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Regulatory Flexibility for Small Entities

Potential SBAR Panel: C.I. Pigment Violet 29 (PV29) Risk Management Rulemaking Under the Toxic Substances Control Act

What is the Implication of the Proposed Action on Small Entities?

After issuing the final risk evaluation for PV29 under section 6(a) of the Toxic Substances Control Act (TSCA), EPA is taking the next step in the process by moving to risk management. This process requires EPA to develop regulations to protect public health from the unreasonable risks identified in the final risk evaluation.
 

Entities potentially regulated by this rulemaking include those relevant to 10 conditions of use that EPA determined present an unreasonable risk, including domestic manufacturing, import, processing uses of PV29, recycling, some industrial and commercial uses of PV29 (such as paintings and coatings in the automobile sector, and merchant ink for commercial printing), and disposal. A full list of conditions of use subject to this rulemaking is in the non-technical summary of the PV29 risk evaluation.

Additional information about the PV29 risk management rulemaking under TSCA is available on EPA's Risk Management for C.I. Pigment Violet 29 (PV29) web page.

What is a Small Business Advocacy Review Panel? 

EPA expects to conduct a Small Business Advocacy Review (SBAR) Panel to gain input from small entities on the agency’s development of a proposed rule to address unreasonable risks identified in EPA’s January 2021 final risk evaluation for PV29. After issuing the final risk evaluation for PV29, EPA is taking the next step in the process by moving to risk management. This process requires EPA to develop regulations to protect public health from the unreasonable risks found in the final risk evaluation.
 
The Regulatory Flexibility Act as amended by the Small Business Regulatory Enforcement Fairness Act (RFA/SBREFA) requires EPA to convene an SBAR Panel for a proposed rule unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The Panel process offers an opportunity for small businesses, small governments, and small not-for-profit organizations (collectively referred to as small entities) to provide advice and recommendations to ensure that EPA carefully considers small entity concerns regarding the impact of the potential rule on their organizations. The Panel itself is comprised of federal employees from EPA, the Office of Management and Budget’s (OMB’s) Office of Information and Regulatory Affairs (OIRA), and the Office of Advocacy in the Small Business Administration (SBA). Small Entity Representatives (SERs) provide advice and recommendations to the Panel. Typically, EPA prefers that SERs be owners or operators of small businesses, small organization officials, or small government officials. Other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, also may serve as SERs. These other representatives are evaluated on a case by case basis.
 
Information about what constitutes a "small business" is available at the SBA’s web page on size standards. A "small government" is defined as a jurisdiction serving a population of 50,000 residents or fewer. A “small organization” is defined as any “not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” To learn more, review EPA’s Small Entities and Rulemaking – Frequent Questions web page.

How Can I Get Involved? 

If you are a small formulator or commercial user of PV29 or products containing PV29 for the conditions of use within the scope of this rulemaking, and that may be directly subject to this rule, you are eligible to serve as a SER. As mentioned above, other representatives that exclusively or at least primarily represent potentially regulated small entities may also serve as SERs. The role of a SER is to provide advice and recommendations to ensure that the Panel carefully considers small entity concerns regarding the impact of the potential rule on their organizations and to communicate with other small entities within their sector who do not serve as SERs. 
 
You may nominate yourself to serve as a SER by following the directions in the next section. Depending on the volume of responses, EPA may not be able to invite all eligible candidates to participate as SERs.  Generally, SERs will be asked to review background information, listen to informational briefings, and provide oral and written advice and recommendations to the Panel. At least one face-to-face or virtual meeting is typically held with the SERs in Washington, DC; a toll-free conference line is provided for this meeting.

Who Should I Contact?

 
SERs must:
 
  • Qualify as “small” under SBA’s definition AND expect to be directly subject to requirements of the proposed rule; or
  • Exclusively represent or at least primarily represent potentially regulated small entities (e.g., a trade association that exclusively or primarily represents small entities). Nominees such as these will be evaluated on a case by case basis.
 
Individuals who are interested in potentially serving as a SER should send an email message to RFA-SBREFA@epa.gov by no later than March 5, 2021. In the message, please provide:
 
  • Your name
  • Name of your company, governmental jurisdiction, or not-for-profit organization
  • Size of your company, governmental jurisdiction, or not-for-profit organization
    • If you are representing a business, you may confirm that your business meets the definition of “small” by consulting SBA’s web page on size standards. Please provide the primary North American Industry Classification System (NAICS) code for your firm and either average annual receipts or average annual employment for your firm corresponding to the definition of small for your primary NAICS code. Note that a ‘firm’ includes parent company and all subsidiaries.
    • A small governmental jurisdiction means governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than 50,000.
    • A small organization means any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
    • If you are with a group such as a trade association that represents small entities, please provide a list of your members, the size of your members (if possible), and a qualitative statement describing how your group can truly represent only the unique interests of your members that qualify as small entities.  
  • Address
  • Contact information (including phone number and email address)
  • USE THIS AS THE SUBJECT LINE OF YOUR EMAIL: SER Self-Nomination for PV29 Risk Management Rulemaking under the Toxic Substances Control Act
 
Please remember: Depending on the volume of responses, EPA may not be able to invite all qualified candidates to participate as SERs.