Determining the Chemical Substances Subject to the CDR Rule
- Chemical Substances on the TSCA Inventory — General
- 8.1. For what chemical substances must CDR information be submitted?
In general, chemical substances that are listed on the TSCA Inventory and manufactured (including imported) may be subject to CDR. Carefully review the regulations located at 40 CFR part 711 to determine your reporting requirements. You should consider the following three steps to determine whether and what you are required to report for each chemical substance that you manufactured (including import) in/into the United States since the last principal reporting year:
- Step I: Is your chemical substance subject to the CDR rule?
- Step II: Are you a manufacturer (including importer) who is required to report?
- Step III: What information must you report?
See the Instructions for Reporting on the CDR website for help with each of these steps.
Chemical substances that are the subject of certain TSCA actions have different reporting requirements. Please see the Chemical Substances which are the Subject of Certain TSCA Actions fact sheet for additional information about these specific reporting requirements.
- 8.2. Are all substances on the TSCA Inventory subject to the CDR requirements?
No, some substances are fully exempt or partially exempt from CDR reporting obligations. See 40 CFR 711.6 for information about certain exemptions. The chemical substances that are partially exempt from reporting requirements under CDR are listed in 40 CFR 711.6(b)(1) and 711.6(b)(2). The most recent additions to partially exempt chemicals list can be found on the Petitions page of the CDR website.
EPA’s Substance Registry Services (SRS) contains searchable information regarding the reporting status of particular chemical substances. Please see the How to Search for Chemicals Subject to Certain TSCA Actions page of the CDR website for additional guidance.
In contrast to reporting periods prior to the 2012 CDR, inorganic chemical substances are no longer partially exempt from reporting requirements. Therefore, submitters should report complete information on inorganic chemical substances.
In the event that you are not able to find your chemical substance on the TSCA Inventory, contact the TSCA Hotline at (202) 554-1404 for assistance to determine whether reporting is required.
- 8.3. Are chemical analyses needed to report CDR information?
No. The CDR regulation does not require submitters to perform chemical analyses. The information required by EPA is limited to information that is “known to or reasonably ascertainable” by the submitter. This standard is applicable to all information reported in accordance with 40 CFR 711.15(b).
- 8.4. How does a person access the TSCA Inventory?
Visit the TSCA Chemical Substance Inventory (https://19january2021snapshot.epa.gov/tsca-inventory) webpage to access the TSCA Inventory. In addition, the electronic CDR reporting tool, e-CDRweb, has the ability to access the TSCA Inventory using EPA’s Substance Registry Services (SRS). The public version of the TSCA Inventory lists chemical substances by chemical name and CAS number, except for chemical substances for which specific identities have been claimed as TSCA confidential business information; such confidential chemical substances are identified by generic chemical names and accession numbers.
- 8.5. What should a company do if it determines that it manufactures a chemical substance that is not included on the TSCA Inventory?
If your chemical substance is not on the TSCA Inventory, please see the EPA’s Review Process for New Chemicals page (www.epa.gov/tsca) to view the Pre-Manufacture Notice (PMN) Requirement flowchart to determine if a Notice must be submitted to the Agency, prior to manufacture (including import). You can also phone the TSCA Hotline at (202)-554-1404 for assistance.
If a company discovers that it is manufacturing (including importing) a substance which is not on the TSCA Inventory and should have been reported to EPA as a new chemical substance, such manufacture or importation is in violation of Section 5 of TSCA and implementing regulations and could subject the company to enforcement action. In this situation, visit EPA’s Audit Policy page to learn how to self-disclose and about the conditions for penalty mitigation. The Audit Policy page is: https://19january2021snapshot.epa.gov/compliance/epas-audit-policy
Significant reductions in penalties may be given to persons who voluntarily disclose such information. Even if a company does not meet the conditions for reductions under the Audit Policy, it may still be eligible for penalty relief under other EPA media-specific enforcement policies in recognition of good faith efforts. Note, however, that continued manufacture (including importation) or use of such chemical substances remains a violation per Section 15 of TSCA, even after a company has contacted EPA, until the requirements of TSCA Section 5 and implementing regulations have been met. These reporting requirements are distinct from the CDR.
- 8.6. What should a company do if it determines that it manufactures a chemical substance that has the commercial activity status “inactive” on the TSCA Inventory?
If your chemical substance has the commercial activity status “inactive” on the TSCA Inventory and you intend to manufacture (including import) it for a nonexempt commercial purpose, you will need to notify EPA to have the substance re-designated as “active.” If you need assistance, please contact the TSCA Hotline at (202)-554-1404.
If the chemical substance is going to be manufactured for a nonexempt commercial purpose: You will need to file a Notice of Activity (NOA) Form B before manufacturing the chemical substance, but not more than 90 days prior to the date of manufacturing. For more information, visit EPA’s TSCA Inventory Notification (Active-Inactive) Requirements Rule (NOA rule) and NOA Form B webpages.
If the chemical substance is already being manufactured for nonexempt commercial purpose: If a company discovers that it is manufacturing (including importing) for nonexempt commercial purpose a substance which has the commercial activity status “inactive” on the TSCA Inventory and should have been reported to EPA using an NOA Form A or B, such manufacture (including importation) is in violation of Section 8(b) of TSCA and implementing regulations and could subject the company to enforcement action. In this situation, visit EPA’s Audit Policy page to learn how to self-disclose and about the conditions for penalty mitigation. The Audit Policy page is: https://19january2021snapshot.epa.gov/compliance/epas-audit-policy.
Significant reductions in penalties may be given to persons who voluntarily disclose such information. Even if a company does not meet the conditions for reductions under the Audit Policy, it may still be eligible for penalty relief under other EPA media-specific enforcement policies in recognition of good faith efforts. Note, however, that continued manufacture (including importation) or use of such chemical substances remains a violation per Section 15 of TSCA, even after a company has contacted EPA, until the requirements of TSCA Section 8(b) and implementing regulations have been met. These reporting requirements are distinct from the CDR.
- 8.7. How do the TSCA Inventory flags relate to CDR and have they been updated to reflect reporting requirements?
Special flags are used throughout the TSCA Inventory to identify those substances that are the subject of an EPA rule or order promulgated under TSCA, as well as to indicate the types of full exemptions from CDR reporting requirements. A list of flags is available on EPA’s website at: https://19january2021snapshot.epa.gov/tsca-inventory/how-access-tsca-inventory#formatted.
These flags are embedded into the Substance Registry Services (SRS) (www.epa.gov/srs) chemical lookup used by the e-CDRweb reporting tool. Updated prior to each submission period, the SRS lookup lists reflect the reporting requirements of CDR. If accessing the SRS directly, look for lists appropriate to the submission period of interest (e.g., 2016 TSCA Inventory for the 2016 CDR submission period or 2020 TSCA Active Inventory for the 2020 CDR submission period). If accessing the SRS using the chemical lookup function from within the CDR reporting tool, if the selected chemical has been assigned a special flag the reporting tool will display a notice indicating the TSCA action or exemption status of the chemical.
Please note that you are advised to use the flags only as a guide; you are responsible for verifying whether a chemical substance listed on the TSCA Inventory is exempt from reporting or ineligible for exemption from reporting.
- 8.1. For what chemical substances must CDR information be submitted?
- 9.1. Are mixtures listed on the TSCA Inventory?
The TSCA Inventory lists chemical substances, not mixtures. For purposes of the CDR regulation, EPA uses the definition of “mixture” from TSCA Section 3(8): “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; except that such term does include any combination which occurs, in whole or in part, as a result of a chemical reaction if none of the chemical substances comprising the combination is a new chemical substance and if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined.”
- 9.2. Are mixtures ever reportable?
Mixtures are not themselves reported under the CDR, but the individual component chemical substances of a mixture may be reportable. If you manufacture (including import) the substances as part of a mixture, you would evaluate the CDR requirements for each chemical substance in the mixture. For example, for imported mixtures, you need to identify each component chemical substance to determine if the amount of any individual chemical substance in the mixture when combined with the amount(s) of the same chemical substance otherwise manufactured (including imported) at the same site is sufficient to meet or exceed a CDR reporting threshold.
Note, however, that if you process chemical substances to form a mixture without a chemical reaction by combining domestically manufactured chemical substances you purchase, such that you do not synthesize or produce any of the component chemical substances of the mixture or any different chemical substance, you are not a manufacturer of those chemical substances and are not required to report those chemical substances under the CDR regulation.
- 9.3. How are catalysts reported under CDR?
The CDR requirements for catalysts follow the same rules as for other chemical substances. Note that some catalytic substances supported on an inert substrate are considered under TSCA to be a mixture of the catalyst and substrate. If you manufacture the catalyst and the substrate and process these chemical substances to form a mixture, you would report your manufacture of the catalyst and the substrate separately.
- 9.4. When metal catalysts supported on fixed, inert substrates are regenerated, the catalyst is subjected to high temperatures which convert the metal to its oxide. This is followed by a reduction step which converts the metal oxide back to the base metal. Is this activity subject to CDR requirements?
The metal catalyst supported on an inert substrate is considered to be a mixture under TSCA. Conversion of the metal catalyst to an oxide and subsequent reduction to the base metal are both manufacturing of different chemical substances for commercial purposes. If the regeneration is all conducted in the same vessel (i.e., the oxide is reduced in the same vessel in which it is made, without storing the oxide or intending to remove it from the vessel for a reason that is not essential to this chemical process), the oxide may satisfy the definition of a non-isolated intermediate for purposes of CDR and be exempt from reporting for that reason. The metal oxide and elemental metal would otherwise both be subject to CDR requirements. Note, however, that only the amounts of the metal oxide and the regenerated base metal must be reported; in many instances, these amounts will be less than the applicable CDR threshold. Because the inert substrate does not undergo a chemical reaction in this scenario, there is no change in the chemical identity of the inert substrate that triggers CDR reporting requirements.
- 9.5. How does a company report the importation of a solid solution?
Import of solid solutions that are mixtures of chemical substances should be reported in the same manner in which import of liquid solutions or other mixtures are reported; i.e., report the amount imported of each chemical substance in the mixture. Please note, however, that mixed (metal) oxides, for which an oxide contains cations of more than one chemical element or cations of a single element in multiple oxidation states, are not considered to be solid solutions for purposes of CDR and are subject to reporting. Also, intermetallic compounds of well-defined stoichiometry are not considered alloys or solid solutions and are reportable as chemical substances. Although alloys themselves are not reportable as such, manufacture (including import) of the individual metals comprising an alloy must be reported under the CDR.
- 9.6. A company manufactures many different compounds containing the metal magnesium, for example MgSO4, MgO, and MgCl2. Is each compound a reportable chemical substance or are they mixtures of magnesium? Should the amount of magnesium in each substance be aggregated and reported as the total amount of magnesium?
The three magnesium compounds are unique chemical substances each of which has its own distinct CAS Registry Number and entry on the TSCA Inventory. Therefore, the CDR requirements must be evaluated for each of these different compounds and, if necessary, separate reporting would be required for MgSO4, MgO, and MgCl2. The compounds would be reported separately because they are separate, unique chemical substances. No reporting would be required of elemental magnesium in this scenario because elemental magnesium is not one of the substances manufactured.
- 9.7. If a company purchases chemical substances from manufacturers and then mixes it for their own use, do they need to report on the mixture?
A company only reports on the chemical substance that it manufactures. If no other chemical substance is manufactured when the chemical substances are mixed together, then there is no obligation to report.
- 9.8. Must hydrates of chemical substances be reported under the CDR rule?
Yes, if you manufacture (including import) a hydrated chemical substance, report its manufacture using the anhydrous or non-hydrated form and adjust the production volume to exclude water, thereby reporting only the volume associated with the anhydrous or non-hydrated form.
For purposes of CDR, a hydrated form of a chemical substance is considered a mixture of the corresponding anhydrous form and water. See TSCA section 3(2)(B)(i) for the definition of chemical substance.
- 9.1. Are mixtures listed on the TSCA Inventory?
- 10.1. What is a byproduct?
Byproduct means a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance or mixture (40 CFR 711.3, referencing 704.3).
- 10.2. How is a byproduct chemical substance characterized for identification purposes?
Byproducts are formed by a reaction, and generally, EPA considers each combination of substances resulting from a reaction to be either:
- A mixture, composed of two or more fully identified chemical substances to be named and listed separately, or
- A reaction product, or combination of chemicals from a reaction, to be listed as a single chemical substance, using one name that collectively describes the products or, if that is not feasible, describes the reactants used to make the products. This type of byproduct is often identified as a single chemical substance using nomenclature for substances of Unknown or Variable composition, Complex reaction products and Biological materials (a “UVCB” substance) to represent what is often a process stream.
As described below, it may be appropriate for CDR purposes to treat a complex byproduct as a mixture of well-defined chemical substances or even just a single well-defined chemical substance, even though there are uncharacterized components to the mixture. This would be instead of treating the byproduct as a single UVCB chemical substance. The manufacturing company should determine, based on the specific manufacturing scenario, whether the byproduct is more appropriately represented as a single well-defined chemical substance, a mixture of individual chemical substances or a UVCB chemical substance.
Where a manufacturer reasonably concludes (after considering all the facts known and reasonably ascertainable) that the uncharacterized components of a byproduct will have no subsequent commercial purpose after they are manufactured, for CDR purposes the manufacturer may treat the byproduct as a mixture of the remaining characterized components. The manufacturer would report each component as a separate substance. For each reported substance, the manufacturer would report the production volume associated only with that substance. The uncharacterized components that have no subsequent commercial purpose would not be reported to CDR.
- 10.3. How do you characterize a byproduct that is a complex combination of chemical substances?
Byproduct chemical substances are often chemical combinations of variable or complex composition. A complex combination of chemical substances can be identified as a chemical substance of Unknown or Variable composition, a Complex reaction product, or a Biological material (a “UVCB” chemical substance). In this manner, the byproduct can be identified as a single UVCB chemical substance that represents the process stream. Approximately one-third of the more than 85,000 chemical substances listed on the TSCA Inventory are UVCB chemical substances. UVCB substances may have an Inventory definition to further describe the substance.
The following two information documents provide further information about UVCB chemical substances and complex reaction products:
- 10.4. When is a byproduct reportable for CDR purposes? Does the term reportable byproduct in the CDR pertain to a substance with commercial value only?
A byproduct may be reportable when it is manufactured for a commercial purpose. The definition of manufacture for commercial purposes at 40 CFR 704.3 includes: “…substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including…byproducts...”
While byproducts may or may not, in themselves, have commercial value, they are nonetheless produced for the purpose of obtaining a commercial advantage when they are formed as part of the manufacture of a chemical product for a commercial purpose. Thus, chemical substances that are produced as byproducts during the manufacture, processing, use, or disposal of another chemical substance or mixture, like any other manufactured chemical substance, are subject to CDR reporting if they (1) are listed on the TSCA Inventory, (2) are not otherwise excluded from reporting, (3) are manufactured (including imported) in a volume of 25,000 pounds or more at a single site during any calendar year since the last principal reporting year, or 2,5000 pounds for chemical substances subject to certain TSCA actions, and (4) their manufacturers are not specifically exempted or excepted from CDR requirements (see the Instructions for Reporting for a flowchart describing how to determine if your chemical needs to be reported for CDR). If the applicable reporting threshold is met or exceeded during any calendar year since the last principal reporting year, reporting is required for each calendar year in the CDR submission period. Learn more about the reporting thresholds for CDR on the CDR website.
Once you have established that your byproduct was manufactured for a commercial purpose, it becomes potentially reportable when it is used for a non-exempt separate commercial purpose. A byproduct may have a separate commercial purpose even if it is not intentionally commercialized. If a manufacturer sends the byproduct to another person or site where it is used in such a manner that it has a commercial purpose or if the byproduct manufacturer itself uses the byproduct for commercial purposes, then the byproduct manufacturer is potentially required to report the byproduct for purposes of CDR.
In most cases, a byproduct that is used for a commercial purpose is reportable by the manufacturer; however, under 40 CFR 711.10(c), byproducts are not subject to reporting when they meet the requirements of 40 CFR 720.30(g) or when they are not used for commercial purposes (40 CFR 720.30(h)).
- 10.5. How does the byproduct exemption at 40 CFR 720.30(g) affect reporting for CDR?
Under 40 CFR 711.10(c), CDR reporting is not required for those substances meeting the requirements of 40 CFR 720.30(g). 40 CFR 720.30(g) covers byproducts whose “...only commercial purpose is for use by public or private organizations that (1) burn it as a fuel, (2) dispose of it as a waste, including in a landfill or for enriching soil, or (3) extract component chemical substances from it for commercial purposes. (This exclusion only applies to the byproduct; it does not apply to the component substances extracted from the byproduct.)”
In other words, when a byproduct is only burned as a fuel, disposed of as a waste material (including disposal in a landfill or for enriching the soil), or used for extracting component chemical substances (or some combination thereof), the manufacture of that byproduct is not required to be reported for CDR purposes. Additional discussion can be found in the Instructions for Reporting.
- 10.6. Byproducts whose only commercial purpose is as a source from which component chemical substances are extracted are not subject to reporting for CDR, because they are exempt under 40 CFR 720.30(g)(3). What is meant by “extract a component chemical substance”?
A component chemical substance is a chemical substance that is present in the byproduct prior to extraction. Heat or chemical reactions can only be used to extract a component chemical substance if the component substance being extracted is being left chemically unchanged by the extraction process. Thus, for example, a chemical reaction could be employed on a byproduct to convert component Chemical Substance X into Chemical Substance Y, so as to facilitate the extraction of component Chemical Substance Z (which undergoes no chemical transformation) from the byproduct. However, if component Chemical Substance Z from the byproduct were first transformed into another chemical substance, and then that different chemical substance were extracted, the overall process would not qualify as extraction of a “component chemical substance.”
Note that the exemption at 40 CFR 720.30(g)(3) only applies to the manufacture of the byproduct itself and does not apply to the manufacture of another chemical substance by extraction from a UVCB byproduct. Thus, regardless of whether the manufacturer of a UVCB byproduct receives the benefit of this exemption (determined in part by whether or not the byproduct is subsequently used to extract component chemical substances), the manufacture of a different chemical substance by extraction from the UVCB byproduct is subject to CDR.
Note also that the component chemical substance must be a chemical substance having a particular molecular identity. For instance elemental Nickel (Ni0) and nickel hydroxide Ni(OH)2 have different molecular identities and are not the same chemical substance. Additionally, because the Ni+2 ion cannot exist on its own and is therefore not considered a chemical substance, the Ni+2 ion is not considered a component chemical substance of the byproduct. Consider the following scenarios:
- Scenario 1: Ni0 is recovered from a UVCB byproduct containing Ni(OH)2. Ni0 is not a component chemical substance of Ni(OH)2, because Ni0 does not exist in Ni(OH)2. A chemical reaction of Ni(OH)2 is required to produce Ni0. Therefore, an extraction of a component chemical substance has NOT occurred. Rather, the byproduct has been used as a chemical feedstock to manufacture Ni0, and both the byproduct and Ni0 are therefore subject to CDR.
- Scenario 2: Ni(OH)2 is recovered from a UVCB byproduct containing Ni(OH)2 as a component chemical substance. The Ni(OH)2 was recovered without reacting the Ni(OH)2, although a chemical reaction of other components of the UVCB may have occurred in order to recover the Ni(OH)2. In this case, an extraction of a component chemical substance has occurred. Assuming the byproduct was not put to any other commercial purpose, the manufacture of the byproduct is exempt from reporting under CDR. The manufacture of the Ni(OH)2 is subject to CDR, as the extracted chemical itself does not qualify for the exemption at 40 CFR 720.30(g)(3) (the provision applies to the byproduct, not to the chemical substance extracted from the byproduct).
For TSCA purposes, chemical substances are specifically and uniquely identified when listed on the TSCA Inventory (https://19january2021snapshot.epa.gov/tsca-inventory).
- 10.7. How do the exemptions at 40 CFR 720.30(h) affect byproduct reporting for CDR?
Under 40 CFR 711.10(c), reporting is not required for those substances meeting the requirements of 40 CFR 720.30(h). That provision lists certain “chemical substances,” including “any impurity” (720.30(h)(1)), “any byproduct which is not used for commercial purposes” (720.30(h)(2)), and “any nonisolated intermediate” (720.30(h)(8)), and notes that “Although they are manufactured for commercial purposes under the Act, they are not manufactured for distribution in commerce as chemical substances per se and have no commercial purpose separate from the substance, mixture, or article of which they are a part.”
In interpreting 40 CFR 720.30(h)(1), (h)(2), and (h)(8), one needs to consider the following important points.
- Regarding 40 CFR 720.30(h)(1), note that the term impurity has a specific definition when determining reporting obligations under TSCA. Under 40 CFR 704.3 (cross-referenced in 40 CFR 711.3), impurity means a chemical substance which is unintentionally present with another chemical substance. When considering how to characterize a separate byproduct stream, it is not proper to consider as an impurity a component of the byproduct stream that was created as part of the process that created the intended product and byproduct stream. It may be proper, however, to consider as an impurity a substance that was introduced as an impurity as part of one of the raw materials used as an input to the process. If such an impurity reacts during the process, however, the result is a manufactured substance that does not meet the impurity definition when separated from the intended product into a byproduct stream.
- Regarding 40 CFR 720.30(h)(2), note that “commercial purpose” refers back to the broad definition in 40 CFR 704.3 (“the purpose of obtaining an immediate or eventual commercial advantage”). It is not synonymous with the narrower definition of “commercial use” at 40 CFR 711.3, which is only intended for further subcategorizing reportable uses (in Part II – Section D reporting) between industrial, commercial, and consumer settings.
- Regarding 40 CFR 720.30(h)(8), note that non-isolated intermediate means: “any intermediate that is not intentionally removed from the equipment in which it is manufactured, including the reaction vessel in which it is manufactured, equipment which is ancillary to the reaction vessel, and any equipment through which the substance passes during a continuous flow process, but not including tanks or other vessels in which the substance is stored after its manufacture. Mechanical or gravity transfer through a closed system is not considered to be intentional removal, but storage or transfer to shipping containers ‘isolates’ the substance by removing it from process equipment in which it is manufactured.” (40 CFR 704.3). Refer to the Fact Sheet: Non-isolated Intermediates for more information.
Although 720.30(h) has descriptions of eight different types of chemical substances, the three listed above are generally the most relevant when considering reporting of byproducts under CDR.
There are, however, other conditions under which byproducts are not required to be reported. See 40 CFR 711.10 (d). As a general rule, if, after it is manufactured, your byproduct chemical substance is not put to use for a separate commercial purpose (see 40 CFR 711.10(c)), you do not need to report it.
- 10.8. How do the exemptions at 40 CFR 711.10(d) affect byproduct reporting for CDR?
There are conditions under which byproducts are not required to be reported (40 CFR 711.10(d)).
- If a byproduct substance listed in 40 CFR 711.10(d)(1)(i) (see below) is produced as part of the listed manufacturing processes and: (1) the byproduct substance is recycled or otherwise used within a site-limited, physically enclosed system that is part of the same overall manufacturing process from which the byproduct substance was produced, and (2) the site is reporting the byproduct or a different chemical substance that was manufactured from the recycled byproduct or manufactured in the same overall manufacturing process, that byproduct is not required to be reported (40 CFR 711.10(d)(1)).
As of June 1, 2020, the processes and related byproduct substances listed are:
- Portland Cement Manufacturing:
- CASRN 68475-76-3, Flue dust, Portland cement (commonly referred to as cement kiln dust or CKD)
- Kraft Pulping Process:
- CASRN 66071-92-9, Sulfite liquors and cooking liquors, spent (often comprised of what is referred to as black liquor)
- CASRN 68514-09-0, Sulfite liquors and Cooking liquors, spent, oxidized (often comprised of what is referred to as oxidized black liquor)
- CASRN 471-34-1, Carbonic acid calcium salt (1:1) (commonly referred to as calcium carbonate)
For submission periods after the 2020 CDR, check the listing at 40 CFR 711.10(d)(1) for any updates.
Note that this exclusion only applies to the amount of the byproduct that is recycled in physically enclosed equipment; it does not apply to amounts that are not recycled or that are recycled, but not in physically enclosed equipment.
- If a byproduct substance is manufactured solely in specifically listed equipment when it is not integral to the chemical manufacturing processes of the site, that byproduct is not required to be reported (40 CFR 711.10(d)(2)). The specifically listed equipment are:
- Pollution control equipment, and
- Boilers used to generate heat or electricity for that site.
- 10.9. Is a reaction product formed upon end use of a catalyst always exempt under 40 CFR 720.30(h)(5)?
Not always. 40 CFR 720.30(h)(5) states: “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.”
A chemical substance may qualify for the 40 CFR 720.30(h)(5) exemption if it is not manufactured or imported for distribution in commerce or for use as an intermediate. If it is to qualify for the 720.30(h)(5) exemption, a chemical substance cannot have a commercial purpose separate from the substance, mixture, or article of which it is a part. (See the introductory language of 40 CFR 720.30(h)). Therefore, where a used or spent catalyst is both a reaction product of the end use of a catalyst for commercial purposes and an intermediate in the manufacturing of fresh catalyst for commercial purposes, it would not qualify for the 720.30(h)(5) exemption.
- 10.10. It is unclear to me whether I am burning my byproduct for energy recovery or destruction. Is this an issue I need to resolve in order to determine whether I have a reporting obligation under CDR?
Probably not. The distinction between whether a byproduct is burned for energy recovery or incinerated solely for destruction is generally not relevant under the CDR. This is because the CDR exempts both byproducts whose “only commercial purpose” is for burning as a fuel (40 CFR 720.30(g)(1)), and byproducts that are “not used for commercial purposes” (40 CFR 720.30(h)(2)). This latter category would include incineration, solely for destruction. Note, though, that where a byproduct is burned for energy recovery, but that is not the only commercial purpose for the byproduct (e.g., if the combustion residue is used as a process input), then the exemption under 40 CFR 720.30(g)(1) would not apply. This exemption also does not apply if you have manufactured a coproduct and not a byproduct. For example, if a substance you manufacture is normally intended to be used as a fuel product, it would be considered a co-product instead of a byproduct.
- 10.11. How could a byproduct be manufactured in the course of manufacturing an article?
If the use or processing of a chemical substance (Chemical A) to manufacture an article coincidentally produces a different substance (Chemical B), apart from the article, then a byproduct chemical substance has been manufactured. This situation may occur, for example, when a substance is being stripped off of a part of the article, and the stripping process results in the formation of a different substance (possibly resulting in a “used” stripping solution).
Note that if the byproduct chemical substance (Chemical B, in the above scenario) has been intentionally manufactured for a commercial purpose separate from that of the article, then a coproduct and not a byproduct has been manufactured.
- 10.12. What is the difference between manufacturing a byproduct and manufacturing a coproduct?
The simultaneous manufacture of multiple chemical substances can occur for a variety of reasons. In the case of byproduct manufacture, the byproduct is manufactured without any separate commercial intent — that is, without any commercial intent other than the commercial intent to manufacture, process, use, or dispose of some other chemical substance or mixture. See 40 CFR 704.3 (definition of “byproduct”). The Inventory listing and CDR requirements are based on the disposition of the byproduct, as explained above.
In the case of coproduct manufacture, there is commercial intent to produce the coproduct, separate from whatever commercial intent may concurrently exist to manufacture some other chemical substance or mixture. If both coproducts are chemical substances under TSCA, both are required to be listed on the Inventory unless otherwise excluded and, unless exempted from CDR, both are subject to the CDR requirements if listed on the Inventory.
- 10.13. How does a submitter report under the data element “Is chemical substance being recycled?" and how does the 2020 CDR Revisions rule affect this data element?
For purposes of CDR, a manufactured chemical substance is being recycled when all or a portion of that substance, which otherwise would be disposed of as a waste, and is being used for commercial purpose. EPA generally expects that byproduct manufacturers often may report that some or all of their byproduct substances may be recycled or otherwise used rather than being disposed of as a waste (as many still have value, e.g., as a feedstock or for other material recovery). Product finishing, on the other hand, does not involve removing a chemical substance from a waste stream and would not qualify as recycling for purposes of this data element.
During the 2020 TSCA CDR Revisions rule under TSCA Section 8(a), EPA modified the data element “recycled, manufactured, reprocessed, or reused” by removing the terms “remanufactured, reprocessed, reused” from the data element description and changing the term to “recycled or otherwise used for a commercial purpose instead of being disposed of as a waste or included in a waste stream.” A chemical substance that is manufactured from a recycled chemical substance may previously have reported “Yes” under this data element, but would now report “no” because the term “remanufactured” is no longer a part of the data element.
- 10.14. EPA has a lot of programs encouraging recycling. If I am recycling my byproduct, do I need to be concerned about the CDR?
EPA encourages recycling and has many programs to educate people about recycling and the reuse of materials. Many recycling activities involve bringing materials (that were manufactured for a commercial purpose) into commerce that otherwise would be disposed of as a waste. If your substances that you manufactured are being recycled and are listed on the TSCA Inventory, those substances may be subject to the CDR.
- 10.15. If my waste material is exempted from reporting by the RCRA program, do I need to be concerned with reporting under CDR? Likewise, if I report under CDR, do I need to be concerned with reporting for RCRA purposes?
The determinations of the need to report for CDR and for RCRA are independent determinations.
- 10.16. How do I determine if I am manufacturing or purifying a chemical substance?
Start by making sure you have properly chemically identified for TSCA purposes the precursor or impure chemical substance(s). Then compare the specific chemical identities of the precursor or impure chemical substance(s) and the finished chemical substance(s). Purification does not involve a change in chemical identity between the precursor/impure chemical substance and the purified chemical substance. By contrast, removing a chemical substance from a precursor chemical substance having a different chemical identity (for example, the extraction of a discrete chemical substance from a UVCB precursor) is manufacturing. See 40 CFR 711.3 (“[m]anufacture includes the extraction, for commercial purposes, of a component chemical substance from a previously existing chemical substance or complex combination of chemical substances.”)
- 10.17. Please provide an example of when a substance is purified.
In general, when 80% pure Chemical A (correctly identified, for TSCA purposes, as that discrete substance and not as a UVCB substance) is purified to make 98% pure Chemical A, the activity does not constitute manufacturing of Chemical A, but it is considered to be processing of Chemical A for purposes of CDR and PMN reporting. The two batches of Chemical A differ only in their purity. For purposes of TSCA, they are considered to be the same chemical substance.
Note that it is the original manufacturing of the 80% pure Chemical A that triggers reporting of Chemical A under CDR. Note also that the need to report any substance produced during the purification process may need to be addressed (e.g., the substance(s) removed from Chemical A may trigger reporting itself, depending upon the specific situation and the use of the removed substance(s)).
- 10.18. Please provide examples of when a substance is extracted and not purified.
For recycling or reclaiming, it is important to determine whether the resulting chemical substance has the same or different specific chemical identity as the starting material. If the starting and resulting substances are the same (e.g., a newly manufactured substance that one intends to make, such as salicylic acid, which is initially impure but then is purified), then the activity is considered to be processing and no manufacturing has occurred. If the resulting substance is different, for example, the extraction of cresol from “Phenols (petroleum)” [CASRN 64743-03-9], then the activity is considered to be manufacturing.
- 10.19. My manufacturing process uses Solvent A, resulting in Spent Solvent A. I recover Solvent A from the Spent Solvent A. Under CDR, what are my reporting obligations for the recovered Solvent A?
Depending on your specific manufacturing scenario, Spent Solvent A may be appropriately characterized as a mixture or may be properly characterized as a UVCB substance. The difference between a mixture and a UVCB is that a mixture is when all components are known and UVCBs can be identified as chemical substances of Unknown or Variable composition, Complex reaction products and Biological materials (“UVCB” substances). In this manner, the byproduct can be identified as a single UVCB chemical substance that represents the process stream. There are many thousands of UVCB substances listed on the TSCA Inventory. Reporting obligations associated with the reclaimed Solvent A are dependent upon your characterization of Spent Solvent A.
- 1. Spent Solvent A is characterized as a mixture of individual chemical substances: In this case, separating Solvent A from the mixture is not considered manufacturing, and the manufacturer does not report for CDR purposes the reclaimed Solvent A. Note that, depending upon what is done with the remaining portion of the mixture, any components of the mixture that were manufactured may need to be individually reported.
- 2. Spent Solvent A is characterized as a manufactured UVCB chemical substance: In this case, the Solvent A extracted from the Spent Solvent A is also considered to be manufactured, and therefore is reportable for purposes of CDR.
For a more detailed discussion of UVCBs, spent solvents and mixtures, please refer to the fact sheet “2020 Chemical Data Reporting Byproduct and Recycling Scenarios.”
- 10.20. At a site, an ore (e.g., bauxite) is refined to create a product (e.g., alumina). The ore contains another metal compound or salt, which is reduced to the elemental metal, removed from the product during processing, and disposed of as waste. Should the elemental form of this metal be reported under the CDR rule? If the elemental metal byproduct is sold for commercial use, is it subject to CDR reporting requirements?
Reporting is not required if the metal byproduct from the refining is only disposed of as a waste. See 40 CFR 711.10(c) which references 40 CFR 720.30(g).
Reporting is required if the elemental metal byproduct is used for commercial purposes, because neither the exemption provision at 40 CFR 720.30(g) nor the exemption provision at 40 CFR 720.30(h)(2) would apply to the manufacture of this byproduct metal. Because the byproduct metal is being used for a commercial purpose (other than the commercial purposes listed in 40 CFR 720.30(g)), you would evaluate the CDR reporting requirements for this substance (e.g., was the amount of the byproduct metal produced at a single site during any calendar year since the last principal reporting year 25,000 pounds or more?).
- 10.21. My metal smelting process generates a large amount of dust, which is collected in a baghouse. Since this dust has a high metal content, we recycle the baghouse dust rather than disposing of it. Do I have any reporting obligations for this material?
This depends on what chemicals comprise the baghouse dust and how it is used. The baghouse dust is a byproduct of your manufacturing process that is captured by pollution control equipment. If the baghouse only captures unreacted starting material, see question 10.22. Otherwise, if you use it for a non-exempt commercial purpose, you would evaluate the CDR reporting requirements for the baghouse dust (e.g., was the amount of the baghouse dust produced at a single site during any calendar year since the last principal reporting year 25,000 pounds or more (or 2,500 pounds or more if subject to certain TSCA actions)?). If it meets those requirements, you would report it.
An example of using the baghouse dust for a non-exempt commercial purpose is to smelt the baghouse dust to produce a metal. The smelting process uses chemical reduction, a form of extractive metallurgy. A common mistake is to think that at high temperature the metal melts out of the ore or baghouse dust. However, if you heat up the ore without the proper reducing agent, you will just obtain molten ore. A metal obtained from baghouse dust by chemical reduction or smelting is manufactured using a chemical reaction and cannot be considered to be a component chemical substance of the baghouse dust (so that the 40 CFR 720.30(g) exclusion from reporting would not apply). Both the baghouse dust and the metal produced by the smelting process are subject to reporting under CDR.
Beginning with the 2020 CDR, an exemption for byproducts manufactured by pollution control equipment that is not integral to the chemical manufacturing process is in place. Although the baghouse dust is captured by pollution control equipment, it was not manufactured by the pollution control equipment and therefore the new exemption would not apply (without the need to consider whether the pollution control equipment is integral or not). See 40 CFR 711.10(d)(2). The simple separation of a mixture is not considered to be manufacture under TSCA.
- 10.22. My process uses a baghouse, but it only captures unreacted starting material. I reintroduce the contents of the baghouse into my processing stream in order to use those materials. Do I have any reporting obligations for the collection of the unreacted starting materials into the baghouse?
EPA does not consider the mere recapture of unreacted starting materials to constitute manufacturing. Therefore, in this situation, reporting under CDR would not be required on the capture of unreacted starting material in the baghouse. Note, though, that if the baghouse dust were to include other components, such as partially reacted intermediates or other substances from a chemical reaction, the baghouse dust may be a byproduct that you are manufacturing. If you use baghouse dust byproduct for a non-exempt commercial purpose after manufacturing it, you would need to evaluate your CDR requirements as a manufacturer of the baghouse dust.
- 10.23. Chemical X is formed unintentionally, without any separate commercial purpose, during the manufacture of another chemical, Chemical Y. Furthermore, Chemical X is not separated from Chemical Y. Would it be accurate to describe substance Chemical X as an impurity with no reporting obligation?
Chemical X could be described as an impurity because it is unintentionally present with Chemical Y, but it would be more accurate to describe it as a byproduct because it is manufactured without a separate commercial purpose. The manufacture of this byproduct/impurity is not reportable for CDR purposes. See 40 CFR 711.10(c) and 40 CFR 720.30(h)(1).
However, if a manufactured chemical substance that remained with the primary product did have a separate commercial purpose – for instance, if it improved the performance of the primary product or provided a primary property to the commercial product – it would be a coproduct, not an impurity or a byproduct, and its manufacture would be reportable for CDR purposes.
- 10.24. The paper pulping process involves a recycling loop for the pulping chemicals. The spent pulping liquors (also called black liquor) is a byproduct of the pulping process. The black liquor is burned to produce power, and the resulting smelt is turned into green liquor and ultimately white liquor. Since the black liquor is used as a fuel, do I need to report it under the CDR?
Prior to the 2020 CDR Revisions rule, the black liquor byproduct was reportable under CDR. This changed with the addition of 40 CFR 711.10(d), added as part of the 2020 CDR Revisions rule.
Under 40 CFR 711.10(d), certain pulping cycle byproduct chemical substances are exempted if the manufacturing process and site meet the requirements of the exemption. The specifically listed substances for the Kraft pulping process are:
- Black liquor: CASRN 66071-92-9, Sulfite liquors and cooking liquors, spent
- Oxidized black liquor: CASRN 68514-09-0, Sulfite liquors and Cooking liquors, spent, oxidized
- Calcium carbonate: CASRN 471-34-1, Carbonic acid calcium salt (1:1)
If the listed kraft pulping process byproduct substances are recycled or otherwise used within a site-limited, physically enclosed system that is part of the same overall manufacturing process from which the byproduct substance was produced, and the site is reporting the byproduct or a different chemical substance that was manufactured from the recycled byproduct or manufactured in the same overall manufacturing process, that byproduct is not required to be reported (40 CFR 711.10(d)(1)(i)).
In addition, 40 CFR 720.30(g) exempts the manufacture of a byproduct from CDR reporting if: “…its only commercial purpose is for use by public or private organizations that (1) burn it as a fuel, (2) dispose of it as a waste, including in a landfill or for enriching soil, or (3) extract component chemical substances from it for commercial purposes. (This exclusion only applies to the byproduct; it does not apply to the component substances extracted from the byproduct.)” See also 40 CFR 711.10(c), which refers to 40 CFR 720.30(g) for activities for which CDR reporting is not required.
While the black liquor is burned, the volume is burned both for its fuel value and for its value as a feedstock to the production of smelt. The example indicates that the manufactured smelt is then put to non-exempt commercial purposes (to make white liquor, a pulping chemical). Therefore, it is not the case that the only commercial purpose of the black liquor is to “burn it as a fuel.” 40 CFR 720.30(g) therefore does not provide an exemption for the manufacture of the black liquor byproduct.
For more information on this topic, please refer to: CDR Fact Sheet on Kraft Pulp and Paper.
- 10.25. Our company purchases a cation resin (H+-Resin) for our ion exchange system from a domestic supplier. The ion-exchange resin is used to remove dissolved Metal G from a liquid process stream, which contains metal G in the form of a metal cation. Following removal of the G+ metal ions, the remainder of the liquid process stream is disposed as a waste. The metal ion is subsequently displaced from the ion-exchange resin by the addition of an acid solution and further processed on-site to recover Metal G. Which reaction products should our company report under CDR?
EPA assumes that the liquid process stream is the company’s own byproduct. Also, based on the information provided, EPA assumes that the following reactions occur within the ion exchange system:
Ion Exchange: [G+][anions-] + [H+][Resin] ⇌ [G+][Resin] + [H+][anions-]; (where the particular anions balancing G+ in the liquid process stream are assumed to be unknown or of variable composition) and Regeneration: [G+][Resin] + [H+][Y-] ⇌ [G+][Y-] + [H+][Resin]; Where Y- is a known anion.
As the liquid process stream passes through a cation resin, H+ cations on the resin are exchanged for G+ cations via chemical absorption (forming a [G+][Resin] complex). As the performance of the resin declines, an acid solution ([H+][Y-]) is typically used to regenerate the cation resin. A subsequent drying step results in the metal salt [G+][Y-]. The metal salt is subsequently chemically reduced to form elemental metal G.
From this set of reactions, EPA has determined (assuming that all pertinent production volumes thresholds are exceeded) that CDR reporting requirements apply to the company as follows:
Liquid Process Stream: Since the stream contains unknown or variable salts of G+, and there is not a basis to conclude that these various salts would necessarily be exempt from CDR if they were treated as mixture components, it is appropriate to treat the entire liquid process stream as a single UVCB chemical substance. The process stream has a non-exempt commercial purpose (the production of [G+][Resin]) and is subject to CDR. The manufacture of the liquid process stream does not receive the reporting exemption at 40 CFR 720.30(g)(3) because the component chemical substances at issue ([G+][anions-]) are not extracted from the stream. Rather, they are chemically reacted with [H+][Resin] to produce [G+][Resin].
Metal-Depleted Liquid Process Stream: This liquid, which remains after formation of the [G+][Resin], is a byproduct of the chemical processing of the original liquid process stream. The metal-depleted liquid process stream (including [H+][anions-] and other constituents) has no commercial purpose except to be disposed as a waste and it is exempt from reporting under 40 CFR 720.30(g)(2).
Metal-Resin Complex: Reporting requirements for the metal-resin complex should be evaluated by each manufacturer. If the process is one of continuous formation of the [G+][Resin] complex and regeneration of the [H+][Resin], the metal-resin complex satisfies the definition of a non- isolated intermediate and is exempt from CDR reporting requirements (see 40 CFR 711.10(c) which references 720.30(h)(8)). However, if the [G+][Resin] complex is stored in the ion- exchange column, such as during periods when the ion exchange system is not in use, the metal- resin complex would not be a non-isolated intermediate. Alternatively, if the [G+}[Resin] complex is described as a polymer on the TSCA Inventory and meets the criteria of the CDR polymer definition, it is exempted from reporting (see 40 CFR 711.6(a)(1)).
Regenerated Cation Resin: The regenerated ion-exchange resin ([H+][Resin]) is an insoluble matrix fabricated from an organic polymer substrate, often polystyrene. Many polymers on the TSCA Inventory are exempt from CDR because they meet the criteria of 40 CFR 711.6(a)(1).
Metal Salt: The regeneration process forms a metal salt, [G+][Y-]. This salt is manufactured for a non-exempt commercial purpose and is subject to CDR reporting requirements.
Metal G: The recovery of Metal G from the metal salt requires a chemical reduction process. This involves the chemical conversion of one chemical substance (the metal salt [G+][Y-]) into a different chemical substance: elemental G. The manufacture of elemental G from [G+][Y-] is subject to reporting.
- 10.1. What is a byproduct?
- Non-TSCA Uses
- 11.1. If a company manufactures a chemical substance for a non-TSCA use, is the company required to submit CDR information for this chemical substance?
Substances that do not meet the definition of “chemical substance” in TSCA Section 3(2)(B) need not be reported. Those substances include: any pesticide as defined by the Federal Insecticide, Fungicide, and Rodenticide Act, when manufactured, processed, or distributed in commerce for use as a pesticide; any food, food additive, drug, cosmetic, or device, as defined by the Federal Food, Drug, and Cosmetic Act, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic or device; tobacco or any tobacco product; any source material, special nuclear material, or byproduct material as such terms are defined in the Atomic Energy Act of 1954; and, any article the sale of which is subject to the tax imposed by Section 4181 of the Internal Revenue Code.
- 11.2. If a company manufactures a chemical substance which may be used for purposes regulated by TSCA and also for uses which are excluded from regulation under TSCA Section 3(2)(B), should the entire quantity that the company manufactures be reported on the CDR submission?
No. Report the manufactured quantity intended for the TSCA use and do not report the quantity that is excluded from TSCA regulation pursuant to Section 3(2)(B).
- 11.3. A company manufactures Chemical C. Its customers use Chemical C for a variety of uses including the manufacture of a chemical substance to be used as a pesticide active ingredient. Pesticides are exempt from regulation by TSCA. Does the company need to report industrial processing and use data for this chemical substance?
Where persons manufacture chemical substances for a variety of uses, the CDR rule does not require the reporting of processing and use information on the non-TSCA uses of the TSCA chemical substances they manufacture. Therefore, a person manufacturing a chemical substance which is an active ingredient in a pesticide formulation should report the amount of the chemical substance manufactured but need not report processing and use information for activities occurring after it is incorporated into the pesticide formulation.
- 11.1. If a company manufactures a chemical substance for a non-TSCA use, is the company required to submit CDR information for this chemical substance?
- Exemptions from Reporting
- 12.1. Which chemical substances on the TSCA Inventory are generally exempt from CDR requirements and do not need to be reported?
Naturally occurring substances, including naturally occurring water, are exempt from CDR requirements. Polymers, microorganisms, water, and certain forms of natural gas are generally exempt from CDR requirements. These general exemptions are further defined at 40 CFR 711.6 (a). Note that a particular polymer, microorganism, manufactured water, or certain form of natural gas is no longer covered under this exemption if the chemical substance becomes the subject of any of certain TSCA actions (a final or proposed rule under TSCA Section 4, 5(a)(2), 5(b)(4), or 6; a consent agreement developed under the procedures of 40 CFR Part 790; an order issued under TSCA Sections 4, 5(e), or 5(f); or relief under TSCA Section 5 or 7).
- 12.2. Many polymers are exempt from CDR regulations. How is “polymer” defined under the CDR rule?
The CDR definition of polymer is found in 40 CFR 711.6 (a)(1), which identifies polymers that are fully exempted from reporting under CDR. The regulatory text states:
(1) Polymers—(i) Any chemical substance described with the word fragments “*polym,” “*alkyd,” or “*oxylated” in the Chemical Abstracts (CA) Index Name in the Master Inventory File, where the asterisk (*) in the listed word fragments indicates that any sets of characters may precede, or follow, the character string defined.(ii) Any chemical substance that is identified in the Master Inventory File as an enzyme, lignin, a polysaccharide (cellulose, gum, starch), a protein (albumin, casein, gelatin, gluten, hemoglobin), rubber, siloxane and silicone, or silsesquioxane.(iii) This exclusion does not apply to a polymeric substance that has been depolymerized, hydrolyzed, or otherwise chemically modified, except in cases where the intended product of this reaction is totally polymeric in structure.
Note that this definition differs from the definition of polymer used in the Polymer Exemption at 40 CFR 723.250 to determine reportability of new polymers under Section 5 of TSCA.
- 12.3. Are there any types of polymers that are ineligible for the exemption?
Substances that are not considered to be polymers result from hydrolysis, depolymerization, or chemical modification of polymers, regardless of the extent of these processes, so that as long as the final products are no longer polymeric at all (e.g., a mixture of amino acids that is the result of hydrolysis of a polypeptide); such substances, must be reported to CDR if they are not otherwise excluded.
In addition, a particular polymer is no longer covered under this exemption if the chemical substance becomes the subject of any of certain TSCA actions (a final or proposed rule under TSCA Section 4, 5(a)(2), 5(b)(4), or 6; a consent agreement developed under the procedures of 40 CFR Part 790; an order issued under TSCA Sections 4, 5(e), or 5(f); or relief under TSCA Section 5 or 7).
- 12.4. A company has facilities to recycle used plastic cartridges. These existing plastic cartridges have been previously manufactured and sold to consumers. The cartridges get returned for recycling. On return, the cartridges are crushed and processed (grinding, fusing and blending, etc.) to form a mixture of pellets. No new materials are added and it is not believed that a chemical reaction is taking place that would chemically change the material into different polymers, etc. It is intended that the original plastic materials are being recycled into pellets and thereafter available for reuse. Are the recycled plastic products subject to CDR requirements?
The plastic cartridges are a combination of polymers, and polymers are generally exempt from reporting under the CDR. The actions listed in this question do not appear to depolymerize the material or otherwise manufacture a chemical substance. Therefore, there is no reporting required for the recycling of the plastic cartridges.
- 12.5. Microorganisms are usually exempt from CDR requirements. How does the CDR regulation define microorganism?
A microorganism is any combination of chemical substances that is a living organism and that meets the definition of “microorganism” at 40 CFR 725.3. Note that any chemical substance produced from a living microorganism is reportable unless otherwise excluded (40 CFR 711.6(a)(2)).
- 12.1. Which chemical substances on the TSCA Inventory are generally exempt from CDR requirements and do not need to be reported?