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<distribution-code display="yes">II</distribution-code><congress>117th CONGRESS</congress><session>1st Session</session><legis-num>S. 1019</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20210325">March 25, 2021</action-date><action-desc><sponsor name-id="S311">Ms. Klobuchar</sponsor> (for herself and <cosponsor name-id="S386">Ms. Duckworth</cosponsor>) introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSHR00">Committee on Health, Education, Labor, and Pensions</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To amend the Federal Food, Drug, and Cosmetic Act to limit the presence of toxic elements in, and otherwise regulate, infant and toddler food, and for other purposes.</official-title></form><legis-body style="OLC" display-enacting-clause="yes-display-enacting-clause" id="H568931183216430F9D8673319D5AD30C"><section section-type="section-one" id="H0EEEC9D7C3D2439EA7D4389006E107C6"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Baby Food Safety Act of 2021</short-title></quote>.</text></section><section id="HC588AB2D7EB5414B98C3ACB0DBC0F5D9"><enum>2.</enum><header>Definition of infant and toddler food</header><text display-inline="no-display-inline">Section 201 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H44EB1DE660A645A988901EBD2F18BD01"><subsection id="HD1B2464A84DE43819A8BF2276DB84245"><enum>(ss)</enum><text display-inline="yes-display-inline">The term <term>infant and toddler food</term> means food intended for sale to children up to 36 months of age, including infant formula.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="H3F27BDAB4ADA4DE6BF74EC226C3A7DB6"><enum>3.</enum><header>Infant and toddler food hazard analysis and risk-based preventive controls</header><subsection id="H94D3A018919549A5B2E9251EEC515B05"><enum>(a)</enum><header>Preventive controls</header><text display-inline="yes-display-inline">Section 418(c) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/350g">21 U.S.C. 350g(c)</external-xref>) is amended—</text><paragraph id="HB5D2D738FBE04F0ABE31C7DEF9B0BACC"><enum>(1)</enum><text>in paragraph (2), by striking <quote>and</quote> at the end;</text></paragraph><paragraph id="HAB764306DCDF49A0B9D76D1BE53627F2"><enum>(2)</enum><text>in paragraph (3), by striking the period at the end and inserting <quote>; and</quote>; and</text></paragraph><paragraph id="H38CA8CED8917444ABAF75F89C7AD2986"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HAF00C57584AF4BA281064821387E0B10"><paragraph id="HB6DD67AEA4A04E098C2AF2643EA0DC9B"><enum>(4)</enum><text display-inline="yes-display-inline">the infant and toddler foods manufactured, processed, packed, or held by such facility will comply with the performance standards and action levels for toxic elements in infant and toddler foods required under section 104 of the FDA Food Safety Modernization Act.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HC2BEE6FEB8DF44EDB62A421628FAF8CE"><enum>(b)</enum><header>Verification</header><text display-inline="yes-display-inline">Paragraph (4) of section 418(f) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/350g">21 U.S.C. 350g(f)</external-xref>) is amended to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HD56BF5FD9D9C4332A38F4FE153DBFDBA"><paragraph id="HD726BDB377AC4A6B8F74E1FC2F263C7A"><enum>(4)</enum><text display-inline="yes-display-inline">the preventive controls implemented under subsection (c) are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means, including representative testing by manufacturers of infant and toddler foods that are finished products; and</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H2ADB48139CE54CD5AA7B60784B6DB53D"><enum>(c)</enum><header>Biannual reporting</header><text display-inline="yes-display-inline">Section 418(h) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/350g">21 U.S.C. 350g(h)</external-xref>) is amended by adding at the end the following: <quote>The owner, operator, or agent in charge of a facility that manufactures infant and toddler foods shall make publicly available on a web page a biannual report summarizing the results of monitoring under subsection (d), and verification results under subsection (f), with respect to such facility and infant and toddler foods.</quote>.</text></subsection></section><section id="H41DB8E42D3484D8AADE0E163FC24A0C7"><enum>4.</enum><header>Infant and toddler food action levels</header><subsection id="HB213191AB205467B82FC7730DCA8B7CC"><enum>(a)</enum><header>Performance standard guidance documents and regulations</header><text>Section 104(b) of the FDA Food Safety Modernization Act (<external-xref legal-doc="usc" parsable-cite="usc/21/2201">21 U.S.C. 2201(b)</external-xref>) is amended—</text><paragraph id="H10BC98E1329F4882B2BACD018E048A4A"><enum>(1)</enum><text display-inline="yes-display-inline">in the matter preceding paragraph (1), by striking <quote>reduce the risk of serious illness or death</quote> and inserting <quote>reduce the risk of serious illness, including neurological impairment, or death</quote>; and</text></paragraph><paragraph id="HB56E5FF14A5C4D0AB2DE4EEA0CA89EFF"><enum>(2)</enum><text>in paragraph (1), by inserting <quote>and toxic elements in infant and toddler foods</quote> before the semicolon.</text></paragraph></subsection><subsection id="HBF284E257E8F40548469EC022D32308E"><enum>(b)</enum><header>Action levels</header><text display-inline="yes-display-inline">Section 104 of the FDA Food Safety Modernization Act (<external-xref legal-doc="usc" parsable-cite="usc/21/2201">21 U.S.C. 2201</external-xref>) is amended by adding at the end the following: </text><quoted-block style="OLC" display-inline="no-display-inline" id="H3EDADD7F04974749B36BB35272FBC22F"><subsection id="H3BA643C78D2B4EE8B7CB2B1FF16D9012"><enum>(e)</enum><header>Action levels</header><paragraph id="HC8D207B23D7941FD8AB1F52F069DE755"><enum>(1)</enum><header>In general</header><text>Beginning not later than 1 year after the date of enactment of the <short-title>Baby Food Safety Act of 2021</short-title>, infant and toddler food is deemed to be adulterated if it meets or exceeds the action level or regulatory limit that is applicable with respect to such food under this subsection.</text></paragraph><paragraph id="H69D24B36EBA74CC593714381689209B4"><enum>(2)</enum><header>Initial levels</header><text>The initial action levels under this subsection are the following:</text><table blank-lines-before="1" table-type="" table-template-name="Generic: 1 text, 1 num" align-to-level="section" frame="all" colsep="1" rowsep="1" line-rules="all-gen" rule-weights="4.4.4.4.4.0"><tgroup cols="2" grid-typeface="1.1" rowsep="1" thead-tbody-ldg-size="10.10.12"><colspec coldef="txt" colname="column1" min-data-value="100" colwidth="108pts"></colspec><colspec coldef="txt" colname="column2" min-data-value="200" colwidth="217pts"></colspec><thead><row><entry align="center" morerows="0" namest="column1" colname="column1"><bold>Toxic Element</bold></entry><entry align="center" morerows="0" namest="column2" colname="column2"><bold>Action Level</bold></entry></row></thead><tbody><row><entry align="left" stub-definition="txt-ldr" stub-hierarchy="1" colname="column1">Inorganic arsenic</entry><entry align="right" colname="column2">10 ppb for infant and toddler food (except cereal) and 15 ppb for infant and toddler food that is cereal </entry></row><row><entry align="left" stub-definition="txt-ldr" stub-hierarchy="1" colname="column1">Cadmium</entry><entry align="right" colname="column2">5 ppb for infant and toddler food (except cereal) and 10 ppb for infant and toddler food that is cereal </entry></row><row><entry align="left" stub-definition="txt-ldr" stub-hierarchy="1" colname="column1">Lead</entry><entry align="right" colname="column2">5 ppb for infant and toddler food (except cereal) and 10 ppb for infant and toddler food that is cereal </entry></row><row><entry align="left" stub-definition="txt-ldr" stub-hierarchy="1" colname="column1">Mercury </entry><entry align="right" colname="column2">2 ppb</entry></row></tbody></tgroup></table></paragraph><paragraph id="HFC25B3DA2CB14695B50125994BDF75EE"><enum>(3)</enum><header>Interim action levels</header><text display-inline="yes-display-inline">Not later than 2 years after the date of enactment of the <short-title>Baby Food Safety Act of 2021</short-title>, the Secretary shall—</text><subparagraph id="HEF0928A9C24E49218D145F6D14139A40"><enum>(A)</enum><text>review relevant health and dietary data; and</text></subparagraph><subparagraph id="H98A86A5EC0F3408396E46B39C1F2849B"><enum>(B)</enum><text display-inline="yes-display-inline">by guidance, lower the initial action levels established by paragraph (2) to further minimize exposure to toxic elements in infant and toddler food to further reduce potential clinical or population-level health effects as indicated by the Secretary’s review of relevant health and dietary data.</text></subparagraph></paragraph><paragraph id="H22CC7B7CE2284AC3AFBFFE948F3808E7"><enum>(4)</enum><header>Final regulatory limits; periodic review</header><text display-inline="yes-display-inline">The Secretary shall—</text><subparagraph id="H59E83F495C5A4F8FBE43B08A25C93B42"><enum>(A)</enum><text display-inline="yes-display-inline">not later than 3 years after the date of enactment of the <short-title>Baby Food Safety Act of 2021</short-title>, by regulation set regulatory limits lower than the action levels established by paragraphs (2) and (3) to levels protective of infant and toddler neurological development, taking into account the most sensitive testing available; and</text></subparagraph><subparagraph id="H071F14A1075649A593556957AF799156"><enum>(B)</enum><text display-inline="yes-display-inline">every 5 years thereafter—</text><clause id="H409502EEE60F40648B7260311CD26AA7"><enum>(i)</enum><text>review the levels established under this subsection to consider whether such levels should be lowered further consistent with the standard described in subparagraph (A); and</text></clause><clause id="HA659804A70744DB3978781C09DBD3350"><enum>(ii)</enum><text>if so, by regulation so lower such levels.</text></clause></subparagraph></paragraph><paragraph id="H6599A8B1024347CE9B28C8471FA77DE9"><enum>(5)</enum><header>Toxic elements</header><text display-inline="yes-display-inline">The Secretary may by guidance or regulation, as applicable, establish interim action levels and regulatory limits for toxic elements in infant and toddler food in addition to the toxic elements specified in the table in paragraph (2) if determined by the Secretary to be appropriate upon review of relevant health and dietary data.</text></paragraph><paragraph id="HC38EF7861B744836941EF7BE7B707517"><enum>(6)</enum><header>Progress reports</header><text>Not later than 1 year, 2 years, and 3 years after the date of enactment of the <short-title>Baby Food Safety Act of 2021</short-title>, the Secretary shall submit a report to the Congress containing—</text><subparagraph id="HB62CF3423D524F16A4ACEF13879084AA"><enum>(A)</enum><text>a summary of progress towards establishing the required levels under this subsection;</text></subparagraph><subparagraph id="HA45D3747BC284D14A2C339E20E4C1FBD"><enum>(B)</enum><text display-inline="yes-display-inline">an evaluation of the effectiveness of preventive controls for infant and toddler food based on monitoring results and verification results under section 418 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/350g">21 U.S.C. 350g</external-xref>) compared to levels under this subsection; and</text></subparagraph><subparagraph id="H1D738682C2274FD88F95BE9BBEBEB32A"><enum>(C)</enum><text display-inline="yes-display-inline">an estimate of progress in reducing the cumulative exposure of children to toxic elements in infant and toddler food.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HC6E15ABB871E4513B804115A3FA1A1CE"><enum>(c)</enum><header>Definition</header><text display-inline="yes-display-inline">Section 104 of the FDA Food Safety Modernization Act (<external-xref legal-doc="usc" parsable-cite="usc/21/2201">21 U.S.C. 2201(b)</external-xref>), as amended by subsections (a) and (b), is further amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HAB7853C368AE4C4DACDD675E4951CB35"><subsection id="H17C9FB34D2DE4C318974E3ECE7FA08F5"><enum>(f)</enum><header>Infant and toddler food defined</header><text display-inline="yes-display-inline">In this section, the term <term>infant and toddler food</term> has the meaning given to such term in section 201(ss) of the Federal Food, Drug, and Cosmetic Act.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HA0CEFC3ED79F4B10B230F68C8B9300B5"><enum>(d)</enum><header>Mandatory recall authority</header><text display-inline="yes-display-inline">Section 423(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/350l">21 U.S.C. 350l(a)</external-xref>) is amended—</text><paragraph id="H28B4859C5E0A4B09B022D0083B99A06D"><enum>(1)</enum><text>by striking <quote>(other than infant formula)</quote>; and</text></paragraph><paragraph id="H3797E3F9590940C1AB780C9595E6D9D9"><enum>(2)</enum><text>by inserting after <quote>animals,</quote> the following: <quote>or the Secretary determines that an article of infant and toddler food contains a toxic element that meets or exceeds the action level applicable under subsection (e) of section 104 of the FDA Food Safety Modernization Act,</quote>.</text></paragraph></subsection><subsection id="HA028CB1482E14DA185618DF96A727519"><enum>(e)</enum><header>Public awareness campaign</header><text>Section 1009 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/399">21 U.S.C. 399</external-xref>) is amended—</text><paragraph id="H1A4441D065704C49AC29D3D59F4D8FC0"><enum>(1)</enum><text>by redesignating subsection (h) as subsection (i); and</text></paragraph><paragraph id="HF4EE8599C2364BCDBBC2E3E22C86BD69"><enum>(2)</enum><text>after executing the amendment made by paragraph (1), by inserting after subsection (g) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HEA84244616A746F094FFD8940B67A17D"><subsection id="H040A0FA851EF4BDCB8DE1102147C566E"><enum>(h)</enum><header>Baby food public awareness campaign</header><text display-inline="yes-display-inline">The Secretary, acting through the Director of the Centers for Disease Control, shall carry out a public awareness campaign to highlight the risks posed by toxic elements in infant and toddler food and make recommendations to the public with respect to such toxic elements and food.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H303DB087CBF24E86BD22E15896F7C8F1"><enum>(f)</enum><header>Grants for farming research</header><text>Section 401 of the FDA Food Safety Modernization Act (<external-xref legal-doc="public-law" parsable-cite="pl/111/353">Public Law 111–353</external-xref>; 124 Stat. 3967) is amended by adding the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H15BE80BF6C0E41C1A441E4F6DE093A63"><subsection id="HFD76A1BC9B904B2C910006C17D6D70CF"><enum>(c)</enum><header>Grants for farming research</header><paragraph id="H875095B7C2A94A168AA6CC08B223D791"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Commissioner of Food and Drugs shall commission the National Academy of Sciences (or, if the National Academy declines, another appropriate entity) to conduct research on agricultural methods of minimizing levels of toxic heavy metals in crops. </text></paragraph><paragraph id="H8EE846699668493E96D971A766C57F40"><enum>(2)</enum><header>Authorization of appropriations</header><text>To carry out this subsection, there is authorized to be appropriated $50,000,000.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section></legis-body></bill> |
