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<bill bill-stage="Introduced-in-Senate" public-private="public">
	<form>
		<distribution-code display="yes">II</distribution-code>
		<congress>110th CONGRESS</congress>
		<session>1st Session</session>
		<legis-num>S. 2077</legis-num>
		<current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber>
		<action>
			<action-date date="20070920">September 20, 2007</action-date>
			<action-desc><sponsor name-id="S172">Mr. Harkin</sponsor> (for himself,
			 <cosponsor name-id="S209">Mr. Kohl</cosponsor>, and <cosponsor name-id="S253">Mr. Durbin</cosponsor>) introduced the following bill; which was
			 read twice and referred to the <committee-name committee-id="SSAF00">Committee
			 on Agriculture, Nutrition, and Forestry</committee-name></action-desc>
		</action>
		<legis-type>A BILL</legis-type>
		<official-title>To establish a program to assure the safety of fresh
		  produce intended for human consumption, and for other
		  purposes.</official-title>
	</form>
	<legis-body>
		<section id="ID90D4CD9AFE3346D2904E9E20E8721500" section-type="section-one"><enum>1.</enum><header>Short title; table of
			 contents</header>
			<subsection id="ID37FC50703AE14296B6E5F570652DEC13"><enum>(a)</enum><header>Short
			 title</header><text>This Act may be cited as the <quote><short-title>Fresh Produce Safety Act</short-title></quote>.</text>
			</subsection><subsection id="ID3CF3DCE408964F189257EF16B40015F3"><enum>(b)</enum><header>Table of
			 contents</header><text>The table of contents for this Act is as follows:</text>
				<toc>
					<toc-entry idref="ID90D4CD9AFE3346D2904E9E20E8721500" level="section">Sec. 1. Short title; table of contents.</toc-entry>
					<toc-entry idref="ID0A445EB3F0F14C0B9CF10019007B74F5" level="section">Sec. 2. Findings.</toc-entry>
					<toc-entry idref="ID0F88961469104DFBA5372858DF2DFD50" level="section">Sec. 3. Definitions.</toc-entry>
					<toc-entry idref="ID8313EE555AA246A4A9D007E77EED00FF" level="title">TITLE I—Food safety activities</toc-entry>
					<toc-entry idref="ID239BB32182254C00BCB0B0F46FCC1FBF" level="section">Sec. 101. Administration of national program.</toc-entry>
					<toc-entry idref="IDF33AF0BAB1E34E8D9E194C2BEC81141D" level="subtitle">Subtitle A—Minimally processed produce</toc-entry>
					<toc-entry idref="IDD1776AB3481C4A1FBA0900378FD40015" level="section">Sec. 111. Good manufacturing practices.</toc-entry>
					<toc-entry idref="ID069DAA2F149940DB9CAA8609949185FC" level="section">Sec. 112. Inspections of processors.</toc-entry>
					<toc-entry idref="IDE88AAE7A1A2646E6B200B62FA54B8CB3" level="subtitle">Subtitle B—Raw agricultural commodities</toc-entry>
					<toc-entry idref="ID8C72BE9E0F674C6984C2AAD300654F5E" level="section">Sec. 121. Good agricultural practices.</toc-entry>
					<toc-entry idref="ID856BA41AF8F24D1D83C3E0D2CD00B485" level="section">Sec. 122. Inspections of facilities.</toc-entry>
					<toc-entry idref="ID6F0F55DD12C949EE8620D07B5CE30254" level="title">TITLE II—Research and education</toc-entry>
					<toc-entry idref="ID05EC2E52CA15475785E5C9135D0012C5" level="section">Sec. 201. Public health assessment system.</toc-entry>
					<toc-entry idref="ID33475D7AA003407D914CD9C2CD7C7FEC" level="section">Sec. 202. Public education system.</toc-entry>
					<toc-entry idref="ID883CEAC85C77492BBA295647AA07EE72" level="section">Sec. 203. Research.</toc-entry>
					<toc-entry idref="IDABF44CFF9A6F4FF8AD3C08E8ACFD0001" level="title">TITLE III—Imported produce and other provisions</toc-entry>
					<toc-entry idref="IDCD4E243F3E7D47BCBE07BB58F5862700" level="section">Sec. 301. Imported produce.</toc-entry>
					<toc-entry idref="id960A2684735E4407A9C7108D90DB0DCD" level="section">Sec. 302. Authorization of appropriations.</toc-entry>
				</toc>
			</subsection></section><section id="ID0A445EB3F0F14C0B9CF10019007B74F5"><enum>2.</enum><header>Findings</header><text display-inline="no-display-inline">Congress finds that—</text>
			<paragraph id="ID5c2f33c9c6aa43c892e27323d0165351"><enum>(1)</enum><text>consumption of
			 fresh fruits and vegetables can promote health and prevent disease, and should
			 be encouraged;</text>
			</paragraph><paragraph id="IDbf6510d3ab4648ba96d460e7b18475d6"><enum>(2)</enum><text>an estimated
			 76,000,000 cases of foodborne disease occur each year in the United States,
			 causing about 325,000 hospitalizations and 5,000 deaths annually, according to
			 the Centers for Disease Control and Prevention (referred to in this section as
			 the <quote>CDC</quote>);</text>
			</paragraph><paragraph id="IDeed5f0aefc4a4cf19dac0889a991ad28"><enum>(3)</enum><text>data reported to
			 the CDC indicate that outbreaks of foodborne illness in the United States
			 associated with fruits and vegetables have increased in absolute numbers and as
			 a proportion of all reported foodborne outbreaks;</text>
			</paragraph><paragraph id="IDdcf6b2285fa64b68a05879c113517903"><enum>(4)</enum><text>illnesses caused
			 by E. coli O157:H7, Salmonella spp., and norovirus have been traced to a wide
			 variety of produce, including lettuce, salads, melons, sprouts, tomatoes, and
			 many fruit- and vegetable-containing dishes;</text>
			</paragraph><paragraph id="id0707B5B8FB0A4FC4ABC3B64AD4BC288E"><enum>(5)</enum><text>outbreaks of
			 food-borne illness associated with produce in the United States have been
			 documented from both imported produce and domestically grown produce;</text>
			</paragraph><paragraph id="ID23f9dba31caf4d57880497d744b74320"><enum>(6)</enum><text>large scale
			 processing of produce can easily spread pathogens into minimally processed food
			 and a single outbreak can affect hundreds of people;</text>
			</paragraph><paragraph id="ID41888D6E444240C5B3CA609BDF955DC8"><enum>(7)</enum><text>persons who
			 process produce for human consumption have the responsibility to prevent or
			 minimize food safety hazards related to their products;</text>
			</paragraph><paragraph id="IDF5EDA762B9324FFCA2CCFD641F86D631"><enum>(8)</enum><text>rising consumer
			 demand for minimally processed produce, the growing market for various kinds of
			 domestic and imported minimally processed produce, and the increasing variety
			 of processing techniques for produce, are causing newly recognized or
			 unpredicted safety hazards; and</text>
			</paragraph><paragraph id="IDF0113743C62B493E949F3CFFB8C4962F"><enum>(9)</enum><text>risk-based
			 sanitation practices, and commodity-specific good agricultural and
			 manufacturing practices, tailored to the hazards and the level of risk that a
			 specific food product presents, should be applied to the processing of produce
			 to minimize these hazards.</text>
			</paragraph></section><section id="ID0F88961469104DFBA5372858DF2DFD50"><enum>3.</enum><header>Definitions</header><text display-inline="no-display-inline">In this Act:</text>
			<paragraph id="IDA16AC9877EC749B4A65139AD988B7E71"><enum>(1)</enum><header>Contaminant</header><text>The
			 term <term>contaminant</term> includes a bacterium, chemical, natural or
			 manufactured toxin, virus, parasite, physical hazard, or other human pathogen
			 that, when in food, can cause human illness, injury, or death.</text>
			</paragraph><paragraph id="IDCBA52BC434694F4AABCBB83B3F13D554"><enum>(2)</enum><header>Minimally
			 process</header>
				<subparagraph id="id5D6F5164136C40CE9F82DB28C998C52E"><enum>(A)</enum><header>In
			 general</header><text>The term <term>minimally process</term> means—</text>
					<clause id="ID216F5306D1234B6AB7BF76BA21534E32"><enum>(i)</enum><text>to
			 carry out the commercial preparation or manufacture of produce,
			 including—</text>
						<subclause id="ID7B2C2BC12E3449E38F001130B31EBF47"><enum>(I)</enum><text>the peeling,
			 coring, stemming, trimming, mashing, or shredding of produce;</text>
						</subclause><subclause id="IDF7F4683A07654C2E90DD230944A72C5D"><enum>(II)</enum><text>the cutting of
			 produce after harvesting;</text>
						</subclause><subclause id="ID91707BF5F7FD4EE5BF68D51CE53479AE"><enum>(III)</enum><text>the preparation
			 of fresh produce so to as to appear ready for consumption without further
			 washing or preparation; and</text>
						</subclause><subclause id="IDA70BCB4B9BAB487BABC9D6C97D318921"><enum>(IV)</enum><text>the mixing or
			 blending of minimally processed produce with other produce; and</text>
						</subclause></clause><clause id="ID0FC4FD458D474E34A01920812F60427C"><enum>(ii)</enum><text>does not include
			 carrying out the harvesting, washing (except as provided in clause (i)(III)),
			 waxing, packing, or sorting, of a raw agricultural commodity.</text>
					</clause></subparagraph><subparagraph id="id76A091602CD74203AA8FBBD8EFD59255"><enum>(B)</enum><header>Exception</header><text>The
			 term <term>minimally process</term> shall not apply to a raw agricultural
			 commodity that is stemmed but not subject to further commercial
			 preparation.</text>
				</subparagraph></paragraph><paragraph id="IDe293fe7e6d00432da7332497ad6dff7f"><enum>(3)</enum><header>Processor of
			 produce</header><text>The term <term>processor of produce</term> means a person
			 that minimally processes produce.</text>
			</paragraph><paragraph id="ID1A245A0FE9FE46F3AFF757E9A5C47082"><enum>(4)</enum><header>Produce</header>
				<subparagraph id="IDB2A328C2E58C4EBDB6F921AC00A0D9AC"><enum>(A)</enum><header>In
			 general</header><text>The term <term>produce</term> means any perishable
			 agricultural commodity, as defined in section 1(b) of the Perishable
			 Agricultural Commodities Act, 1930 (<external-xref legal-doc="usc" parsable-cite="usc/7/499a(b)">7 U.S.C. 499a(b)</external-xref>).</text>
				</subparagraph><subparagraph id="IDD29FE35E8F064F4B9D40E4AA97C80093"><enum>(B)</enum><header>Inclusions</header><text>The
			 term <term>produce</term> includes a mixture of—</text>
					<clause id="IDFBAA655B27674D649800BB17F855A573"><enum>(i)</enum><text>a
			 commodity described in subparagraph (A); and</text>
					</clause><clause id="IDFC71B0738A5C474A8FFCE60050A02576"><enum>(ii)</enum><text>any other food,
			 as defined in <external-xref legal-doc="act" parsable-cite="FFDCA/201">section
			 201</external-xref> of the <act-name parsable-cite="FFDCA">Federal Food, Drug,
			 and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>).</text>
					</clause></subparagraph><subparagraph id="id86354C998EB94B4892B6CE705BD26884"><enum>(C)</enum><header>Exclusions</header><text>The
			 term <term>produce</term> does not include—</text>
					<clause id="IDC143445283F04590AC0059FCD42C249E"><enum>(i)</enum><text>other food in the
			 mixture described in subparagraph (B)(ii); and</text>
					</clause><clause id="ID3FA54AC8812845028E0500953BDFE4EF"><enum>(ii)</enum><text>an
			 article used for food or drink for animals, or an article used for a component
			 of such an article.</text>
					</clause></subparagraph></paragraph><paragraph id="IDC66630721D9D434BAEB120632B40D5BD"><enum>(5)</enum><header>Raw
			 agricultural commodity</header><text>The term <term>raw agricultural
			 commodity</term> means a perishable agricultural commodity, as defined in
			 section 1(b) of the Perishable Agricultural Commodities Act, 1930
			 (<external-xref legal-doc="usc" parsable-cite="usc/7/499a(b)">7 U.S.C.
			 499a(b)</external-xref>) that is a raw agricultural commodity, as defined in
			 <external-xref legal-doc="act" parsable-cite="FFDCA/201">section
			 201</external-xref> of the <act-name parsable-cite="FFDCA">Federal Food, Drug,
			 and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>).</text>
			</paragraph><paragraph id="IDD7C2FEA994CE46DCB0C046AD137DEAEF"><enum>(6)</enum><header>Secretary</header><text>The
			 term <term>Secretary</term> means the Secretary of Health and Human
			 Services.</text>
			</paragraph></section><title id="ID8313EE555AA246A4A9D007E77EED00FF"><enum>I</enum><header>Food
			 safety activities</header>
			<section id="ID239BB32182254C00BCB0B0F46FCC1FBF"><enum>101.</enum><header>Administration
			 of national program</header>
				<subsection id="ID8A99312AA79349A489945D26821887FA"><enum>(a)</enum><header>In
			 general</header>
					<paragraph id="ID03C86AB7D8B14550924B5570678800C6"><enum>(1)</enum><header>National
			 program</header><text>The Secretary shall administer a national program for the
			 purpose of protecting human health by ensuring that—</text>
						<subparagraph id="ID9731A660D0C84B61A806D32BE2F69600"><enum>(A)</enum><text>there are
			 effective programs in place to assure the safety of produce minimally processed
			 in the United States; and</text>
						</subparagraph><subparagraph id="id2685BE2A1A4B451095FAEF4A54E2FA99"><enum>(B)</enum><text>producers of raw
			 agricultural commodities have effective programs in place to assure the safety
			 of those commodities produced in the United States.</text>
						</subparagraph></paragraph><paragraph id="ID02CC8670930F44F9BF51535F1BC200C1"><enum>(2)</enum><header>Basis for
			 program</header><text>The program shall take into consideration the distinctive
			 characteristics of minimal processing of produce and the differing practices
			 and levels of risk associated with the production of different raw agricultural
			 commodities.</text>
					</paragraph></subsection><subsection id="ID8EA9FA5E9BE642F8B9DF4964C02F8DEB"><enum>(b)</enum><header>Program
			 elements</header><text>The program shall provide for implementation of the
			 authorities described in—</text>
					<paragraph id="IDCF6CC72D9E5B4D56B5E91DB74B5E67DA"><enum>(1)</enum><text>sections 402A,
			 402B, 704A, and 704B of the <act-name parsable-cite="FFDCA">Federal Food, Drug,
			 and Cosmetic Act</act-name>, as added by subtitles A and B; and</text>
					</paragraph><paragraph id="IDB5310C2647C44056A8C808621FBC54AB"><enum>(2)</enum><text>title II.</text>
					</paragraph></subsection></section><subtitle id="IDF33AF0BAB1E34E8D9E194C2BEC81141D"><enum>A</enum><header>Minimally
			 processed produce</header>
				<section id="IDD1776AB3481C4A1FBA0900378FD40015"><enum>111.</enum><header>Good
			 manufacturing practices</header>
					<subsection id="IDD2821E5FC3144309BD3D3C38D3F095DB"><enum>(a)</enum><header>In
			 general</header><text>Chapter IV of the <act-name parsable-cite="FFDCA">Federal
			 Food, Drug, and Cosmetic Act</act-name> is amended by inserting after section
			 402 (<external-xref legal-doc="usc" parsable-cite="usc/21/342">21 U.S.C.
			 342</external-xref>) the following:</text>
						<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="ID244A416763A140CB897E9442BF839225">
							<section id="ID20230E9B89334372842EAC9893131F5C"><enum>402A.</enum><header>Good
				manufacturing practices for produce</header>
								<subsection id="ID3D0457B1914F435C82AAAABBDF56278F"><enum>(a)</enum><header>Good
				manufacturing practice regulations</header>
									<paragraph id="idD6A439B5415645D2BE75CD95F238FBC7"><enum>(1)</enum><header>In
				general</header><text>Not later than 1 year after the date of enactment of this
				section, the Secretary shall by regulation establish standards for good
				manufacturing practices for the minimal processing of produce.</text>
									</paragraph><paragraph id="id93FB441BA71840FA881605EC6F193C34"><enum>(2)</enum><header>Content</header><text>The
				regulations issued under paragraph (1) shall include the following
				requirements:</text>
										<subparagraph id="id7C7FD449466C44BF82AD1620ADD1F688"><enum>(A)</enum><header>Sanitation</header><text>Processors
				of produce shall—</text>
											<clause id="idCBE3733A77B7474BB3D5482EE9A32BAD"><enum>(i)</enum><text>establish
				mandatory sanitation standard operating procedures, including cleaning
				procedures for equipment, storage areas, air systems, and water storage
				areas;</text>
											</clause><clause id="idD2D35398022C443BA6917B1FDA8E79B8"><enum>(ii)</enum><text>design
				processing facilities to facilitate maintenance and good sanitation practices
				so that contamination may be controlled throughout receiving, cooling,
				processing, packing, and storage operations; and</text>
											</clause><clause id="id417AA748D9894B6592BD1AFFB230ECDB"><enum>(iii)</enum><text>ensure—</text>
												<subclause id="idF53F1F101C524A89B2EF7AEECEC806DD"><enum>(I)</enum><text>controlled access
				to the facility and to processing areas;</text>
												</subclause><subclause id="id4B89FB7CE9414410B4126DE9683C81A6"><enum>(II)</enum><text>adequate space
				for operations;</text>
												</subclause><subclause id="id19C0C5B95B3346DA923CE227551C4B1C"><enum>(III)</enum><text>adequate
				drainage of processing and wash water;</text>
												</subclause><subclause id="id734A519FA55C4E8F83D8FBD60B087B7D"><enum>(IV)</enum><text>food contact
				surfaces that are easy to clean and maintain;</text>
												</subclause><subclause id="idBE1E637A5C6942ADB7C8BD78504FCAC7"><enum>(V)</enum><text>that areas and
				structures designed to protect the product and equipment from contamination;
				and</text>
												</subclause><subclause commented="no" id="id35F8102F8BF74D8FBBD5BE3ED00D5C69"><enum>(VI)</enum><text>that sanitation
				standards established in clause (i) are adhered to in the transportation of
				minimally processed produce to the extent practicable.</text>
												</subclause></clause></subparagraph><subparagraph id="id8C956326ED4E44988FC25CF946E8A840"><enum>(B)</enum><header>Water</header>
											<clause id="id2045E02EA31C4A04B4AA2C5F1C5D4517"><enum>(i)</enum><header>In
				general</header><text>Processors of produce shall ensure that—</text>
												<subclause id="id2D0237FD01E348F4B5B4D574D489E64B"><enum>(I)</enum><text>the water supply
				used in food processing plants is suitable for its intended use;</text>
												</subclause><subclause id="idC632776BA36842ED9BB81D081B62178E"><enum>(II)</enum><text>facilities have
				an environmental monitoring program that includes sampling for pathogens to
				detect areas of harborage and to verify the effectiveness of cleaning and
				sanitizing programs in preventing cross-contamination; and</text>
												</subclause><subclause id="id5EE067138C844580B3304D3F9B163B52"><enum>(III)</enum><text>each sanitizer
				used for washing vegetables is appropriate for its intended use.</text>
												</subclause></clause><clause id="idB8302C0EA58046FEAF77BB88FF6933CF"><enum>(ii)</enum><header>Sampling
				programs for water</header><text>If the Secretary determines that effective
				sampling programs can be developed, processors of produce shall ensure that the
				water used for washing produce is monitored for the presence of pathogens at a
				rate adequate to ensure highly contaminated batches are identified and
				eliminated.</text>
											</clause></subparagraph><subparagraph id="id0FDBA726488948719DD251EBB3A004B7"><enum>(C)</enum><header>Additional
				requirements</header><text>Other requirements as determined appropriate by the
				Secretary.</text>
										</subparagraph></paragraph><paragraph id="idE2B12C4B35AD4DBBB82381206A361C58"><enum>(3)</enum><header>Risk
				assessment</header><text>The standards established under paragraph (1) shall be
				based on risk assessment tools and metrics developed by the Food and Drug
				Administration in consultation with the Department of Agriculture and
				processors of produce. The risk assessments shall include—</text>
										<subparagraph id="IDb3085c20c77843899d9c243b820ab068"><enum>(A)</enum><text>identification of
				existing and potential hazards at facilities;</text>
										</subparagraph><subparagraph id="id0C19FA43A788489EAC88039DD5398C42"><enum>(B)</enum><text>evaluation of
				human health risks posed by hazards identified in subparagraph (A); and</text>
										</subparagraph><subparagraph id="ID8dd306ed63dd4953a96a1ad5baf5e3e8"><enum>(C)</enum><text>proposed controls
				to minimize hazards based on subparagraph (B).</text>
										</subparagraph></paragraph><paragraph id="ID8d4a7e2c4cba4f01a0a089ce964e1a20"><enum>(4)</enum><header>Risk
				classification</header><text>The Secretary shall classify facilities as high-,
				medium-, or low-risk according to the risk assessments in paragraph (3), and by
				considering the hazards associated with the type of produce being minimally
				processed at a facility, the facility’s history of compliance and food safety
				problems, and such other factors as the Secretary may determine to be
				appropriate. Such risk classification shall determine the specific standards
				and controls required at each facility.</text>
									</paragraph><paragraph id="IDdff75f6bc2a2468b97f77ee6b9ba3bb7"><enum>(5)</enum><header>Science-based
				standards</header><text>The standards established under paragraph (1)
				shall—</text>
										<subparagraph id="ID66671659950c40e2a07271a1cdc1d6a9"><enum>(A)</enum><text>reflect the best
				available science; and</text>
										</subparagraph><subparagraph id="ID859bdf08143244618387167810b2873b"><enum>(B)</enum><text>be subject to
				change through regulations promulgated by the Secretary as new scientific
				evidence on risk becomes available.</text>
										</subparagraph></paragraph></subsection><subsection id="ID06708874CD2349A0A6AA18072E9789B4"><enum>(b)</enum><header>Implementation
				plan for processors</header>
									<paragraph id="IDF588BBF997F044AEBB5C003278422BDC"><enum>(1)</enum><header>In
				general</header><text>Not later than 2 years after the date of enactment of
				this section, the Secretary shall require every processor of produce to have a
				written plan detailing the controls utilized the processor of produce.</text>
									</paragraph><paragraph id="idC44E8A723EAB46F19BC4444F31FBA8A4"><enum>(2)</enum><header>Content</header><text>A
				plan under paragraph (1) shall—</text>
										<subparagraph id="id53CE4A54BE244C5E88CD7BB9B025A8FE"><enum>(A)</enum><text>address good
				manufacturing standards set forth by the Secretary;</text>
										</subparagraph><subparagraph id="id3F319C765ABD43CCB38579EA3761B620"><enum>(B)</enum><text>require
				recordkeeping to monitor compliance;</text>
										</subparagraph><subparagraph id="id2986C1F0CD2C433FB9973C977DDDB751"><enum>(C)</enum><text>require the
				sampling of products and process to be tested, at a frequency and in a manner
				commensurate with the risk presented by the facility and produce processed, as
				determined in subsection (a)(3), if the Secretary deems this appropriate, and
				sufficient to ensure that the standards or process controls are effective on an
				on-going basis and that regulatory standards are met; and</text>
										</subparagraph><subparagraph id="id6D8B98879DD3447DA5A1EF04D57240E9"><enum>(D)</enum><text>provide access to
				the Food and Drug Administration to records maintained by the facility pursuant
				to section 414.</text>
										</subparagraph></paragraph><paragraph id="idCD785BD6D13541309AF541120204FDE7"><enum>(3)</enum><header>Specific
				controls</header><text>In addition to complying with standards established
				under section 402A(a)(1), the Secretary may require processors to adopt
				specific process controls identified in section 402A(a)(3), if the process
				controls are needed to ensure the protection of the public health.</text>
									</paragraph><paragraph id="IDeb019e85154341beb076267e224278bb"><enum>(4)</enum><header>Tiered
				implementation</header><text>The Secretary shall require such a plan for
				high-risk facilities first, and then for medium-risk facilities, and then for
				low-risk facilities, as classified under subsection (a)(4).</text>
									</paragraph></subsection><subsection id="IDB4B727C6C0FF4BF98533082E3086F535"><enum>(c)</enum><header>Exceptions</header><text>In
				issuing regulations under subsection (a), the Secretary may modify the good
				manufacturing process regulations if the Secretary determines, for good cause
				shown and stated together with the regulations, that for a specific
				product—</text>
									<paragraph id="IDB84B8071BCBE4E95942710A2586D44EB"><enum>(1)</enum><text>a modification of
				such provisions would be more effective to prevent the contamination of, or
				promote the sanitation of, minimally processed produce; or</text>
									</paragraph><paragraph id="ID032BA160FDCB4D58BA046E83AA08FE04"><enum>(2)</enum><text>the application
				of a portion of such provisions would not result in the prevention of
				contamination of, or promotion of sanitation of, minimally processed
				produce.</text>
									</paragraph></subsection><subsection id="ID42F85E3E0B724574B1F2FFBB0173086C"><enum>(d)</enum><header>Effective
				date</header><text display-inline="yes-display-inline">The regulations
				promulgated under subsection (a) shall take effect 2 years after the date of
				enactment of this section.</text>
								</subsection><subsection id="ID114894AFD84140C687A5E294C4A12601"><enum>(e)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section:</text>
									<paragraph id="ID0CC7B7AE25F24275B0F65FBC37CBD1CB"><enum>(1)</enum><header>Contaminant;
				minimally process; produce</header><text>The terms <term>contaminant</term>,
				<term>minimally process</term>, and <term>produce</term> have the meanings
				given those terms in section 3 of the <short-title>Fresh
				Produce Safety Act</short-title>.</text>
									</paragraph><paragraph id="idE3D08620A66746039F1359030E874900"><enum>(2)</enum><header>Facility</header><text>The
				term <term>facility</term> includes any factory, warehouse, or establishment,
				in which produce is minimally processed.</text>
									</paragraph><paragraph id="IDD96E9631EFAE4159B1CC00E833166E00"><enum>(3)</enum><header>Good
				manufacturing practice regulations</header><text>The term <term>good
				manufacturing practice regulations</term> means the good manufacturing practice
				regulations for manufacturing, packing, or holding food, issued under sections
				402, 701, and 704 of this Act and under section 361 of the
				<act-name parsable-cite="PHSA">Public Health Service Act</act-name>
				(<external-xref legal-doc="usc" parsable-cite="usc/42/264">42 U.S.C.
				264</external-xref>).</text>
									</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
					</subsection><subsection id="ID0C18917D5A4842B39B4982AED5497641"><enum>(b)</enum><header>Violation</header><text><external-xref legal-doc="act" parsable-cite="FFDCA/402">Section 402</external-xref> of the
			 <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
			 (<external-xref legal-doc="usc" parsable-cite="usc/21/342">21 U.S.C.
			 342</external-xref>) is amended by adding at the end the following:</text>
						<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="ID40912C2BD6E549FD8EF6207400231466">
							<subsection id="IDA9A10557EA444B408E86C11D21A038C5"><enum>(j)</enum><text>It is an article
				of produce processed in violation of section
				402A.</text>
							</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
					</subsection></section><section id="ID069DAA2F149940DB9CAA8609949185FC"><enum>112.</enum><header>Inspections of
			 processors</header>
					<subsection id="IDB756881BF87D41859F76782B1679A712"><enum>(a)</enum><header>In
			 general</header><text>Chapter VII of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> is
			 amended by inserting after section 704 (<external-xref legal-doc="usc" parsable-cite="usc/21/374">21 U.S.C. 374</external-xref>) the following:</text>
						<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="IDFAB1F92A9A684996AA889500F825528E">
							<section id="ID4DACE32E7A994536912501AFD0652711"><enum>704A.</enum><header>Inspections
				of processors</header>
								<subsection id="IDFBF6DECE93CA4F15A699012995FA16CB"><enum>(a)</enum><header>Nature of
				inspections</header>
									<paragraph id="ID8E76E42A99AD4AFE88A14BDE17822111"><enum>(1)</enum><header>In
				general</header><text>The Secretary shall provide for unannounced inspections
				of processing facilities to determine if produce processed in the facilities is
				in compliance with the requirements of this Act that relate to produce.</text>
									</paragraph><paragraph id="ID7E186E0A16884241954226385B009C61"><enum>(2)</enum><header>Schedule</header><text>The
				Secretary shall establish a schedule for the unannounced inspections, which
				shall provide for—</text>
										<subparagraph id="IDBF07805130CE4F9A9E9983BE8575D1E0"><enum>(A)</enum><text>inspections at
				least once per growing season for facilities classified as high-risk under
				section 402A(a)(4); and</text>
										</subparagraph><subparagraph id="ID514DD5667BDF4952B3F2009191C2F800"><enum>(B)</enum><text>less frequent
				inspections, as determined by the Secretary, for facilities classified as
				medium- or low-risk facilities under section 402A(a)(4).</text>
										</subparagraph></paragraph><paragraph id="ID8C857B0D647B40DB9F1068D5ECE0B908"><enum>(3)</enum><header>Examination of
				classifications</header><text>Each such inspection of a facility shall include
				an examination of whether the facility is appropriately classified under
				section 402A(a)(4).</text>
									</paragraph></subsection><subsection id="ID90C3AE85EEF649209B017E003C03EDE1"><enum>(b)</enum><header>Conduct of
				inspections</header>
									<paragraph id="IDD3BBA20378A74751AF94873200F0C0F3"><enum>(1)</enum><header>Scope</header><text>An
				inspection under subsection (a) of any facility described in subsection (a)
				shall extend to all things in the facility, any required records, processes,
				controls, and premises that bear on whether minimally processed produce is in
				compliance with the requirements of this Act that relate to produce. Access to
				records may include the copying of the records.</text>
									</paragraph><paragraph id="IDB23FCDC8BCD544899FEFC41CE1E9C0F5"><enum>(2)</enum><header>Authorities</header><text>In
				conducting such an inspection, an officer or employee duly designated by the
				Secretary shall have the same authorities and duties as the officer or employee
				would have under subsection (a)(1), (c), or (d) of section 704 to inspect
				facilities in which food is minimally processed.</text>
									</paragraph><paragraph id="ID7525B590518F41D291E1C4C6A7B613A3"><enum>(3)</enum><header>Report</header><text>Not
				later than 48 hours after completion of the inspection, the officer or employee
				making the inspection shall give to the owner, operator, or agent in charge a
				written report setting forth any conditions or practices observed that indicate
				that any produce from the facility is in violation of the requirements of this
				Act that relate to produce.</text>
									</paragraph></subsection><subsection id="ID5710B3193E1243CAB3AB9D8DF4933BE4"><enum>(c)</enum><header>Product
				detention and condemnation</header>
									<paragraph id="ID863BFAF3847340AFAF71DDE02DBF317E"><enum>(1)</enum><header>In
				general</header><text>If, during an inspection conducted under this section, an
				officer or employee making the inspection determines that minimally processed
				produce is in violation of the requirements of this Act that relate to produce,
				the officer or employee may order the produce segregated, impounded, and if
				objection is not made no later than 48 hours after the issuance of the
				impoundment order, condemned. If objection is made during such 48-hour period,
				minimally processed produce that is perishable may be processed to the extent
				necessary to prevent spoilage, and the Secretary shall expeditiously commence a
				hearing within 24 hours after the objection regarding the determination and any
				action required for compliance with the requirements of this Act that relate to
				produce. The decision of the Secretary following the hearing shall be
				considered to be a final agency action.</text>
									</paragraph><paragraph id="ID3122CE1CA39E4CB18E9BD6CC51A75750"><enum>(2)</enum><header>Release</header><text>If
				the Secretary determines that, through relabeling or other action, the produce
				can be brought into compliance with the requirements of this Act that relate to
				produce, the produce may be released following a determination by the Secretary
				that the relabeling or other action as specified by the Secretary has been
				performed.</text>
									</paragraph><paragraph id="ID4674CB247B3B484094C8D2952383BCDF"><enum>(3)</enum><header>Destruction</header><text>Any
				minimally processed produce condemned under paragraph (1)—</text>
										<subparagraph id="ID8D5E6147D9874292A4A85970B6C500D1"><enum>(A)</enum><text>in a case in
				which no objection is made under paragraph (1);</text>
										</subparagraph><subparagraph id="IDE36C65A5688344ECA50000D297F51979"><enum>(B)</enum><text>after the hearing
				and any judicial review; or</text>
										</subparagraph><subparagraph id="ID81EC1D2A6DE84936811393742B113C36"><enum>(C)</enum><text>after failure of
				the owner, operator, or agent to perform relabeling or other action described
				in paragraph (2),</text>
										</subparagraph><continuation-text continuation-text-level="paragraph">shall be
				destroyed under supervision of the Secretary.</continuation-text></paragraph></subsection><subsection id="IDD3A74245B811413B94B5AC6C3C254E22"><enum>(d)</enum><header>Maintenance of
				records</header>
									<paragraph id="IDACC9A7B2DF844742AEFE83E59BB075A1"><enum>(1)</enum><header>In
				general</header><text>The owner, operator, or agent in charge of each facility
				shall maintain such records as the Secretary may prescribe. The records shall
				be maintained for a reasonable period of time as determined by the Secretary.
				The records shall include information concerning—</text>
										<subparagraph id="ID3DF3B735B22C4040B4B4C200ADAC42CE"><enum>(A)</enum><clause commented="no" display-inline="yes-display-inline" id="IDBAF248DFFFF94F04AC2DA21864BE3FE1"><enum>(i)</enum><text>the origin, receipt,
				delivery, sale, movement, holding, and disposition of produce minimally
				processed at the facility;</text>
											</clause><clause id="IDC46E7574FD58433EA2C86412135F8400" indent="up1"><enum>(ii)</enum><text>the minimal processing of the
				produce; and</text>
											</clause><clause id="ID943E72CE3A394C75886E1F6270AC76C6" indent="up1"><enum>(iii)</enum><text>other matters reasonably related
				to whether produce minimally processed at the facility may be in violation of
				the requirements of this Act that relate to produce; and</text>
											</clause></subparagraph><subparagraph id="IDB288197CF9984A0EA2142D7256B7B396"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="ID27FA921172CE4C5C855E84120010E13C"><enum>(i)</enum><text>the origin, receipt,
				delivery, sale, movement, holding, and disposition of ingredients used in the
				produce minimally processed at the facility, including sufficient information
				to permit lot identification to facilitate traceback of produce found to be in
				violation of the requirements of this Act that relate to produce, or to be
				causing human illness or injury;</text>
											</clause><clause id="IDE41C79FA55964FD78440E3563FDD962C" indent="up1"><enum>(ii)</enum><text>the identity and amount of
				ingredients used in the produce;</text>
											</clause><clause id="ID235D997438C249DEB57300BA087B92C1" indent="up1"><enum>(iii)</enum><text>the results of laboratory,
				sanitation, or other quality control tests performed on the produce or in the
				facility; and</text>
											</clause><clause id="ID585A57437B7A4C56A4710399DE87CE8F" indent="up1"><enum>(iv)</enum><text>consumer complaints concerning the
				safety of the produce or the packaging of the produce.</text>
											</clause></subparagraph></paragraph><paragraph id="ID7CAFCC1E27EB4C26981E153745FBA694"><enum>(2)</enum><header>Availability of
				records</header><text>The owner, operator, or agent shall—</text>
										<subparagraph id="ID67DB2B9851A947F2BD35AFAA8E8979D3"><enum>(A)</enum><text>make available,
				during an inspection conducted under subsection (a), the records described in
				paragraph (1)(A); and</text>
										</subparagraph><subparagraph id="IDCFDD3800D45D4D6A98C2297CE9DCAF04"><enum>(B)</enum><text>at the request of
				the Secretary, if the officer or employee finds as a result of the inspection
				that produce from the facility is associated with foodborne disease or poses an
				imminent health hazard, make available for inspection the records described in
				paragraph (1)(B).</text>
										</subparagraph></paragraph><paragraph id="id174CBB9757764A3D8C17C9D14CC58A66"><enum>(3)</enum><header>Required
				disclosure</header><text>The owner, operator, or agent in charge of a facility
				shall have an affirmative obligation to take corrective action, including
				ensuring the product is not introduced into commerce, as approved by the
				Commissioner of Food and Drugs or the Secretary, if the results of testing or
				sampling of produce, equipment, or material in contact with produce are
				positive for any contaminant, in accordance with section 414. The owner,
				operator, or agent in charge of a facility shall have an affirmative obligation
				to disclose to the Commissioner of Food and Drugs or the Secretary if the
				results of testing finds a positive test result and the product is in
				commerce.</text>
									</paragraph></subsection><subsection id="ID71D250DF51CD4F409FB284B1DDC6EF41"><enum>(e)</enum><header>Definitions</header>
									<paragraph id="ID9308F86DD390411A85E019EBBB79575E"><enum>(1)</enum><header>Facility</header><text>The
				term <term>facility</term> includes any factory, warehouse, or establishment,
				in which produce is minimally processed.</text>
									</paragraph><paragraph id="IDA4F35C41463146B3B8C17B8E00F9D63F"><enum>(2)</enum><header>Minimally
				process; produce</header><text>The terms <term>minimally process</term> and
				<term>produce</term> have the meanings given those terms in section 3 of the
				<short-title>Fresh Produce Safety
				Act</short-title>.</text>
									</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
					</subsection><subsection id="IDA72F981A79AA4B0DABD202F192EAFD8F"><enum>(b)</enum><header>Remedies</header>
						<paragraph id="IDC5441731F2BC4ED0B539D0F9A4663D1E"><enum>(1)</enum><header>In
			 general</header><text>Paragraphs (f) and (n) of
			 <external-xref legal-doc="act" parsable-cite="FFDCA/301">section 301,
			 and</external-xref><external-xref legal-doc="act" parsable-cite="FFDCA/304(g)(1)"> section 304(g)(1),</external-xref> of the
			 <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
			 (<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C.
			 331</external-xref>, 334(g)(1)) are amended by striking <quote>section
			 704</quote> and inserting <quote>section 704 or 704A</quote>.</text>
						</paragraph><paragraph id="ID1AEC4BE5C6124AC083D1DF0172FBBABA"><enum>(2)</enum><header>Prohibited
			 disclosures</header><text><external-xref legal-doc="act" parsable-cite="FFDCA/301(j)">Section 301(j)</external-xref> of the
			 <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
			 (<external-xref legal-doc="usc" parsable-cite="usc/21/331(j)">21 U.S.C.
			 331(j)</external-xref>) is amended by striking <quote>704,</quote> and
			 inserting <quote>704, 704A,</quote>.</text>
						</paragraph></subsection><subsection id="ID7654B11D5D784555A11C5152DAF9BC6C"><enum>(c)</enum><header>Conforming
			 amendment</header><text><external-xref legal-doc="act" parsable-cite="FFDCA/742(a)(2)">Section 742(a)(2)</external-xref> of the
			 <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
			 (<external-xref legal-doc="usc" parsable-cite="usc/21/379l(a)(2)">21 U.S.C.
			 379l(a)(2)</external-xref>) is amended by striking <quote>section 704</quote>
			 and inserting <quote>section 704 or 704A</quote>.</text>
					</subsection></section></subtitle><subtitle id="IDE88AAE7A1A2646E6B200B62FA54B8CB3"><enum>B</enum><header>Raw agricultural
			 commodities</header>
				<section id="ID8C72BE9E0F674C6984C2AAD300654F5E"><enum>121.</enum><header>Good
			 agricultural practices</header>
					<subsection id="ID0D7C920CD98D4DBC9971BFE670F30005"><enum>(a)</enum><header>In
			 general</header><text>Chapter IV of the <act-name parsable-cite="FFDCA">Federal
			 Food, Drug, and Cosmetic Act</act-name>, as amended by section 111(a), is
			 further amended by inserting after section 402A the following:</text>
						<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="IDE14F58018AE04521AA2227002869BC6F">
							<section id="ID90C3AA0A2D42490A85850009822D673E"><enum>402B.</enum><header>Good
				agricultural practices for raw agricultural commodities</header>
								<subsection id="ID4748C1A8C49C4C01BEDF836036072E11"><enum>(a)</enum><header>Good
				agricultural practice regulations</header>
									<paragraph id="idE99A3E656A7C4BD5988BF4D9EFAC40F9"><enum>(1)</enum><header>In
				general</header><text>Not later than 1 year after the date of enactment of this
				section, the Secretary, in consultation with the Secretary of Agriculture,
				shall by regulation establish general standards for good agricultural practices
				for the production of raw agricultural commodities, in order to minimize the
				violations of this Act and maximize the safety of those commodities.</text>
									</paragraph><paragraph id="idA393307753764D8BA86D57472528513C"><enum>(2)</enum><header>Contents</header><text>The
				regulations issued under paragraph (1) shall include the following
				requirements:</text>
										<subparagraph id="id873813AA25424374B9B6259221E4B5CE"><enum>(A)</enum><header>Manure</header><text>Growers
				of a raw agriculture commodity shall—</text>
											<clause id="idCFEC3111CADA4D82B8929B8131205873"><enum>(i)</enum><text>manage the
				application of manure to ensure that it does not contribute to the
				contamination of crops, including limitations on the crops where and when
				manure may be applied; and</text>
											</clause><clause id="idCB8F3ECB602C441BBCDE10077E303495"><enum>(ii)</enum><text>monitor and
				maintain records relating to use of manure in composting intended for use on
				food crops to ensure effective controls are used to destroy pathogens.</text>
											</clause></subparagraph><subparagraph id="idDEC8892735C742C6B01DEE6A68219750"><enum>(B)</enum><header>Animals,
				domestic and wildlife</header><text>Growers of a raw agricultural commodity
				shall ensure that domestic animals should be excluded, to the extent reasonably
				practicable, from fields and orchards during the growing and harvesting season,
				and growing areas should have wildlife deterrents.</text>
										</subparagraph><subparagraph id="id112569166FD44D289E10119FEF6619A8"><enum>(C)</enum><header>Water</header><text>Growers
				of a raw agricultural commodity shall ensure that the water supply used for
				irrigation and for washing is suitable for its intended use and that ground
				water is regularly monitored for the presence of pathogens at a rate adequate
				to ensure that contaminated water is identified and diverted from use on food
				crops.</text>
										</subparagraph><subparagraph id="id1A4B3D9F17044B16A875BF3F152C96C3"><enum>(D)</enum><header>Environmental
				conditions</header><text>Growers of a raw agricultural commodity shall consider
				the unique environmental conditions that might increase the likelihood of crop
				contamination, including flooding, runoff, drought, and other conditions and
				develop safety plans to ensure contaminated crops are not distributed.</text>
										</subparagraph><subparagraph id="ID383be90bc91b4a54a1818df8fe207cbd"><enum>(E)</enum><header>Additional
				requirements</header><text>Other requirements as determined appropriate by the
				Secretary.</text>
										</subparagraph></paragraph><paragraph id="ID60858e6f371d492482472ee861125be0"><enum>(3)</enum><header>Risk
				assessment</header><text>The standards established under paragraph (1) shall be
				based on risk assessment tools and metrics developed by the Food and Drug
				Administration in consultation with the Department of Agriculture and growers
				of produce. The risk assessments shall include—</text>
										<subparagraph id="ID35847eb669984ea7982ca117e8eceea1"><enum>(A)</enum><text>identification of
				existing and potential hazards at facilities;</text>
										</subparagraph><subparagraph id="IDc1d802c2f22148a4b644dcafae804e47"><enum>(B)</enum><text>evaluation of
				human health risks posed by hazards identified in subparagraph (A); and</text>
										</subparagraph><subparagraph id="ID0d9029612b174e449fb7633e6ed76fe5"><enum>(C)</enum><text>proposed controls
				to minimize hazards based on subparagraph (B).</text>
										</subparagraph></paragraph><paragraph id="ID2655533650904d2aa6a78a503e3171f5"><enum>(4)</enum><header>Risk
				classification</header><text>The Secretary shall classify facilities as high-,
				medium-, or low-risk according to the risk assessments in paragraph (3), and by
				considering the hazards associated with the type of produce being grown at a
				facility, the facility’s history of compliance and food safety problems, and
				such other factors as the Secretary may determine to be appropriate. Such risk
				classification shall determine the specific standards and controls required at
				each facility.</text>
									</paragraph><paragraph id="ID71e497cba06349599d75ecd31457d156"><enum>(5)</enum><header>Science-based
				standards</header><text>The standards established under paragraph (1)
				shall—</text>
										<subparagraph id="ID9568638e24d04b12b483cb6f350244c4"><enum>(A)</enum><text>reflect the best
				available science; and</text>
										</subparagraph><subparagraph id="IDff306f3f6b95492fbe90e9e8eb99ad77"><enum>(B)</enum><text>be subject to
				change as new scientific evidence on risk becomes available.</text>
										</subparagraph></paragraph></subsection><subsection id="IDD1A1E3CF5E194A1498D64795AB4D269F"><enum>(b)</enum><header>Implementation
				plan</header>
									<paragraph id="id878B568EA3324BB7A4331979608B8D5A"><enum>(1)</enum><header>In
				general</header><text>Not later than 2 years after the date of enactment of
				this section, the Secretary shall require growers of a raw agricultural
				commodity to have a written plan detailing the controls utilized by the grower
				that limit the presence and growth of contaminants.</text>
									</paragraph><paragraph id="id07974BF1BA7149FF854663AB08AD9724"><enum>(2)</enum><header>Content</header><text>A
				plan under paragraph (1) shall—</text>
										<subparagraph id="id88E1C738C5D142C9989C6CEBA9AA840E"><enum>(A)</enum><text>address standards
				for good agricultural practices developed under subsection (a);</text>
										</subparagraph><subparagraph id="idECF1067CAA7349C08C3E47E285CAB9C8"><enum>(B)</enum><text>require
				recordkeeping to monitor compliance;</text>
										</subparagraph><subparagraph id="idBE7BF99C777D4B978D75EFD4BC917DAC"><enum>(C)</enum><text>require sampling
				of product to be tested at a frequency and in a manner commensurate with the
				risk presented by the facility and produce grown as determined in subsection
				(a)(3), if the Secretary deems this appropriate, and sufficient to ensure that
				the standards or process controls are effective on an on-going basis and that
				regulatory standards are met; and</text>
										</subparagraph><subparagraph id="id498D22F0F1C9416096CB7C7C74777BD6"><enum>(D)</enum><text>provide access to
				the Food and Drug Administration to records maintained by the facility.</text>
										</subparagraph></paragraph><paragraph id="id3AD063C228E143AC9B15D14D16868F33"><enum>(3)</enum><header>Specific
				controls</header><text>The Secretary may require growers of a raw agricultural
				commodity to adopt as part of a plan under paragraph (1) specific process
				controls, if the process controls are needed to ensure the protection of the
				public health.</text>
									</paragraph><paragraph id="ID659b722b7fbf41e7bf53dc15c99e16b8"><enum>(4)</enum><header>Tiered
				implementation</header><text>The Secretary shall require such a plan for
				high-risk facilities first, and then for medium-risk facilities, and then for
				low-risk facilities, as classified under subsection (a)(4).</text>
									</paragraph></subsection><subsection id="IDC33FFAED412243928D03107D3C379070"><enum>(c)</enum><header>Effective
				date</header><text>The regulations described in subsection (a) shall take
				effect 2 years after the date of enactment of this section.</text>
								</subsection><subsection id="ID747346A9976543F1BCE698C3ADC863EF"><enum>(d)</enum><header>Definitions</header><text>In
				this section:</text>
									<paragraph id="idC60A81CAD2F8471586876F8FDFC879B9"><enum>(1)</enum><header>Facility</header><text>The
				term <term>facility</term> means a farm or other facility of a grower of a raw
				agricultural commodity.</text>
									</paragraph><paragraph id="id91CE2AE09F7944699DEF5B1C30C9899A"><enum>(2)</enum><header>Raw
				agricultural commodity</header><text>The term <term>raw agricultural
				commodity</term> means a perishable agricultural commodity, as defined in
				section 1(b) of the Perishable Agricultural Commodities Act, 1930
				(<external-xref legal-doc="usc" parsable-cite="usc/7/499a(b)">7 U.S.C.
				499a(b)</external-xref>) that is a raw agricultural commodity, as defined in
				section
				201.</text>
									</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
					</subsection><subsection id="ID955A8133684A446091B2E51F667F7C53"><enum>(b)</enum><header>Violation</header><text><external-xref legal-doc="act" parsable-cite="FFDCA/402(h)">Section 402(j)</external-xref> of
			 the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
			 Act</act-name>, as added by section 111(b), is amended by inserting before the
			 period the following: <quote>or a raw agricultural commodity produced in
			 violation of section 402B</quote>.</text>
					</subsection></section><section id="ID856BA41AF8F24D1D83C3E0D2CD00B485"><enum>122.</enum><header>Inspections of
			 facilities</header>
					<subsection id="ID92683C00A4054FD6BC1E787771633472"><enum>(a)</enum><header>In
			 general</header><text>Chapter VII of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>, as
			 amended by section 112(a), is further amended by inserting after section 704A
			 the following:</text>
						<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="ID703F208A9BF14439B14B6E00C112AF00">
							<section id="ID8F0984DEB58743B3917E05E93410EF19"><enum>704B.</enum><header>Inspections
				of facilities</header>
								<subsection id="IDF03A4C3688B14695B71E98CC4107244D"><enum>(a)</enum><header>Nature of
				inspections</header><text>Officers and employees duly designated by the
				Secretary shall have the authority to inspect appropriate facilities (as
				defined in section 402B) to determine compliance with the standards described
				in section 402B.</text>
								</subsection><subsection id="ID0F26668A50EA45B58B6B52ABF5410982"><enum>(b)</enum><header>Regulations</header><text>Not
				later than 2 years after the date of enactment of this section, the Secretary,
				in consultation with the Secretary of Agriculture, shall by regulation issue
				procedures for conducting the inspections.</text>
								</subsection><subsection id="IDEEE73708A86041559FEC388D02C7BB2E"><enum>(c)</enum><header>Effective
				date</header><text>Subsection (a) and the regulations promulgated under
				subsection (b) shall take effect 3 years after the date of enactment of this
				section.</text>
								</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
					</subsection><subsection id="ID1457D08668144D43B1112B8136095D14"><enum>(b)</enum><header>Remedies</header>
						<paragraph id="IDA50A1A01188F4930A6EECAA974382D40"><enum>(1)</enum><header>In
			 general</header><text>Paragraphs (f) and (n) of
			 <external-xref legal-doc="act" parsable-cite="FFDCA/301">section 301, and
			 </external-xref><external-xref legal-doc="act" parsable-cite="FFDCA/304(g)(1)">section 304(g)(1),</external-xref> of the
			 <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
			 (<external-xref legal-doc="usc" parsable-cite="usc/21/331(j)">21 U.S.C.
			 331(j)</external-xref>), as amended in section 112(b), are further amended by
			 striking <quote>or 704A</quote> and inserting <quote>, 704A, or
			 704B</quote>.</text>
						</paragraph><paragraph id="IDF00FC390AC5141809E374B74325B6C28"><enum>(2)</enum><header>Prohibited
			 disclosures</header><text><external-xref legal-doc="act" parsable-cite="FFDCA/301(j)">Section 301(j)</external-xref> of the
			 <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
			 (<external-xref legal-doc="usc" parsable-cite="usc/21/333(j)">21 U.S.C.
			 333(j)</external-xref>), as amended in section 112(b), is further amended by
			 inserting <quote>704B,</quote> after <quote>704A,</quote>.</text>
						</paragraph></subsection><subsection id="IDC43358476F8645E4B3285B0039E32EAB"><enum>(c)</enum><header>Conforming
			 amendment</header><text><external-xref legal-doc="act" parsable-cite="FFDCA/742(a)(2)">Section 742(a)(2)</external-xref> of the
			 <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
			 (<external-xref legal-doc="usc" parsable-cite="usc/21/379l(a)(2)">21 U.S.C.
			 379l(a)(2)</external-xref>), as amended in section 112(c), is further amended
			 by striking <quote>or 704A</quote> and inserting <quote>, 704A, or
			 704B</quote>.</text>
					</subsection></section></subtitle></title><title id="ID6F0F55DD12C949EE8620D07B5CE30254"><enum>II</enum><header>Research and
			 education</header>
			<section id="ID05EC2E52CA15475785E5C9135D0012C5"><enum>201.</enum><header>Public health
			 assessment system</header>
				<subsection id="ID80B292CE5F8249C7A3EEA52C919FBD29"><enum>(a)</enum><header>Cooperation
			 with the centers for Disease Control and Prevention</header><text>The
			 Commissioner of Food and Drugs, in cooperation with the Secretary of
			 Agriculture, the Director of the Centers for Disease Control and Prevention,
			 and the Administrator of the Environmental Protection Agency, shall establish
			 and maintain an active surveillance system, for surveillance of a
			 representative proportion of the population of the United States, to assess
			 more accurately the frequency and sources of human illness in the United States
			 associated with the consumption of fresh produce.</text>
				</subsection><subsection id="ID601BDB2E2D18437984FFF4C2603E43FE"><enum>(b)</enum><header>Public health
			 sampling</header>
					<paragraph id="ID3A23FBF4D72D443782E10031ABFA0018"><enum>(1)</enum><header>Guidelines</header><text>Not
			 later than 3 years after the date of enactment of this Act, the Commissioner of
			 Food and Drugs, in cooperation with the Secretary of Agriculture, the Director
			 of the Centers for Disease Control and Prevention, and the Administrator of the
			 Environmental Protection Agency, shall establish guidelines for a sampling
			 system under which the Commissioner and the Secretary of Agriculture shall
			 collect and analyze samples of fresh produce, both minimally processed and
			 unprocessed, to assist the Commissioner in carrying out this Act and the
			 requirements of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and
			 Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301</external-xref> et seq.) that relate
			 to produce, and to assess more accurately the nature, frequency of occurrence,
			 and amounts of contaminants in the produce.</text>
					</paragraph><paragraph id="ID84E519ED64CC42BC93A03F73851F0020"><enum>(2)</enum><header>Monitoring and
			 other information</header><text>In carrying out the sampling system, the
			 Commissioner of Food and Drugs and the Secretary of Agriculture shall provide
			 for—</text>
						<subparagraph id="ID9BFB5B4048E742B9BE56D96DF2F659EC"><enum>(A)</enum><text>statistically
			 valid monitoring, including the conduct of market-basket studies, on the
			 nature, frequency of occurrence, and amounts of contaminants in produce
			 available to consumers; and</text>
						</subparagraph><subparagraph id="ID8776A1FB6F334F72A2E2AA3B7BA4EB51"><enum>(B)</enum><text>at the request of
			 the Commissioner, the collection and analysis of such other information,
			 including analysis of information from monitoring and verification samples, as
			 the Commissioner determines may be useful in assessing the occurrence of
			 contaminants in produce.</text>
						</subparagraph></paragraph><paragraph id="IDDF38EA3A0B1C469A9C79A59BA45BBF99"><enum>(3)</enum><header>Process
			 verification standard</header><text>The Commissioner of Food and Drugs and the
			 Secretary of Agriculture shall conduct sampling to identify—</text>
						<subparagraph id="IDA0EAFCDAB01B4A38A73F58BD389EF44E"><enum>(A)</enum><text>a contaminant, or
			 other substance, that is commonly found on minimally processed produce and,
			 when present at low levels, accurately indicates that the produce has been
			 appropriately processed, with adequate sanitation; and</text>
						</subparagraph><subparagraph id="ID293CDC66A3BE476B95540816CD147D10"><enum>(B)</enum><text>a standard for
			 the level of that substance that indicates that the produce has been minimally
			 processed as described in subparagraph (A).</text>
						</subparagraph></paragraph></subsection></section><section id="ID33475D7AA003407D914CD9C2CD7C7FEC"><enum>202.</enum><header>Public
			 education system</header><text display-inline="no-display-inline">The
			 Commissioner of Food and Drugs and the Secretary of Agriculture, in cooperation
			 with private and public organizations, including the State cooperative
			 extension services and appropriate State entities, shall design and implement a
			 national public education program on food safety relating to produce. In
			 carrying out the program, the Commissioner shall—</text>
				<paragraph id="ID61BE4D988936448082ED8EFDECA0947C"><enum>(1)</enum><text>provide
			 information to the public regarding Federal standards and good agricultural and
			 manufacturing practice requirements relating to food safety and promote public
			 awareness, understanding, and acceptance of the standards and requirements;
			 and</text>
				</paragraph><paragraph id="ID5C0EDB17AC89411D963380B7397905EB"><enum>(2)</enum><text>provide such
			 other information or advice to persons that work with the growing and minimal
			 processing of produce, the food service and retail industry, consumers, and
			 other persons as the Commissioner determines will promote the purposes of this
			 Act.</text>
				</paragraph></section><section id="ID883CEAC85C77492BBA295647AA07EE72"><enum>203.</enum><header>Research</header>
				<subsection id="ID77EA217D9B6A4951B821AA3C9536BFBD"><enum>(a)</enum><header>In
			 general</header><text>The Secretary of Agriculture, in consultation with the
			 Commissioner of Food and Drugs, shall conduct research to assist in the
			 implementation of this Act and the requirements of the
			 <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
			 (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C.
			 301</external-xref> et seq.) that relate to produce, including studies relating
			 to—</text>
					<paragraph id="ID9686BFB43801404384227F07B92FDF2B"><enum>(1)</enum><text>improving
			 sanitation and food safety practices in the minimal processing of
			 produce;</text>
					</paragraph><paragraph id="IDA0E1BAEF72434A07883691E2A7834F36"><enum>(2)</enum><text>developing
			 improved techniques for the monitoring of produce and inspection of
			 produce;</text>
					</paragraph><paragraph id="IDDF8104C9639D49FEBAED652DFC787E6D"><enum>(3)</enum><text>developing
			 efficient, rapid, and sensitive methods for determining and detecting the
			 presence of contaminants in produce;</text>
					</paragraph><paragraph id="ID3CF992B409C4436F89804F69DE134F7B"><enum>(4)</enum><text>determining the
			 sources of contamination of produce, including contamination from growing,
			 harvesting, and minimal processing produce and post-processing contamination of
			 produce;</text>
					</paragraph><paragraph id="IDB415AEF02A614A95B356A337FD6BA7E5"><enum>(5)</enum><text>developing
			 consumption data with respect to produce (including minimally processed
			 produce); and</text>
					</paragraph><paragraph id="id911AF1D09B0040829F320AAE7BC3FC9D"><enum>(6)</enum><text>mitigation
			 strategies to aid produce processors and produce growers in deciding what
			 actions to take when contamination is found.</text>
					</paragraph></subsection><subsection id="ID14A2538735A946BAB757903B1D25EADA"><enum>(b)</enum><header>Contract
			 authority</header><text>The Secretary of Agriculture is authorized to enter
			 into contracts and agreements with States, institutions of higher education,
			 other government agencies, and other persons to carry out the activities
			 described in this section.</text>
				</subsection></section></title><title id="IDABF44CFF9A6F4FF8AD3C08E8ACFD0001"><enum>III</enum><header>Imported
			 produce and other provisions</header>
			<section id="IDCD4E243F3E7D47BCBE07BB58F5862700"><enum>301.</enum><header>Imported
			 produce</header>
				<subsection id="ID2f394ae0a0474548be7bad02a0de90a7"><enum>(a)</enum><header>Equivalency
			 procedures</header><text>Not later than 1 year after the date of enactment of
			 this Act, the Secretary, in consultation with the Secretary of Agriculture,
			 shall by regulation establish procedures for equivalency with foreign countries
			 that intend to export raw agricultural commodities and minimally processed
			 produce to the United States.</text>
				</subsection><subsection id="ID87b7bbe56cf04cd0b04dba191d4cb766"><enum>(b)</enum><header>Content</header><text>The
			 Secretary, in consultation with the Secretary of Agriculture, shall establish
			 procedures to require that imported raw agricultural commodities and minimally
			 processed produce meet the criteria established in this Act (and the amendments
			 made by this Act).</text>
				</subsection></section><section id="id960A2684735E4407A9C7108D90DB0DCD"><enum>302.</enum><header>Authorization
			 of appropriations</header><text display-inline="no-display-inline">There are
			 authorized to be appropriated such sums as may be necessary to carry out this
			 Act (and the amendments made by this Act) for each fiscal year.</text>
			</section></title></legis-body>
</bill>
