N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 352-1.4

Current through Register Vol. 46, No. 45, November 2, 2024

Section 352-1.4 - Waiver Application

(a) General Provisions

(1) A manufacturer of any household cleansing, personal care, or cosmetic product may apply to the department for a one-year waiver from the applicable requirements of section 352-1.3 of this Part for a specific household cleansing, personal care, or cosmetic product upon proof that the manufacturer has taken steps to reduce the presence of 1,4-dioxane in that product and is unable to comply with the applicable requirements of section 352-1.3 of this Part. Thereafter, a manufacturer may apply for one additional one-year waiver for that product, upon the submission of similar proof. Waivers will be granted in the departments sole discretion, based upon the departments evaluation of the application and the efforts undertaken by the manufacturer to comply with the 1,4-dioxane limits set forth in section 352-1.3 of this Part.

(2) A manufacturer must submit its waiver application in a format approved by the department. Each application must contain a certification signed by an authorized representative of the manufacturer. Such application with a certifying signature shall be considered a written instrument that could subject the signatory to liability under article 175 of the New York State Penal Law for filing a false statement or false information.

(3) Each household cleansing, personal care, or cosmetic product for which a waiver is sought must be individually named in the application and identified by product type, i.e., household cleansing, personal care or cosmetic product.

(4) Each household cleansing, personal care, or cosmetic product that contains the same formulation, but different fragrance blends, must be identified as a separate product, although the manufacturer can rely on the same proof for the purpose of requesting a waiver if the proof is the same. All information required in subdivision (b) of this section must be provided for each product but may be aggregated into one manufacturer-wide waiver application.

(5) At the time of submission of a waiver application, a manufacturer may request in writing that certain information in its application be deemed confidential business information by the department in accordance with the provisions of Part 616 of this Title. The department will evaluate such a request in accordance with and subject to the criteria set forth in Part 616. The name of the product, whether the product is a household cleansing, personal care or cosmetic product, and the current level of 1,4-dioxane in such product may not be claimed as confidential.

(b) Proof for Waiver

(1) A manufacturer must provide proof that it has taken steps to reduce the concentration of 1,4-dioxane for each household cleansing, personal care, or cosmetic product identified in its waiver application, but is not able to meet the 1,4-dioxane limits set forth in section 352-1.3 of this Part by the applicable statutory deadline. The waiver application must include:

(i) Certification of the concentration of 1,4-dioxane that is currently in each product for which a waiver is sought. The reported concentration must be the highest of any variation that exists on the market at the time the waiver is submitted.

(ii) A written explanation of the efforts conducted, or those that are being conducted, to reduce the concentration of 1,4-dioxane in a product or formulation, and why additional time is necessary to comply with the limits set forth in section 352-1.3 of this Part.

(iii) If a manufacturer is seeking waivers for multiple products based on the same explanation for not meeting the limitations set forth in section 352-1.3 of this Part, the manufacturer may provide a detailed explanation once and create a shorthand for such explanation to identify the products to which that explanation is applicable.

(2) While a waiver is in effect, the manufacturer must be able to produce documentation of the stated concentration of 1,4-dioxane upon request by the department. Documentation must include the information specified below.

(i) If the stated 1,4-dioxane concentration is a result of testing that has been conducted on the product, such documentation must be dated, detail the test method(s) used, show that the criteria detailed in section 352-1.6 of this Part were met, and name the lab that conducted the test(s).

(ii) If the stated 1,4-dioxane concentration is a result of a dilution calculation, such documentation must include:

('a') the name of the ingredient(s) that cause(s) 1,4-dioxane to be present in the final product;

('b') a dated test result that shows the concentration of 1,4-dioxane in the ingredient(s);

('c') documentation of the test method(s) used and that the criteria detailed in section 352-1.6 of this Part were met, and the name of the lab that conducted the test(s);

('d') the percentage of the final product that consists of each ingredient identified as containing 1,4-dioxane;

('e') the dilution calculation that was used to obtain the reported 1,4-dioxane concentration in the product; and

('f') an attestation that no other ingredients in the product contain 1,4-dioxane.

(c) Filing Process and Timeline. A manufacturer may submit its waiver application via e-mail or regular mail following directions published by the department. The department may set a date for the submission of applications. (d) Additional One-Year Waiver

(1) A manufacturer of any household cleansing, personal care, or cosmetic product may apply to the department for one additional one-year waiver from the applicable requirements of section 352-1.3 of this Part, in accordance with subdivisions (a)-(c) of this section upon the submission of similar proof.

(2) An application for an additional one-year waiver must update all the information required in subdivision (b) of this section that was included in the original application, in addition to updating information on the efforts undertaken towards meeting the statutory limits.

(3) An application for waiver renewal must be submitted in the third quarter of the effective timeframe of the initial waiver.

(4) Applications for an additional one-year waiver must state that more time is needed to comply with the 1,4-dioxane limitations set forth in section 352-1.3(b) or (c) of this Part. Additional one-year waivers will not be granted to allow more time to comply with the 1,4-dioxane limitations set forth in section 352-1.3(a) of this Part.

(e) Applicability of Waiver

(1) A waiver of the limitations set forth in section 352-1.3(a) or (c) of this Part will be valid through December 30, 2023. A waiver of the limitations set forth in section 352-1.3(b) of this Part will be valid until December 30, 2024.

(2) If the department grants an additional one-year waiver of the limitation set forth in section 352-1.3(b) of this Part, the waiver will be valid until December 30, 2025.

(3) A household cleansing, personal care, or cosmetic product that has been granted a waiver may be sold in the State while the waiver is in effect notwithstanding that it contains 1,4-dioxane in excess of the limits set forth in section 352-1.3 of this Part. In no case shall a waiver issued by the department be effective after December 30, 2025.

N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 352-1.4

Adopted New York State Register September 18, 2024/Volume XLVI, Issue 38, eff. 9/18/2024