Page:United States Statutes at Large Volume 124.djvu/3918

124 STAT. 3892 PUBLIC LAW 111–353—JAN. 4, 2011 Low-Acid Foods Packaged in Hermetically Sealed Containers under part 113 of chapter 21, Code of Federal Regulations (or any successor regulations). ‘‘(k) EXCEPTION FOR ACTIVITIES OF FACILITIES SUBJECT TO SEC- TION 419.—This section shall not apply to activities of a facility that are subject to section 419. ‘‘(l) MODIFIED REQUIREMENTS FOR QUALIFIED FACILITIES.— ‘‘(1) QUALIFIED FACILITIES.— ‘‘(A) IN GENERAL.—A facility is a qualified facility for purposes of this subsection if the facility meets the condi- tions under subparagraph (B) or (C). ‘‘(B) VERY SMALL BUSINESS.—A facility is a qualified facility under this subparagraph— ‘‘(i) if the facility, including any subsidiary or affil- iate of the facility, is, collectively, a very small business (as defined in the regulations promulgated under sub- section (n)); and ‘‘(ii) in the case where the facility is a subsidiary or affiliate of an entity, if such subsidiaries or affiliates, are, collectively, a very small business (as so defined). ‘‘(C) LIMITED ANNUAL MONETARY VALUE OF SALES.— ‘‘(i) IN GENERAL.—A facility is a qualified facility under this subparagraph if clause (ii) applies— ‘‘(I) to the facility, including any subsidiary or affiliate of the facility, collectively; and ‘‘(II) to the subsidiaries or affiliates, collec- tively, of any entity of which the facility is a sub- sidiary or affiliate. ‘‘(ii) AVERAGE ANNUAL MONETARY VALUE.—This clause applies if— ‘‘(I) during the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, proc- essed, packed, or held at such facility (or the collec- tive average annual monetary value of such food at any subsidiary or affiliate, as described in clause (i)) that is sold directly to qualified end-users during such period exceeded the average annual monetary value of the food manufactured, proc- essed, packed, or held at such facility (or the collec- tive average annual monetary value of such food at any subsidiary or affiliate, as so described) sold by such facility (or collectively by any such sub- sidiary or affiliate) to all other purchasers during such period; and ‘‘(II) the average annual monetary value of all food sold by such facility (or the collective aver- age annual monetary value of such food sold by any subsidiary or affiliate, as described in clause (i)) during such period was less than $500,000, adjusted for inflation. ‘‘(2) EXEMPTION.—A qualified facility— ‘‘(A) shall not be subject to the requirements under subsections (a) through (i) and subsection (n) in an applicable calendar year; and ‘‘(B) shall submit to the Secretary— Applicability.