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 SNUN 
recordkeeping 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: ~b ~ 6 200— 

Wendy Cleland-Hamnett, Director, 

Office of Pollution Prevention and Toxics