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4. General

• 4.1. How do I determine my reporting requirements?

  Carefully review the regulations located at 40 CFR 711.5 to determine your reporting requirements. You should consider the following three steps to determine whether you are required to report for each chemical substance that you domestically manufactured (including imported) 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?

5. Manufactured Chemicals (Including Imported) for Commercial Purposes

• 5.1 If a company purchases chemicals and blends them into finished products, with no chemical reactions, is the company required to report these materials?

  No. The CDR rule requires only manufacturers, including importers, of chemical substances listed on the TSCA Chemical Substance Inventory to report. Therefore, if a company purchases all of its chemicals from domestic sources and does not use them to manufacture other chemicals, the company is not required to report.

• 5.2. If a company manufactures a chemical substance on the TSCA Inventory solely for export, is the company subject to CDR regulations?

  Yes. Persons who manufacture chemical substances solely for export are considered manufacturers for the purposes of CDR and need to comply with the CDR regulations. Note, however, that the processing and use information required by 40 CFR 711.15(b)(4) is restricted to domestic activities, i.e., within the customs territory of the United States. If all processing and use occurs outside the United States, the company would fill out Parts I and II of Form U and check the box labeled “N/A” in the upper right-hand corner of Sections A and B of Part III on Form U.

• 5.3. Is a company a manufacturer if it buys a chemical substance domestically and resells it or if the company buys a chemical substance domestically and packages it into drums?

  In 40 CFR 711.3 “manufacture” is defined in part as "manufacture, produce, or import for commercial purposes. Manufacture includes the extraction, for commercial purposes, of a component chemical substance from a previously existing chemical substance or complex combination of substances.” In both of the examples included in the question, the company is not manufacturing as long as the company is purchasing from a domestic source. If the company is importing, then it is considered to be manufacturing for CDR purposes.

• 5.4. What is an “exporter” under the rule?

  The CDR rule does not define or reference a definition for exporter because there are no reporting obligations under CDR for exporters. The definition of manufacture includes importing but not exporting.

• 5.5. Is reporting required if a chemical substance is simply diluted with water?

  No. Simply diluting another substance with water does not trigger reporting.

6. Toll Manufacturers

• 6.1. What are toll manufacturing and co-manufacturing?

  For CDR purposes, toll manufacturing refers to a particular kind of co-manufacturing situation involving two parties: one company contracts with a second company to domestically produce a chemical substance exclusively for the first company. The first company, or contracting company, determines the specific chemical identity of the substance, and controls the total amount produced and the basic technology for the plant process. The second company, or toll manufacturer, generally provides the site, staff, and equipment necessary to manufacture the chemical substance. See 40 CFR 711.3 (definition of “manufacture”)

  For additional information about toll manufacturing and reporting for CDR purposes, please see: TSCA Chemical Data Reporting Fact Sheet: Toll Manufacturing.

• 6.2. Company B is a “toll” manufacturing facility which has a contract with Company A to make a specific chemical substance using Company A’s technology and raw materials. Company B supplies Company A with the resulting product, charging a “toll” fee for the conversion process, and is not involved with subsequent marketing or sales of the product. Company A has indicated that Company B is responsible for completing the CDR Form U. Company B believes that Company A should be the responsible party since it is their material and Company B has no control over the product, market, applications or uses. What should Company B do?

  Company B should refer Company A to the CDR regulations, specifically to 40 CFR 711.22(c), which states that while the companies can work out among themselves who should report, EPA holds both of the parties (i.e., contracting company and toll manufacturer) responsible for the submission of a report by either one of the parties. Company B and Company A should then decide how to comply with the CDR regulations for the chemical substance.

  Additional information about toll manufacturing and reporting for CDR purposes is found in: TSCA Chemical Data Reporting Fact Sheet: Toll Manufacturing.

• 6.3. Who is primarily or solely responsible for meeting CDR requirements — the contracting manufacturer or the toll manufacturer? Does the contracting company have to submit information on behalf of the toll manufacturer?

  In a co-manufacturing situation, the toll and contracting manufacturers can share information and agree between themselves that one or the other will undertake all or a portion of the work associated with meeting the CDR regulations for a given co-manufactured chemical substance. EPA expects that in most instances, a person that contracts with a toll manufacturer will generally know more about the particular chemical substances, and will usually be in a better position to report about industrial processing and use of a chemical substance, and about commercial and consumer uses of products containing the chemical substance. Similarly, EPA expects that the toll manufacturer will generally be in a better position to report the number of workers and other information associated with the manufacturing site.

  Additional information about toll manufacturing and reporting for CDR purposes is found in: TSCA Chemical Data Reporting Fact Sheet: Toll Manufacturing.

• 6.4. If the contracting manufacturer agrees to report the chemical for the given CDR submission period, does that take the burden off of the toll manufacturer? For example, if Company A tolls for Company X and Company X agrees to report the chemical, does that absolve Company A from any reporting?

  Not necessarily. If Company X agrees to report the manufacturing, but fails to do so, Company A is still responsible to report. The contracting company and the toll manufacturer are to decide among themselves how to meet the CDR requirements for a specific co-manufactured chemical substance. Both parties (i.e., contracting manufacturer and toll manufacturer) are responsible to ensure that one of the parties reports the chemical substance. Care should be taken to avoid duplicative reporting, so that only one Form U for the co-manufactured chemical substance is submitted to EPA.

  Additional information about toll manufacturing and reporting for CDR purposes is found in: TSCA Chemical Data Reporting Fact Sheet: Toll Manufacturing.

7. Importers

• 7.1. Are importers of chemical substances required to report under the CDR rule?

  Yes, potentially. 40 CFR 711.3 and TSCA Section 3 define “manufacture” to include import. Any person who manufactured (including imported) for commercial purposes a subject chemical substance at any single site during any calendar year since the last principal reporting year and meets a production volume threshold may be subject to reporting requirements (40 CFR 711.8(b)).

  For additional information, see: TSCA Chemical Data Reporting Fact Sheet: Importers.

• 7.2. Although Company S is a non-resident (i.e., non-U.S.) company, Company S is the importer of a chemical substance (shipping directly to Company R, customer in the United States, and acting as the importer of record for purposes of completing the necessary forms for U.S. Customs, including the payment of duties). Can Company S, an entity that is a non-resident importer, file a CDR Form U?

  Yes, but Company S must give its U.S. site address. The definition of “site” at 40 CFR 711.3 states that for an importer, the “site” is “the U.S. site of the operating unit within the person’s organization that is directly responsible for importing the chemical substance” but also indicates that if there is no such operating unit within the United States, the U.S. address of an agent acting on behalf of the importer may be used. EPA expects that all importers will have a U.S. site meeting the 40 CFR 711.3 definition, because under Customs regulations at 19 CFR 141.18, a non-resident corporation is not permitted to enter merchandise for consumption unless it has a resident agent in the United States.

  For additional information, see: TSCA Chemical Data Reporting Fact Sheet: Importers.

• 7.3. Is a company operating in a Foreign Trade Zone subject to the CDR rule?

  Yes. A company is subject to reporting if it manufactures (including imports) a chemical substance covered under 40 CFR 711.5 in a Foreign Trade Zone. For purposes of CDR, companies operating in a Foreign Trade Zone have the same reporting responsibilities as companies not operating in a Foreign Trade Zone.

• 7.4. A company receives a chemical substance from a foreign source and uses it as a reactant. The reaction completely consumes the chemical substance. Is this chemical substance considered to be site-limited?

  For purposes of CDR, imported chemical substances are never site-limited (40 CFR 711.3).

• 7.5. A company transports a chemical substance via pipeline from outside the customs territory of the United States to a plant site in the United States. Is the company subject to the CDR rule for this chemical substance?

  Yes. The company is importing the chemical substance into the United States, and, therefore, is potentially subject to CDR regulations. The mode of transporting the chemical substance to a company’s site is not relevant when determining CDR obligations.

• 7.6. If the corporate headquarters is the site of import and the imported substances never come to headquarters but are sent directly to several plants, how is manufacturing, process and use, and consumer and commercial use data reported? Is the information for the several plants for a particular substance combined?

  Report the manufacturing information associated with your site of import as you would for any manufacturing site. For each chemical substance indicate that the chemical was never physically at the site, and because there would be no potential exposure to the chemical substance at the import site, the code W1 corresponding to fewer than 10 workers would be reported. For production volume, aggregate the volumes for each chemical substance imported by your site, regardless of where the chemical substances are physically shipped.

  Also report the industrial processing and use and consumer and commercial use information for all the plants, whether owned by your company or not. Aggregate the information, such that for the industrial information, you report the top ten combinations of industrial function category, industrial sector, and functional use for each chemical substance across all plants where that particular chemical is used. For the consumer and commercial information, report the top ten product categories for each chemical substance, aggregating the information from all the plants in which the chemical substances are used.