1,4-Dioxane Limits for Household Cleansing, Personal Care, and Cosmetic Products

NY-ADR

12/6/23 N.Y. St. Reg. ENV-49-23-00007-P
NEW YORK STATE REGISTER
VOLUME XLV, ISSUE 49
December 06, 2023
RULE MAKING ACTIVITIES
DEPARTMENT OF ENVIRONMENTAL CONSERVATION
PROPOSED RULE MAKING
HEARING(S) SCHEDULED
 
I.D No. ENV-49-23-00007-P
1,4-Dioxane Limits for Household Cleansing, Personal Care, and Cosmetic Products
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Addition of Subpart 352-1 to Title 6 NYCRR.
Statutory authority:
Environmental Conservation Law, sections 1-0101, 3-0301, 35-0105(7), 37-0117(6) and 71-3703
Subject:
1,4-Dioxane Limits for Household Cleansing, Personal Care, and Cosmetic Products.
Purpose:
Implement the maximum allowable concentrations of 1,4-dioxane as set forth in art. 35 and 37 of the ECL.
Public hearing(s) will be held at:
1:00 p.m., Feb. 6, 2024 at Virtual via Webex.
Instructions on how to “join” the hearing webinar and provide an oral statement will be published on the Department’s proposed regulations webpage for 6 NYCRR Subpart 352-1 by December 6, 2023. The proposed regulations webpage for 6 NYCRR 352-1 may be accessed at: https://www.dec.ny.gov/regulations/propregulations.html#public or https://www.dec.ny.gov/chemical/121658.html.
Persons who wish to receive the instructions by mail or telephone may call the Department at 518-402-8706. Please provide your first and last name, address, and telephone number and reference the 6 NYCRR Subpart 352-1 public comment hearing.
The Department will provide interpreter services for hearing impaired persons, and language interpreter services for individuals with difficulty understanding or reading English, at no charge upon written request submitted no later than January 24, 2024. The written request must be addressed to ALJ Timothy M. MacPherson, NYS DEC Office of Hearings and Mediation Services, 625 Broadway, 1st Floor, Albany, NY 12233-1550 or emailed to ALJ Timothy M. MacPherson at [email protected].
Interpreter Service:
Interpreter services will be made available to hearing impaired persons, at no charge, upon written request submitted within reasonable time prior to the scheduled public hearing. The written request must be addressed to the agency representative designated in the paragraph below.
Accessibility:
All public hearings have been scheduled at places reasonably accessible to persons with a mobility impairment.
Substance of proposed rule (Full text is posted at the following State website: https://www.dec.ny.gov/regulations/propregulations.html #public):
6 NYCRR Part 352, Product Chemical Restrictions and Disclosure
Subpart 352-1, 1,4-Dioxane Limits for Household Cleansing, Personal Care, and Cosmetic Products
The New York State Department of Environmental Conservation is proposing to add 1,4-Dioxane Limits for Household Cleansing, Personal Care, and Cosmetic Products to the New York Codes, Rules and Regulations by Statutory authority. The Department is adding a new 6 NYCRR Part 352, Product Chemical Restrictions and Disclosure. The express terms for this rulemaking will be included in Subpart 352-1, 1,4-Dioxane Limits for Household Cleansing, Personal Care and Cosmetic Products and are summarized below.
Section 352-1.1 includes the purpose and applicability of the regulations.
Section 352-1.2 includes definitions for the terms “continuing calibration verification,” “correlation coefficient,” “cosmetic product,” “household cleansing product,” “initial calibration,” “initial calibration verification,” “internal standard,” “laboratory control sample/laboratory control sample duplicate,” “limit of detection (LOD),” “limit of quantitation (LOQ),” “manufacturer,” “matrix spike/matrix spike duplicate,” “method blank,” “multiple reaction monitoring,” “percent recovery,” “percent relative standard deviation,” “person,” “personal care product,” “relative percent difference,” “selected ion monitoring,” “signal to noise ratio,” and “State”.
Section 352-1.3 includes the prohibitions on the allowable concentration of 1,4-dioxane in household cleansing, personal care, and cosmetic products that may be distributed, sold, offered or exposed for sale in the state. The allowable concentration will be two parts per million of 1,4-dioxane on or after December 31, 2022. The allowable concentration will be and one part per million of 1,4-dioxane on or after December 31, 2023.
Section 352-1.3 also includes the prohibitions on the allowable concentration of 1,4-dioxane in cosmetic products that may be distributed, sold, offered, or exposed for sale in the state. The allowable concentration will be ten parts per million of 1,4-dioxane on or after December 31, 2022.
Section 352-1.4 includes the provisions for waiver applications. Under the general provisions of section 352-1.4(a)(1), a manufacturer of household cleansing, personal care, or cosmetic product(s) may apply to the Department for a one-year waiver from the applicable requirement in section 352-1.3 for a specific product upon such 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 requirement in section 352-1.3. Thereafter, a manufacturer may apply for one additional one-year waiver for such product, upon such the satisfaction of such similar proof. Waivers will be granted, in the Department’s sole discretion, based upon the Department’s evaluation of the application and the efforts undertaken by the manufacturer to comply with the 1,4-Dioxane limits set forth in this section. Additionally, this section includes the provisions on the proof requirements for a waiver, the filing process and timeline, waiver renewal, and applicability of a waiver.
Section 352-1.5 includes the requirements for a compliance evaluation, which are the actions a manufacturer must conduct to demonstrate compliance with the limitations set forth in section 352-1.3 for any household cleansing product that is distributed, sold, offered, or exposed for sale, or for any personal care or cosmetic product sold or offered for sale in the State. A compliance evaluation must include one or more of the following: a reasonable inquiry of raw material suppliers regarding the composition of raw materials; a reasonable assessment of the sum of the 1,4-dioxane concentrations contributed by each raw material; or analytical testing of finished product formulations.
Section 352-1.6 includes the guidelines for laboratory tests criteria to ensure analytical testing of a product or raw material is reliable. These guidelines include method performance criteria laying out the appropriate sample preparation, method, instrument, calibration, and quality control criteria.
Section 352-1.7 includes a severability clause for the express terms.
Text of proposed rule and any required statements and analyses may be obtained from:
Carmelle Sanders, Department of Environmental Conservation, 625 Broadway, Albany NY 12233, (518) 402-5326, email: [email protected].
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
February 12, 2024.
Additional matter required by statute:
Pursuant to Article 8 of the ECL, the State Environmental Quality Review Act, an Environmental Assessment Form, determination of significance (negative declaration), and Coastal Assessment Form have been prepared and are on file with the Department.
Summary of Regulatory Impact Statement (Full text is posted at the following State website: https://www.dec.ny.gov/regulations/propregulations.html#public):
The New York State Department of Environmental Conservation (Department) is proposing to adopt 6 NYCRR Subpart 352-1 to implement the amendments to Article 35 and Article 37 of the Environmental Conservation Law (ECL), adopted in 2019, which established limits on the amount of 1,4-dioxane that can be present in household cleansing, personal care, and cosmetic products sold or offered for sale in New York State (L.2019, c. 613, § 1, eff. Jan. 1, 2022; L.2020, c. 44, § 1, eff. Jan. 1, 2022) (hereinafter referred to as “the Law”). The Law establishes a maximum allowable concentration of 2 parts per million (ppm) of 1,4-dioxane effective December 31, 2022, and 1 ppm effective December 31, 2023, for household cleansing and personal care products, and 10 ppm of 1,4-dioxane effective December 31, 2022, for cosmetic products.
The Department’s statutory authority for these regulations is found in ECL sections 1-0101, 3-0301, 35-0105, and 37-0117. The New York State Legislature enacted the Law to protect New York’s public waters and drinking water, by reducing the amount of 1,4-dioxane entering the State’s waters by way of the covered products. The Legislature also included waiver provisions in the Law to allow manufacturers who cannot meet the statutory limits additional time to develop methods for removing 1,4-dioxane from their products. This proposed regulation is in line with the Legislature’s intent, as it implements the provisions of the Law.
This proposed regulation implements the statutory limits on the amount of 1,4-dioxane allowed in covered products, provides detail on how manufacturers can apply for a waiver of these limits for a limited amount of time, and sets method performance criteria, which would allow regulated entities to use any analytical method of their choosing provided the method meets the criteria set forth in the regulation, ensuring manufacturers use a consistent approach to determine compliance with these limits.
According to United States Environmental Protection Agency’s (EPA’s) Integrated Risk Information System (IRIS) database, 1,4-dioxane is identified as “likely to be carcinogenic to humans.” Despite the known health risks, 1,4-dioxane is still found in many consumer products, such as cosmetics, detergents, deodorants, and shampoos, where it is typically formed as a contaminant during the manufacturing process of such products. These products are used by consumers and then enter from sinks and drains into residential septic systems where they enter local wastewater treatment systems. Elevated levels of 1,4-dioxane have been found in municipalities across the State.
In response to the elevated levels, in 2020, New York State adopted a Maximum Contaminant Level (MCL) for drinking water for 1,4-dioxane of 1 part per billion (ppb).
The Law establishes maximum allowable, trace concentrations and authorizes the Department to periodically review such trace concentrations and determine whether such concentrations should be lowered. This proposed regulation will implement the statutory limitations of 1,4-dioxane in covered products, thereby reducing the amount of 1,4-dioxane in the State’s waters.
The proposed regulation does not impose any additional costs to the regulated community (manufacturers) beyond that which is imposed by the Law. The cost of compliance with the Law greatly depends on how much 1,4-dioxane is currently in each product and the method by which compliance is achieved. If a manufacturer does not sell any covered products that have more 1,4-dioxane than the maximum concentration, their initial cost of compliance is essentially zero. However, each product a manufacturer sells with 1,4-dioxane in excess of the maximum concentration will add to their cost of initial compliance. To bring each product into compliance, manufacturers may choose to reformulate with substitute surfactants, modify manufacturing facilities to remove 1,4-dioxane from raw materials, or work with raw material suppliers to do either of the above or find other options that satisfy compliance obligations. More details on the options and costs are discussed in the complete Regulatory Impact Statement.
The State will not incur additional costs due to the issuance of the proposed regulations beyond the costs associated with implementing the Law. However, to implement the Law and regulations, the Department will incur costs associated with purchasing and testing products for compliance. To evaluate compliance, staff overseeing the program will need to conduct sampling and analysis of products to determine the concentration of 1,4-dioxane and may utilize existing contracts with laboratories for support in evaluating compliance. There are no known costs to local government that are directly related to the implementation and continuing compliance of the proposed regulations.
Neither the proposed Subpart 352-1 nor the Law impose any requirements on local governments.
The proposed regulation does not impose any reporting requirements beyond that which is imposed by the Law. However, the proposed regulation does provide more detail than the Law on certain paperwork requirements. In most cases, paperwork may be submitted and maintained in electronic format.
Manufacturers who seek a waiver from the statutory limits must submit an application to the Department. If a manufacturer chooses to seek a waiver, it must maintain records for the duration of the waiver documenting the levels 1,4-dioxane in the product(s) for which a waiver is granted.
A manufacturer must also, upon request by the Department, submit records that demonstrate the compliance evaluation that was conducted for the covered product(s).
This proposed regulation does not duplicate any existing regulations pertaining to the presence of 1,4-dioxane in these product categories at the federal or state level.
The Department considered other alternatives to the proposed regulation but determined that a regulation was necessary to implement the statutory requirements.
Since the Law and the proposed Subpart 352-1 set quantitative standards on the 1,4-dioxane content in household cleansing, personal care and cosmetic products, the Department sought to include an approved analytical method in the regulation to clarify how 1,4-dioxane content should be measured in covered products; however because certain methods have not yet been peer-reviewed or are not being used by authoritative entities for regulatory purposes, the Department felt it appropriate to instead develop method performance criteria, which would allow regulated entities to use any analytical method of their choosing so long as it meets the outlined criteria, which ensures the method will produce reliable results.
The Department also clarified certain definitions and statutory requirements based on inquiries received from the public during public meetings, and further, considered additional regulatory provisions based on comments received, but decided not to implement all suggestions for reasons detailed in the full Regulatory Impact Statement.
The federal government does not have a standard for how much 1,4-dioxane is acceptable in household cleansing, personal care, or cosmetic products.
Summary of Regulatory Flexibility Analysis (Full text is posted at the following State website: https://www.dec.ny.gov/regulations/propregulations.html#public):
The New York State Department of Environmental Conservation (Department) is proposing to adopt 6 NYCRR Part 352, Product Chemical Restrictions and Disclosure, which will include Subpart 352-1, 1,4-Dioxane Limits in Household Cleansing, Personal Care, and Cosmetic Products. This rulemaking will implement the amendments to Article 35 and Article 37 of the Environmental Conservation Law (ECL), adopted in 2019, which established limits on the amount of 1,4-dioxane that can be present in household cleansing, personal care, and cosmetic products sold or offered for sale in New York State (L.2019, c. 613, § 1, eff. Jan. 1, 2022; L.2020, c. 44, § 1, eff. Jan. 1, 2022) (“the Law”). The Law establishes a maximum allowable concentration of 2 ppm of 1,4-dioxane effective December 31, 2022, and 1 ppm effective December 31, 2023, for household cleansing and personal care products; and 10 ppm of 1,4-dioxane effective December 31, 2022, for cosmetic products. The proposed regulations seek to implement these statutory provisions.
The Law also includes a waiver provision to allow manufacturers to apply for additional time to meet these limits. Proposed Subpart 352-1 will implement these statutory limits by providing details on how manufacturers can apply for a waiver and establishes method performance criteria for test methods a manufacturer uses to determine compliance with 1,4-dioxane limits.
The Department conservatively estimates that there are approximately 120 potential small businesses in the manufacturing sector that could be affected by the proposed regulation, and 36,000 retail small businesses in the retail trade, statewide that may be impacted by the proposed regulation.
The implementation of these regulations will not adversely affect local governments since it does not impose any mandates, including compliance obligations or reporting and record keeping requirements, on local governments.
To minimize the impact of the proposed regulation on manufacturers, the proposed regulation does not prescribe specific steps manufacturers must take to reduce 1,4-dioxane concentrations in their products. There are several methods available to manufacturers for complying with the 1,4-dioxane limits in the Law, which have varying levels of economic and technological feasibility. A manufacturer may apply for a waiver pursuant to proposed section 352-1.4, if it is unable to comply with the applicable 1,4-dioxane limits but has taken steps to do so.
Under proposed section 352-1.5, a manufacturer must conduct a compliance evaluation to determine whether their covered product(s) complies with the limitations set forth in proposed section 352-1.3. The proposed regulation allows manufacturers to choose from various options to evaluate compliance. This approach offers flexibility to businesses, including small businesses, that is not otherwise available under the Law and thereby minimizes adverse economic impacts.
Manufacturers conducting compliance evaluations pursuant to section 352-1.5 may need to engage with an analytical laboratory to determine the concentrations of 1,4-dioxane in their products. However, as the Law requires manufacturers to comply with 1,4-dioxane limits beginning December 31, 2022, they likely have engaged with a laboratory to determine concentrations of 1,4-dioxane in their products. Additionally, manufacturers have the option to base their determination on reasonable inquiry of their ingredient suppliers, which would not require professional services. The Department has provided guidance on compliance evaluation to allow manufacturers maximum flexibility in meeting this requirement.
The Department cannot determine with certainty the cost of compliance with the Law and proposed regulation. The cost of compliance greatly depends on how much 1,4-dioxane is currently in each product and the method by which compliance is ensured. If a manufacturer does not sell any covered products that have more 1,4-dioxane than the maximum concentration, their initial cost of compliance is essentially zero. However, each product a manufacturer sells with 1,4-dioxane in excess of the maximum concentration will add to their cost of initial compliance. Further, the cost of initial compliance depends greatly on how the manufacturer is able to bring each product into compliance. Since product reformulation will be driven by the 1,4-dioxane limits contained in the Law, and the proposed regulation implements statutory standards, manufacturers would incur the costs associated with product reformulation notwithstanding the proposed regulation. A more detailed estimate of compliance costs is included in the complete Regulatory Flexibility Analysis for Small Businesses and Local Governments document.
All manufacturers, regardless of size, may be required to maintain records and submit information to the Department. The proposed regulation requires manufacturers to retain records demonstrating that a compliance evaluation was conducted for as long as a product is distributed, sold, offered, or exposed for sale in the State. Upon request by the Department, a manufacturer must submit records that demonstrate the compliance evaluation that was conducted for the product(s) identified by the Department within fifteen days or respond that no such records exist. A manufacturer who has been granted a waiver must be able to produce documentation of the concentration of 1,4-dioxane in its products upon request by the Department for the duration of the waiver. Professional services are not expected to be needed to submit and maintain records.
A cure period or other opportunity for ameliorative action was not included in the proposed regulation as the Law already included a waiver provision which effectively delays the need for manufacturers to comply with the 1,4-dioxane restrictions by up to two years while they conduct actions to reduce the presence of 1,4-dioxane in their products. As this provision offers an opportunity to achieve compliance over an extended schedule, additional ameliorative actions were not deemed necessary.
Rural Area Flexibility Analysis
INTRODUCTION
Proposed Subpart 352-1 codifies in regulation the statutory limits on 1,4-dioxane and will not place any additional burdens on rural areas or increase regulatory requirements applicable to such areas. The requirements that exceed those set forth in the Law apply to manufacturers of household cleansing, personal care, and cosmetic products. The Law will impact retailers across the State, including in rural areas, who must now ensure that the products they sell comply with the 1,4-dioxane limits established in the Law.
The Department has provided significant outreach to manufacturers; and has provided additional outreach via direct email to rural retailers regarding the Law and the sale of covered products. The Department will continue to provide a statewide outreach program to all entities affected by the regulations and other interested parties, including public and private interests in rural areas.
1. TYPES AND ESTIMATED NUMBERS OF RURAL AREAS
For purposes of this analysis, “rural area” means those portions of the state so defined by Executive Law section 481(7) and SAPA section 102(10). Under Executive Law section 481(7), rural areas are defined as “counties within the state having less than two hundred thousand population, and the municipalities, individuals, institutions, communities, programs and such other entities or resources as are found therein. In counties of two hundred thousand or greater population, ‘rural areas’ means towns with population densities of one hundred fifty persons or less per square mile, and the villages, individuals, institutions, communities, programs and such other entities or resources as are found therein.” There are 44 counties in the State that have populations of less than 200,000 people and 71 towns in non-rural counties where the population densities are less than 150 people per square mile. The proposed Subpart 352-1 will apply statewide, including rural areas of the State.
2. REPORTING, RECORDKEEPING, OTHER COMPLIANCE REQUIREMENTS; AND PROFESSIONAL SERVICES
The proposed regulation does not include routine reporting requirements related to the 1,4-dioxane limits. However, there are regulatory provisions which may require manufacturers to submit information to the Department. Specifically, under the waiver application provisions of section 352-1.4, a manufacturer may apply for a waiver if they are unable to comply with the applicable 1,4-dioxane limits. While the 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. The application process to obtain a waiver is applicable to manufacturers and will not affect rural areas. In any event, waivers will expire after December 30, 2025, and the waiver provisions will have no effect after that.
Additionally, under section 352-1.5, a manufacturer must conduct a compliance evaluation to determine whether their household cleansing, personal care, or cosmetic product(s) complies with the limitations set forth in section 352-1.3. Upon request by the Department, a manufacturer must submit records that demonstrate the compliance evaluation that was conducted for the product(s) identified by the Department within fifteen days or respond that no such records exist. Manufacturers conducting a compliance evaluation may need to engage an analytical laboratory to determine the concentrations of 1,4-dioxane in their products. However, the proposed regulation also provides for other options for determining compliance. Manufacturers may base their determination on reasonable inquiry of their ingredient suppliers or on a reasonable assessment of the sum of the concentrations of 1,4-dioxane contributed by each raw material in the finished product formulation.
There is also a recordkeeping requirement associated with the compliance evaluation provisions of section 352-1.5 requiring that manufacturers retain records demonstrating that a compliance evaluation was conducted for as long as a product is distributed, sold, offered, or exposed for sale in the State. Professional services are not expected to be needed to maintain records associated with the compliance evaluation.
3. COSTS
The proposed regulation does not impose any additional costs on the regulated community, including manufacturers of covered products and retailers who must ensure that the products they sell are compliant, other than any increased costs that may result from the Law. The Department cannot determine with certainty the cost of compliance with the Law and regulation. Manufacturers will bear the brunt of the costs of the Law, which are associated with various methods of product reformulation. The Department does not expect that there will be variation in costs based on a manufacturer being located in a rural area. Below is a discussion of those costs.
The cost of compliance greatly depends on how much 1,4-dioxane is currently in each product and the method by which compliance is ensured. If a manufacturer does not sell any covered products that have more 1,4-dioxane than the maximum concentration, their initial cost of compliance is essentially zero. However, each product a manufacturer sells with 1,4-dioxane in excess of the maximum concentration will add to their cost of initial compliance. Further, the cost of initial compliance depends greatly on how the manufacturer is able to bring each product into compliance.
For the purposes of this analysis, we will assume the only way that 1,4-dioxane enters final products is through the surfactant. In reality, 1,4-dioxane may be a byproduct formed in another ingredient or it may be in the final product from multiple sources. However, the concepts discussed are applicable to these scenarios as well.
If a manufacturer can purchase a version of the same surfactant from their supplier with lower 1,4-dioxane, which can be achieved through chemical stripping, the cost of compliance would be the difference in cost between the surfactant with a higher level of 1,4-dioxane and the cost of the surfactant with lower 1,4-dioxane. While initially manufacturers would bear this cost, discussions with manufacturer industry associations lead the Department to believe that this difference would ultimately be passed to consumers through price increases.
If a manufacturer’s surfactant supplier does not have the necessary technology to strip 1,4-dioxane out of its products, the manufacturer could either find a new supplier for their surfactant or request their current supplier to purchase stripping equipment. Based on conversations with equipment manufacturers, the cost of this equipment depends on the flowrate of the plant and could range from several hundred thousand dollars to several million dollars. And while the surfactant supplier is not a regulated entity under this Law, the cost would likely ultimately be borne by the manufacturer and then the end consumer.
The last initial compliance option for manufacturers is to reformulate their products so a surfactant that produces 1,4-dioxane as a byproduct is no longer used. This option is likely to be the most expensive as it requires research and development to find a new viable formulation, test it for performance and stability, secure suppliers for new ingredients, produce the new formulation and distribute it to retailers. If, in aggregate, this process required one full-time employee (FTE) per product, the cost of reformulating each product could be as high as $300,000 (assuming an FTE costs the manufacturer $100,000 per year).
In the long term, if a manufacturer assesses compliance using a lab for hire, the cost for each test may vary among labs. Research done for the Department shows a wide range in the price of testing products for 1,4-dioxane. The lowest rate found was $250 per sample and the highest was $1030 per sample. However, it is common for commercial labs to decrease the per sample price based on the total number of samples being tested. Likewise, if a manufacturer assesses compliance by testing each finished product, the cost is likely to be much higher than if they test each surfactant used among their products and calculate how much 1,4-dioxane is present in each final product based on dilution. The cost to the manufacturer is even lower, if not zero, if they rely on reports from their supplier of the amount of 1,4-dioxane in the surfactants to calculate the amount of 1,4-dioxane in the final product.
As a result of the statutory limits that took effect on December 31, 2022, retailers, including those located in rural areas, may need to obtain assurances from manufacturers that the products on their shelves as well as any new products they purchase, comply with the Law. Proposed 352-1 does not create any additional burdens for retailers.
4. MINIMIZING ADVERSE IMPACT
The Law establishes the 1,4-dioxane limits for covered products. The proposed regulation will not impose additional regulatory burdens on rural areas beyond what the statute requires. The Department estimates that there are fewer than ten manufacturers located in rural areas of the State that make products covered by the Law. Nonetheless, the proposed regulation minimizes adverse impacts on all affected manufacturers in several ways. First, the regulations allow manufacturers flexibility in the way they achieve compliance with the 1,4-dioxane thresholds in that it does not prescribe specific actions that manufacturers need to take to reduce 1,4-dioxane concentrations in their products. The proposed regulation also offers regulatory flexibility by allowing manufacturers to use several options to evaluate compliance with the Law. However, other than the measures discussed here and the statutory provision for a waiver, the Department cannot provide additional flexibility regarding the sale and distribution of noncompliant products after December 31, 2022.
5. RURAL AREA PARTICIPATION
Based on the definition of ‘Rural area’ by Executive Law section 481(7) and SAPA section 102(10), the U.S. Census 2020 data was used to determine the rural counties and towns of the State. The Department of Labor’s website was utilized to filter for companies employing up to 99 employees in manufacturing in rural counties. According to this information, there are less than ten companies located in rural areas that manufacture covered products and that will be affected by this Law. Proposed Subpart 352-1 will apply statewide, including all rural areas of the State. The Department has provided outreach to the identified manufacturers and retailers in rural areas and will continue to provide a statewide outreach program to all affected entities and other interested parties, including public and private interests in rural areas. The Department does not believe that public sector entities will have any obligations under these regulations.
For potentially affected manufacturers in rural areas, the Department has held two public meetings providing an overview of the regulations, sought public comment, and posted response to those comments, along with a recording of one of the meetings, on the webpage.
In addition, the Department has held stakeholder meetings with various stakeholder groups, including several major manufacturers and numerous industry associations that can share information on the Law and rulemaking with members, including manufacturers and retailers in rural areas that were identified using DOL’s website via targeted email correspondence. Further, association categories applicable to these stakeholders were researched, compiled and included in outreach efforts to disseminate information on the Law.
6. INITIAL REVIEW OF PROPOSED REGULATION
The Department will conduct an initial review of the proposed regulation within 3 years, as required by SAPA § 207.
Job Impact Statement
1. NATURE OF IMPACT
There should be no impact on jobs associated with this proposed regulation. In most cases there are surfactants with lower 1,4-dioxane concentration, or alternative ingredients that do not contain the chemical as a contaminant that can be used to manufacture the covered products of the Law. In the few cases where there may be few alternatives available, research and new product development and practices will find replacements for these products. Consequently, the proposed amendment should not inhibit the growth of or employment in the personal care, household cleansing, and cosmetic industry.
2. CATEGORIES AND NUMBERS OF JOBS OR EMPLOYMENT OPPORTUNITIES AFFECTED
The proposed regulation will not have an impact to jobs and employment opportunities in the State beyond that which would result from the implementation of the Law itself. The 1,4-dioxane limits on household cleansing, personal care, and cosmetic products will take effect by operation of Law regardless of whether this proposed rule is adopted. Further, manufacturers of household cleansing, personal care, and cosmetic products have several options for complying with the Law, which may include reformulating their products, including a stripping process to remove 1,4-dioxane, or finding alternative raw material suppliers to comply with the limits. While adoption of these options may result in increased costs to manufacturers, these costs will likely be passed along to consumers, and are not expected to create substantial adverse impacts on jobs or employment opportunities in New York State.
3. REGIONS OF ADVERSE IMPACT
The regulation applies statewide, and as such, there will be no disproportionate adverse impact on existing jobs, nor will it disproportionately promote the development of new employment opportunities. Therefore, the Department does not anticipate any region-specific adverse impacts.
4. MINIMIZING ADVERSE IMPACT
The Department concludes that this regulatory proposal would not have a substantial adverse impact on jobs within the State.
End of Document