DETERMINATION OF NO SIGNIFICANT ADVERSE ECONOMIC IMPACT ON A SUBSTANTIAL NUMBER OF SMALL ENTITIES FOR CERTAIN SIGNIFICANT NEW USE RULES UNDER SECTION 5(a)(2) OF THE TOXIC SUBSTANCES CONTROL ACT

Backeround Section 5(a)(2) of TSCA, 15 U.S.C. §2604(a)(2), authorizes EPA to determine that a use of a chemical substance is a significant new use. EPA must make this determination by rule (a Significant New Use Rule, or SNUR) after considering all relevant factors, including those listed in §5(a)(2). Once EPA issues a SNUR, §5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture (including import), or process the chemical substance for the use subject to the SNUR. The Regulatory Flexibility Act, 5 U.S.C. §601 

### et seq., generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations and small governmental jurisdictions. For purposes of assessing the impacts of a proposed or final action on small entities, small entity is defined as: (1) a small business that is a small industrial entity as defined in the U.S. Small Business Administration (SBA) size standards (see 13 CFR 121.201); (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; or (3) a small organization that is any not-for-profit enterprise that is independently owned and operated and is not dominant in its field. Analysis The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a significant new use. Where a use is new, by definition no small or large entities presently engage in such activities. Although some small entities may decide to manufacture or process a substance for the new use after the SNUR is promulgated, EPA receives very few SNUNs, and few of those are submitted by small entities. In response to the promulgation of SNURs covering over 1000 chemical substances, the Agency receives only a handful of SNUNs per year. For example, the number of SNUNs was four in Federal fiscal year 2005, eight in FY2006, six in FY2007, eight in FY2008, seven in FY2009, two in 2010, and ten in 2011, for an average of 6 per year from all SNURs. EPA has no reason to believe that the pattern of SNUN submissions that EPA has historically seen is likely to change. In addition, the estimated reporting cost for submission of a SNUN is minimal regardless of the size of the firm, averaging about $8,300 including SNUNrecordkeeping and reporting costs. The Agency currently offers some relief to certain small businesses

with sales (including those of subsidiary/parent companies) of less than $40 million per year by reducing the SNUN submission fee from $2,500 to $100. This lower fee reduces the cost of submitting a SNUN to about $5,800 for smaller firms. During the five year period from 2005-2008, only three submitters self-identified as small in their SNUN submission. EPA believes the cost of submitting a SNUN is relatively small compared to the cost of developing and marketing a chemical new to a firm and that the requirement to submit a SNUN generally does not have a significant economic impact. In response to a SNUR, firms could also decide to request an equivalency determination or a request for SNUR modification or revocation. The submission cost for these requests is about $5200. EPA believes this cost to be low compared to the cost of developing and marketing a chemical new to the firm. The expected number of requests is also expected to be small. In general, EPA receives from zero to three modification/revocation requests per year due to SNURs, therefore it is unlikely that a substantial number of small entities would be affected. 

### Determination I hereby certify that promulgation of a SNUR would not have a significant economic impact on a substantial number of small entities where the following are true:
1. a significant number of SNUNs would not be submitted by small entities in response to the SNUR; and 2. the SNUN submitted by any small entity would not cost significantly more than $8,300.

Dated: 

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200—

Wendy Cleland-Hamnett, Director, Office of Pollution Prevention and Toxics