Finally, FDA is proposing the provisions in subparts B and C and related requirements in subparts A, D, and F, under section 1002(a) of Title X of the FDAAA of 2007 (21 U.S.C. 2102), which requires the Secretary to establish processing standards for pet food. The proposed animal food safety system would require tailored standards for facilities processing animal food (including animal feed, pet food, and their raw materials and ingredients).
XVI. Preliminary Regulatory Impact Analysis
FDA has examined the impacts of this proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). FDA has developed a PRIA that presents the benefits and costs of this proposed rule (Ref. 52). FDA believes that the proposed rule will be a significant regulatory action as defined by Executive Order 12866. FDA requests comments on the PRIA.
The summary analysis of benefits and costs included in this document is drawn from the detailed PRIA (Ref. 52) which is available at http://www.regulations.gov (enter Docket No. FDA-2011-N-0922), and is also available on FDA's Web site at http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM366905.pdf.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because many small businesses will need to implement a number of new preventive controls, FDA acknowledges that the final rules resulting from this proposed rule will have a significant economic impact on a substantial number of small entities.
C. Small Business Regulatory Enforcement Fairness Act of 1996
The Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) defines a major rule for the purpose of congressional review as having caused or being likely to cause one or more of the following: An annual effect on the economy of
D. Unfunded Mandates Reform Act of 1995
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing "any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of
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