Page:United States Statutes at Large Volume 124.djvu/3932

 124 STAT. 3906 PUBLIC LAW 111–353—JAN. 4, 2011 ‘‘(2) in bulk or batch form, prior to being packaged for the final consumer. ‘‘(d) EXCEPTION.—This section shall not apply to farms, except for those that produce milk. ‘‘(e) DEFINITION.—For purposes of this section, the term ‘farm’ has the meaning given that term in section 1.227 of title 21, Code of Federal Regulations (or any successor regulation).’’. (b) GUIDANCE DOCUMENTS.— (1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Secu- rity and the Secretary of Agriculture, shall issue guidance documents related to protection against the intentional adulteration of food, including mitigation strategies or measures to guard against such adulteration as required under section 420 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a). (2) CONTENT.—The guidance documents issued under para- graph (1) shall— (A) include a model assessment for a person to use under subsection (b)(1) of section 420 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a); (B) include examples of mitigation strategies or meas- ures described in subsection (b)(2) of such section; and (C) specify situations in which the examples of mitiga- tion strategies or measures described in subsection (b)(2) of such section are appropriate. (3) LIMITED DISTRIBUTION.—In the interest of national secu- rity, the Secretary of Health and Human Services, in consulta- tion with the Secretary of Homeland Security, may determine the time, manner, and form in which the guidance documents issued under paragraph (1) are made public, including by releasing such documents to targeted audiences. (c) PERIODIC REVIEW.—The Secretary of Health and Human Services shall periodically review and, as appropriate, update the regulations under section 420(b) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), and the guidance docu- ments under subsection (b). (d) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331 et seq.), as amended by section 105, is amended by adding at the end the following: ‘‘(ww) The failure to comply with section 420.’’. SEC. 107. AUTHORITY TO COLLECT FEES. (a) FEES FOR REINSPECTION, RECALL, AND IMPORTATION ACTIVI- TIES.—Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by adding at the end the following: ‘‘PART 6—FEES RELATED TO FOOD ‘‘SEC. 743. AUTHORITY TO COLLECT AND USE FEES. ‘‘(a) IN GENERAL.— ‘‘(1) PURPOSE AND AUTHORITY.—For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, in accordance with this section, assess and collect fees from— ‘‘(A) the responsible party for each domestic facility (as defined in section 415(b)) and the United States agent 21 USC 379j–31. 21 USC 350i note. Deadline.