An amendment numbered 1 printed in House Report 109-386 to delete section (f) from 403B; insert in 403A a new clause clarifying when states may act to implement food adulteration standards in absence of a federal adulteration standard for a particular food. Under the amendment,if the FDA has established a federal adulteration or food tolerance standard the state must enforce that standard. If the FDA has considered and officially rejected a federal standard then states may not enforce requirements rejected by the Secretary. However, if the Secretary has not acted to establish a standard or rejected a standard then a state could establish its own adulteration or tolerance standard without having to petition or seek approval from the FDA. Also clarifies that uniformity in notification requirements for warnings does not apply to warnings related to dietary supplements.

1. 1

   Change 1: Replaces “403A(a)” with “403A”

   ReplacesPage 2, line 7Printed page

   [struck: 403A(a)][inserted: 403A]

   Original wording

   Page 2, line 7, strike “403A(a)” and insert “403A”.

2. 2

   Change 2: Replaces “343-1(a)” with “343-1”

   ReplacesPage 2, line 8Printed page

   In H.R. 4167 · Reported in House

   SEC. 2. NATIONAL UNIFORMITY FOR FOOD.

   (a) National Uniformity.--Section 403A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343-1[struck: (a])[struck: )] is amended--

   (1) in paragraph (4), by striking "or" at the end;

   Original wording

   Page 2, beginning on line 8, strike “343-1(a)” and insert “343-1”.

3. 3

   Change 3: Replaces “in paragraph (4)” with “in subsection (a)(4)”

   ReplacesPage 2, line 10Printed page

   In H.R. 4167 · Reported in House

   (a) National Uniformity.--Section 403A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343-1(a)) is amended--

   (1) in [struck: paragraph][inserted: subsection] ([inserted: a)(]4), by striking "or" at the end;

   (2) in paragraph (5), by striking the period and inserting ", or";

   Original wording

   Page 2, line 10, strike “in paragraph (4)” and insert “in subsection (a)(4)”.

4. 4

   Change 4: Replaces “in paragraph (5)” with “in subsection (a)(5)”

   ReplacesPage 2, line 12Printed page

   In H.R. 4167 · Reported in House

   (1) in paragraph (4), by striking "or" at the end;

   (2) in [struck: paragraph][inserted: subsection] ([inserted: a)(]5), by striking the period and inserting ", or";

   (3) by inserting after paragraph (5) the following:

   Original wording

   Page 2, line 12, strike “in paragraph (5)” and insert “in subsection (a)(5)”.

5. 5

   Change 5: Inserts “in subsection (a),” after “(3)”

   InsertsPage 2, line 14Printed page

   …(3)[inserted: in subsection (a),]…

   Original wording

   Page 2, line 14, insert “in subsection (a),” after “(3)”.

6. 6

   Change 6: Rewrites page 3, lines 5–15

   ReplacesPrinted page

   Removes page 3, lines 5–15 of the printed bill. See that page

   Inserted: (4) by adding at the end the following:

   Inserted: "(c)(1) For purposes of subsection (a)(6) and section 403B, the term 'identical' means that the language under the laws of a State or a political subdivision of a State is substantially the same language as the comparable provision under this Act and that any differences in language do not result in the imposition of materially different requirements. For purposes of subsection (a)(6), the term 'any requirement for a food' does not refer to provisions of this Act that relate to procedures for Federal action under this Act.

   Inserted: "(2) For purposes of subsection (a)(6), a State or political subdivision of a State may enforce a State law that contains a requirement that is identical to a requirement in a section of Federal law referred to in subsection (a)(6) if--

   Inserted: "(A) the Secretary has promulgated a regulation or adopted a final guidance relating to the requirement and the State applies the State requirement in a manner that conforms to the regulation or guidance; or

   Inserted: "(B) the Secretary has not promulgated a regulation or adopted a final guidance relating to the requirement, except that if the Secretary has considered a proposal for a regulation or final guidance relating to the requirement and has, after soliciting public comment, made a determination not to promulgate such regulation or adopt such guidance, which determination is published in the Federal Register, the State may not enforce any requirements in State law that are policies rejected by the Secretary through such determination.".

   Original wording

   Page 3, strike lines 5 through 15 and insert the following:

7. 7

   Change 7: Strikes page 13, lines 13–19

   StrikesPrinted page

   Removes page 13, lines 13–19 of the printed bill. See that page

   Original wording

   Page 13, strike lines 13 through 19.

8. 8

   Change 8: Replaces “(g)” with “(f)”

   ReplacesPage 13, line 20Printed page

   In H.R. 4167 · Reported in House

   "(f) No Effect on Identical Law.--Nothing in this section relating to a food shall be construed to prevent a State or political subdivision of a State from establishing, enforcing, or continuing in effect a requirement that is identical to a requirement of this Act, whether or not the Secretary has promulgated a regulation or issued a policy statement relating to the requirement.

   "([struck: g][inserted: f]) No Effect on Certain State Law.--Nothing in this section or section 403A relating to a food shall be construed to prevent a State or political subdivision of a State from establishing, enforcing, or continuing in effect a requirement relating to--

   "(1) freshness dating, open date labeling, grade labeling, a State inspection stamp, religious dietary labeling, organic or natural designation, returnable bottle labeling, unit pricing, or a statement of geographic origin; or

   Original wording

   Page 13, line 20, strike “(g)” and insert “(f)”.

9. 9

   Change 9: Strikes “or”

   StrikesPage 14, line 4Printed page

   Struck: or

   Original wording

   Page 14, line 4, strike “or”

10. 10

    Change 10: Inserts “, or dietary supplements” before the semicolon

    InsertsPage 14, line 5Printed page

    Inserted: , or dietary supplements

    Original wording

    Page 14, line 5, insert before the semicolon the following: “, or dietary supplements”.

11. 11

    Change 11: Replaces “(h)” with “(g)”

    ReplacesPage 14, line 13Printed page

    In H.R. 4167 · Reported in House

    "(2) a consumer advisory relating to food sanitation that is imposed on a food establishment, or that is recommended by the Secretary, under part 3-6 of the Food Code issued by the Food and Drug Administration and referred to in the notice published at 64 Fed. Reg. 8576 (1999) (or any corresponding similar provision of such a Code).

    "([struck: h][inserted: g]) Definitions.--In section 403A and this section:

    "(1) The term 'requirement', used with respect to a Federal action or prohibition, means a mandatory action or prohibition established under this Act or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.), as appropriate, or by a regulation issued under or by a court order relating to, this Act or the Fair Packaging and Labeling Act, as appropriate.

    Original wording

    Page 14, line 13, strike “(h)” and insert “(g)”.

Read automatically from the Congressional Record. Check the original before relying on it.

As printed