Determining the Chemical Substances Subject to the CDR Rule

On this page:

General
Chemicals manufactured (including Imported) for commercial purposes
Co-Manufacturing by contract
Importers

4. General

4.1. How Do I Determine My Reporting Requirements?

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 information you are required to report for each chemical substance that you manufactured (including imported) 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 document on the CDR website (www.epa.gov/cdr) for additional guidance regarding reporting requirements.

4.2. Do you have to report for each year during the period of 2016-2019 or file for one of the years?

For each potentially reportable chemical substance at your site, consider the production volume for each of the years 2016-2019.?If the reporting threshold is reached during any one of those four years, then submitters must report the following for each chemical substance at a single site:

Annual production volume for 2016-2019
Certain manufacturing information for 2019
Processing and use information for 2019

5. Chemicals Manufactured (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 in a manner that manufactures 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 requirements?

Yes. Persons who manufacture chemical substances solely for export are considered manufacturers for 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 the company does not process or use the chemical substance within the customs territory of the United States, the company does not report processing and use information for that chemical.

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. However, if your chemical substance reacts with water to create a different chemical substance, you may have manufactured a reportable chemical substance.

6. Co-Manufacturing by Contract

6.1. What is the difference between toll manufacturing and co-manufacturing?

As part of the CDR Revisions rule, EPA replaced the term “toll manufacturing” with “co-manufacturing” to add clarity for the co-manufacturing situation. In instructions, guidance, and other communication with submitters prior to the CDR Revisions rule, EPA may have referred to co-manufacturing as toll manufacturing, and more specifically to the two parties as the contracting manufacturer and the toll manufacturer. Because EPA does not specifically define the term “toll manufacturer,” EPA believes it is clearer to use terms associated with the CDR definition of manufacturer in 40 CFR 711.3. Additionally, EPA believes the chemical industry often refers to toll manufacturing in a more general manner, where both of the criteria for co-manufacture included in the CDR definition for manufacture are not met. These criteria are: (1) The chemical substance is produced exclusively for another person who contracts for such production, and (2) that other person specifies the identity of the chemical substance and controls the total amount produced and the basic technology for the plant process.

6.2. What is co-manufacturing by contract?

For CDR purposes, co-manufacturing by contract 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 producing company, 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 co-manufacturing and reporting for CDR purposes, please see: TSCA Chemical Data Reporting Fact Sheet: Co-Manufactured Chemicals.

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

Both the contracting company and producing company are responsible for meeting the CDR requirements. Contracting and producing companies must work together to select between the two following reporting methodologies for preparing their CDR submission. Depending on the reporting methodology selected, the contracting company and producing company will submit distinct information to EPA.

First reporting procedure: Under the first reporting methodology, the contracting company (as the primary submitter) has the responsibility to initiate a co-manufacturer report that will prompt the reporting requirements for the producing company (as the secondary submitter). Each party will complete its part of the co-manufacturer joint report as part of its overall CDR submission and will not have access to the information submitted by the other party. Although the contracting company would be submitting the report, both parties are responsible for the report. Therefore, if no report is filed, both the contracting company and the producing company can be held liable.
Second reporting procedure: This reporting methodology requires the contracting and producing company, upon written agreement, to work together to complete the report. For this second methodology, the producing company (instead of the contracting company) initiates and completes the report in e-CDR Web. The producing company would then coordinate with the contracting company to obtain the additional information needed to complete the submission. This coordination of information between the two parties must be done outside of e-CDRweb. Although the producing company would be submitting the report, both parties are responsible for the report. Therefore, if no report is filed, both the contracting company and the producing company can be held liable. EPA expects this reporting mechanism would be most appropriate in a scenario in which the producing company has the majority of the information regarding the production of a specific chemical.

Additional information about co-manufacturing and reporting for CDR purposes is found in: TSCA Chemical Data Reporting Fact Sheet: Co-Manufactured Chemicals.

6.4. Can the contracting company report all of the information for a co-manufactured chemical?

No, the contracting company is not able to be the sole reporter of the co-manufactured chemical. If the contracting company initiates the co-manufactured chemical report, it must request that the producing company provide certain manufacturing-related information for the chemical. See frequent question 6.3 for more information.

6.5. If the producing company agrees to report the chemical for the given CDR submission period, does that take the burden off of the contracting company? For example, if Company A produces the chemical for Company X and Company A agrees to report the chemical, does that absolve Company X from any reporting?

Not necessarily. If Company A agrees to report the manufacturing, but fails to do so, Company X is still responsible for reporting. The contracting company and the producing company are to decide among themselves how to meet the CDR requirements for a specific co-manufactured chemical substance by selecting between the first reporting procedure or the second reporting procedure for co-manufactured reports. Both parties (i.e., contracting company and producing company) are responsible to ensure that the report is submitted for the chemical substance. Depending on the reporting methodology selected, the contracting company and producing company will submit distinct information to EPA.

Additional information about co-manufacturing and reporting for CDR purposes is found in: TSCA Chemical Data Reporting Fact Sheet: Co-Manufactured Chemicals.

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). Certain chemical substances and manufacturers are excepted, exempted, or excluded from reporting (see, e.g., 40 CFR 711.6, 711.8(b), 711.9, 711.10).

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

7.2. If we are an importer, and reselling to manufacturers, we may not have the life cycle details. Is this correct?

Importers are responsible for reporting under CDR. If you don’t know the specific chemical identity of the imported chemicals or mixtures, you may use a joint submission to ask your foreign supplier to send the identity and composition information directly to EPA. You are also responsible for reporting the processing and use information to the extent that it is known or reasonably ascertainable. Please see the Instructions for Reporting for a more detailed discussion of “known or reasonably ascertainable,” and below for a discussion of “joint submissions.”

7.3. 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, a 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.

7.4. 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.

7.5. 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?

No. For purposes of CDR, imported chemical substances are never site-limited (40 CFR 711.3).

7.6. 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.

7.7. 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 each chemical substance for all the plants that received the chemical substance from your company, 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 processed or used. For the consumer and commercial use information, report the top ten product categories for each chemical substance, aggregating the information from all the plants in which the chemical substances received from your company are used. (40 CFR 711.15(b)(3))

For additional information, see the Instructions for Reporting and the TSCA Chemical Data Reporting Fact Sheet: Importers.