A. Your foreign supplier must follow the same procedures as a U. S. submitter to obtain a CA name and provide the correct chemical identity to EPA as a joint submission or letter of support, clearly referencing your notice and PMN user fee identification number. Information on the IES service including available resource materials is available through 614 447 3600 or by facsimile ( 614 447 3747). Chemical Abstracts Services in general can be reached on 800 631 1884. See 40 CFR 720.40( e)( 2) and the PMN Instructions Manual for further information on joint submission or letter of support. In cases where the entire identity is known to neither party, each must tell EPA what it does know, and provide EPA with a CA name for the component( s) it provides.

113 Trade Mark Reactant ( TMR) Supplier 113 1. Q. Who is considered a trade mark reactant supplier?

A. Trade mark reactant suppliers manufacture chemicals and supply them to other Section 1: General Program Information 1 44 companies, generally under a trade name. Trade mark reactant suppliers can be either foreign or domestic manufacturers. They may or may not be toll manufacturers, depending on the extent of control exerted by the customer companies. EPA requires the exact chemical identity of a trade mark reactant for purposes of new chemical review. See 40 CFR 720.25( a)( 3)( ii).

113 2. Q. How is the identity of a chemical supplied by a trade mark reactant supplier determined?

A. The chemical identity of the substance supplied by trade mark reactant suppliers is often kept confidential. If the company being supplied is submitting a PMN and needs the chemical identity of the chemical substance supplied by the trade mark reactant suppliers to complete its PMN, the trade mark reactant supplier can provide this information to EPA by a letter of support or a joint submission. The trade mark reactant supplier and the company are co partners in providing chemical identity.

It is our experience that joint submissions are unusual in such cases: generally the trade mark reactant companies do not want to get involved in PMN submissions and prefer to submit letters of support. EPA does not have a preference between letters of support and joint submissions.

Manufacturers do, in such cases, need to take reasonable steps to protect themselves against a change of materials in a trade mark reactant material with confidential specific chemical identity, if the trade mark reactant material is used as a constituent in, e. g., a polymer. EPA does not use brand names in maintaining its Inventory, in part because formulations in branded materials can change and in part because the TSCA regulatory apparatus is focused on substances rather than on formulations. Reliance on EPA's, or a supplier's, confirmation of TSCA Inventory status at the time of PMN filing should be supplemented with an agreement that the supplier will notify the PMN submitter of any changes in the chemical identity of the material. A letter of support can be used.

114 Analytical Method Recommendations for Polymers 114 1. Q. There is no guidance on measurement of oligomer content. Is accumulated weight fraction on a gel permeation chromatography ( GPC) trace an adequate determination? In the absence of GPC, how can this be done?

A. Cumulative weight fraction is a commonly accepted method. EPA has not prescribed any analytical methodology, so others may be acceptable, depending on circumstances.

114 2. Q. What are the analytical requirements with respect to insoluble polymers? Can inference from melt flow data and comparison to other polymers be adequate? Can I use Monte Section 1: General Program Information 1 45 Carlo simulation methods ( such as Oligo 5) to estimate the MW of an insoluble polymer theoretically?

A. EPA does not require any specific analytical methodology. Inference from physical behavior, from comparison to close analogues, and from theoretical calculation is acceptable where appropriate or where other methods are inapplicable. Monte Carlo methods, while widely used, have not been subjected to much experimental verification. If your polymer is expected to have values of MW or oligomer content near the allowable thresholds, you should probably not rely too strongly on such methods.

115 Test Data Requirements 115 1. Q. What is EPA's definition of health or environmental test data?

A. According to 40 CFR 720.3( ff), " Test data" means data from a formal or informal test or experiment, including information concerning the objectives, experimental methods and materials, protocols, results, data analysis, recorded observations, monitoring data, measurements, and conclusions from a test or experiment. " Health and safety study" is defined at TSCA § 3( b) and 40 CFR 720.3( k). The scope of the definition is quite broad and all encompassing. The statutory definition is, " any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological, or other studies of a chemical substance or mixture, and any test performed under the Act. Chemical identity is always part of a health and safety study." The scope of the definition elaborates that the study can be formal or informal, and can include assessment of exposure effects and risk to human health or the environment. See Q& A section 117 below for more on health and safety studies.

115 2. Q. What type( s) of test data must a submitter include with a § 5 Notice to EPA?

A. Under § 5( d)( 1) of TSCA and 40 CFR 720.50, each notice must contain all test data in the submitter's possession or control which are related to the effects on health or the environment of any manufacture, processing, distribution in commerce, use or disposal of the new chemical substance or any mixture or article containing the new chemical substance, or any combination of such activities. This includes test data concerning the new chemical substance in a pure, technical grade, or formulated form. The following types of test data must be submitted with a full report or standard literature citation: health effects data, ecological effects data, physical and chemical properties data, environmental fate characteristics, monitoring data, and other test data related to human exposure to or environmental release of the chemical substance.

There is no required minimum data set. If, however, you are expecting to make a high Section 1: General Program Information 1 46 volume of the chemical substance (" high" is 100,000 kilograms per year or greater) you are likely to be asked to conduct the New Chemicals Exposure Based Core Data Set or High Production Volume Data Set. A related discussion can be found on the Internet at: www. epa. gov/ chemrtk/ volchall. htm. See Q& A # 100 12 for more on EPA's exposure based policy. If EPA reviewers find that they need data not included with the submission to be able to appropriately assess the substance, the submitter will be required either to suspend review and develop the needed data for submission to EPA before any manufacture, or to agree to develop the data as part of a § 5 Consent Order with EPA. ( There is an exception to this requirement, if the data is available in the open scientific literature. See 40 CFR 720.65( c)( 1)( iii) and Q& A # 115 5.) In addition, all data must be submitted in English.

In addition, the submitter must describe other data known to, or reasonably ascertainable by, the submitter. See 40 CFR 720.50( b) for additional details.

115 3. Q. Does your office want test data on similar substances when a company submits a PMN?

A. Test data on similar substances can be extremely helpful, particularly if no data exist on the new chemical substance itself. EPA encourages the submission of data on similar substances with the premanufacture notice. If the submitter plans to submit a series of notices on members of a chemical class, EPA encourages submitters to contact EPA and negotiate a testing program for that class prior to submission of the PMNs.

115 4. Q. Can alternatives to the exposure based base set of tests requested by EPA be submitted if there are valid scientific reasons?

A. Yes, if you reach agreement with EPA to do so, the standard § 5( e) Consent Order can be modified. EPA realizes that there are often a number of different but acceptable means to provide testing information. Companies can always submit any data to EPA but EPA reviewers may not accept the data as satisfactorily addressing the risk assessment issues EPA believes need to be addressed for a given chemical. EPA believes that the core tests on the PMN substance are the preferred testing and in any request to substitute a different test protocol, the protocol must be submitted to EPA in writing with the rationale for that change. EPA must then approve the different test( s). EPA's acceptance of a proposed test protocol not specified by EPA depends on multiple factors including the specifics of the test substance, purpose of the testing, familiarity with specific procedures and equipment, validation of the method, etc. Typical TSCA § 5( e) Consent Orders require the use of OPPTS Harmonized Test Guidelines. The OPPTS Harmonized Test Guidelines are available through the Internet at www. epa. gov/ opptstrs/ home/ guidelin. htm  these guidelines have been developed by OPPTS for use in the testing of pesticides and toxic substances, and the development of test data that must be submitted to EPA for review under Federal regulations. Section 1: General Program Information 1 47 OPPTS has developed these guidelines through a process of harmonization that blended the testing guidance and requirements that existed in the Office of Pollution Prevention and Toxics ( OPPT) and appeared in title 40, chapter I, subchapter R of the Code of Federal Regulations ( CFR), the Office of Pesticide Programs ( OPP) which appeared in publications of the National Technical Information Service ( NTIS), and the guidelines published by the Organization for Economic Cooperation and Development ( OECD).

The purpose for harmonizing these guidelines into a single set of OPPTS guidelines is to minimize variations among the testing procedures that must be performed to meet the data requirements both of the U. S. Environmental Protection Agency under the Toxic Substances Control Act ( TSCA) ( 15 U. S. C. 2601) and the Federal Insecticide, Fungicide and Rodenticide Act ( FIFRA) ( 7 U. S. C. 136 et seq.) and of other regulatory bodies in OECD countries.

115 5. Q. How should test data be submitted if the data is available in open scientific literature?

A. Per 40 CFR 720.50( a)( 3)( ii), if data appears in the open scientific literature, the submitter need only provide a standard literature citation. A standard literature citation includes author, title, periodical name, date of publication, volume, and page numbers. EPA encourages the submitter to assist EPA by providing a photocopy of the article, if desired. This is the only exception to the requirement that all information must be submitted in English; open literature reports can be submitted in their original languages. If an English translation is available, EPA encourages its submission.

115 6. Q. How should test data be submitted if the data is not available in the open scientific literature?

A. Per 40 CFR 720.50( a)( 3)( i), if the data does not appear in the open scientific literature, the submitter must provide a full report, and it must be in English. A full report includes the experimental methods and materials, results, discussion and data analysis, conclusions, references, and the name and addresses of the laboratory that developed the data.

115 7. Q. What should a submitter do if a study, report, or test is not complete when the notice is submitted?

A. This question is answered by 40 CFR 720.50( a)( 4). EPA encourages the notice submitter to schedule any testing so that it will be complete before the submission of a § 5 notice. However, if a study, report, or test is incomplete when a person submits a notice, the submitter must identify the nature and purpose of the study; name and address of the laboratory developing the data; progress to date; types of data collected; significant preliminary results; and anticipated completion date. If a significant preliminary result of a test or experiment is completed before the notice review period ends, the person must submit the study, report, or test to the address listed Section 1: General Program Information 1 48 on the notice form within ten days of receiving it, but no later than five days before the end of the review period. If information becomes available during the last 5 days of the review period, the submitter must immediately inform EPA by telephone. ( See also the provision at 40 CFR 720.40( f) on " new information" obtained during the notice review period.)

115 8. Q. Does a submitter need to resubmit data previously sent to EPA?

A. Not if the data was previously submitted as non confidential. Per 40 CFR 720.50( d)( 1), a submitter need not submit any data previously submitted to EPA with no claims of confidentiality if the PMN includes the office or person to whom the data were submitted, the date of submission, and, if appropriate, a standard literature citation. On the other hand, if data were submitted with claims of confidentiality, the submitter must resubmit the data with the § 5 notice and any claim of confidentiality under 40 CFR § 720.80.

115 9. Q. Does a submitter need to collect data outside the United States for EPA?

A. Per 40 CFR 720.50( d)( 3), a PMN submitter need not provide any data which relates only to exposure of humans or the environment outside the United States. However, under 40 CFR 720.50( b), any non exposure data known to or reasonably ascertainable by the submitter such as data on health effects ( including epidemiological studies), ecological effects, physical and chemical properties, or environmental fate characteristics must be provided.

115 10. Q. What scientific disciplines are represented on the Structure Activity Team ( SAT)?

A. The following scientific disciplines are represented on the SAT: chemistry, environmental fate, ecotoxicity, absorption/ metabolism, mutagenicity, oncogenicity, developmental/ reproductive toxicity, neurotoxicity, acute toxicity, and subchronic/ chronic toxicity.

115 11. Q. Does EPA recommend pre meetings to discuss new chemical testing needs?

A. Consultation with EPA's personnel prior to submission of a PMN ( referred to as prenotice communication) can help submitters strengthen future § 5 submissions. This consultation can be accomplished through a letter to EPA outlining the proposed submission which may or may not need to be supplemented by a meeting with EPA's personnel. If a submitter plans to perform toxicity or other testing on a new chemical substance, EPA will provide guidance on the types of tests that would be useful to EPA in assessing the health and environmental effects of the new chemical substance. This can enable a potential submitter to begin needed work in advance of PMN review. Prenotice personnel will coordinate EPA's response to a proposed submission, including scheduling of a meeting if necessary. Prenotice personnel can usually do at least as well, and often better, in meeting a submitter's information needs through written communication Section 1: General Program Information 1 49 supplemented by phone calls as through a meeting.

Pre notice meetings, as opposed to phone and letter consultations, are most often useful when a potential submitter wants an overall understanding of the review process and of the criteria which will be used to assess applications.

115 12. Q. We have studies provided to us by our parent company in a foreign country. They are not written in English. We understand that we have to provide material to EPA in English. How formal does our translation have to be?

A. The translation has to be good enough that our scientists can confidently use the translated studies in assessing the risk potential of the chemical substance. A relatively informal translation can be adequate, if it is clear to our assessors what has been done and how. If the translation is unsatisfactory, the New Chemicals Program may ask you to suspend the review period on your PMN until an adequate translation is submitted.

115 13. Q. How will the toxicity information I provide be used by EPA to assess my PMN chemical?

A. EPA uses toxicity data for the PMN substance when available and fills in data gaps with toxicity data on other chemicals with molecular structures similar to the PMN substance (" structural analogs") to conduct risk assessments. If it is determined that a potential risk exists during any part of the life cycle of the chemical, EPA will look for ways to minimize potential risks. Risk management may be accomplished through use of appropriate controls, including prohibition of releases to water, use of workplace personal protective equipment or, for inhalation exposures only, the development of a new chemical exposure limit ( NCEL). A NCEL is an airborne exposure concentration in the workplace at which an adult would be unlikely to suffer adverse effects if exposed for a working lifetime. Exposures above the NCEL require the use of respirators.

To conduct a risk assessment for non cancer endpoints, EPA compares the estimated exposures with no adverse effect levels ( NOAELs) or lowest adverse effect levels ( LOAELs) from the toxicity studies. The ratio between the estimated exposure level and the NOAEL or LOAEL is called the margin of exposure ( MOE). The new chemicals program is usually looking for a MOE of 100 or greater for a NOAEL from a developmental toxicity study or a subchronic study. The MOE should be one order of magnitude larger when using a LOAEL ( a MOE of 1000).

To conduct a risk assessment for carcinogens, the estimated exposure is multiplied by the q1* ( or slope factor) derived from a cancer study ( usually for a structural analog) to give a cancer risk estimate. EPA generally uses an acceptable risk of 10 5 ( 1 in 100,000) for workers and 10 6 Section 1: General Program Information 1 50 ( 1 in 1,000,000) for the general population. A NCEL for a cancer concern is developed based on a cancer risk of 10 4 ( 1 in 10,000) but assumes a worker is exposed over an entire lifetime  a maximum of 250 days per year for 40 years out of a 70 year lifespan.

116 Environmental Fate Data 116 1. Q. What information on physical and chemical properties is routinely needed for an assessment of the environmental fate of a PMN substance?

A. PMN reviewers assessing environmental fate generally need:

° for solids, the melting point; ° for inorganic substances, water solubility at 25 degrees C, pH 7; ° for organics which hydrolyze, hydrolysis half life at 25 degrees C, pH 7; and ° results of a ready aerobic biodegradation test See Chemical Assistance Manual for Premanufacture Notification Submitters at www. epa. gov/ oppt/ newchems/ chem pmn/ chap2. pdf. EPA guidelines for testing methods, both for Physical/ Chemical properties and specific environmental fate values, are at www. epa. gov/ opptstrs/ home/ guidelin. htm.

117 Health and Safety Data 117 1. Q. What types of data are covered by EPA's definition of health and safety studies?

A. " Health and safety study" is defined at TSCA § 3( 6) and 40 CFR 720.3( k). A health and safety study means any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological, or other studies of a chemical substance or mixture, and any test performed under the Act. Chemical identity is always part of a health and safety study. Not only is information which arises as a result of a formal, disciplined study included, but other information relating to the effects of a chemical substance or mixture on health or the environment is also included. In sum, any data bearing on the effects of a chemical substance on health or the environment would be included.

117 2. Q. What types of health studies is EPA interested in?

A. Examples of health studies EPA is concerned with include: tests on mutagenicity, carcinogenicity, developmental toxicity, aquatic toxicity, etc.; data on behavioral disorders; dermal toxicity; pharmacological effects; mammalian absorption, distribution, metabolism, and excretion; cumulative, additive, and synergistic effects, subchronic, and chronic effects; worker Section 1: General Program Information 1 51 inhalation and dermal exposure monitoring; and structure/ activity analysis.

117 3. Q. What are some of the core health studies that EPA may require? What are some additional data which can be useful?

A. For those PMN substances meeting significant or substantial human exposure criteria ( see www. epa. gov/ opptintr/ newchms/ expbased. htm) and warranting testing as determined by EPA, a submitter may be asked to perform some or all of the following health core tests on the PMN substance: an Ames assay; an in vivo micronucleus ( mice, gavage); an acute oral toxicity ( rats, gavage); and a 28 day repeated dose oral study. This list is not exhaustive; if another study is believed to be more appropriate for a specific substance, it may be substituted for one or more of these studies. Examples of other types of information which may be sought include: for salts of pigments, dissociation or stability at pH 1.0; for powdered solids, particle size distribution; for aerosols, aerosol size distribution.

EPA's guidelines for testing methods, both for physical/ chemical properties and specific environmental fate values, appear at www. epa. gov/ opptstrs/ home/ guidelin. htm. See Q& A section 115 for more on testing.

117 4. Q. What are some of the endpoints of maternal toxicity?

A. Maternal toxicity refers to mortality, infertility, changes in body weight, lessened weight gain, or organ weight, gestation length, clinical signs of toxicity, food and water consumption, and necropsy and histopathology findings.

117 5. Q. What is the study design for a short term in vivo developmental toxicity study?

A. An example of a satisfactory short term in vivo study design is one that includes: ° timed mating; ° implantation success; ° exposure of the mother during major organogenesis midway to end of term ( exposure groups: vehicle control, high dose minimal maternal toxicity, second dose recommended); and ° condition of offspring at term ( maternal evaluation, litter size/ gross malformations, viability/ weight). ( See the OPPTS Harmonized Test Guidelines # 870.3700 at www. epa. gov/ opptsfrs/ home/ guidelin. htm. A comparable test guideline appears at 40 CFR 799.9370.)

117 6. Q. What are some of the endpoints of developmental toxicity? Section 1: General Program Information 1 52 A. Some of the endpoints of developmental toxicity are pre implantation loss, post implantation loss, structural abnormalities, fetal weights, sex ratio, stillbirths, postnatal offspring weights, clinical signs, functional deficits, necropsy and histopathology findings.

117 7. Q. What are the objectives of the guidelines for developmental toxicity testing?

A. The objectives of the guidelines on developmental toxicity testing are to: provide guidance for evaluating risk to humans from exposure to chemicals during development; define developmental toxicity and provide the rationale for approaches to evaluating data; detail types of adverse effects seen in developing organisms and the relationship to adult toxicity; provide guidance for evaluating animal study data; and lastly, establish consistency in evaluating data and assessing risk for developmental toxicity.

117 8. Q. Who reviews toxicology data on a PMN?

A. OPPT toxicologists who are specialists in either human health or environmental/ wildlife effects review PMN toxicology data. The PMN review process is diagramed and discussed in the New Chemicals Program brochure ( available from the Hotline) and at www. epa. gov/ oppt/ newchems/.

117 9. Q. A PMN for a chemical I wish to import in liquid phase has just passed the 90 day review. The first batch we want to import is going to be in powder phase, not liquid, though it is the same exact chemical identity. Does this require submission of a new PMN?

A. The PMN/ § 5 form asks for information about the physical form of the substance [ e. g., solid ( crystals, granules, powder, dust), liquid ( solution, paste, slurry, emulsion, mist, spray), gas ( vapor, fume), wet press cake] to which individuals or the environment will be exposed, percent new chemical substance ( if in a mixture), and protective equipment and engineering controls employed to safeguard the worker from potential exposure associated with the new chemical substance, i. e., gloves, goggles, respirators, etc. This is for the purpose of enabling reviewers to assess worker exposure and environmental release. Clearly, if the physical form identified in the § 5 submission form is not the one which is to be used, the ability of EPA reviewers to do their job in protecting workers' health and the environment effectively is compromised.

PMN submitters are required to describe their intended process to the best of their knowledge and intent as of the time the PMN is filed ( and, as required at 40 CFR 720.40( f), to notify EPA of any new information becoming available during the PMN review period.) A NOC may be filed years after the PMN was submitted. NOC submitters are required only to file the information required at 40 CFR § 720.102, most recently amended at 60 FR 16298 16351 ( March 29, 1995). Changes in the submission, including physical form, is not addressed in the NOC. In the interim, the information provided in the original PMN may have changed due to advances in Section 1: General Program Information 1 53 synthetic technique, change of location, change in ownership, change of toll manufacturer, etc.

It is very important to try to identify all conditions which may be important in assessing exposure in the originally submitted § 5 submission form, and to describe the submitter's intent as accurately as possible. Although EPA recognizes that a company may make changes after the PMN review period has expired such as switching from import to domestic manufacture ( or vice versa), from liquid to powder form, changing synthetic process, etc., it would be unusual for such a change to happen immediately after the PMN review period has expired without prior intent/ knowledge on the part of the submitter. In such a case, EPA may find cause to investigate such changes. In a case such as this, it would be prudent for a submitter to prepare a narrative for its files to describe how it came to make such a shift so quickly after the PMN was filed, to enable any future EPA inspector to understand how it came to be. See, e. g., In re DuPont, TSCA III 731. See www. epa. gov/ aljhomep/ orders/ denemour. htm.

117 10. Q. If a high volume PMN substance is recognized as having low toxicity, what size of exposed population does EPA consider to be significant? Is there a formula?

A. § 5( e)( 1)( A)( ii)( II) of TSCA authorizes EPA to regulate a new chemical for which there is insufficient information about the chemical's effects on human health and the environment and for which substantial production volume and substantial or significant human exposure or substantial environmental release is anticipated.

EPA's rationale for selecting cases for exposure based actions was first discussed publicly in a September 22, 1988 letter. This letter is available through EPA's TSCA Hotline. A current discussion of EPA's exposure based policy, as well as the scanned text of this letter with updated attachments, is available at www. epa. gov/ oppt/ newchems/ expbased. htm.

118 Ecotoxicity Data 118 1. Q. What types of ecological or other environmental effects studies is EPA interested in?

A. EPA is concerned with studies on ecological or other environmental effects on fish, invertebrates, or other animals, and plants. These studies include: 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. EPA's New Chemicals Program pays particular attention to potential aquatic toxicity.

118 2. Q. What is the base set for ecotoxic concerns?

A. The base set for ecotoxicity includes acute toxicity to fish, acute toxicity to daphnia, Section 1: General Program Information 1 54 and algal growth inhibition. See www. epa. gov/ oppt/ newchems/ expbasedtesting. htm and www. epa. gov/ oppt/ newchems/ co xbeco. txt. Beyond the base set, additional testing will be requested depending in part on how an organism responds to base set tests, comparison to similar substances ( SAR), expected amount of the substance to be released to the environment, testing on biodegradability and abiotic degradation, and on what the producers recommend as appropriate.

118 3. Q. What are some of the ecotoxicity tests that EPA may require?

A. For those PMN substances meeting the substantial environmental release criterion and warranting testing as determined by EPA, submitters may be asked to perform some or all of the following core environmental tests on the PMN substance ( this is called the aquatic acute toxicity " base set"): 96 hour LC50 in fish ( flow through method and measured concentrations), 48 hour LC50 test in daphnia ( flow through method and measured concentrations), and a 96 hour bioassay in algae ( static method and measured concentrations).

118 4. Q. How does EPA utilize the information from structure activity relationships ( SARs)?

A. Structure activity relationships ( SARs) can provide estimates of the inherent toxicity of chemicals based upon the relationship among the physico chemical properties of chemicals and toxicity to organisms. Relationships vary from statistical regression techniques to identification of the nearest analogs. The product of statistical regression is generally an equation whose predictive capability is measured by the degree of correlation between the independent and dependent variables.

118 5. Q. What estimation methods are used by EPA when characterizing a chemical's ecotoxicity?

A. Fewer than 5% of all PMN submissions contain ecotoxicity data. Therefore, when data are not available to characterize a chemical's toxicity, estimation methods are used to predict the chemical's ecotoxicity based on its chemical structure and physical/ chemical properties.

The most important estimation method is the substance's similarity to others with known properties. This assessment is called structure activity relationship ( SAR) analysis. Current SAR techniques for ecotoxicity allow prediction of inherent toxicity to fish, invertebrates, and algae. Analysis of large ecotoxicity data sets has revealed predictive relationships which are useful in determining a chemical's toxicity. As examples:

° when the 24/ 96 hour ratio of acute fish LC50s or 24/ 48 hour ratio of acute daphnid LC50s are equal to or greater than 2, the chemical has a higher probability for chronic toxicity; Section 1: General Program Information 1 55 ° when the acute LC or EC50 is less than 1 ppm the chemical has a higher probability for chronic toxicity; and ° for anionic surfactants, the chronic value can be predicted by dividing the fish and daphnia acute values by 6.5.

119 Polymer Issues 119 1. Q. Where can I find more information about the Polymer Exemption Rule?

A. See Q& A section 304.

119 2. Q. Is a PMN required for Inventory listing of a polymer if the monomers comprising the polymer are on the Inventory?

A. If the polymer is not included on the Inventory then a PMN is required for Inventory listing unless the polymer qualifies for manufacture under one of the Exemptions. A PMN may be filed, even on a polymer which is eligible for the Polymer Exemption, if the submitter desires Inventory listing. See 40 CFR 723.250( d)( 4).

119 3. Q. If a polymer is on the Inventory but contains a non Inventory monomer, can you import it?

A. Yes. If the polymer is on the Inventory it is an existing chemical, and no PMN or other notice or exemption is required to import it. Even if a polymer is on the Inventory, however, it may not be manufactured domestically unless all the reactants are on the Inventory, because, in the US, a chemical may not be manufactured, processed, or used unless it is on the TSCA inventory. See TSCA § 5( a).

Please note that the Polymer Exemption cannot be used for a material which contains a non Inventory monomer or reactant. See 40 CFR 723.250( d)( 4). Unless you have a real intent to import or manufacture a monomer, you cannot file a PMN or an exemption for that monomer. Thus a PMN ( or an LVE or LoREX exemption) is the only mechanism to import a polymer which contains a non Inventory monomer.

119 4. Q. An imported polymer is described as a sodium salt and the submitter determines analytically that sodium is present at two percent or less. Can the submitter assume that sodium hydroxide was the neutralizing agent used to produce that material, and should the submitter therefore use the sodium hydroxide molecular weight in determining the percent incorporated ( and hence the chemical identity)? Section 1: General Program Information 1 56 A. Yes. In the absence of information about the source of the sodium ion, sodium hydroxide should be used as the default source and the calculations should be based on the molecular weight of sodium hydroxide. The hydroxides of magnesium, aluminum, potassium and calcium should also be used as the default sources of the respective ions. See the Polymer Exemption Guidance Manual at www. epa. gov/ opptintr/ newchems/ polyguid. pdf for more details.

119 5. Q. Is a regular PMN for a polymer ever necessary, if a Polymer Exemption PMN was submitted prior to the effective date ( May 30, 1995) of the 1995 amendments and approved? If a Polymer Exemption PMN is already commercialized, when would the commercialization of such a regular PMN for the polymer begin, if the manufacturing process was not changed?

A. A pre 1995 Polymer Exemption would have been listed in the Inventory ( with a " Y1" flag if meeting the general category for exemptible polymers, and a " Y2" flag if meeting the Exemption category for certain polyester polymers). The filing on which the listing was based would ordinarily have included limits on composition ( maximum percentage of residual amounts of unreacted monomers and low molecular weight species below 500 and 100 molecular weight, e. g.). If a person plans to manufacture the polymer outside the composition limits of the alreadygranted Polymer Exemption, or if the intending manufacturer does not want to meet the procedural requirements of the 1995 amended Polymer Exemption, or if the polymer itself is not compliant with the requirements of the 1995 amended Polymer Exemption, then a PMN will be required.

As noted above, the composition limits are not published with the Inventory, so someone who was not the original submitter of the notice filed under the original ( pre 1995) Polymer Exemption could manufacture the material under the exemption ( if within the composition limits) only after first contacting EPA to determine whether they would satisfy the composition limits.

If a PMN is filed for the purpose of removing the composition limits, manufacture after the end of the PMN review period can be either within or outside of the composition values or ranges specified in the exemption notice submitted under the original ( pre 1995) Polymer Exemption. The submitter MUST submit a NOC when the polymer is manufactured outside of the compositional values or ranges specified in the pre 1995 Polymer Exemption notice for the first time after expiration of the PMN review period. See the Polymer Exemption Guidance Manual at www. epa. gov/ opptintr/ newchems/ polyguid. pdf for more details.

119 6. Q. Is it acceptable to submit a PMN for a polymer already being manufactured under the terms of the Polymer Exemption?

A. Yes. Certain manufacturers choose to do so, in order to have the polymer listed on the TSCA Inventory. Section 1: General Program Information 1 57 119 7. Q. Would chain transfer agents used in polymer manufacturing be in the same category as free radical initiators or must they be included in the polymer identity?

A. Chain transfer agents that are used in the manufacturing of a polymer at a level of greater than 2% ( by weight) must be included in the polymer description. If a monomer or other reactant, such as a chain transfer agent, is used at a level of 2% or less, the submitter has the option to either include or exclude it from the polymer description to be used in the Inventory listing.

If a monomer or other reactant is not included or reflected in the Inventory polymer name, that monomer or other reactant cannot later be used at greater than 2 percent in the polymer. See 40 CFR 720.45( a)( 2)( iii). Conversely, if monomers or other reactants are included in the Inventory name, they may be used at any level as long as they are not eliminated completely without the resulting polymer name ( not including those monomers/ reactants) also being on the Inventory or unless the manufacturer's PMN for that resulting polymer has completed review. In such situations, it may be appropriate for a manufacturer to request permission from the Prenotice Coordinator to submit a consolidated notice encompassing a series of similar polymers.

Note that a free radical initiator must also be included in a polymer name when used at more that 2% unless the corresponding polymer name without the initiator was " grandfathered" onto the Inventory by July 28, 1989. Refer below to Q& A # 119 8. Also, see the Polymer Exemption Guidance Manual at www. epa. gov/ opptintr/ newchems/ polyguid. pdf for more details.

119 8. Q. Polymer A B C is already on the Inventory. A new proposed process now uses a free radical initiator. Must a PMN be filed?

A. If the polymer A B C was on the Inventory before July 28, 1989 ( the effective date of the FR notice clarifying the policy on manufacturing polymers using free radical initiators), then polymers of that  composition using initiators are also considered to be A B C, and consequently on the Inventory, regardless of the level of initiator. If Polymer A B C was not on the Inventory prior to July 28, 1989, and the initiator D is used at 2% or more, the resulting polymer must be identified as A B C D. If that polymer is not on the Inventory, a PMN [ or exemption] is necessary. Thus, free radical initiators must be reported and included in polymer names when used at more than 2% by weight in the manufacture of any post July 28, 1989, new polymer. ( See 54 FR 27174).

119 9. Q. A submitter wants to manufacture a polymer of 4 monomers plus use an initiator at > 2% ( The initiator will be incorporated into the final polymer). The polymer of the 4 monomers plus the initiator is not on the TSCA Inventory. What options are available to the submitter to begin commercialization as soon as possible? Section 1: General Program Information 1 58 A. If the polymer name of the specified 4 monomers without the free radical initiator was not on the Inventory as of July 28, 1989, then a PMN { or Exemption other than the Polymer Exemption} will need to be filed unless the polymer qualifies for the 1995 amended Polymer Exemption. If the polymer name without the initiator was added to the Inventory after July 28, 1989, an alternative in this situation could be to switch to two or more different TSCA listed initiators, either charging each at  2% or determining via the " incorporation method" that each would be considered present in the polymer at  2%. ( Refer to the 1995 PMN Rule Amendments and Q& A # 119 10 below.) In addition, one should set up procedures to ensure that the 2% level will not be exceeded at some later date. One might also consider using the Polymer Exemption, if the polymer is eligible for it.

119 10. Q. In light of the modified " Two Percent Rule," which now allows reporting of polymers as incorporated as well as charged, can all polymer listings on the Inventory now be read either as incorporated or as charged?

A. Yes. All polymers on the Inventory can be interpreted either as incorporated or as charged. Remember that " incorporated" means the minimum amount of free radical initiator in theory required to be charged in order to account for the amount of initiator molecules or fragments found in the polymer itself.

119 11. Q. How do you apply the molecular weight ( MW) distribution requirement of the polymer definition ( i. e., < 50 percent of any one MW) to highly cross linked polymers of essentially infinite MW?

A. For polymers of " essentially infinite" MW, unless the entire mass of polymer produced were in one continuous phase, the actual molecular weight would be limited by the size of the individual droplets, beads, pellets, flakes, etc. No two of these would be likely to have the exact same mass, and the distribution criterion would be met. For that matter, the molecular weight ( MW) determination itself would produce a range of values because of the finite precision of the instrument. See the Polymer Exemption Guidance Manual at www. epa. gov/ opptintr/ newchems/ polyguid. pdf for more details.

119 12. Q. Would the following example ( where the longest continuous chain of reactant units is 1 + 1 + 2 = 3 + 1) count as a " polymer molecule?"

H( oxypropylene) O sorbitol O( propyleneoxy) 2 H A. No. Sorbitol cannot be a repeating monomer unit under the conditions of the relevant polymerization reaction ( propoxylation), so it is considered an " other reactant". Therefore the longest sequence of monomer units ( considered as derived from propylene oxide) is two. A continuous string of at least three monomer units is required, plus one additional monomer unit or Section 1: General Program Information 1 59 other reactant. See the Polymer Exemption Guidance Manual at www. epa. gov/ opptintr/ newchems/ polyguid. pdf for more details.

120 Principal Importer 120 1. Q. Who is considered the principal importer?

A. 40 CFR § 720.3( z) states that: " The principal importer is the first importer, who, knowing that a new chemical substance will be imported rather than manufactured domestically, specifies the identity of the chemical substance and the total amount to be imported. Only persons who are incorporated, licensed or doing business in the United States may be principal importers." The principal importer may specify the chemical identity and amount either to the foreign producer or to a US entity ( customs broker, e. g.) which transmits the order abroad.

120 2. Q. We are the sole customer for a compound being imported by another company. Can we be considered the principal importer and submit a PMN?

A. The sole customer in the U. S. may meet the definition of " principal importer" by specifying the chemical substance and the amount to be imported. The Prenotice Communications Coordinator can provide guidance on particular situations.

121 Import Issues 121 1. Q. For the purpose of TSCA, is importation considered to be manufacture? If so, if a PMN has been filed for an imported product, will a domestic manufacturer have to file a PMN prior to manufacture in this country?

A. TSCA defines " manufacture" to include " import". See TSCA § ( 3)( 7) and 40 CFR 720.3( q). Once EPA receives a NOC and the chemical is listed on the Inventory, it may be manufactured or imported by anyone, unless there is a restriction as described below. If as a result of the original PMN submission, a Significant New Use Rule ( SNUR) was issued restricting the chemical to import only, a Significant New Use Notice ( SNUN) would have to be filed and successfully reviewed before the chemical could be manufactured domestically.

In any case, even after filing and successful review of the submission, if no NOC has been received by EPA from the submitter, no one but the submitter can initiate manufacture.

121 2. Q. For imported chemicals, what is considered the first day of commercialization  the day it leaves the shipping country, the day it arrives in customs, or the day it clears customs? Section 1: General Program Information 1 60 A. " Day 1" is the date the new chemical substance clears US customs.

121 3. Q. How can a Ninth Collective Index ( 9CI) Chemical Abstracts ( CA) name be obtained for an imported substance whose identity is claimed as confidential by its foreign supplier?

A. Your foreign supplier must follow the same procedures as a U. S. submitter to obtain a CA name and provide the correct chemical identity to EPA as a joint submission or letter of support, clearly referencing your notice and PMN user fee identification number.

Information on the CAS Inventory Expert Service ( CAS IES) including available resource materials is available through 614 447 3600 or by facsimile ( 614 447 3747). For general Chemical Abstracts Services call 800 848 6538.

122 Biotechnology 122 1. Q. Are microbes/ microorganisms subject to TSCA?

A. Yes, certain microorganisms are subject to TSCA. However, the required notification form called a Microbial Commercial Activity Notice ( MCAN), is necessary only for intergeneric microorganisms formed by the deliberate combination of genetic material originally isolated from organisms of different taxonomic genera. Non intergeneric microorganisms are considered implicitly on the Inventory. See 40 CFR Part 725; G2 FR 17910, April 11, 1997; and 59 FR 45526, Sept. 1, 1994.

Microorganisms that are used as foods, food additives, drugs, cosmetics, medical devices, and pesticides are regulated by the Food and Drug Administration ( FDA), USDA, or EPA's Office of Pesticide Programs. Requirements for foods, food additives, drugs, cosmetics, and medical devices are described in the FDA and USDA notices in the Federal Register and Code of Federal Regulations.

122 2. Q. Are plants and animals subject to TSCA?

A. As EPA has previously stated, although plants and animals do fall within the scope of the definition of a " chemical substance" under TSCA § 3, plants and animals are not currently subject to the new chemical provisions of TSCA, either as whole organisms or as in vitro cultures. EPA has stated that it is reserving authority under TSCA to screen transgenic plants and animals in the future as needed. See 59 FR 45526, 45527 ( September 1, 1994). However, if plant or animal gene segments are intentionally incorporated into microorganisms, the microorganisms that contain those plant or animal genes would be subject to the TSCA § 5 requirements established at 40 CFR part 725, providing that the microorganism does not fall within one of the specific exclusions found in TSCA section 3 ( e. g., the microbe is not itself a food, food additive, or Section 1: General Program Information 1 61 tobacco). In addition, a chemical extracted from a plant or animal would generally be subject to TSCA, presuming that it does not fall within the exclusions listed at TSCA section 3. See 40 CFR § 720.3( e).

123 Significant New Use Rule ( SNUR)

123 1. Q. What are consent orders and significant new use rules?

A. EPA review of a PMN can result in a finding of potential unreasonable risk or substantial production and exposure. In these cases, EPA can negotiate a TSCA § 5( e) Consent Order, which generally allows the PMN submitter to manufacture or import the new substance for the PMN identified use( s) only under specified conditions ( e. g., use of worker protective equipment or environmental release controls). However, a § 5( e) Consent Order is not binding on any companies that may subsequently manufacture or import the substance other than the submitter who signed the § 5( e) Consent Order. Consequently, after signing a § 5( e) Consent Order with the PMN submitter, EPA generally promulgates a Significant New Use Rule ( SNUR), which applies similar restrictions as in the § 5 ( e) Consent Order to other potential manufacturers and processors. Such a SNUR is often referred to as a " § 5( e) SNUR." SNURs require that manufacturers, importers and processors of certain substances notify EPA at least 90 days before beginning any activity that EPA has designated as a " significant new use." The new use designations in a § 5( e) SNUR correspond with activities prohibited by the § 5( e) Consent Order and are generally promulgated on an expedited (" direct final", see 54 FR 31299) basis. The advance notification required by SNURs ( called a Significant New Use Notice or SNUN) allows EPA to prevent or limit potentially adverse exposure to, or effects from, the new use of the substance.

When the EPA review determines that the exposure scenario proposed in a PMN is not expected to pose an unreasonable risk, EPA generally does not issue a § 5( e) Consent Order. The reviewers may, however, identify potential new uses different from those identified in the PMN which could result in increased exposures to or releases of the substance, and in turn a potential unreasonable risk to health or the environment. In such cases, EPA can issue a SNUR that requires the submission of a SNUN 90 days prior to commercial manufacture not conforming to the conditions reviewed under the PMN. Such a SNUR is called a " non § 5( e) SNUR," and may also be issued on an expedited basis. ( The 1995 TSCA PMN rule amendments expanded the types of significant new use designations that EPA may promulgate in expedited " non § 5( e)" SNURs. This change is intended to improve the efficiency of the SNUR procedure for both EPA and the chemical industry. See Q& A # 123 2 and 60 FR 16298ff.)

123 2. Q. Why did EPA create the non 5( e) Significant New Use Rule ( SNUR) amendment to 40 CFR 721.170 ( c)( 1)? What did the amendment change? Section 1: General Program Information 1 62 A. EPA created the non 5( e) SNUR amendment to enable the regulation of potentially risky new chemicals using fewer EPA resources, and to allow PMN submitters to commence commercial manufacture sooner. The amendment to 40 CFR § 721.170( c)( 1) eliminated the provision that prevented EPA from promulgating expedited non 5( e) SNURs containing worker protection or hazard communication requirements. Before the amendment, expedited non 5( e) SNURs were limited to requirements controlling disposal ( § 721.85), releases to water ( § 721.90), and certain industrial, commercial and consumer activities ( § 721.80). After the amendment, expedited non 5( e) SNURs may include any of the requirements in Subpart B, including worker protection ( § 721.63), hazard communication ( § 721.72), and all of the industrial, commercial and consumer activities ( § 721.80).

123 3. Q. What chemicals are affected by the non 5( e) Significant New Use Rule ( SNUR) amendment to 40 CFR 721.170( c)( 1)?

A. This amendment of the " Generic SNUR" did not automatically apply to any specific chemical substance. It is merely a procedural tool that EPA can use to impose " significant new use" reporting requirements in individual, chemical specific SNURs for PMN substances where EPA reviewers identify other potential uses that may present unreasonable risk or have the potential for substantial production volume and substantial or significant human exposure or substantial environmental release.

123 4. Q. What is the difference between a § 5( e) Order and a Significant New Use Rule ( SNUR)?

A. An order under § 5( e) applies only to the manufacturer who submitted the PMN. SNURs apply to everyone who manufactures or processes the chemical substance. A SNUR establishes a requirement to notify EPA 90 days before commencing any activity that the SNUR defines as a " significant new use." In response to a Significant New Use Notice ( SNUN), EPA will review the proposed use, and may issue a § 5( e) Order to control potential unreasonable risks or substantial and/ or significant exposures that may be presented by the significant new use.

123 5. Q. What is the difference between a § 5( e) SNUR and a Non 5( e) SNUR?

A. A § 5( e) SNUR is a SNUR which is promulgated only after a § 5( e) Order is issued for the same chemical substance, and which extends to all subsequent manufacturers/ users the provisions of the § 5( e) Consent Order. " Non 5( e) SNURs" are those SNURs which are promulgated without issuance of a § 5( e) Order, because EPA did not find that the exposure scenario described in the PMN " may present unreasonable risk," but other exposure scenarios might. See Q& A # 100 12 for more on EPA's exposure based policy.

123 6. Q. What is the difference between a " Notice and Comment SNUR" versus an " Expedited Section 1: General Program Information 1 63 SNUR"?

A. Notice and Comment rulemaking involves publishing a proposed rule, receiving public comment, and publishing a final rule. This is the " standard" rulemaking process. Expedited rulemaking involves publishing a " Direct Final" rule that automatically becomes final unless someone requests a comment period. Expedited rulemaking also allows batching of individual SNURs and abbreviated review within EPA. If a comment period is requested, this process takes more of EPA's resources and takes longer than Notice and Comment rulemaking. EPA uses expedited rulemaking in cases where it does not think comment is likely ( e. g., SNURs which put into place restrictions already agreed upon between EPA and a PMN filer). Expedited rulemaking enables those who wish to manufacture under the terms of a SNUR to initiate their activity quickly, and saves EPA resources. Both types of rulemaking provide opportunity for comment by interested persons, as required by the Administrative Procedures Act. See 40 CFR 721.160( c) and 721.170( d)( 4).

123 7. Q. What type of case is appropriate for a non 5( e) SNUR?

A. A non 5( e) SNUR is typically appropriate when a PMN is filed for a chemical substance which is expected to be toxic but the PMN describes intended use( s) and an exposure scenario that is not expected to pose unreasonable risk of injury to human health or the environment. Intended uses and activities can be limited, or the submitter can state that it will implement control measures, or otherwise adequately mitigate human exposures and environmental releases. Although activities described in such PMNs may be judged not to present an unreasonable risk of injury to human health or the environment, if there are significant deviations from the described activities the substance may present an unreasonable risk warranting the imposition of regulatory controls pending the development of information. In those cases, a non 5( e) SNUR may be the most appropriate regulatory alternative for EPA to pursue, as it will allow the PMN submitter to proceed with planned activities while requiring notification to, and review by, EPA for activities which have not been reviewed and may involve significantly increased exposures. Such review will be undertaken upon receipt of a SNUN.

123 8. Q. How can I determine whether my substance is subject to a SNUR?

A. To facilitate determining whether a substance is subject to a SNUR, substances on the Inventory that are subject to SNUR requirements are indicated by an " S" flag in the Inventory listing ( In electronic versions of the Inventory, the flags may be on another line, rather than following the substance name.) If your chemical substance is subject to a SNUR and you intend to engage in an activity defined as a " significant new use" in the SNUR, you would be required to submit a SNUN to EPA at least 90 days before commencing that activity.

Several options are available to ascertain the TSCA Inventory/ SNUR status of a chemical Section 1: General Program Information 1 64 substance. See Q& A section102. Information on non confidential chemical substances can be found in the TSCA Chemical Substance Inventory. If an intended manufacturer submits a PMN or a Notice of bona fide Intent to Manufacture ( pursuant to 40 CFR § 720.25) on a substance/ mixture which has a listing on the Confidential Inventory, EPA will notify the submitter of the existence of the SNUR when it informs the submitter a PMN is not necessary. Any manufacturer of a substance subject to a SNUR must notify anyone they distribute the substance to about the SNUR.

124 Pollution Prevention 124 1. Q. What type of pollution prevention information does EPA want?

A. EPA would like to collect information on pollution prevention activities, such as source reduction and recycling. In addition, EPA would like waste management information ( i. e., treatment, and disposal data). This information will be used in the evaluation of the new chemical substance and in comparison of the relative risks and benefits of the substance as a substitute for substances currently on the market. The PMN form ( EPA Form 7710 25) encourages submitters to report on page 11 any and all relevant information not reported elsewhere which is believed to be important for a thorough regulatory evaluation. There is a substantial discussion of how to provide this information in the PMN Manual, posted at www. epa. gov/ oppt/ newchems/ tscaman2. pdf.

125 Recycling 125 1. Q. An intending recycler will take articles from municipal waste, and grind and melt them to cast them into new articles. The recycler will make a good faith effort to select articles ( for example, soda pop bottles) of uniform probable composition, but the chemistry of each article is known to the recycler only in general terms. In addition to the intending recycler's lack of specific knowledge and control on the materials in the articles, it is expected that, if any new chemical substances had been formed during final manufacture of the articles, they would have been exempt from PMN requirements per 40 CFR § 720.30( h)( 6) ( which excludes substances that form during the manufacture of an article destined for the marketplace without further chemical change (" end use")). Because of the availability of the ( h)( 6) exclusion, the intending recycler believes that the articles were probably manufactured without premanufacture notification ( PMN) to EPA for any new substances formed during manufacture.

The recycler intends to prepare for recycling by grinding, chipping, or other physical manipulation. No actual chemical reactions are believed to be involved in this process, just the physical manipulation of the material. It is the recycler's plan to melt the material and cast or form it into new articles for sale. Section 1: General Program Information 1 65 Is a PMN required for this activity?

A. Where no chemical reactions are believed to be taking place, EPA considers melting and manual grinding to constitute " processing" under TSCA, and a PMN would thus not be required. However, if the component substances in the articles were to be chemically changed ( e. g. partially de synthesized, depolymerized, etc., e. g.), the intending recycler would need to submit a PMN and describe the material using a reaction product or process type name that indicates the nature of the chemical conversion. See 40 CFR 720.( 3)( s) and ( aa).

While TSCA holds a person strictly liable for the illegal manufacture or import of a new chemical substance, a person processing an illegally manufactured new chemical substance would not be in violation of TSCA unless the person knew or had reason to know that the substance had been illegally manufactured. See § 15( 2) of TSCA.

126 New Chemical Exposure Limits 126 1. Q. What are New Chemical Exposure Limits?

A. New Chemical Exposure Limits ( NCELs) are workplace respiratory exposure limits established in TSCA 5( e) Consent Orders and incorporated by reference in corresponding TSCA 5( a)( 2) SNURs. They are modeled after OSHA Permissible Exposure Limits (" PELs") and are comprehensive standards. NCELs set what are considered to be safe airborne concentrations for new chemicals that may cause toxicity via inhalation exposure. Periodic monitoring is required and, if concentrations above the NCEL are measured, respirators must be worn.

126 2. Q. Where can I find the actual NCELs values listed for various new chemicals?

A. The internet address is www. epa. gov/ oppt/ newchems/ nceltbl. htm. The NCELs values originate in TSCA § 5( e) Consent Orders that are signed by the individual PMN submitters who propose to manufacture the PMN substance. The NCELs provisions are incorporated by reference in corresponding TSCA § 5( a)( 2) SNURs, which essentially extend the requirements of the § 5( e) Order to other manufacturers and processors of the same chemical substance. SNURs are published in 40 CFR Part 721. 126 3. Q. Where does EPA's exposure limit jurisdiction end and OSHA's begin?

A. There will generally be no overlapping regulation of new chemicals, because EPA's NCELs apply to new chemicals with little or no data, so risk assessment is generally based on analog data from similar substances. EPA added an explicit sunset provision to its § 5( e) Orders which states that the NCEL and respirator requirements are automatically nullified if OSHA promulgates a permissible exposure limit ( PEL) for the same substance. ( This would automatically nullify the NCELs in SNURs as well, since the NCELs provisions in SNURs simply Section 1: General Program Information 1 66 incorporate by reference the § 5( e) Consent Order provision.) EPA may raise NCELs cases to the attention of OSHA and NIOSH, in the unlikely event that a referral is warranted by the toxicity data and production volume associated with the new chemical substance.

EPA has sought to make its program consistent with OSHA's wherever possible. EPA has ongoing communication with OSHA and NIOSH on worker protection issues and has solicited input on the NCELs program. EPA's NCELs provisions are modeled after OSHA PELs and comprehensive standards.

126 4. Q. When setting NCELs concentrations for specific chemicals, does EPA consider feasibility issues and relevant concentration limits set by other organizations?

A. On a case by case basis, EPA will consider setting NCELs concentrations based on relevant OSHA PELs and American Conference of Government Industrial Hygienists ( ACGIH) Threshold Limit Values ( TLVs), and will consider economic and technological feasibility, especially in cases where there is sufficient evidence that the new chemical may present less risk than existing substances which the new chemical may replace. Section 2: Exclusions 2 1 2. EXCLUSIONS 201 Impurities 201 1. Q. What is an impurity?

A. " Impurity" is defined at 40 CFR § 720.3 to mean a chemical substance which is unintentionally present with another chemical substance. The term " manufacture or import for commercial purposes" also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts that are separated from that other substance or mixture and impurities that remain in that substance or 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 of a chemical substance for commercial purposes. See 40 CFR 720.3( r).

Information on all impurities anticipated to be present with a chemical substance must be included in a PMN, and is considered in the assessment of risk posed by that substance. Maximum weight percent, as well as the CASRN, if available, should be provided on page 6 of the § 5 submission form. If the impurities are unidentified, their presence should be noted and their total weight percent estimated.

201 2. Q. Are impurities included in the chemical identification for the Inventory?

A. No, impurities are not included in the chemical identification for the Inventory listing of a chemical substance. EPA has determined that chemical substances which are identical except with respect to their impurities will not receive separate Inventory listings. Impurities that are discovered in a chemical substance after a Notice of Commencement ( NOC) has been submitted do not change the Inventory status of the chemical substance. If there are unreasonable risks posed by impurities present in existing chemical substances, TSCA § 4, § 6, § 7, and § 8 can be used to identify, prevent, and reduce those risks.

This differs from the identification of a new component determined to be included in a listed chemical substance, when that component has commercial value. If a previously unknown commercially valuable component is found in a listed chemical substance and if the listed chemical substance including the new component is determined not to be accurately listed on the Inventory, then the manufacturer of the component chemical substance is considered to be the manufacturer of a new chemical substance. The submitter should contact EPA in order to determine whether a PMN or a Form C ( Inventory correction) should be submitted.

201 3. Q. At what level do impurities become insignificant, i. e., not subject to reporting? Section 2: Exclusions 2 2 A. As defined in 40 CFR § 720.3, an " impurity" means a chemical substance which is unintentionally present with another chemical substance. The definition is not based on the amount of the substance. Impurities at any level are significant and must be reported as impurities in § 5 notices, to the extent they are known or reasonably ascertainable by the submitter. An impurity need not, itself, be the subject of a § 5 notice. See 40 CFR § 720.30( h)( 1).

201 4. Q. Is there a restriction on the level or amount of an impurity detected in a chemical substance?

A. No. There is no restriction on the level or amount of an impurity detected in a chemical substance. Specifically, there is no relationship between the impurity reporting requirements and the 2% rule which applies in relation to polymers.

202 Mixtures 202 1. Q. What is the definition of a mixture?

A. " Mixture" is defined at § 3( 8) of TSCA and 40 CFR § 720.3 as any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction. Mixture also includes the combination which occurs, in whole or in part, as a result of a chemical reaction where none of the chemical substances comprising the combination is a new chemical substance and where the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined.

202 2. Q. Is a PMN required for a new mixture?

A. TSCA § 5 requires a PMN for new chemical substances, not for new mixtures. A PMN is not required for a mixture as a whole entity. However, if any chemical substance which is included in the mixture is a new chemical substance, a PMN is required to be submitted for that new chemical at least 90 days before a submitter intends to manufacture or import the mixture. See 40 CFR 720.30( b) and especially its footnote.

202 3. Q. Are multi nutrient mixed fertilizers considered mixtures if they are prepared by physically blending dry products?

A. A multi nutrient mixed fertilizer is considered a mixture of the ingredients being blended. Such multi nutrient mixed fertilizers can be prepared by physically blending dry products such as urea, superphosphate, and potash or by a method that involves a chemical reaction, such as by combining liquid ammonium phosphate and granulating with potash. Per the definition of ` mixture' at 40 CFR 720.3( u), these substances are considered mixtures regardless of whether Section 2: Exclusions 2 3 they are produced by physically mixing or by chemical reaction.

202 4. Q. Are alloys, inorganic glasses, ceramics, frits, and cements, including Portland cement, considered mixtures under TSCA?

A. Yes, alloys, inorganic glasses, ceramics, frits, and cements, including Portland cement, are considered statutory mixtures under TSCA. See www. epa. gov/ oppt/ newchems/ mixtures. txt. In general, a PMN is not required for these products. However, as stated in a note at 40 CFR § 710.4( c)( 2) and 40 CFR § 720.30( b), the exclusion of these products applies only to the mixture and not to the chemical substances of which the mixture is comprised. Thus, any additive which is contained in a mixture, other than an impurity, should be included on the Inventory. The burden of reporting is incident on the manufacturers of any new chemical additive.

202 5. Q. Does the definition of mixture under TSCA include hydrates?

A. Yes. EPA views a hydrate as a mixture of water and the non hydrated form of the substance. Hydrated forms of chemical substances are excluded from reporting if the corresponding anhydrous chemical substances are included on the Inventory. However, this provision does not apply to the products of discrete chemical reactions in which either water or a solvent is a reactant, e. g., water reacting with an ester to form an acid and an alcohol. See 40 CFR 720.3( u)( 2).

202 6. Q. A submitter is manufacturing an alloy and the individual metals are on the Inventory, is a PMN required?

A. No, alloys are considered to be mixtures. As long as all the components comprising the mixture are on the Inventory, a PMN is not required. Intermetallic compounds of well defined stoichiometry such as NbAl3 are not considered alloys and should be reported. Inventory nomenclature guidance is available on this question at www. epa. gov/ oppt/ newchems/ mixtures. txt in the paper entitled Toxic Substances Control Act Inventory Representation For Products Containing Two or More Substances: Formulated and Statutory Mixtures.

203 Non isolated Intermediates 203 1. Q. What is a nonisolated intermediate?

A. Nonisolated intermediates are exempt from PMN per 40 CFR 720.30( h)( 8). As defined at 40 CFR 720.3( w), a " nonisolated intermediate" is any intermediate that is not intentionally removed from the equipment in which it is manufactured, including the reaction vessel, and any equipment through which the chemical substance passes during a continuous flow Section 2: Exclusions 2 4 process, but not including tanks or other vessels in which the substance is stored after its manufacture. Questions on specific manufacturing processes should be directed to the Prenotice Communication Coordinator. A fact sheet on nonisolated intermediates is available from the TSCA Hotline.

203 2. Q. What is an isolated intermediate?

A. An isolated intermediate is defined in part as any chemical substance intentionally removed from the equipment in which it is manufactured. See 40 CFR 720.3( w). This phrase includes the reaction vessel in which the substance was manufactured and other equipment which is strictly ancillary to the reaction vessel, and any other equipment through which the chemical may flow during a continuous flow process, but does not include tanks or other vessels in which the chemical substance is stored after its manufacture.

Some manufacturers have questioned whether storage for a period of two or three hours is still considered to be part of a continuous flow process. Without a complete description of the manufacturing operation, it is difficult to give a precise answer. In general, any chemical substances which are held temporarily in an otherwise continuous flow process for purposes that are clearly related to the necessity of the manufacturing process  such as heating, cooling, filtration or reaction  are not considered reportable, while those that are held principally for purposes of storage would be considered reportable. If manufacturers have further questions, they should consult EPA individually.

The following examples offer clarification:

( 1) Reaction in the Same Vessel: Reactants A and B are charged to a reaction vessel to form a chemical substance X. Then C is added to react with X to form another substance Y, which is then drummed for shipment. In this example, X is considered to be nonisolated, since it is not intentionally removed from the process equipment of manufacture. Y will be considered to be isolated, since it is intentionally removed by drumming for transport.

( 2) Reaction in one vessel with Purification in Another and Transfer to a Second Vessel: The reaction is carried out in one enclosed reactor and the reaction mixture is then pumped through an enclosed drum filter to another vessel for the next reaction step. The reaction intermediate is considered to be nonisolated since there is no intentional removal and all transfer is mechanical and through closed equipment. However, if the filtration is not closed or if the transfer is manual ( for example, involving the removal of the intermediate as a filter cake), then the intermediate would be considered to be isolated since the transfer would not be through closed equipment. A similar interpretation applies to other processing steps between manufacture and subsequent reaction ( e. g., distillation, drying size reduction, etc.).

In the case of batch processes, which for purposes of discussion also includes Section 2: Exclusions 2 5 semi continuous processes, intentional storage is considered isolation, regardless of whether the equipment is closed or not. As discussed in the March 6, 1978 Federal Register ( 43 FR 9256), any chemical substances which are held temporarily in an otherwise continuous flow process principally for purposes of storage are considered reportable. The fact that a material remains in the reaction vessel for a period of time does not determine whether the material is isolated and must be reported. It is a matter of intent: if the residence time is for storage purposes, the material is reportable. If the material is held for a non storage purpose ( e. g., if holding an intermediate in a vessel is to provide for maintenance or repair), it is not considered to be isolated. The period of time is not crucial, as long as the intent is not for storage.

As an example, the annual removal and replacement of an enzyme catalyst used in the production process or the exchange of filters during routine maintenance would not affect the nonisolated status of an intermediate in an otherwise closed system. However, if a filter is opened to manually transfer a filter cake containing an intermediate substance, this intermediate is considered to be isolated. In addition, the removal of samples of an intermediate substance strictly for quality control testing would not affect the nonisolated status of an intermediate substance.

203 3. Q. What is the difference between a batch and continuous flow process?

A. In a batch process, a reaction occurs when the reagents are charged as a fixed quantity ( usually expressed as mass per batch) and the reaction is allowed to go to completion. In a continuous reaction, the reagents are added continuously ( generally given in terms of mass per unit time) and the reaction mixture is constantly flowing; its residence time in any piece of equipment can only be given by a probability function.

EPA defines " nonisolated intermediate" at 40 CFR 720.3( w) as " any intermediate that is not intentionally removed from the equipment in which it is manufactured .... but not including tanks or other vessels in which the substance is stored after its manufacture." " In general, any chemical substances which are held temporarily in an otherwise continuous flow process for purposes that are clearly related to the necessity of the manufacturing process   such as heating, cooling, filtration or reaction   are not considered reportable, while those that are held principally for purposes of storage would be considered reportable." 43 FR 9256, March 6, 1978.

203 4. Q. Does removal of substance from a reaction vessel for sampling constitute isolation?

A. Quality control sampling of a nonisolated intermediate is not isolation and does not disqualify the intermediate from the premanufacture notification exclusion for nonisolated intermediates at 40 CFR 720.30 ( h)( 8).

204 Byproducts Section 2: Exclusions 2 6 204 1. Q. What is the definition of a byproduct?

A. As defined at 40 CFR 720.3( d), a " byproduct" is a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance or mixture. Byproducts and impurities without separate commercial value are nonetheless produced for the purpose of obtaining commercial advantage, since they are part of the manufacture of a chemical substance for commercial purposes. See 40 CFR 720.3( r). A byproduct is subject to notification requirements unless its only commercial purpose is use by public or private organizations that burn it as a fuel, dispose of it as a waste, or extract component chemical substances from it for commercial purposes. See 40 CFR 720.30( g). ( This exclusion only applies to the byproduct; it does not apply to any component substances extracted from the byproduct.) In addition, any byproduct which is not used for commercial purposes is not subject to notification requirements. See TSCA § 5( i) and 40 CFR 720.22.

204 2. Q. A product is already on the TSCA Inventory but its by product is not listed in the Inventory. At a later date, if there is a demand for the by product, is the manufacturer required to submit a PMN before he begins to manufacture the by product for commercial purposes?

A. Yes, you must submit a PMN if a by product begins to be produced with a separate commercial intent, unless its only commercial purpose is for use by public or private organizations that burn it as fuel, dispose of if as waste, or extract component chemical substances from it for commercial purposes, per 40 CFR 720.30( g).

204 3. Q. Can a by product which is not on the Inventory be used as an intermediate in the manufacture of another chemical substance which is on the Inventory?

A. Not without first submitting a PMN. As with any new chemical, use as a raw material or intermediate in the manufacture of another chemical is commercial use requiring submission of a PMN, unless the by product is on the Inventory or has gone through PMN review. A by product cannot ( unless it is never isolated) be used in manufacture.

204 4. Q. We have filed a PMN and the 90 day review period has expired. This is a material which, until now, had been manufactured as a waste byproduct that was typically disposed of by incineration ( and thus was exempted from PMN at 40 CFR § 720.30( g)( 2)). Can we now distribute material which had been generated prior to the expiration date of the PMN review period?

A. Until the PMN review period is over, a new chemical cannot be manufactured for commercial use or sale. During the review period, the only permitted manufacture is for R& D purposes or for disposal as a waste. Obviously, once the substance is manufactured with the intention of being used for TSCA nonexempt purposes, it is subject to PMN requirements if it is Section 2: Exclusions 2 7 not already included on the TSCA Chemical Substance Inventory ( Inventory). See 40 CFR 720.30( g).

Once the PMN review period has expired, if the substance was previously manufactured as a byproduct, and was stored with the intent that it would be disposed of in case the PMN was not approved, it may be used for commercial purposes. However, a Notice of Commencement ( NOC) cannot be filed until the first manufacture with intent for commercial use after the end of the 90 day PMN review period.

The material manufactured prior to the termination of the 90 day PMN review has to be dealt with as a substance manufactured for R& D purposes, thus subject to the R& D procedural and record keeping requirements at 40 CFR 720.36 and 720.78.

Once a NOC has been filed on later ( post PMN review) manufacture of the same material, the material produced prior to the termination of the 90 day PMN review period can also be used for commercial purposes.

205 End Use Reactions 205 1. Q. When is a chemical substance that is formed upon end use of another chemical substance ( which is on the Inventory) not subject to notification requirements?

A. 40 CFR § 720.30( h)( 5) excludes from PMN requirements " any chemical substance which results from a chemical reaction that occurs upon end use of another chemical substance, mixture, or article such as an adhesive, paint, miscellaneous cleanser or other housekeeping product, fuel additive, water softening and treatment agent, photographic film, battery, match, or safety flare, and which is not itself manufactured or imported for distribution in commerce or for use as an intermediate."

206 Modifier of Physicochemical Characteristics 206 1. Q. When is a substance that modifies a physicochemical characteristic not subject to notification requirements?

A. A substance is subject to notification requirements even if its sole intention is to act as a modifier of a physicochemical characteristic. This is to be distinguished from a chemical substance that is exempt from PMN notification requirements under 40 CFR 720.30( h)( 7)( ii) if it results from a chemical reaction that occurs when a chemical substance intended solely to modify a specific physicochemical characteristic, functions as intended.

207 Articles Section 2: Exclusions 2 8 207 1. Q. What is the definition of an article?

A. " Article" is defined at 40 CFR § 720.3 as a manufactured item which: ( 1) is formed to a specific shape or design during manufacture; ( 2) has end use function( s) dependent in whole or in part upon its shape or design during end use; and ( 3) either has no change of chemical composition during its end use or only those changes in composition which have no commercial purpose separate from the article of which it is a part and that may occur as described in 40 CFR § 710.4( d)( 5) and 40 CFR § 720.30( h)( 5), except that fluids and particles are not considered articles regardless of shape or design. Substances imported as part of an article are exempt from PMN per 40 CFR 720.22( b)( 1), and certain chemicals formed during manufacture of an article are exempt from PMN per 40 CFR 720.30( h)( 6).

207 2. Q. Is brake fluid in a domestically manufactured car reportable? Is brake fluid in an imported car reportable? Is the same brake fluid imported in a drum reportable?

A. A substance such as brake fluid would be subject to premanufacture notification when made for installing in a vehicle that is manufactured domestically. With respect to imports, 40 CFR section 720.22( b)( 1) states, that " Any person who intends to import a new chemical substance into the United States for commercial purposes must submit a notice, unless the substance is excluded under section 720.30 or unless the substance is imported as part of an article." Chemical substances or mixtures will be considered to be imported as part of an article if the substance or mixture is not intended to be removed from that article and has no end use or commercial purpose separate from the article of which it is a part. Chemical substances or mixtures which are imported within articles such as drums, barrels, or other containers used for purposes of transportation or containment are considered to be chemical substances imported in bulk and are subject to PMN reporting requirements, because they are intended to be removed from the container eventually and have an end use or commercial purpose separate from the container.

Therefore, brake fluid is exempt from Inventory/ PMN reporting when imported as a component of an article ( for example in the brake system of an imported car), provided the article which it accompanies in commerce is not solely a container for it, and it is not intended to be released during use, and does not serve a function during use that is related to its release. However, brake fluid imported in a drum would be reportable.

207 3. Q. Is a pen an article? Is the ink in the pen a part of an article?

A. A pen meets the definition of an article at 40 CFR 720.3( c). However, the ink is intended for release during use, and thus is not exempt from PMN requirements. ( Refer to the above question). Section 2: Exclusions 2 9 207 4. Q. Is a candle an article? Is the substance released by a candle as it burns considered part of an article?

A. A candle meets the definition of an article at 40 CFR 720.3( c). With respect to the combustion products of a candle, 40 CFR 720.30( h)( 5) excludes from PMN requirements any chemical substance which results from a chemical reaction that occurs upon end use of an article and which is not itself manufactured or imported for distribution in commerce or for use as an intermediate. Therefore, combustion products of a candle are exempt.

207 5. Q. Is a candle or pen that contains a new chemical substance excluded from premanufacture notification?

A. A substance that forms during the manufacture of an article destined for the marketplace without further chemical change is excluded from premanufacture notification per 40 CFR 720.30( h)( 6). Thus, any new substances which comprise the candle or pen would be excluded from PMN reporting as part of an article, but new substances isolated before the domestic manufacture of a candle or pen would be reportable. On the other hand, ink, which is intended to be released from the pen is not exempt. See Q& A # 207 3.

207 6. Q. Are fibrous materials considered articles?

A. They can be. Fibrous materials are considered articles ( see 40 CFR § 710.2( f) & § 720.3( c)) if their end use functions depend in whole or in part upon their shape or design and they are functional in their end use without a change of chemical composition except for changes that have no commercial purpose separate from the articles of which they are a part. If a person shapes a chemical substance into a filament or fiber, he would be a processor of that substance and would not have to report the fiber based on the fact that the final product of the processing meets the definition of an article. The chemical substance would be reportable by the manufacturer. However, if that fibrous material was intended to be used as an intermediate in the manufacture of another chemical substance, it would not be considered an article, but rather a chemical substance or mixture. Particles are not articles whether they are round or asymmetric. If a whisker or other fibrous material may be used as a particle in its subsequent processing, it would not be considered an article.

207 7. Q. Are dyes and/ or fire retardants excluded from reporting with regard to the finishing process of an article?

A. The intent of the exclusions at 40 CFR § § 710.5( d)( 6) and 720.30( h)( 6) with regard to the finishing process of an article ( i. e., dyes and fire retardants) is to exclude chemical substances that are not manufactured for distribution in commerce as a chemical substance per se and have no commercial purpose separate from the mixture or article of which they may be a part. This Section 2: Exclusions 2 10 excludes chemical substances formed when the dye or fire retardant reacts with fibers of a garment or other article upon end use of those substances by a processor. The dyes and fire retardants themselves are not excluded from reporting requirements if applied domestically, but could be exempt when imported as part of an article. End use reaction products should not be reported.

207 8. Q. Please clarify what is covered by the article exemption: what about chemical components of articles?

A. " Article" is defined at 40 CFR § 720.3( c). In general, an item would meet the definition of an article if it is manufactured in a specified shape or design for a particular end use application, and this design is maintained as an essential feature in the finished product. An example would be an automobile bumper, which had to fit the auto model for which it is made. If an item is manufactured in a particular shape for the purpose of shipping convenience and the shape of the item has no function in the end use, it would not be viewed as an article. An example would be a metal ingot, or a pellet intended to be melted and extruded in the manufacture of an article.

Chemical substances that are imported " as part of an article" are excluded from the PMN requirements by 40 CFR § 720.22 ( b)( 1). It is EPA's policy that a chemical substance is not " part of an article" where ( 1) the article is a container of the substance used to transport, contain, and/ or dispense it, and/ or ( 2) the substance is intended to be removed ( or released) from the article and has an end use or commercial purpose separate from the article. A substance which is intended to be removed or released from its article/ container, and serves a function during use related to the removal/ release of the substance, is considered to have an end use or commercial purpose separate from the article. Components contained by articles that are released upon end use and have a function separate from the article are subject to PMN reporting requirements. Depending on circumstances, the same component can meet, or not meet, the criteria. For example, brake fluid contained in the brake cylinder of an imported automobile would be part of the automobile, which is an article. The same brake fluid contained in a can ( which is an article), and intended to be installed in the automobile after import, is considered to have an end use or commercial purpose separate from the article.

207 9. Q. Would a chemical substance formed upon end use of an article, such as adhesive or photographic film, be subject to notification requirements?

A. No. 40 CFR § 720.30( h)( 5) provides that any chemical substance which results from a chemical reaction that occurs upon end use of another chemical substance, mixture, or article such as an adhesive, paint, miscellaneous cleanser or other housekeeping product, fuel additive, water softening and treatment agent, photographic film, battery, match, or safety flare, and which is not itself manufactured or imported for distribution in commerce or for use as an intermediate, is Section 2: Exclusions 2 11 excluded from notification requirements.

207 10. Q. Would a chemical substance that results from a chemical reaction that occurs upon use of any other chemical substance, and formed during the manufacture of an article, such as curable plastic, be subject to notification requirements?

A. No. 40 CFR § 720.30( h)( 6) exempts any chemical substance which results from a chemical reaction that occurs upon use of curable plastic or rubber molding compounds, inks, drying oils, metal finishing compounds, adhesives, or paints, or any other chemical substance formed during the manufacture of an article destined for the marketplace without further chemical change of the chemical substance except for those chemical changes that occur as described elsewhere in § 720.30( h) is excluded from notification requirements.

208 The Two Percent Rule for Polymers 208 1. Q. Please explain the changes in the " two percent rule" for polymers.

A. The " two percent rule," which has been in effect since 1977, allows manufacturers and importers of polymers to add monomers or other reactants to an Inventory listed polymer at levels of 2 percent or less ( based on the dry weight of the manufactured polymer) without being considered to have made a polymer with a different chemical identity than the Inventory listed polymer. The two percent rule also serves as a basis for determining the identity of a polymer that must be reported. This method is calculated based on the weight percentage of the monomer or other reactant " charged" to the reaction vessel. The 1995 amendments to the New Chemicals Program regulations ( 60 Federal Register 16298, 16310, 40 CFR 720.45( a)( 2)( iii)) allow persons greater flexibility in determining the two percent level. In addition to being able to use the " charged" method, the 1995 amendments allow persons to use an alternative method, e. g., to determine the amount of monomer or other reactant that is " chemically incorporated ( chemically combined)" in a polymer, and to report the minimum weight percent of that monomer or reactant that is needed in theory to account for the amount incorporated. A manufacturer is free to use either method to determine a two percent level, however the " incorporated" method, while providing more flexibility, also requires supporting analytical data or theoretical calculations per 720.45( a)( 2)( iv).

This change in the " two percent rule" applies to all polymers under TSCA, including Inventory listings, PMN submissions, and Polymer Exemptions.

208 2. Q. In light of the modified " two percent rule," which now allows reporting of polymers as incorporated as well as charged, can all polymer listings on the Inventory now be read either as incorporated or as charged? Section 2: Exclusions 2 12 A. Yes. All polymers on the Inventory can be interpreted either as incorporated or as charged. Remember that " incorporated" means the minimum amount that theory requires to be charged in order to account for the amount of monomer/ reactant molecules or fragments found in the polymer itself.

208 3. Q. Does a manufacturer need to test every batch of polymer to prove that less than two percent is incorporated, or would one documented test on a typical batch be sufficient?

A. A company is not required to test every batch, but is required to maintain in its records analytical data or theoretical calculations to demonstrate compliance with the " two percent rule" when using the " incorporated" method. See 40 CFR 720.28. If the amount normally incorporated is expected to be close enough to two percent that occasional batches might exceed that level, either more frequent testing, or always considering the reactant to be part of the chemical identity, or manufacturing a separate exempt polymer with the reactant present at greater than two percent and included in the polymer identity, might be appropriate.

208 4. Q. If a non Inventory listed monomer is charged or incorporated at less than or equal to two percent can the resultant polymer still be eligible for the Polymer Exemption?

A. Yes. However, under § 5( a), if a monomer or other reactant is not on the Inventory or otherwise excluded from reporting or exempted from § 5 requirements, it cannot be used for domestic manufacture, regardless of its concentration in the product polymer.

A polymer containing a non Inventory listed monomer at less than or equal to two percent may be eligible for the polymer exemption provided that the monomer does not " introduce into the polymer elements, properties, or functional groups that would render the polymer ineligible for the exemption". 40 CFR 723.250( g)( 1).

It is important to note that a non Inventory listed monomer that is not on the list of permitted reactants for the § 723.250( e)( 3) exemption ( polyesters) will render it ineligible for that exemption. There are in fact reactants on that list that are not on the Inventory. These are not subject to the two percent limitation, since they have already been reviewed for inclusion in this list by EPA and are considered not to be of concern.

208 5. Q. Can polymers that utilize less than or equal to two percent of non Inventory listed monomers be eligible for the Polymer exemption?

A. Such polymers would be eligible for exemption as long as they meet all the other exemption criteria. However, a monomer used at any concentration must be on the Inventory or exempt before it can be used in the domestic manufacture of the polymer. Section 2: Exclusions 2 13 208 6. Q. A prepolymer that is on the Inventory, is used to make a polymer. The prepolymer contains a non Inventory monomer, and the final polymer contains greater than two percent of that monomer. Will my polymer be ineligible for the Polymer exemption?

A. Not on the basis of the non Inventory monomer; § 723.250( d)( 4) bars the use of " monomers and/ or other reactants... that are not already included on the TSCA Chemical Substance Inventory...". However, in this case the Inventory listed prepolymer is the reactant that is actually charged to the polymerization reaction vessel. Thus, the polymer is eligible for exemption as long as it meets all the other exemption criteria. The name of the final polymer will include the non Inventory listed monomer if the prepolymer is identified for TSCA Inventory purposes with a random monomer based polymer name.

208 7. Q. If an initiator is incorporated at no more than two percent, does it have to be on the TSCA Inventory for the polymer to be eligible for the Polymer Exemption?

A. An initiator or other reactant present at no more than two percent does not have to be on the Inventory for a polymer to be eligible for the Polymer exemption. However, if the reactant is not on the Inventory, it cannot be used for commercial manufacture in the United States. Consequently, this discussion will for all practical purposes be applicable only to imported polymers. See the Polymer Exemption Guidance Manual at www. epa. gov/ opptintr/ newchems/ polyguid. pdf for more details.

208 8. Q. Can I use less than or equal to two percent of any monomer that is on the Inventory and still be eligible for the Polymer Exemption?

A. Yes, as long as that monomer does not introduce elements, groups or properties that would render the polymer ineligible at the concentration of monomer used. Note, though, that for the § 723.250( e)( 3) " polyester" exemption, all components of the polymer must be on the list of allowable reactants. In this case the use of non listed monomers, even at two percent or less, would render the polymer ineligible for the ( e)( 3) exemption.

208 9. Q. If the " chemically combined" method is used and a company claims that two percent or less of a reactant is incorporated into the polymer even though the company charges a higher level to the reaction vessel, what records need to be maintained?

A. The company's records must contain analytical data or appropriate theoretical calculations to demonstrate that the minimum weight of monomer or other reactant required in theory to account for the actual weight of monomer of other reactant molecules or fragments chemically incorporated is 2 percent or less. In addition, your records should take into account potential batch to batch variation. See 40 CFR 723.250( j). Section 2: Exclusions 2 14 208 10. Q. If a TSCA listed brominated flame retardant is mixed at greater than two percent in a polymer base, is the polymer subject to PMN requirements or is it exempt?

A. The material is considered to be a mixture of polymer and the flame retardant. Mixtures are not subject to reporting under TSCA, provided that there is no intended reaction between the components of the mixture. The components of the mixture are separately subject to reporting if they are not on the Inventory. See Q& A section 202 above and 40 CFR 720.3( u). If they are both on the Inventory, no reporting is required. If the polymer is eligible for the exemption, the presence of the other component will not render it ineligible. See the Polymer Exemption Guidance Manual at www. epa. gov/ opptintr/ newchems/ polyguid. pdf for more details.

208 11. Q. A company has been importing a polymer containing a cross linking agent used at a concentration of less than 1% by weight. If the cross linking agent is used at a level greater than 2%, will a PMN be required?

A. Monomers and other reactants ( including cross linking agents), added at greater than 2% by weight, must be included in the polymer description in the Inventory. See 40 CFR 723.250( e). A PMN would be required if no polymer is listed in the Inventory with the same composition including the cross linking agent.

208 12. Q. It appears from the Polymer Exemption rule that a person does not have the option of including a reactant/ monomer at less than or equal to two percent in the polymer identity. Is this true?

A. Yes, it is true. See 40 CFR 723.250( e). Polymers covered by a Polymer Exemption, however, do not have a formal name. The " identity" is established by the percentages monomers/ reactants charged or incorporated in the polymer, and is maintained in the exemption holder's records. If a polymer has less than or equal to two percent of a monomer/ reactant, the identity does not contain that monomer/ reactant. If an otherwise identical polymer is made, and the same monomer/ reactant is used at greater than two percent, the identity of the second polymer is different from the first. Two exemptions would have to be claimed to cover both polymers, and a second end of year notification would have to be made to EPA. See the Polymer Exemption Guidance Manual at www. epa. gov/ opptintr/ newchems/ polyguid. pdf for more details.

For polymers for which a PMN is submitted, the submitter does have the option of including a reactant/ monomer used at two percent or less in the polymer identity. See 40 CFR 723.250( e).

209 Chemicals Manufactured Solely for Export Section 2: Exclusions 2 15 209 1. Q. What does " manufacturing solely for export" mean?

A. As defined at 40 CFR 720.3( s), " manufacture solely for export" means to manufacture or import a chemical substance solely for export from the US, except for: ( 1) distribution solely for export or processing solely for export, or ( 2) R& D per 40 CFR 720.36 and 720.78. According to TSCA § 12( a) and 40 CFR 720.30( e), chemicals manufactured solely for export and labeled as such are exempt from much of TSCA, including § 5 and the PMN requirement. The chemical substance may not be used in the United States. TSCA § 12( a)( 1)( A).

209 2. Q. Do chemicals manufactured solely for export require premanufacture notification?

A. No. See Q& A # 209 1.

209 3. Q. Who is considered an exporter?

A. An exporter is defined at 40 CFR 707.63( b) ( covering reporting regulations under § 12( b) of TSCA) as the person who, as the principal party in interest in the export transaction, has the power and responsibility for determining and controlling the sending of the chemical substance or mixture to a destination out of the customs territory of the United States.

209 4. Q. Under what circumstances is an exporter required to notify EPA of export to a particular country?

A. Section 12( b) of TSCA requires any person who exports or intends to export a chemical substance or mixture to notify EPA of the export of that chemical to a particular country if any of the following actions has been taken with respect to the chemical substance or mixture:

( 4) Data are required under § 4 or § 5( b); ( 5) An order has been issued under § 5; ( 6) A rule has been proposed or promulgated under § 5 or § 6; or ( 7) An action is pending or relief has been granted under § 5 or § 7.

EPA's regulations implementing TSCA section 12( b) are at 40 CFR 707 Subpart D.

209 5. Q. To whom at EPA must export notices be sent, and what information must they include?

A. Mark the notice and the envelope containing the notice " Section 12( b) Notice". Mail to: Section 2: Exclusions 2 16 US EPA Office of Pollution Prevention and Toxics Document Control Office ( 7407M) 1200 Pennsylvania Ave., NW Washington, DC 20460 If the notice is sent by courier, the delivery address is:

US EPA Office of Pollution Prevention and Toxics Confidential Business Information Center ( CBIC) EPA East Building, Room 6428 1201 Constitution Ave. Washington, DC 20004 3302 Please note that , for courier deliveries, the CBIC is open from 8 AM to 4 PM. If you send the notice by courier service and the courier comes after that time he or she will be turned away. You can give the courier the phone number ( 202) 564 8930 and ( 202) 564 8940, to call if there is a problem with delivery. If using US mail, the room number is not necessary. Nonuniformed ( bicycle, etc) couriers will be met at the 1201 Constitution Ave. entrance by CBIC personnel. Uniformed couriers are admitted to deliver directly to the CBIC.

Per 40 CFR 707.67, a Notice of Intent to Export should contain the following information:

( 1) the name of the regulated chemical as it appears in the § 4, 5, 6, or 7 action ( If a category is regulated, the name of the individual regulated chemical within that category, as well as the name of the category, must be given. Use the name which appears in Volume I of the EPA Chemical Substance Inventory or its supplements, if the chemical appears there.); ( 2) the name and address of the exporter; ( 3) the country( ies) of import; ( 4) the date( s) of export or intended export; and ( 5) the section of TSCA under which EPA has taken action.

According to 40 CFR 707.65, a Notice of Intent to Export must be submitted for the first export or intended export to a particular country in the calendar year if the substance is the subject of any of the following actions:

( 8) data are required under § 5( b), ( 2) an order has been issued under § 5, ( 3) a rule has been proposed or promulgated under § 5 or 6, or ( 4) an action is pending or relief has been granted under § 5 or 7. In addition, a Notice of Intent to Export must be submitted for the first export or intended Section 2: Exclusions 2 17 export to a particular country when data are required under § 4.

A Notice of Intent to Export must be in writing ( after EPA develops procedures for receipt of electronic notices, these will be acceptable, too). A Notice of Intent to Export must be based on a definite contractual obligation or an equivalent intra company agreement, to export the chemical. Your Notice of Intent to Export must be postmarked within seven days of forming the intent to export or on the date of export, whichever is earlier.

Less than 2% of Notices of Intent to Export contain any assertion of confidential business information ( CBI). For submitters who do feel they have a need to have information about their submissions kept confidential, the requirements for making a CBI claim are discussed at 40 CFR § 707.75.

209 6. Q. Are isolated intermediates used in the manufacture of a final chemical substance which is solely for export subject to the PMN requirement?

A. Yes. Only the specific chemical substance which is manufactured solely for export is excluded from PMN requirements. See 40 CFR 720.30( e).

210 Uses Covered by FIFRA 210 1. Q. Are pesticides included in the definition of a chemical substance?

A. No. The definition of the jurisdictional term" chemical substance" under § 3( 2) ( and at 40 CFR 720.3( e)) of TSCA excludes any chemical when manufactured, processed, or distributed in commerce for use as a pesticide, food, drug, cosmetic, tobacco, tobacco product, or special nuclear material. The term pesticide has the meaning contained in the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), 7 U. S. C. 136 et seq. and the regulations issued under it.

210 2. Q. Do pesticides fall under the jurisdiction of FIFRA or TSCA?

A. Pesticides are regulated under FIFRA. A substance that is regulated under FIFRA would not be regulated under TSCA, unless the substance has multiple uses. In the case of multiple uses, some of which come under FIFRA and others which come under TSCA, the substance would fall under the jurisdiction of both TSCA and FIFRA. If a substance is manufactured, processed, or distributed for undifferentiated uses, then the substance will be presumed to be subject to TSCA. See 42 FR 64585 ( comment 37), Dec. 23, 1977.

210 3. Q. How is it determined whether a substance is regulated under FIFRA or TSCA? Section 2: Exclusions 2 18 A. If a manufacturer, processor, or distributor of a substance has intent, either by making express or implied pesticide claims for the product, or by the product's having no other significant commercially valuable use except as a pesticide, or if the seller or distributor has knowledge that the product will be used or is intended to be used as a pesticide, it would be considered a pesticide within the meaning of FIFRA. If the manufacturer is making a pesticidal claim for the material, this is evidence that a substance is a pesticide within the meaning of FIFRA. Also, if the substance bears no pesticidal claims, but has no commercially valuable use except as a pesticide, it could still be a pesticide under FIFRA.

211 Pesticide Inerts 211 1. Q. Are inert ingredients used in the manufacturing of a pesticide subject to the reporting requirements of TSCA or FIFRA?

A. Inert ingredients produced or used in the manufacture of a pesticide are substances or mixtures which can be regulated under TSCA. In order to be considered a pesticide, a substance must be intended for use as a pesticide. An inert ingredient which is not itself a pesticide would, accordingly, be a chemical substance within the jurisdiction of TSCA; it comes within the jurisdiction of FIFRA when it becomes a component of a pesticide product. 42 FR 64586 ( comment 39), Dec. 23, 1977.

211 2. Q. Are there situations where the manufacturer, processor, or distributor of pesticides are covered by TSCA versus FIFRA?

A. Any single chemical substance is subject to TSCA and FIFRA only if it has both pesticidal and non pesticidal uses. TSCA authority covers the substances involved in manufacturing a pesticide. It also covers inert ingredients until they become a part of the pesticide product, i. e., the formulation of the pesticide product. Once formulated, the pesticide product, including its inert ingredients, is solely regulated by FIFRA for distribution and sale.

If a substance is also used in non pesticide products, the ingredient may be regulated in those products under TSCA at the same time that it is regulated under FIFRA as a component of the pesticide product.

211 3. Q. Are ingredients used in either pesticide or non pesticide products that fall under the jurisdiction of TSCA eligible for the TSCA R& D exemption?

A. In some circumstances, yes. There is no specific R& D exemption in FIFRA. However, the pesticide products containing the inert ingredients may require an experimental use permit ( EUP) under FIFRA, or if used in small quantities, may not require an EUP ( 40 CFR 172.3). EUP requirements apply only to the pesticide products, not the ingredients separately. Section 2: Exclusions 2 19 A new chemical substance used in small quantities as a pesticide inert ingredient falls within the jurisdiction of TSCA and is eligible for the R& D exemption if the research and development is conducted on the inert substance itself. A new chemical will be covered by TSCA's R& D exemption until it becomes part of a pesticide product. Once it becomes part of a pesticide product, it becomes subject solely to FIFRA requirements. Note that 40 CFR 720.36( g) waives compliance with the R& D requirements for activities intended solely to determine whether a substance can be used as a pesticide.

212 Pesticide Ingredients 212 1. Q. Are the raw materials or intermediates used in the manufacturing of a pesticide subject to the reporting requirements of TSCA or FIFRA?

A. Raw materials and intermediates used in the manufacture of a pesticide can be regulated under TSCA. In order to be considered a " pesticide" under FIFRA, a substance must be intended for use as a pesticide. A raw material or intermediate which is not itself a pesticide would, accordingly, be a chemical substance within the jurisdiction of TSCA; it would come within the jurisdiction of FIFRA only when it becomes a component of a pesticide product. 42 FR 64586 ( comment 39), Dec. 23, 1977.

213 Pesticide Intermediates 213 1. Q. Are intermediates produced or used in the manufacturing of a pesticide subject to the reporting requirements of TSCA or FIFRA?

A. In order to be considered a " pesticide" under FIFRA, a substance must be intended for use as a pesticide. An intermediate which is not itself a pesticide would, accordingly, be a chemical substance within the jurisdiction of TSCA; it would come within the jurisdiction of FIFRA when it becomes a component of a pesticide product. 42 FR 64586 ( comment 39), Dec. 23, 1977.

213 2. Q. When is reporting required under TSCA versus FIFRA regarding the manufacturing, processing, or distribution of pesticides?

A. Discussion of EPA's position on this topic can be found at 42 FR 64585 86, comments 37 39, Dec. 23, 1977, and 51 FR 15098, April 22, 1986. To summarize, as a general rule, a pesticide may be subject to TSCA prior to registration under FIFRA or application for an Experimental Use Permit. However, " a person who manufactures or imports a chemical substance in small quantities solely for research and development is not required to comply with the requirements of [ the TSCA R& D exemption from the PMN requirement] if the person's exclusive intention is to perform research and development activities solely for the purpose of Section 2: Exclusions 2 20 determining whether the substance can be used as a pesticide." 40 CFR 720.36( g). A chemical substance may be subject to TSCA and FIFRA if it is manufactured for both pesticidal and nonpesticidal uses. TSCA authority also covers substances involved in manufacturing a pesticide. It also covers inert ingredients until they become a part of the pesticide product, i. e., the formulation of the pesticide product. Once formulated, the pesticide product, including its inert ingredients, is solely regulated by FIFRA for distribution and sale. If a substance is also used in non pesticide products, the ingredient may be regulated in those products under TSCA at the same time that it is regulated under FIFRA as a component of the pesticide product.

213 3. Q. Are pesticide intermediates that fall under the jurisdiction of TSCA eligible for the R& D exemption?

A. The intermediate of a FIFRA registered pesticide is eligible for the R& D exemption only if the research and development is conducted on the intermediate itself. Under FIFRA, an Experimental Use Permit ( EUP) may be used to allow a pesticide maker to undertake scientific experimentation, research or analysis or to determine customer acceptance or economic viability. An intermediate for a pesticide allowed under an EUP is eligible for the TSCA R& D exemption if the intermediate is only being used in small quantities for scientific experimentation, research or analysis.

214 Uses Covered by FDA 214 1. Q. Are food, food additives, drugs, or cosmetics included in the definition of a chemical substance?

A. Under TSCA § 3( 2) ( and 40 CFR 720.3( e)), the definition of " chemical substance" does not include any food, food additive, drug, cosmetic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device. The terms cosmetic, device, drug, food, and food additive have the meanings contained in the Federal Food, Drug, and Cosmetic Act, 21 U. S. C. 321 et seq., and the regulations issued under it. However, if these same chemicals are also intended for a TSCA use, then they are subject to TSCA. See 42 FR 64585 ( comment 37), Dec. 23, 1977.

214 2. Q. What is FDA's definition of a drug?

A. The definition of " drug" in the Federal Food, Drug, and Cosmetic Act ( FFDCA) includes articles intended for use as a component of substance included in the definition of drug. ( Note that the FFDCA uses the term " article" in a generic sense to mean item, thing, substance, material, and not the term of art that " article" connotes under TSCA.) See http:// www. fda. gov/ opacom/ laws/ fdcact/ fdcact1. htm for a more complete definition of drug under the FFDCA. As used in that Act, the term " component" does not mean only an item which Section 2: Exclusions 2 21 may be identified as an ingredient of a drug in its final dosage form, but also includes any item used in the production of the drug. Thus, precursors, intermediates, and catalysts intended for use in the production of drugs in their final dosage form are drugs within the meaning of FFDCA.

Moreover, FFDCA clearly covers drugs during the investigation or research stage. Consequently, the definition of drug in that Act includes chemical substances used for drug research and development. The same is true of the definitions of food, food additives, and cosmetics.

214 3. Q. Are detergent substances, other than soap, included in FDA's definition of cosmetics?

A. In its definition of the term " cosmetic", FFDCA § 201( i), 21 USC 321( i), specifically excludes soap. The term " soap" is not defined in the Act. At 21 CFR 701.20( a), the Food and Drug Administration interprets the term " soap" to apply only to articles that meet the following conditions: the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali fatty acid compounds; and the product is labeled, sold, and represented only as soap.

Products intended for cleansing the human body and which are not soap as described above are cosmetics, thus they are subject to the requirements of the FFDCA and its regulations. Detergents NOT intended for cleansing the human body are TSCA regulated.

214 4. Q. Are intermediates and catalysts of a drug or cosmetic regulated under FFDCA or TSCA?

A. The definitions of FFDCA provide that chemical substances which are intended for use as a component of a food, food additive, drug, cosmetic, or device are encompassed within the meaning of such terms, respectively. The FDA considers intermediates and catalysts to be such components. Therefore, they are subject to regulation under FFDCA. Any such substance is excluded from regulation under TSCA if it is actually manufactured, processed, or distributed in commerce solely for use in the production of a food, food additive, drug, cosmetic or device.

214 5. Q. How would a substance with multiple uses which falls under the jurisdiction of FFDCA and TSCA be regulated in order to avoid duplicative requirements?

A. If a substance has multiple uses only some of which are regulated under FFDCA, then the manufacturing, processing, distribution, and use of the substance for the remaining uses would be within the jurisdiction of TSCA. Under these regulations, that substance should be reported for the Inventory. EPA does not intend to impose duplicative requirements on manufacturers and processors subject to regulation under another Federal authority. Accordingly, EPA will consult with FDA or any other Federal agency, as appropriate, prior to taking regulatory action on Section 2: Exclusions 2 22 substances which are also regulated under other authorities.

214 6. Q. Are new substances that are isolated intermediates used only in the manufacture of a drug subject to PMN?

A. No, if the intermediates are regulated by FDA, they are not subject to TSCA requirements.

215 Naturally Occurring Substances 215 1. Q. What is the definition of a naturally occurring chemical substance and what are some examples?

A. According to 40 CFR 710.4( b), any chemical substance which is naturally occurring and which is either unprocessed or processed only by manual, mechanical, or gravitational means; by dissolution in water; by flotation; or by heating solely to remove water; or which is extracted from air by any means, shall automatically be included in the Inventory under the category Naturally Occurring Chemical Substances. Examples of such substances are: raw agricultural commodities; water, air, natural gas, and crude oil; and rocks, ores, and minerals.

216 Precipitation Inhibitors 216 1. Q. If a new chemical is formed when a precipitation inhibitor is added to a product and acts as intended, is the new chemical subject to PMN reporting requirements?

A. No PMN needs to be filed for any chemical substance which results from a chemical reaction that occurs when a precipitation inhibitor, stabilizer, colorant, odorant, antioxidant, filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation inhibitor, binder, emulsifier, deemulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutralizer, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended. See 40 CFR § 720.30( h)( 7)( i).

217 pH Adjustment 217 1. Q. If a new chemical is formed when a specific reagent is used to adjust the pH and acts as intended, is the new chemical subject to PMN reporting requirements?

A. No. If a new chemical substance is formed when a pH adjuster is included in a product and functions as intended, and the pH adjuster is not the substance itself, the substance formed is excluded from PMN. See 40 CFR § 720.30( h)( 7)( i). Section 2: Exclusions 2 23 217 2. Q. What is the difference between pH adjustment and pH neutralization?

A. The terms pH adjustment and pH neutralization are not synonymous terms. pH adjustment deals with the fine tuning of the pH of a solution. For example, an acid with a pH of 3 is made more acidic by adjusting the pH to 2. In this example, material used to adjust the pH is of course potentially subject to PMN reporting, but the chemicals resulting from the adjustment reaction are excluded from PMN reporting. However, if the change in pH is undertaken for the purpose of making a new substance, the substance with the new pH will qualify for PMN reporting.

pH neutralization, on the other hand, means that the pH of a solution brought to neutrality or near neutrality. This is generally a larger change in conditions. For example, a change in pH from 14 to 7 would be considered a pH neutralization. This change in pH will usually result in a substantial change in the chemical species present and contribute to the function of the chemical. The new chemicals resulting from the pH neutralizing reaction are subject to PMN reporting requirements. If you have a situation for which you think this guidance is ambiguous, it is appropriate to contact an EPA prenotice coordinator for resolution.

218 The "( h)( 7)" Exemption  40 CFR § 720.30( h)( 7)

218 1. Q. What are the criteria that must be met, for a substance to be excluded from the Inventory or PMN reporting under 40 CFR 720.30( h)( 7)?

A. It must fully satisfy all of the following criteria: 1. The substance is formed from a chemical reaction that involves the use of a chemical substance of the type described under 40 CFR 710.4( d)( 7) or 720.30( h)( 7); 2. The substances does not function to provide one or more primary properties that would determine the use of the product or product mixture distributed in commerce, even though it may impart certain physicochemical characteristics to the product or product mixture of which it is a part; and 3. The substance is not itself the one intended for distribution in commerce as a chemical substance per se. Although it may be a component of the product, product mixture, or formulation actually distributed in commerce, it has no commercial purpose separate from the product, product mixture, or formulation of which it is a component.

( See EPA's published clarification on this issue available through the TSCA Hotline ( 202) 554 1404: the package from Joseph Carra, Deputy Director, Office of Pollution Prevention and Toxics, to the regulated community, dated June 29, 1994.)

218 2. Q. If a polymer is partly ionized during use by a pH change which increases its water absorption to greater than 100 percent by weight, is the polymer no longer eligible for the Section 2: Exclusions 2 24 exemption? Does the so called "( h)( 7)" pH neutralizer exclusion apply to polymers > 10,000 MW that absorb more than 100 percent of their weight of water upon neutralization? Does the "( h)( 7)" exclusion take precedence over the Polymer Exemption, or vice versa?

A. If the polymer becomes water absorbing upon use in neutral water, it is a water absorbing polymer, whether or not ionization is involved. Treatment of high molecularweight polymers in the New Chemicals Program is described at " www. epa. gov/ oppt/ newchems/ hmwtpoly. htm." Water absorbing high molecular weight polymers are ineligible for the Polymer Exemption per 40 CFR 723.250( d)( 5). See 60 Fed. Reg. 16,319 16,320 ( March 29, 1995).

If the substance is deliberately converted to a water absorbing polymer by neutralization, that conversion constitutes manufacture for commercial purposes as a chemical substance, rather than processing. The resulting substance would be a different polymer that would be considered water absorbing and consequently not eligible for the Polymer Exemption ( even if the neutralizing agent used is less than or equal to two percent, a polymer must still meet the eligibility requirements in order to be exempt). The resulting neutralized substances would also not be excluded from reporting under 720.30( h)( 7). The unneutralized starting polymer could still be eligible for the Polymer Exemption, if it met the other exemption criteria.

On the other hand, if the neutralization results in a substance excluded from reporting under 40 CFR § 720.30( h)( 7) ( which basically covers processing rather than manufacture), that substance remains excluded from reporting even if it would have been ineligible under the Polymer Exemption. If an exempt polymer is converted into a water absorbing substance as a result of a chemical process or reaction that produces a substance excluded from reporting under ( h) ( 7), the starting polymer remains exempt. Both the Polymer Exemption and 40 CFR § 720.30( h)( 7) apply, independently, to the respective substances.

218 3. Q. If a chemical manufacturer supplies a customer with a TSCA listed acid and the customer, without making notification under § 5, makes a salt not on the Inventory, is the customer in violation of TSCA or subject to an exclusion?

A. The salt would be a reportable chemical substance, and therefore would be subject to the PMN requirements if it is not on the Inventory. If, however, the customer makes the salt under circumstances which are covered by an exclusion ( common exclusions are those at 40 CFR § § 720.30( h)( 5), ( h)( 6), and ( h)( 7)), notification is not required.