2018-01451. Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates: Revision of Determinations Regarding Certain Plastics

AGENCY:

Consumer Product Safety Commission.

ACTION:

Direct final rule.

SUMMARY:

On August 30, 2017, the Commission issued a final rule determining that certain plastics and additives would not contain the phthalates that the Consumer Product Safety Improvement Act of 2008 (CPSIA) prohibits from use in children's toys and child care articles. Subsequently, the Commission issued a final rule that removes some phthalates from the statutory prohibition and adds others. This direct final rule revises the determinations rule to cover the phthalates that the phthalates final rule prohibits from use in children's toys and child care articles.

DATES:

The rule is effective on April 25, 2018, unless we receive significant adverse comment by February 26, 2018. If we receive timely significant adverse comment, we will publish notification in the Federal Register, withdrawing this direct final rule before its effective date.

ADDRESSES:

You may submit comments, identified by Docket No. CPSC-2016-0017, by any of the following methods:

Submit electronic comments in the following way:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. To ensure timely processing of comments, the Commission is no longer accepting comments submitted by electronic mail (email), except through www.regulations.gov.

Submit written submissions in the following way:

Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions), preferably in five copies, to: Office of the Secretary, Consumer Product Safety Commission, Room 820, 4330 East-West Highway, Bethesda, MD 20814; telephone [phone].

Instructions: All submissions received must include the agency name and docket number for this document. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to http://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information electronically. Such information should be submitted in writing.

FOR FURTHER INFORMATION CONTACT:

For information, contact: John W. Boja, Lead Compliance Officer, Office of Compliance and Field Operations, Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814-4408; telephone: [phone]; email: [e-mail].

SUPPLEMENTARY INFORMATION:

A. Background

Statutory Prohibitions

Section 108 of the CPSIA established permanent and interim prohibitions that prohibited the use of certain phthalates in children's toys and child care articles. 15 U.S.C. 2057c(a) and (b). The CPSIA also directed the Commission to issue a rule deciding whether to make the interim prohibitions permanent and whether to prohibit other children's products containing any phthalates. Id. 2057c(b)(3). In the following discussion, we refer to rulemaking under section 108 of the CPSIA as the phthalates rule or rulemaking.

Third Party Testing and Burden Reduction

Section 14(a) of the CPSA requires that products subject to a consumer product safety rule under the CPSA, or to a similar rule, ban, standard, or regulation under any other act enforced by the Commission, be certified as complying with all applicable CPSC requirements. 15 U.S.C. 2063(a). For children's products, certification must be based on testing conducted by a CPSC-accepted third party conformity assessment body. Id. Public Law 112-28 (August 12, 2011) amended the CPSA and directed the CPSC to seek comment on “opportunities to reduce the cost of third party testing requirements consistent with assuring compliance with any applicable consumer product safety rule, ban, standard, or regulation.” Public Law 112-28 also authorized the Commission to issue new or revised third party testing regulations if the Commission determines “that such regulations will reduce third party testing costs consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations.” 15 U.S.C. 2063(d)(3)(B).

The Commission may issue determinations that specific materials do not contain prohibited substances such as lead or phthalates. Based on such a determination, the specified material would not require third party testing for compliance with the applicable mandatory prohibition.

The determinations only relieve the manufacturer's obligation to have the specific materials tested by a CPSC-accepted third party conformity assessment body. Children's products must still comply with the applicable substantive requirements, regardless of any relief from third party testing requirements. Additionally, the manufacturer must issue a certificate stating that the product complies with CPSC requirements.

Determinations Rule

On August 30, 2017, the Commission published a final rule determining that specified plastics and additives would not contain materials subject to the prohibition of children's toys and child care articles containing specified phthalates. 82 FR 41163. The rule created a new part 1308 for “Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates: Determinations Regarding Certain Plastics.” The rule determined that the specified plastics and accompanying additives do not contain the statutorily prohibited phthalates (DEHP, DBP, BBP, DINP, DIDP, DnOP) in concentrations above 0.1 percent, and thus, are not required to be third party tested to assure compliance with section 108 of the CPSIA. At the time the Commission issued the determinations rule, the Commission had issued a proposed rule in the phthalates rulemaking, but had not yet promulgated a final rule in that proceeding. The preambles of both the NPR and final rule for the determinations noted that the research providing the basis for the determinations covering the six phthalates subject to the statutory prohibition, applied as well to the additional four phthalates the Commission had proposed prohibiting in children's toys and child care articles in the phthalates NPR. In the preamble to the final determinations rule, the Commission indicated that when the Commission published the final phthalates rule, the Commission would amend the determinations rule to reflect the phthalates regulated in the phthalates final rule. 82 FR 41163, at 41164.

Phthalates Final Rule

On October 27, 2017, the Commission published the final phthalates rule in the Federal Register. 82 FR 49938. The phthalates rule, which is codified at 16 CFR part 1307, makes permanent the interim statutory prohibition on diisononyl phthalate (DINP) and expands that restriction to prohibit all children's toys and child care articles that contain concentrations of more than 0.1 percent of DINP. The phthalates rule also lifts the interim prohibitions on children's toys that can be placed in a child's mouth and child care articles that contain concentrations of more than 0.1 percent of di-n-octyl phthalate (DNOP) or diisodecyl phthalate (DIDP). Additionally, the phthalates rule also prohibits children's toys and child care articles that contain concentrations of more than 0.1 percent of diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexly phthalate (DCHP). The permanent prohibitions on children's toys and child care articles that contain concentrations of more than 0.1 percent on the use of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and benzyl butyl phthalate (BBP) in children's toys and child care articles in section 108 of the CPSIA are unchanged by the phthalate rule. The phthalates rule takes effect on April 25, 2018.

B. Revisions to 16 CFR Part 1308

This direct final rule amends 16 CFR 1308.1 to cover the phthalates listed in the phthalates final rule discussed in section A of the preamble. This action will bring the determinations into alignment with the phthalates final rule so that firms will be able to use the determinations to reduce testing burdens related to the final phthalates rule as they have with the statutory prohibitions. The amendment does not make any other changes to the determinations rule.

C. Direct Final Rule Process

The Commission is issuing this rule as a direct final rule. The Administrative Procedure Act (APA) generally requires notice and comment rulemaking. 5 U.S.C. 553. The direct final rule process is an appropriate way to satisfy this requirement in certain circumstances. In Recommendation 95-4, the Administrative Conference of the United States (ACUS) endorsed direct final rulemaking as an appropriate procedure to expedite promulgation of rules that are noncontroversial and that are not expected to generate significant adverse comment. See 60 FR 43108 (August 18, 1995). The Commission concludes that a direct final rule is appropriate here. The Commission is taking the limited action of amending the determinations rule at 16 CFR part 1308 to reflect the phthalates that are restricted under the Commission's phthalates rule. The previous determinations rule explained that the reports supporting the determinations regarding the phthalates that are covered by the statutory prohibitions in section 108 of the CPSIA also apply to the phthalates covered by the Commission's phthalates rule. We also note that this determination rule is separate from the Commission's phthalates rulemaking which was concluded with the Commission's issuance of a final rule on October 27, 2017. Because this document merely updates the regulated phthalates in the determinations rule, the Commission believes this rulemaking is a non-controversial matter which is not likely to generate comments. Therefore, the Commission concludes that the direct final rule process is appropriate.

Unless we receive a significant adverse comment within 30 days, the rule will take effect on April 25, 2018. In accordance with ACUS's recommendation, the Commission considers a significant adverse comment to be one where the commenter explains why revising the list of regulated phthalates would be inappropriate. We note that comments on either the underlying determinations or phthalates final rules are not considered significant adverse comments because the only change this rule makes is to revise the list of covered phthalates.

Should the Commission receive significant adverse comment, the Commission would withdraw this direct final rule. Depending on the comments and other circumstances, the Commission may then incorporate the adverse comment into a subsequent direct final rule or publish a notice of proposed rulemaking, providing an opportunity for public comment.

D. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) generally requires that agencies review proposed and final rules for their potential economic impact on small entities, including small businesses, and prepare regulatory flexibility analyses. 5 U.S.C. 603 and 604. CPSC conducted a final regulatory flexibility analysis (FRFA) for the determinations rule that the Commission issued in August 2017. The FRFA found that “the impact of the determinations on small businesses would be to reduce the burden of third party testing for phthalate content and would be expected to be entirely beneficial.” 82 FR 41171. As explained above, this direct final rule takes the limited action of revising the list of covered phthalates to bring the determinations rule into line with the phthalates rule so that companies will be able to use the determinations to reduce third party testing under the phthalates rule as they have under the statutory prohibitions.

E. Effective Date

As discussed in section C of this preamble, this is a direct final rule. Unless we receive a significant adverse comment within 30 days, the rule will take effect on April 25, 2018.

List of Subjects in 16 CFR Part 1308

• Business and industry
• Consumer protection
• Imports
• Infants and children
• Product testing and certification
• Toys

Accordingly, the Commission amends 16 CFR part 1308 as follows:

PART 1308—PROHIBITION OF CHILDREN'S TOYS AND CHILD CARE ARTICLES CONTAINING SPECIFIED PHTHALATES: DETERMINATIONS REGARDING CERTAIN PLASTICS

1. The authority citation for part 1308 continues to read as follows:

Authority: Sec. 3, Pub. L. 110-314, 122 Stat. 3016; 15 U.S.C. 2063(d)(3)(B).

2. Revise § 1308.1 to read as follows:

§ 1308.1

Prohibited children's toys and child care articles containing specified phthalates and testing requirements.

Section 108(a) of the Consumer Product Safety Improvement Act of 2008 (CPSIA) permanently prohibits any children's toy or child care article that contains concentrations of more than 0.1 percent of di-(2-ethylhexl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP). In accordance with section 108(b)(3) of the CPSIA, 16 CFR part 1307 prohibits any children's toy or child care article that contains concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), or dicyclohexly phthalate (DCHP) is prohibited. Materials used in children's toys and child care articles subject to section 108(a) of the CPSIA and 16 CFR part 1307 must comply with the third party testing requirements of section 14(a)(2) of the Consumer Product Safety Act (CPSA), unless listed in § 1308.2.

Alberta E. Mills,

Acting Secretary, U.S. Consumer Product Safety Commission.