Page:United States Statutes at Large Volume 124.djvu/3919

124 STAT. 3893 PUBLIC LAW 111–353—JAN. 4, 2011 ‘‘(i)(I) documentation that demonstrates that the owner, operator, or agent in charge of the facility has identified potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the preven- tive controls to ensure that such controls are effective; or ‘‘(II) documentation (which may include licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of over- sight), as specified by the Secretary, that the facility is in compliance with State, local, county, or other applicable non-Federal food safety law; and ‘‘(ii) documentation, as specified by the Secretary in a guidance document issued not later than 1 year after the date of enactment of this section, that the facility is a qualified facility under paragraph (1)(B) or (1)(C). ‘‘(3) WITHDRAWAL; RULE OF CONSTRUCTION.— ‘‘(A) IN GENERAL.—In the event of an active investiga- tion of a foodborne illness outbreak that is directly linked to a qualified facility subject to an exemption under this subsection, or if the Secretary determines that it is nec- essary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a qualified facility that are material to the safety of the food manufactured, processed, packed, or held at such facility, the Secretary may withdraw the exemption provided to such facility under this subsection. ‘‘(B) RULE OF CONSTRUCTION.—Nothing in this sub- section shall be construed to expand or limit the inspection authority of the Secretary. ‘‘(4) DEFINITIONS.—In this subsection: ‘‘(A) AFFILIATE.—The term ‘affiliate’ means any facility that controls, is controlled by, or is under common control with another facility. ‘‘(B) QUALIFIED END-USER.—The term ‘qualified end- user’, with respect to a food, means— ‘‘(i) the consumer of the food; or ‘‘(ii) a restaurant or retail food establishment (as those terms are defined by the Secretary for purposes of section 415) that— ‘‘(I) is located— ‘‘(aa) in the same State as the qualified facility that sold the food to such restaurant or establishment; or ‘‘(bb) not more than 275 miles from such facility; and ‘‘(II) is purchasing the food for sale directly to consumers at such restaurant or retail food establishment. ‘‘(C) CONSUMER.—For purposes of subparagraph (B), the term ‘consumer’ does not include a business. ‘‘(D) SUBSIDIARY.—The term ‘subsidiary’ means any company which is owned or controlled directly or indirectly by another company. Deadline.