TSCA and lab chemical imports: the R&D exemption and import certification

Why the broker is asking

A laboratory importing a peptide into the United States may get an unexpected question from its customs broker: positive or negative TSCA certification? The question comes from section 13 of the Toxic Substances Control Act and the Customs rule at 19 CFR 12.121. A certification must be signed and filed with CBP by the importer or an authorized agent of the importer, electronically through ACE or in writing, and paper statements must reach the port director before the shipment is released. [1] [2]

EPA states that certification is required for imported substances received by mail or commercial carrier, including those intended for research and development. [1] A small research order is therefore not outside the question just because it is small. This guide explains the two statements, the exclusions that decide between them, and the R&D exemption that often matters for research substances. It is not legal advice, and the importer, not the broker, signs the statement.

Positive and negative certification

19 CFR 12.121 sets out the wording. The certification must include the certifier's name, telephone number and email address. [2] EPA lists the rules a positive certification covers: section 5 premanufacture notice and significant new use rules, section 5(e) and 5(f) orders, section 6 rules, section 7 judicial actions and Title IV. It says section 4 and 8 rules do not affect import certification because they are not tied to individual shipments. [1]

When a peptide is outside TSCA

TSCA's definition of chemical substance, at 15 U.S.C. 2602(2), excludes several categories. The one that matters for peptides is (B)(vi): any food, food additive, drug, cosmetic or device as defined in section 201 of the FD&C Act, "when manufactured, processed, or distributed in commerce for use as" one of those things. [3]

The exclusion is tied to intended use, not to the molecule. A peptide imported as a drug product is regulated by FDA, and EPA lists FDA-regulated products among those that take a negative certification when not clearly identified. [1] A peptide bought as a laboratory reagent with no drug use is not obviously within that exclusion on the statute's wording. Which statement is accurate depends on facts the importer knows, so it should be decided by your institution's compliance or EHS office, not by the supplier's catalog wording.

• Pesticides are excluded only when distributed for use as a pesticide. [3]
• Mixtures are excluded from the definition of chemical substance itself. [3]
• EPA notes that a product may count as clearly identified when it is tied to another agency's entry paperwork. [1]

The R&D exemption in 40 CFR 720.36

Part 720 is EPA's premanufacture notice rule. "Manufacture" in that part means to produce in the United States or import into the customs territory, so an importer is a manufacturer for these purposes. [5] Section 720.36 says the part does not apply to a substance that meets three conditions. [4]

The laboratory shortcut and leftovers

720.36(b)(2) removes the formal risk review where work is done solely in a laboratory, exposure is controlled by prudent laboratory practices for handling chemicals of unknown toxicity, and the substance is distributed only to other such laboratories, other than for disposal. A laboratory here means a contained research facility using relatively small quantities on a non-production basis. [4]

Leftover quantities may be disposed of as waste under applicable federal, state and local rules. [4] That ties the R&D exemption to your disposal records: a closed inventory entry with a waste pickup reference is evidence that the material stayed within research use.

Section 720.36 itself contains no separate recordkeeping clause and no import-specific provisions in the text we read, so the exemption does not replace the section 13 certification at entry. [4] [1]

Worksheet before you answer the broker

Work through these points with your compliance office and keep the answers with the purchase file. If you remain unsure, EPA's import-export page links to a contact form for TSCA import questions. [1]

• What exactly is in the shipment: substance name, CAS number if assigned, salt form, and whether it is a single substance or a mixture.
• Intended use: laboratory research only, with no drug, food, cosmetic or device use. Write it on the purchase order.
• Whether the substance is distributed for use as a drug and therefore excluded under 15 U.S.C. 2602(2)(B)(vi). [3]
• If subject to TSCA, whether it is on the Inventory or relies on the R&D exemption, and who the technically qualified individual is. [4] [5]
• Who signs: the importer or an authorized agent, with name, phone and email on the certification. [2]
• Where the signed statement and broker entry papers are filed, so a later EPA or CBP question can be answered from the record.