required by EPA under this part is true and correct, and to audit data submitted to EPA under this part.

Subpart C  Confidentiality and Public Access to Information § 725.80 General provisions for confidentiality claims.

( a) A person may assert a claim of confidentiality for any information submitted to EPA under this part. However, ( 1) Any person who asserts a claim of confidentiality for portions of the specific microorganism identity must provide the information as described in § 725.85. ( 2) Any person who asserts a claim of confidentiality for a use of a microorganism must provide the information as described in § 725.88. ( 3) Any person who asserts a claim of confidentiality for information contained in a health and safety study of a microorganism must provide the information described in § 725.92.

( b) Any claim of confidentiality must accompany the information when it is submitted to EPA. ( 1) When a person submits any information under this part, including any attachments, for which claims of confidentiality are made, the claim( s) must be asserted by circling the specific information which is claimed and marking the page on which that information appears with an appropriate designation such as " trade secret," " TSCA CBI," or " confidential business information." ( 2) If any information is claimed confidential, the person must submit two copies of the document including the claimed information. ( i) One copy of the document must be complete. In that copy, the submitter must mark the information which is claimed as confidential in the manner prescribed in paragraph ( b)( 1) of this section. ( ii) The second copy must be complete except that all information claimed as confidential in the first copy must be deleted. EPA will place the second copy in the public file. ( iii) If the submitter does not provide the second copy, the submission is incomplete and the review period does not begin to run until EPA receives the second copy, in accordance with § 725.33. ( iv) Any information contained within the copy submitted under paragraph ( b)( 2)( ii) of this section which has been in the public file for more than 30 days will be presumed to be in the public domain, notwithstanding any assertion of confidentiality made under this section. ( 3) A person who submits information to EPA under this part must reassert a claim of confidentiality and substantiate the claim each time the information is submitted to EPA.

( c) Any person asserting a claim of confidentiality under this part must substantiate each claim in accordance with the requirements in § 725.94.

( d) EPA will disclose information that is subject to a claim of confidentiality asserted under this section only to the extent permitted by the Act, this subpart, and part 2 of this title. May 10, 2004 ( e) If a submitter does not assert a claim of confidentiality for information at the time it is submitted to EPA, EPA may make the information public and place it in the public file without further notice to the submitter.

§ 725.85 Microorganism identity.

( a) Claims applicable to the period prior to commencement of manufacture or import for general commercial use  ( 1) When to make a claim. ( i) A person who submits information to EPA under this part may assert a claim of confidentiality for portions of the specific microorganism identity at the time of submission of the information. This claim will apply only to the period prior to the commencement of manufacture or import for general commercial use. ( ii) A person who submits information to EPA under this part must reassert a claim of confidentiality and substantiate the claim each time the information is submitted to EPA. For example, if a person claims certain information confidential in a TERA submission and wishes the same information to remain confidential in a subsequent TERA or MCAN submission, the person must reassert and resubstantiate the claim in the subsequent submission.

( 2) Assertion of claim. ( i) A submitter may assert a claim of confidentiality only if the submitter believes that public disclosure prior to commencement of manufacture or import for general commercial use of the fact that anyone is initiating research and development activities pertaining to the specific microorganism or intends to manufacture or import the specific microorganism for general commercial use would reveal confidential business information. Claims must be substantiated in accordance with the requirements of § 725.94( a). ( ii) If the submission includes a health and safety study concerning the microorganism and if the claim for confidentiality with respect to the specific identity is denied in accordance with § 725.92( c), EPA will deny a claim asserted under paragraph ( a) of this section.

( 3) Development of generic name. Any person who asserts a claim of confidentiality for portions of the specific microorganism identity under this paragraph must provide one of the following items at the time the submission is filed: ( i) The generic name which was accepted by EPA in the prenotice consultation conducted under paragraph ( a)( 4) of this section. ( ii) One generic name that is only as generic as necessary to protect the confidential identity of the particular microorganism. The name should reveal the specific identity to the maximum extent possible. The generic name will be subject to EPA review and approval.

( 4) Determination by EPA. ( i) Any person who intends to assert a claim of confidentiality for the specific identity of a new microorganism may seek a determination by EPA of an appropriate generic name for the microorganism before filing a submission. For this purpose, the person should submit to EPA: ( A) The specific identity of the microorganism. ( B) A proposed generic name( s) which is only as generic as necessary to protect the confidential identity of the new microorganism. The name( s) should reveal the specific identity of the microorganism to the maximum extent possible. ( ii) Within 30 days, EPA will inform the submitter either that one of the proposed generic names is adequate or that none is adequate and further consultation is necessary. May 10, 2004 ( 5) Use of generic name. If a submitter claims microorganism identity as confidential under paragraph ( a) of this section, and if the submitter complies with paragraph ( a)( 2) of this section, EPA will issue for publication in the FEDERAL REGISTER notice described in § 725.40 the generic name proposed by the submitter or one agreed upon by EPA and the submitter.

( b) Claims applicable to the period after commencement of manufacture or import for general commercial use  ( 1) Maintaining claim. Any claim of confidentiality under paragraph ( a) of this section is applicable only until the microorganism is manufactured or imported for general commercial use and becomes eligible for inclusion on the Inventory. To maintain the confidential status of the microorganism identity when the microorganism is added to the Inventory, a submitter must reassert the confidentiality claim and substantiate the claim in the notice of commencement of manufacture required under § 725.190. ( i) A submitter may not claim the microorganism identity confidential for the period after commencement of manufacture or import for general commercial use unless the submitter claimed the microorganism identity confidential under paragraph ( a) of this section in the MCAN submitted for the microorganism. ( ii) A submitter may claim the microorganism identity confidential for the period after commencement of manufacture or import for general commercial use if the submitter did not claim the microorganism identity confidential under paragraph ( a) of this section in any TERA submitted for the microorganism, but subsequently did claim microorganism identity confidential in the MCAN submitted for the microorganism.

( 2) Assertion of claim. ( i) A person who believes that public disclosure of the fact that anyone manufactures or imports the microorganism for general commercial use would reveal confidential business information may assert a claim of confidentiality under paragraph ( b) of this section. ( ii) If the notice includes a health and safety study concerning the new microorganism, and if the claim for confidentiality with respect to the microorganism identity is denied in accordance with § 725.92( c), EPA will deny a claim asserted under paragraph ( b) of this section.

( 3) Requirements for assertion. Any person who asserts a confidentiality claim for microorganism identity must: ( i) Comply with the requirements of paragraph ( a)( 3) of this section regarding submission of a generic name. ( ii) Agree that EPA may disclose to a person with a bona fide intent to manufacture or import the microorganism the fact that the particular microorganism is included on the confidential Inventory for purposes of notification under section 5( a)( 1)( A) of the Act. ( iii) Have available and agree to furnish to EPA upon request the taxonomic designations and supplemental information required by § 725.12. ( iv) Provide a detailed written substantiation of the claim, in accordance with the requirements of § 725.94( b).

( 4) Denial of claim. If the submitter does not meet the requirements of paragraph ( b) of this section, EPA will deny the claim of confidentiality.

( 5) Acceptance of claim. ( i) EPA will publish a generic name on the public Inventory if: ( A) The submitter asserts a claim of confidentiality in accordance with this paragraph. ( B) No claim for confidentiality of the microorganism identity as part of a health and safety study has been denied in accordance with part 2 of this title or § 725.92. May 10, 2004 ( ii) Publication of a generic name on the public Inventory does not create a category for purposes of the Inventory. Any person who has a bona fide intent to manufacture or import a microorganism which is described by a generic name on the public Inventory may submit an inquiry to EPA under § 725.15( b) to determine whether the particular microorganism is included on the confidential Inventory. ( iii) Upon receipt of a request described in § 725.15( b), EPA may require the submitter who originally asserted confidentiality for a microorganism to submit to EPA the information listed in paragraph ( b)( 3)( iii) of this section. ( iv) Failure to submit any of the information required under paragraph ( b)( 3)( iii) of this section within 10 calendar days of receipt of a request by EPA under paragraph ( b) of this section will constitute a waiver of the original submitter's confidentiality claim. In this event, EPA may place the specific microorganism identity on the public Inventory without further notice to the original submitter.

( 6) Use of generic name on the public Inventory. If a submitter asserts a claim of confidentiality under paragraph ( b) of this section, EPA will examine the generic microorganism name proposed by the submitter. ( i) If EPA determines that the generic name proposed by the submitter is only as generic as necessary to protect the confidential identity of the particular microorganism, EPA will place that generic name on the public Inventory. ( ii) If EPA determines that the generic name proposed by the submitter is more generic than necessary to protect the confidential identity, EPA will propose in writing, for review by the submitter, an alternative generic name that will reveal the identity of the microorganism to the maximum extent possible. ( iii) If the generic name proposed by EPA is acceptable to the submitter, EPA will place that generic name on the public Inventory. ( iv) If the generic name proposed by EPA is not acceptable to the submitter, the submitter must explain in detail why disclosure of that generic name would reveal confidential business information and propose another generic name which is only as generic as necessary to protect the confidential identity of the microorganism. If EPA does not receive a response from the submitter within 30 days after the submitter receives the proposed name, EPA will place EPA's chosen generic name on the public Inventory. If the submitter does provide the information requested, EPA will review the response. If the submitter's proposed generic name is acceptable, EPA will publish that generic name on the public Inventory. If the submitter's proposed generic name is not acceptable, EPA will notify the submitter of EPA's choice of a generic name. Thirty days after this notification, EPA will place the chosen generic name on the public Inventory.

§ 725.88 Uses of a microorganism.

( a) Assertion of claim. A person who submits information to EPA under this part on the categories or proposed categories of use of a microorganism may assert a claim of confidentiality for this information.

( b) Requirements for claim. A submitter that asserts such a claim must:

( 1) Report the categories or proposed categories of use of the microorganism. ( 2) Provide, in nonconfidential form, a description of the uses that is only as generic as necessary to protect the confidential business information. The generic use description will be included in May 10, 2004 the FEDERAL REGISTER notice described in § 725.40.

( c) Generic use description. The person must submit the information required by paragraph ( b) of this section by describing the uses as precisely as possible, without revealing the information which is claimed confidential, to disclose as much as possible how the use may result in human exposure to the microorganism or its release to the environment.

§ 725.92 Data from health and safety studies of microorganisms.

( a) Information other than specific microorganism identity. Except as provided in paragraph ( b) of this section, EPA will deny any claim of confidentiality with respect to information included in a health and safety study of a microorganism, unless the information would disclose confidential business information concerning:

( 1) Processes used in the manufacture or processing of a microorganism. ( 2) Information which is not in any way related to the effects of a microorganism on health or the environment, such as, the name of the submitting company, cost or other financial data, product development or marketing plans, and advertising plans, for which the person submits a claim of confidentiality in accordance with § 725.80.

( b) Microorganism identity  ( 1) Claims applicable to the period prior to commencement of manufacture or import for general commercial use. A claim of confidentiality for the period prior to commencement of manufacture or import for general commercial use for the specific identity of a microorganism for which a health and safety study was submitted must be asserted in conjunction with a claim asserted under § 725.85( a). The submitter must substantiate each claim in accordance with the requirements of § 725.94( a).

( 2) Claims applicable to the period after commencement of manufacture or import for general commercial use. To maintain the confidential status of the specific identity of a microorganism for which a health and safety study was submitted after commencement of manufacture or import for general commercial use, the claim must be reasserted and substantiated in conjunction with a claim under § 725.85( b). The submitter must substantiate each claim in accordance with the requirements of § 725.94( b).

( c) Denial of confidentiality claim. EPA will deny a claim of confidentiality for microorganism identity under paragraph ( b) of this section, unless:

( 1) The information would disclose processes used in the manufacture or processing of a microorganism. ( 2) The microorganism identity is not necessary to interpret a health and safety study.

( d) Use of generic names. When EPA discloses a health and safety study containing a microorganism identity, which the submitter has claimed confidential, and if the Agency has not denied the claim under paragraph ( c) of this section, EPA will identify the microorganism by the generic name selected under § 725.85. May 10, 2004 § 725.94 Substantiation requirements.

( a) Claims applicable to the period prior to commencement of manufacture or import for general commercial use   ( 1) MCAN, TME, Tier I certification, and Tier II exemption request requirements. Any person who submits a MCAN, TME, Tier I certification, or Tier II exemption request should strictly limit confidentiality claims to that information which is confidential and proprietary to the business. ( i) If any information in the submission is claimed as confidential business information, the submitter must substantiate each claim by submitting written answers to the questions in paragraphs ( c), ( d), and ( e) of this section at the time the person submits the information. ( ii) If the submitter does not provide written substantiation as required in paragraph ( a)( 1)( i) of this section, the submission will be considered incomplete and the review period will not begin in accordance with § 725.33.

( 2) TERA requirements. Any person who submits a TERA, should strictly limit confidentiality claims to that information which is confidential and proprietary to the business. If any information in such a submission is claimed as confidential business information, the submitter must have available for each of those claims, and agree to furnish to EPA upon request, written answers to the questions in paragraphs ( d) and ( e) of this section.

( b) Claims applicable to the period after commencement of manufacture or import for general commercial use. ( 1) If a submitter claimed portions of the microorganism identity confidential in the MCAN and wants the identity to be listed on the confidential Inventory, the claim must be reasserted and substantiated at the time the Notice of Commencement ( NOC) is submitted under § 725.190. Otherwise, EPA will list the specific microorganism identity on the public Inventory.

( 2) The submitter must substantiate the claim for confidentiality of the microorganism identity by answering all of the questions in paragraphs ( c), ( d), and ( e) in this section. In addition, the following questions must be answered: ( i) What harmful effects to the company's or institution's competitive position, if any, would result if EPA publishes on the Inventory the identity of the microorganism? How could a competitor use such information given the fact that the identity of the microorganism otherwise would appear on the TSCA Inventory with no link between the microorganism and the company or institution? How substantial would the harmful effects of disclosure be? What is the causal relationship between the disclosure and the harmful effects? ( ii) Has the identity of the microorganism been kept confidential to the extent that competitors do not know it is being manufactured or imported for general commercial use by anyone?

( c) General questions. The following questions must be answered in detail for each confidentiality claim:

( 1) For what period of time is a claim of confidentiality being asserted? If the claim is to extend until a certain event or point in time, indicate that event or time period. Explain why the information should remain confidential until such point.

( 2) Briefly describe any physical or procedural restrictions within the company or institution relating to the use and storage of the information claimed as confidential. What other steps, if any, May 10, 2004 apply to use or further disclosure of the information?

( 3) Has the information claimed as confidential been disclosed to individuals outside of the company or institution? Will it be disclosed to such persons in the future? If so, what restrictions, if any, apply to use or further disclosure of the information?

( 4) Does the information claimed as confidential appear, or is it referred to, in any of the following questions? If the answer is yes to any of these questions, indicate where the information appears and explain why it should nonetheless be treated as confidential. ( i) Advertising or promotional materials for the microorganism or the resulting end product? ( ii) Material safety data sheets or other similar materials for the microorganism or the resulting end product? ( iii) Professional or trade publications? ( iv) Any other media available to the public or to competitors? ( v) Patents? ( vi) Local, State, or Federal agency public files?

( 5) Has EPA, another Federal agency, a Federal court, or a State made any confidentiality determination regarding the information claimed as confidential? If so, provide copies of such determinations.

( 6) For each type of information claimed confidential, describe the harm to the company's or institution's competitive position that would result if this information were disclosed. Why would this harm be substantial? How could a competitor use such information? What is the causal connection between the disclosure and harm?

( 7) If EPA disclosed to the public the information claimed as confidential, how difficult would it be for the competitor to enter the market for the resulting product? Consider such constraints as capital and marketing cost, specialized technical expertise, or unusual processes.

( d) Microorganism identity and production method. If confidentiality claims are asserted for the identity of the microorganism or information on how the microorganism is produced, the following questions must be answered:

( 1) Has the microorganism or method of production been patented in the U. S. or elsewhere? If so, why is confidentiality necessary? ( 2) Does the microorganism leave the site of production or testing in a form which is accessible to the public or to competitors? What is the cost to a competitor, in time and money, to develop appropriate use conditions? What factors facilitate or impede product analysis? ( 3) For each additional type of information claimed as confidential, explain what harm would result from disclosure of each type of information if the identity of the microorganism were to remain confidential.

( e) Health and safety studies of microorganisms. If confidentiality claims are asserted for information in a health or safety study of a microorganism, the following questions must be answered: May 10, 2004 ( 1) Would the disclosure of the information claimed confidential reveal: confidential process information, or information unrelated to the effects of the microorganism on health and the environment. Describe the causal connection between the disclosure and harm. ( 2) Does the company or institution assert that disclosure of the microorganism identity is not necessary to interpret any health and safety studies which have been submitted? If so, explain how a less specific identity would be sufficient to interpret the studies.

§ 725.95 Public file.

All information submitted, including any health and safety study of a microorganism and other supporting documentation, will become part of the public file for that submission, unless such materials are claimed confidential. In addition, EPA may add materials to the public file, unless such materials are claimed confidential. Any of the nonconfidential material described in this subpart will be available for public inspection in the TSCA Public Docket Office, Rm. NE B607, 401 M St., SW., Washington, DC, between the hours of noon to 4 p. m., Monday through Friday, excluding legal holidays.

Subpart D  Microbial Commercial Activities Notification Requirements § 725.100 Scope and purpose.

( a) This subpart establishes procedures for submission of a notice to EPA under section 5( a) of the Act for persons who manufacture, import, or process microorganisms for commercial purposes. This notice is called a Microbial Commercial Activity Notice ( MCAN). It is expected that MCANs will in general only be submitted for microorganisms intended for general commercial use. Persons who manufacture, import, or process a microorganism in small quantities solely for research and development as defined in § 725.3 are not required to submit a notice to EPA. Persons who manufacture, import, or process a microorganism for research and development activities that do not fit the definition of small quantities solely for research and development may nonetheless qualify for more limited reporting requirements in Subpart E, including the TERA which can be used for review of research and development involving environmental release. ( b) Persons subject to MCAN submission are described in § 725.105. ( c) Exclusions and exemptions specific to MCAN submissions are described in § 725.110. ( d) Submission requirements applicable specifically to MCANs are described at § 725.150. ( e) Data requirements for MCANs are set forth in § § 725.155 and 725.160. ( f) EPA review procedures specific to MCANs are set forth in § 725.170. ( g) Subparts A through C of this part apply to any MCAN submitted under this subpart.

§ 725.105 Persons who must report.

( a) Manufacturers of new microorganisms. ( 1) MCAN submission is required for any person who intends to manufacture for commercial purposes in the United States a new microorganism. Exclusions are described in § 725.110. May 10, 2004 ( 2) If a person contracts with a manufacturer to produce or process a new microorganism and the manufacturer produces or processes the microorganism exclusively for that person, and that person specifies the identity of the microorganism, and controls the total amount produced and the basic technology for the plant process, then that person must submit the MCAN. If it is unclear who must report, EPA should be contacted to determine who must submit the MCAN.

( 3) Only manufacturers that are incorporated, licensed, or doing business in the United States may submit a MCAN.

( b) Importers of new microorganisms. ( 1) MCAN submission is required for a person who intends to import into the United States for commercial purposes a new microorganism. Exclusions are described in § 725.110.

( 2) When several persons are involved in an import transaction, the MCAN must be submitted by the principal importer. If no one person fits the principal importer definition in a particular transaction, the importer should contact EPA to determine who must submit the MCAN for that transaction.

( 3) Except as otherwise provided in paragraph ( b)( 4) of this section, the provisions of this subpart D apply to each person who submits a MCAN for a new microorganism which such person intends to import for a commercial purpose. In addition, each importer must comply with paragraph ( b)( 4) of this section.

( 4) EPA will hold the principal importer, or the importer that EPA determines must submit the MCAN when there is no principal importer under paragraph ( b)( 2) of this section, liable for complying with this part, for completing the MCAN, and for the completeness and truthfulness of all information which it submits.

( c) Manufacturers, importers, or processors of microorganisms for a significant new use. MCAN submission is required for any person who intends to manufacture, import, or process for commercial purposes a microorganism identified as having one or more significant new uses in subpart M of this part, and who intends either to engage in a designated significant new use of the microorganism or intends to distribute it in commerce. Persons excluded from reporting on significant new uses of microorganisms and additional procedures for reporting are described in subpart L of this part.

§ 725.110 Persons not subject to this subpart.

Persons are not subject to the requirements of this subpart for the following activities:

( a) Manufacturing, importing, or processing solely for research and development microorganisms that meet the requirements for an exemption under subpart E of this part. ( b) Manufacturing, importing, or processing microorganisms for test marketing activities which have been granted an exemption under subpart F of this part. ( c) Manufacturing or importing new microorganisms under the conditions of a Tier I or Tier II exemption under subpart G of this part. May 10, 2004 § 725.150 Procedural requirements for this subpart.

General requirements for all MCANs under this part are contained in subparts A through C of this part. In addition, the following requirements apply to MCANs submitted under this subpart:

( a) When to submit a MCAN. A MCAN must be submitted at least 90 calendar days prior to manufacturing or importing a new microorganism and at least 90 calendar days prior to manufacturing, importing, or processing a microorganism for a significant new use. ( b) Section 5( b) of the Act. The submitter must comply with any applicable requirement of section 5( b) of the Act for the submission of test data. ( c) Contents of a MCAN. Each person who submits a MCAN under this subpart must provide the information and test data described in § § 725.155 and 725.160. ( d) Recordkeeping. Each person who submits a MCAN under this subpart must comply with the recordkeeping requirements of § 725.65.

§ 725.155 Information to be included in the MCAN.

( a) Each person who is required by this part to submit a MCAN must include the information specified in paragraphs ( c) through ( h) of this section, to the extent it is known to or reasonably ascertainable by that person. However, no person is required to include information which relates solely to exposure of humans or ecological populations outside of the United States.

( b) Each person should also submit, in writing, all other information known to or reasonably ascertainable by that person that would permit EPA to make a reasoned evaluation of the health and environmental effects of the microorganism, or any microbial mixture or article, including information on its effects on humans, animals, plants, and other microorganisms, and in the environment. The information to be submitted under this subpart includes the information listed in paragraphs ( c) through ( h) of this section relating to the manufacture, processing, distribution in commerce, use, and disposal of the new microorganism.

( c) Submitter identification. ( 1) The name and headquarters address of the submitter. ( 2) The name, address, and office telephone number ( including area code) of the principal technical contact representing the submitter.

( d) Microorganism identity information. Persons must submit sufficient information to allow the microorganism to be accurately and unambiguously identified for listing purposes as required by § 725.12.

( 1) Description of the recipient microorganism and the new microorganism. ( i) Data substantiating the taxonomy of the recipient microorganism and the new microorganism to the level of strain, as appropriate. In lieu of data, EPA will accept a letter from a culture collection substantiating taxonomy, provided EPA, upon request to the submitter, may have access to the data supporting the taxonomic designation. ( ii) Information on the morphological and physiological features of the new microorganism. ( iii) Other specific data by which the new microorganism may be uniquely identified for Inventory purposes. May 10, 2004 ( 2) Genetic construction of the new microorganism. ( i) Data substantiating the taxonomy of the donor organism( s). In lieu of data, EPA will accept a letter from a culture collection substantiating taxonomy, provided EPA, upon request to the submitter, may have access to the data supporting the taxonomic designation. ( ii) Description of the traits for which the new microorganism has been selected or developed and other traits known to have been added or modified. ( iii) A detailed description of the genetic construction of the new microorganism, including the technique used to modify the microorganism ( e. g., fusion of cells, injection of DNA, electroporation or chemical poration, or methods used for induced mutation and selection). The description should include, for example, a description of the introduced genetic material, including any regulatory sequences and structural genes and the products of those genes; how the introduced genetic material is expected to affect behavior of the recipient; expression, alteration, and stability of the introduced genetic material; methods for vector construction and introduction; and a description of the regulatory and structural genes that are components of the introduced genetic material, including genetic maps of the introduced sequences.

( 3) Phenotypic and ecological characteristics. ( i) Habitat, geographical distribution, and source of the recipient microorganism. ( ii) Survival and dissemination under relevant environmental conditions including a description of methods for detecting the new or recipient microorganism( s) in the environment and the sensitivity limit of detection for these techniques. ( iii) A description of anticipated biological interactions with and effects on target organisms and other organisms such as competitors, prey, hosts, symbionts, parasites, and pathogens; a description of host range; a description of pathogenicity, infectivity, toxicity, virulence, or action as a vector of pathogens; and capacity for genetic transfer under laboratory and relevant environmental conditions. ( iv) A description of anticipated involvement in biogeochemical or biological cycling processes, involvement in rate limiting steps in mineral or nutrient cycling, or involvement in inorganic compounds cycling ( such as possible sequestration or transformation of heavy metals).

( e) Byproducts. A description of the byproducts resulting from the manufacture, processing, use, and disposal of the new microorganism.