Importation of Chemicals Subject to the Toxic Substances Control Act

AGENCY:

Customs Service, Department of the Treasury.

ACTION:

Final rule.

SUMMARY:

This document sets forth final amendments to the Customs Regulations regarding submission of an importer's certification in connection with the importation of chemical substances subject to the Toxic Substances Control Act. The regulatory amendments reduce the regulatory burden by permitting use of a blanket certification for multiple shipments in lieu of a separate certification for each individual shipment. The final regulations also continue the present practice of allowing some flexibility regarding presentation of the required certification with the entry documentation for an individual shipment.

EFFECTIVE DATE:

March 30, 2000.

FOR FURTHER INFORMATION CONTACT:

Brad Lund, Office of Field Operations (202-927-0192).

SUPPLEMENTARY INFORMATION:

Background

The Toxic Substances Control Act (TSCA) (15 U.S.C. 2601 et seq.) was enacted by Congress, among other things, to protect human health and the environment by requiring testing and necessary use restrictions on certain chemical substances. Section 13 of Title I of the TSCA (15 U.S.C. 2612) governs the entry of those chemical substances into the customs territory of the United States and authorizes the Secretary of the Treasury to refuse entry of any chemical substance that (1) Fails to comply with any rule in effect under the TSCA or (2) is offered for entry in violation of section 5 or 6 of Title I (15 U.S.C. 2604 or 2605) or Title IV (15 U.S.C. 2681 et seq.) or in violation of a rule or order under section 5 or 6 or Title IV or in violation of an order issued in a civil action brought under section 5 or under section 7 of Title I (15 U.S.C. 2606) or under Title IV. Section 13 also sets forth procedural and other requirements in connection with an entry refusal and authorizes the Secretary of the Treasury, after consultation with the Administrator of the Environmental Protection Agency (EPA), to issue rules for the administration of section 13.

The regulations implementing section 13 are contained in §§ 12.118-12.127 of the Customs Regulations (19 CFR 12.118-12.127). Within those regulations, § 12.121 concerns reporting requirements. Paragraph (a) of that section covers chemical substances imported in bulk or as part of a mixture and provides for submission of a signed certification by the importer or his authorized agent stating, in the alternative, (1) That all chemical substances in the shipment comply with all applicable rules or orders under the TSCA and that the importer is not offering a chemical substance for entry in violation of the TSCA or any rule or order thereunder (a positive certification) or (2) that all chemicals in the shipment are not subject to the TSCA (a negative certification). Paragraph (a) further requires that the certification be filed with the director of the port of entry before release of the shipment and provides that the certification may appear as a typed or stamped statement (1) on the entry document or commercial invoice, or on a preprinted attachment to the entry document or commercial invoice, or (2) in the case of a release under a special permit for an immediate delivery under § 142.21 of the Customs Regulations (19 CFR 142.21) or in the case of an entry under § 142.3 of the Customs Regulations (19 CFR 142.3), on the commercial invoice or an attachment to the commercial invoice. Paragraph (b) of § 12.121 provides that the provisions of paragraph (a) apply to a chemical substance or mixture as part of an article only if required by a rule or order under the TSCA. Paragraph (c) of that section provides that a certification under paragraph (a) may be signed by means of an authorized facsimile signature.

On January 9, 1990, Customs published a notice of proposed rulemaking in the Federal Register (55 FR 738) to amend § 12.121. The proposed amendments included the following changes to paragraph (a): (1) To provide for placement of the typed or stamped certification statement only on the invoice used in connection with the entry and entry summary procedures (and, thus, no longer on the entry document or on an attachment to the entry document or commercial invoice); and (2) in the case of entries or entry summaries processed electronically, to provide for a certification statement in the form of a certification code transmitted as part of the Automated Broker Interface (ABI) transmission. In addition, in order to simplify procedures for importers who regularly import chemicals, it was proposed to add a new paragraph (b) to permit the use of “blanket” certifications, with a consequential redesignation of present paragraphs (b) and (c) as (c) and (d), respectively. Finally, it was proposed to make a conforming change to newly redesignated paragraph (c), consisting of the addition of a reference to new paragraph (b). The notice solicited comments from the public on the proposals, and the public comment period closed on March 12, 1990. On January 22, 1990, Customs published in the Federal Register (55 FR 2100) a correction document setting forth, with regard to the proposed blanket certification procedure, a statement regarding collection of information review requirements under the Paperwork Reduction Act of 1980 (44 U.S.C. 3504(h)).

Discussion of Comments

A total of 19 commenters responded to the solicitation of comments in the January 9, 1990, notice. A summary of the submitted comments, and the Customs responses to those comments, are set forth below.

Comment: Thirteen commenters were opposed to the proposal regarding inclusion of the certification only on the commercial invoice, and two commenters were in favor of that proposal. Comments against the proposal cited the procedural burden and inefficiency that would result from the proposed restriction, particularly in view of the unavailability of the original invoice for some shipments, the lack of sufficient space on the invoice, the need for a separate certification document in order to avoid delays in the case of air shipments, express consignment shipments and shipments from contiguous countries, and the lack of control by the importer of record where the certification is placed on the invoice by another party.

Customs response: The proposal in question was not intended to increase the regulatory burden or to have any of the other adverse effects cited by these commenters. Based on the submitted comments and as a result of further review of this matter, including consultation with the EPA which raised the issue that the proposal was intended to address, Customs has determined that it would be preferable to maintain the status quo under which the importer has the option of including the certification on the commercial invoice or on the entry document or on an attachment to the commercial invoice or entry document. Accordingly, the text of § 12.121, as set forth below, continues to reflect the substance of the current regulatory text in this regard.

Comment: One commenter requested that the TSCA certification be made a requirement for the entry summary rather than a condition of entry.

Customs response: As indicated above, the TSCA refers specifically to the “entry” of chemical substances into the Customs territory of the United States. Given the wording of the statute and the clear purpose of the TSCA, which is to protect the health and safety of the general public, the regulation in question must apply for admissibility purposes (that is, when a determination is made as to whether the imported merchandise may be released from Customs custody into the commerce of the United States) rather than in connection with a subsequent filing of the entry summary. Accordingly, the suggestion of this commenter should not be adopted.

Comment: Ten commenters specifically supported the proposed blanket certification procedure, four commenters were against it, and two commenters stated that the blanket certification should be optional rather than mandatory. Of the four comments against the proposal, two commenters argued that a blanket procedure is not feasible where imported mixtures are involved because changes in the chemical composition of a product prior to export could render the blanket certification inaccurate. The other two commenters stated that the proposal would not work in practice because it does not provide for nationwide acceptance of the blanket certification but rather requires separate approval at the local level.

Customs response: While it is true that changes in the composition of an imported product could negate the applicability of a previously approved blanket certification, Customs notes that the importer of record is always responsible for ascertaining the true facts regarding an individual import transaction, including for purposes of deciding whether it would be appropriate to rely on a blanket certification on file with Customs. With regard to the lack of provision for nationwide acceptance of a blanket approval, Customs remains of the view that, for operational purposes, approval must take place at the local port level.

Customs believes that the significant number of favorable comments supports the appropriateness of the blanket certification procedure which was intended to simplify procedures and thus reduce the overall regulatory burden on the importing public. Accordingly, § 12.121, as set forth below, incorporates the proposed blanket certification procedure.

With regard to the optional versus mandatory issue, Customs believes that the regulatory text clearly gives the importer the option (and thus does not impose a requirement) of using the blanket certification procedure, subject only to the port director's exercise of his discretion in accepting the blanket certification.

Comment: Three commenters proposed elimination of the TSCA certification for merchandise subject to FDA 701 requirements and for pesticides subject to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as exempted in section 3 of the TSCA and identified in the EPA publication “Toxic Substances Control Act, A Guide for Chemical Importers/Exporters.”

Customs response: Customs has been advised by EPA that the Guide referred to by these commenters provides that articles as defined in the Guide and tobacco and tobacco products do not require a certification but that food items and pesticides require a negative certification, and EPA also suggested to Customs that the Guide would become confusing in the step-by-step instructions for importers if the negative certification for food items and pesticides were to be eliminated. Moreover, while EPA advised Customs that a negative certification would not be needed if the shipment is accompanied by the appropriate form identifying the merchandise as a pesticide or as a food, food additive, drug, cosmetic or device, as is suggested in the Guide, Customs notes that this approach would not appreciably reduce the regulatory burden on importers. Accordingly, Customs believes that the suggestions of these commenters should not be adopted.

Comment: Seven commenters requested that the regulatory text provide for a waiver of the certification requirement for small shipments, samples, low value shipments, mail shipments, and shipments imported for research and development purposes.

Customs response: The EPA has advised Customs that automatic waivers of the certification requirement should not be provided for in the regulatory text because authority to grant waivers must remain with the EPA for consideration on a case-by-case basis; the Guide referred to in the preceding comment discussion sets forth the procedures applicable to the issuance of such waivers by the EPA. Therefore, the suggestion of these commenters should not be adopted.

Other Changes to the Regulatory Texts

In addition to the changes to the proposed regulatory text discussed above in connection with the public comments, Customs has determined that a number of other changes should be made both to the proposed text and to the present § 12.121 text based on further internal review. The principal additional change involves removal of the proposed new language dealing with entries or entry summaries processed electronically: On reconsidering this proposed text, Customs has concluded that it is generally preferable not to set forth specific electronic procedures in a narrow regulatory context but rather to cover them in the context of overall electronic procedures as those procedures are developed and implemented. In addition, the structure of the paragraphs under § 12.121 has been modified without change in substance by setting forth the basic certification requirement in new paragraph (a)(1) and by covering all filing procedures (including the blanket procedure which operates as an exception to the normal entry-by-entry filing procedure) in new paragraph (a)(2). Also, language has been included in the introductory paragraph of the blanket text to clarify that use of the blanket procedure is permissible only for an imported product that conforms to the product description contained in the blanket certification filed with Customs. Finally, a number of editorial, nonsubstantive changes have been made to enhance the clarity of the regulatory text.

Conclusion

Accordingly, based on the comments received and the analysis of those comments and based on the additional considerations as discussed above, Customs believes that the proposed regulatory amendments should be adopted as a final rule with certain changes as discussed above and set forth below. As a consequence of the adoption of these substantive regulatory amendments, this document also includes an appropriate update of the list of information collection approvals contained in § 178.2 of the Customs Regulations (19 CFR 178.2).

Executive Order 12866

This document does not meet the criteria for a “significant regulatory action” as specified in E.O. 12866.

Regulatory Flexibility Act

Pursuant to the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), it is certified that the amendments will not have a significant economic impact on a substantial number of small entities because the amendments are specifically directed toward a reduction of the regulatory burden on the public. Accordingly, the amendments are not subject to the regulatory analysis or other requirements of 5 U.S.C. 603 and 604.

Paperwork Reduction Act

The collection of information contained in this final rule has been reviewed and approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act (44 U.S.C. 3507) under control number 1515-0173. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB.

The collection of information in this final rule is in § 12.121. This information is required in connection with importations of chemical substances under the Toxic Substances Control Act (TSCA) and will be used by the U.S. Customs Service to verify compliance with TSCA requirements on imported chemicals. The likely respondents are business organizations including importers, exporters and manufacturers.

The estimated average annual burden associated with the collection of information in this final rule is 2 minutes per respondent or recordkeeper. Comments concerning the accuracy of this burden estimate and suggestions for reducing this burden should be directed to the U.S. Customs Service, Information Services Group, Office of Finance, 1300 Pennsylvania Avenue, NW, Washington, DC 20229, and to OMB, Attention: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503.

Drafting Information. The principal author of this document was Francis W. Foote, Office of Regulations and Rulings, U.S. Customs Service. However, personnel from other offices participated in its development.

List of Subjects

19 CFR Part 12

• Customs duties and inspection
• Labeling
• Marking
• Reporting and recordkeeping requirements

19 CFR Part 178

• Administrative practice and procedure
• Exports
• Imports
• Reporting and recordkeeping requirements

Amendments to the Regulations

Accordingly, for the reasons stated in the preamble, Parts 12 and 178, Customs Regulations (19 CFR Parts 12 and 178), are amended as set forth below.

PART 12—SPECIAL CLASSES OF MERCHANDISE

1. The authority citation for Part 12 continues to read in part as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 20, Harmonized Tariff Schedule of the United States (HTSUS)), 1624;

Sections 12.118 through 12.127 also issued under 15 U.S.C. 2601 et seq.;

2. Section 12.121 is revised to read as follows:

PART 178—APPROVAL OF INFORMATION COLLECTION REQUIREMENTS

1. The authority citation for Part 178 continues to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 1624; 44 U.S.C. 3501 et seq.

2. Section 178.2 is amended by adding a new listing to the table in numerical order to read as follows: