Determining if You Are a Manufacturer or Importer Required to Report

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• Production volume thresholds
• Small manufacturers
• Certain regulated chemical substances
• Small quantities for research and development
• Imported articles
• Impurities
• Non-isolated intermediate

Production Volume Thresholds

13.1. How does a company determine whether it has reporting obligations for the CDR?

A person who manufactured (including imported) for commercial purposes 25,000 pounds or more of a reportable chemical substance at any single site during any calendar year since the last principal reporting year is generally subject to reporting (see 40 CFR 711.8(b)), unless the person is eligible for certain exemptions, such as the small manufacturer exemption (see 40 CFR 711.9) or exemptions for certain activities (see 40 CFR 711.10). A person who manufactured (including imported) for commercial purposes 2,500 pounds or more of a chemical substance subject to certain TSCA actions at any single site during any calendar year since the last principal reporting year is generally subject to reporting.

You should consider the following three steps to determine whether you are required to report for each chemical substance that you domestically manufacture (including import) 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 (www.epa.gov/cdr) for help with each of these steps.

13.2. Will EPA provide a consolidated list of substances and thresholds that are relevant for this reporting cycle?

A downloadable spreadsheet is available on the EPA website. It consolidates the 2020 CDR chemical status information available through EPA’s Substance Registry Services (SRS) into one spreadsheet, identifying the TSCA Inventory status of each chemical substance, whether the chemical is the subject of the relevant TSCA actions, and whether the chemical is subject to a reduced reporting threshold or ineligible for exemptions. See EPA 2020 CDR Chemical Status Spreadsheet on the “Search for chemicals subject to certain TSCA actions” page at: https://www.epa.gov/chemical-data-reporting/help-chemical-data-reporting-how-search-chemicals-subject-certain-tsca.

13.3. How do manufacturers avoid double counting of chemical substances in intermediates and final products? If a chemical substance is an isolated intermediate during production, that’s to be counted. However, if that same chemical substance is present in the final product, should it be added to the amount of isolated intermediate or should the amount in the final product be reported, assuming that amount is greater than what’s present in the intermediates?

A substance is reported when it is manufactured. If it is manufactured as an intermediate, then the substance is reportable at that time. If the intermediate that is present in the final product is unreacted material, then it does not need to be reported as part of the final product.

13.4. Are domestically bought substances that are used in processes and are reacted to manufacture a product reportable? The final product is not a mixture containing this substance. The substance either is reacted completely, or whatever remains unreacted is sent to waste.

Only the manufacturer or importer of a chemical substance is required to report under CDR. A domestically purchased chemical substance does not have to be reported for CDR. However, any chemical substance that is manufactured from the purchased chemical substance is reportable. For example, if Company X domestically purchased Chemical A and Chemical B and reacts them to create Chemical C, Company X would only report Chemical C.

13.5. If a company began producing a chemical substance in January 2020, does the company need to send EPA a CDR report for 2019 with all zeros?

No. Reporting for chemical substances is determined based on the volumes produced during any calendar year since the last principal reporting year. Because the company did not manufacture the chemical during 2016-2019, the company has no reporting obligations for that chemical for the 2020 CDR submission period.

13.6. If a company manufactured 31,000 pounds of a reportable chemical substance at one site and 20,000 pounds at another site, does the production volume meet or exceed the threshold for reporting?

In general, the company only needs to report for those sites at which it manufactured (including imported) 25,000 pounds or more of a chemical substance in any calendar year since the last principal reporting year. If the chemical does not trigger a reduced threshold, the company would report the 31,000 pounds manufactured at the first site, but is not required to report the 20,000 pounds manufactured at the second site. If the chemical is subject to a reduced threshold of 2,500 pounds because it is the subject of certain TSCA actions, the company would report for each of the sites.

13.7. What if a company both manufactures and imports a chemical substance at a plant site?

The company should aggregate the total amount of the chemical substance manufactured and imported at the site to determine if a threshold has been met.

13.8. An importer with one site in the U.S. imports the same chemical from two different companies (located in two different countries). Does the importer add the amounts from each source together or are they kept separate?

The importer adds the imported volumes of the same chemical imported by the same site, regardless of the source. Note that this also applies to mixtures — when a mixture is imported, the component chemicals of that mixture are subject to CDR. The determination of whether the production volume threshold is met is based upon the total imports for the chemical substance.

13.9. If a company imports 1 million pounds of a mixture containing 90 percent Chemical A, 9 percent Chemical B, and 1 percent Chemical C, how is this reported? Chemicals A, B, and C are all potentially subject to CDR.

The company should evaluate the reporting requirements for each constituent of the mixture.

• Chemical A: 900,000 pounds (1,000,000 pounds x 90 percent)
• Chemical B: 90,000 pounds imported
• Chemical C: 10,000 pounds imported; no reporting because the 25,000 pound threshold was not met. (However, if Chemical C is the subject of certain TSCA actions, reporting is required because the 2,500 pound threshold is exceeded.)

13.10. A company imports 200,000 pounds of Alloy 123 and knows the percentage of each component in the alloy (see table below). How does the company report for Alloy 123 under the CDR regulation?

The company must consider each component of Alloy 123 independently and determine if it meets the CDR criteria. The calculations in pounds for each constituent are shown above in the third column. Only Nickel and Iron would be reportable because they are the only two components with production volumes above 25,000 pounds. If any of these substances are the subject of certain TSCA actions the reporting threshold to consider would be 2,500 pounds.

14. Small Manufacturers

14.1. Are small manufacturers exempt from CDR reporting requirements?

Usually, yes. A submitter meeting either of the following standards (40 CFR 704.3) would be considered a small manufacturer and generally exempt from CDR reporting if:

• Total sales during the principal reporting year, combined with those of the parent company, domestic or foreign (if any), are less than $12 million regardless of annual production volume.
• Total sales during the principal reporting year, combined with those of the parent company, domestic or foreign (if any), are less than $120 million and your annual production volume of that chemical substance does not exceed 100,000 pounds at any individual plant site. If the annual production volume of the chemical substance at any particular site is more than 100,000 pounds, the submitter is required to report for that particular site.

Note that under the second standard, it is possible to qualify as a small manufacturer with respect to some chemical substances and not others or with respect to some sites and not others.

For purposes of the definition of a small manufacturer, total annual sales include all sales of the company, not just the total sales of a given chemical substance (40 CFR 704.3).

14.2. There have been changes to the definition for Small Manufacturers. Will the 100,000 pounds threshold still apply to the small business entities?

Yes. The 100,000 pounds threshold is applied as follows (40 CFR 704.3):

You are exempt from reporting as a small manufacturer if:

• Total sales during the principal reporting year, combined with those of the parent company, domestic or foreign (if any), are less than $12 million regardless of annual production volume. Total sales during the principal reporting year, combined with those of the parent company, domestic or foreign (if any), are less than $120 million and your annual production volume of that chemical substance does not exceed 100,000 pounds at any individual plant site. If the annual production volume of the chemical substance at any particular site is more than 100,000 pounds, the submitter is required to report for that particular site, unless the submitter meets the first standard.
• Total sales during the principal reporting year, combined with those of the parent company, domestic or foreign (if any), are less than $12 million regardless of annual production volume.

14.3. Are small governments also exempt from reporting under CDR?

Yes, small governments are also exempt from reporting under CDR. In May 2020, EPA finalized the Small Manufacturer Definition Update for TSCA Section 8(a) rule, which added a small government definition. For purposes of CDR, a manufacturing site that is owned by a small government is not required to report manufactured (including imported) chemical substances. Small government means the government of a city, county, town, township, village, school district, or special district with a population of less than 50,000. (40 CFR 704.3)

14.4. Are there any situations where small manufacturers are not exempt and may be subject to CDR reporting?

Yes. The exemption for small businesses does not apply to persons who manufacture (including import) a chemical substance that is the subject of a rule proposed or promulgated under Section 4, 5(b)(4), or 6 of TSCA; or is the subject of an order in effect under Section 4 or 5(e) of TSCA; or is the subject of relief that has been granted under a civil action under Section 5 or 7 of TSCA (40 CFR 711.9). In such circumstances, the volume thresholds for reporting found in §711.8 apply.

14.5. When evaluating my small business exemption status with respect to production volume being less than 100,000 pounds, do I consider each chemical substance separately or all of my chemicals together?

You determine your status as a small manufacturer on a chemical-by-chemical basis, taking into account the total sales of the company. Therefore, if your company has total sales of $12 million or over but under $120 million and manufactured 35,000 pounds of Chemical A, 140,000 pounds of Chemical B, and 95,000 pounds of Chemical C, your company qualifies for small manufacturer status with respect to Chemicals A and C, but not Chemical B. Note that, if Chemical A or C is subject to any of certain TSCA actions, your company would be required to report for that chemical, notwithstanding its small manufacturer status.

14.6. If a company qualifies as a small manufacturer, should that information be sent to EPA?

No. A company does not need to send the information regarding qualifying as a small manufacturer to EPA.

14.7. To determine if we qualify as a small manufacturer, when calculating total annual sales of a parent company, should we only add sales of the domestic parent company or are sales of the foreign parent company included too?

To determine whether you meet the small manufacturer definition, calculate total sales for the entire company, including the sales of a foreign parent company. In the definition of a small manufacturer, in 40 CFR 704.3, a parent company is defined more broadly geographically than the definition of U.S. parent company.

15. Certain Regulated Chemical Substances

15.1. One of the chemicals that Company B manufactures is the subject of a TSCA Section 4(a) test rule proposed in 1999. Is this still active and does it affect the CDR status of the chemical substance? Does it matter that Company B didn’t start to manufacture the chemical substance 2019?

Unless EPA has withdrawn or finalized the rule in the Federal Register, the proposal is still pending and the chemical substance is thus still the subject of a proposed TSCA Section 4(a) test rule. Company B cannot claim a reporting exemption for the chemical under 40 CFR 711.6 or, if Company B meets the requirement of a small manufacturer, under 40 CFR 711.9. The fact that Company B did not start to manufacture the chemical substance until 2019 does not change this conclusion.

15.2. A chemical substance that Company C manufactures is the subject of a TSCA Section 4(a) test rule which is listed as having a sunset date before the current CDR reporting year. Does this test rule still affect the CDR status of the chemical substance?

Final TSCA Section 4 test rules, test orders and/or enforceable consent agreements will have a sunset date which is the termination of the TSCA Section 4 requirements. After the sunset date has passed, the chemical substance is no longer subject to TSCA Section 4. Therefore, in this case, Company C would not need to be concerned about a test rule which terminated before the current CDR reporting period. Consider the TSCA regulatory status of the chemical substance at the beginning of the reporting period (e.g., June 1, 2020 for the 2020 reporting period).

16. Small Quantities for Research and Development

16.1. If a company manufactures a small quantity of a chemical substance solely for research and development, is CDR reporting required?

No. A chemical substance manufactured solely in small quantities for research and development need not be reported under the CDR regulation (40 CFR 711.10(a)). However, the company must be sure that it can verify that this chemical substance is used solely for research and development.

16.2. A company manufactures 26,000 pounds of a chemical substance, uses 2,000 pounds for research and development, and sells the remaining chemical substances for industrial uses. Is CDR reporting required? The chemical substance is not otherwise exempted from CDR requirements.

Yes. A person is exempt from CDR requirements for a chemical substance manufactured for research and development only if they do not also manufacture the chemical substance for other non-exempt uses (40 CFR 711.10(a)). The total amount of the chemical substance manufactured, 26,000 pounds, exceeds the reporting threshold and therefore all 26,000 pounds of the chemical must be reported.

17. Imported Articles

17.1. If a chemical substance is part of an article when it is imported, is the chemical substance reportable under the CDR regulation?

Maybe. If the chemical substance is imported solely as part of an article and is not intended to come out of the article during use, the chemical substance is exempt from CDR reporting. 40 CFR 711.10(b). For example, a pen is considered an article and any chemicals that comprise the pen body are not subject to reporting; the ink in the pen is not considered to be part of the article because it is intended to come out of the pen in order for it to be used and any chemicals in the ink are subject to reporting.

An article is defined in 40 CFR 704.3 as “a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end-use function(s) dependent in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design.”

See TSCA Chemical Data Reporting Fact Sheet: Imported Articles for additional information.

17.2. If a company imports metal ingots that are melted and reshaped into finished products in the United States, is the company required to submit a CDR report for the ingots that are imported?

Probably, yes. Although chemical substances imported as part of an article are exempt from CDR reporting (40 CFR 711.10(b)), ingots typically do not qualify for this exemption. If an item is manufactured or imported in a particular shape for convenience during shipping and the shape of the item has no function in the end use, it would not be considered an article. A metal ingot is typically intended to be melted and extruded; the shape or design of the end use application is independent of the shape of the ingot. Consequently, the importation of chemical substances that are present in ingots must be reported for CDR.

17.3. If a company purchases metal ingots from a domestic supplier that are subsequently melted and reshaped into finished products, is the company required to submit a CDR report for the ingots that are purchased from a domestic supplier?

No. The company is not manufacturing (or importing) the metal ingots but is only processing them. The CDR rule applies only to manufacturers (including importers) of chemical substances.

17.4. A metal alloy disk containing iron, nickel, cobalt, and other metals is imported and subsequently machined to design specifications and assembled into the final product. The shape of the imported disk is commonly referred to as “near-final-shape,” in that its overall shape and dimensions are largely preserved following the machining process. Does EPA consider the metal alloy disk an article for CDR purposes?

Yes. The disk comports with the definition of an article and the chemical substances comprising the disk would not need to be reported under CDR. An article is an item manufactured in a specific shape or design that has end use function dependent upon its shape or design. In addition, an article has either no change of chemical composition during its end use or only those changes of composition that have no commercial purpose separate from that of the article (40 CFR 704.3). In this fact pattern, the disk is imported in near-final-shape which is maintained as the part is machined from the disk, the use of the disk depends on the near-net shape of the disk, and the chemical composition of the article does not change during machining or use except for any unintended corrosion. Therefore, the disk satisfies all three parts of the article definition and are eligible for the exemption for imported articles at 40 CFR 711.10(b).

17.5. Can imported metal powders ever be considered “articles” regardless of their end use?

No. Powders cannot be considered articles. The definition of article includes the statement that “fluids and particles are not considered articles regardless of shape or design” (40 CFR 704.3).

18. Impurities

18.1. Must impurities be reported under the CDR regulation?

No. Impurities are exempted from CDR requirements. See 40 CFR 711.10(c) and 40 CFR 720.30(h)(1). An impurity is defined as a chemical substance which is unintentionally present with another chemical substance (40 CFR 704.3). Impurities 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.

18.2. A company purchases Chemical X which contains impurities, and then uses Chemical X as a reactant to manufacture Chemical Y. The impurities that were present in Chemical X may then be present in Chemical Y and there may be other impurities in Chemical Y. Must the company now report the impurities in Chemical Y because they are present in a chemical substance that the company has manufactured?

If the impurities retain their status as impurities (i.e., they remain unintentionally present with Chemical Y) then they are not reportable. However, it should be noted that the company may possibly also have manufactured one or more reportable byproducts as part of making Chemical Y.

19. Non-Isolated Intermediate

19.1. Reactants C and D are charged to a vessel where they react to form Chemical P. Chemical E is then added to the reaction vessel and Chemical P is completely consumed in the formation of Chemical Q, which is then drummed for shipment. Is the manufacture of Chemical P subject to CDR requirements?

No. In this example, EPA considers Chemical P to be a “non-isolated intermediate” because it is not stored in or intentionally removed from the reaction vessel in which it is manufactured and it is reacted in that vessel to form another chemical substance. Persons who manufacture chemical substances solely as non-isolated intermediates are exempt from CDR requirements for those chemical substances (40 CFR 711.10(c) which references 40 CFR 720.30(h)). Note, however, that the manufacturer should determine whether Chemical Q meets the criteria for being reportable under CDR requirements.

19.2. Does sampling for quality control purposes negate the non-isolated intermediate status of a chemical substance?

No. Sampling for quality control does not negate the non-isolated intermediate status of a chemical substance.