EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
Underlining indicates amendments to bill.
Strike out indicates matter stricken from the bill by amendment or deleted from the law by
amendment.
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*hb0097*
HOUSE BILL 97
J1 (4lr1369)
ENROLLED BILL
— Health and Government Operations/Finance —
Introduced by Delegates Taveras and Pasteur, Pasteur, Pena–Melnyk, Cullison,
Alston, Bagnall, Bhandari, Chisholm, Guzzone, Hill, Hutchinson,
S. Johnson, Kaiser, Kerr, Kipke, R. Lewis, Lopez, Martinez, M. Morgan,
Reilly, Rosenberg, Szeliga, White Holland, and Woods
Read and Examined by Proofreaders:
_______________________________________________
Proofreader.
_______________________________________________
Proofreader.
Sealed with the Great Seal and presented to the Governor, for his approval this
_______ day of _______________ at ____________ ____________ o’clock, ________M.
______________________________________________
Speaker.
CHAPTER ______
AN ACT concerning 1
Baby Food – Toxic Heavy Metals – Testing and Labeling 2
(Rudy’s Law) 3
FOR the purpose of requiring, beginning on a certain date, manufacturers of baby food to 4
conduct certain testing on baby food for toxic heavy metals before packaging 5
individual units of baby food for sale or distribution in the State; requiring, beginning 6
on a certain date, manufacturers of baby food to include certain information related 7
to toxic heavy metals on the manufacturer’s website and on the baby food product 8
label; requiring a consumer to report baby food to the Maryland Department of 9
Health if the consumer believes, based on certain information, that the baby food is 10
being sold in the State with toxic heavy metals that exceed limits established by the 11 2 HOUSE BILL 97
U.S. Food and Drug Administration; and generally relating to baby food and toxic 1
heavy metals. 2
BY adding to 3
Article – Health – General 4
Section 21–330.4 5
Annotated Code of Maryland 6
(2023 Replacement Volume) 7
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 8
That the Laws of Maryland read as follows: 9
Article – Health – General 10
21–330.4. 11
(A) (1) IN THIS SECTION THE F OLLOWING WORDS HAVE THE MEANINGS 12
INDICATED. 13
(2) (I) “BABY FOOD” MEANS FOOD PACKAGED IN A JAR, POUCH, 14
TUB, OR BOX SOLD SPECIFIC ALLY FOR BABIES AND CHILDREN UNDER THE A GE OF 2 15
YEARS. 16
(II) “BABY FOOD” DOES NOT INCLUDE INF ANT FORMULA , AS 17
DEFINED IN 21 U.S.C. § 321(Z). 18
(3) “MANUFACTURER ” INCLUDES A FOOD MANU FACTURER, FOOD 19
PROCESSOR, AND FOOD PACKER . 20
(4) “PRODUCTION AGGREGATE ” MEANS A QUANTITY OF PRODUCT 21
THAT IS INTENDED TO HAVE UNIFORM COMPOSITION , CHARACTER , AND QUALITY 22
AND IS PRODUCED ACCO RDING TO A MASTER MA NUFACTURING ORDER . 23
(4) (5) “PROFICIENT LABORATORY ” MEANS A LABORATORY THAT: 24
(I) IS ACCREDITED UNDER THE STANDARDS OF THE 25
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION 26
STANDARDIZATION /INTERNATIONAL ELECTROTECHNICAL COMMISSION 27
17025:2017; 28
(II) USES AN ANALYTICAL ME THOD AT LEAST AS SEN SITIVE AS 29
THE ANALYTICAL METHO D DESCRIBED IN SECTION 4.7 OF THE U.S. FOOD AND DRUG 30
ADMINISTRATION ELEMENTAL ANALYSIS MANUAL FOR FOOD AND RELATED 31
PRODUCTS; AND 32
HOUSE BILL 97 3
(III) DEMONSTRATES PROFICIE NCY IN QUANTIFYING E ACH 1
TOXIC ELEMENT TO AT LEAST 6 MICROGRAMS OF THE TO XIC ELEMENT TO KILOG RAM 2
OF FOOD THROUGH AN I NDEPENDENT PROFICIEN CY TEST BY ACHIEVING A Z–SCORE 3
THAT IS LESS THAN OR EQUAL TO PLUS OR MINUS TWO. 4
(5) (6) “QR CODE” MEANS A MACHINE –READABLE CODE , 5
CONSISTING OF AN ARR AY OF SQUARES, USED FOR STORING AN INTERNET WEBSITE 6
IN ORDER TO ACCESS A WEBPAGE. 7
(7) “REPRESENTATIVE SAMPLE ” MEANS A SAMPLE THAT CONSISTS 8
OF A NUMBER OF UNITS THAT ARE DRAWN BASED ON RA TIONAL CRITERIA , SUCH AS 9
RANDOM SAMPLING , AND INTENDED TO ENSU RE THAT THE SAMPLE A CCURATELY 10
PORTRAYS THE MATERIA L BEING SAMPLED . 11
(6) (8) “TOXIC HEAVY METAL ” MEANS ARSENIC , CADMIUM, LEAD, 12
OR MERCURY . 13
(B) (1) EXCEPT AS PROVIDED IN PARAGRAPH (2) OF THIS SUBSECTION , 14
ON OR AFTER JANUARY 1, 2025, A PERSON MAY NOT SEL L, DISTRIBUTE, OR OFFER 15
FOR SALE BABY FOOD I N THE STATE THAT CONTAINS T OXIC HEAVY METALS TH AT 16
EXCEED THE LIMITS ES TABLISHED BY THE U.S. FOOD AND DRUG ADMINISTRATION . 17
(2) A PERSON MAY SELL , DISTRIBUTE, OR OFFER FOR SALE BA BY 18
FOOD MANUFACTURED BE FORE JANUARY 1, 2026. 19
(B) (C) (1) BEGINNING JANUARY 1, 2025, EACH MANUFACTURER OF 20
BABY FOOD SHALL TEST A REPRESENTATIVE SAMPLE OF EACH PRODUCTION 21
AGGREGATE OF THE MANUFACTURER ’S FINAL BABY FOOD PR ODUCT FOR EACH 22
TOXIC HEAVY METAL BEFORE PACKAGING IND IVIDUAL UNITS OF BAB Y FOOD FOR 23
SALE OR DISTRIBUTION IN THE STATE. 24
(2) THE TESTING REQUIRED UNDER PARAGRAPH (1) OF THIS 25
SUBSECTION SHALL BE CONDUCTED BY A PROFI CIENT LABORATORY AT LEAS T ONCE 26
PER MONTH. 27
(3) A MANUFACTURER MAY TES T THE FINAL BABY FOO D PRODUCT IN 28
ACCORDANCE WITH PARA GRAPH (1) OF THIS SUBSECTION B EFORE PACKAGING 29
INDIVIDUAL UNITS OF BABY FOOD FOR SALE O R DISTRIBUTION. 30
(C) (D) ON THE REQUEST OF THE DEPARTMENT , A MANUFACTURER OF 31
BABY FOOD SHALL PROV IDE THE RESULTS OF T HE TESTING CONDUCTED UNDER 32
SUBSECTION (B) (C) OF THIS SECTION TO A N AUTHORIZED AGENT O F THE 33
DEPARTMENT . 34
4 HOUSE BILL 97
(D) (E) BEGINNING JANUARY 1, 2026, EACH MANUFACTURER OF BABY 1
FOOD SHALL: 2
(1) MAKE PUBLICLY AVAILAB LE ON THE MANUFACTUR ER’S WEBSITE 3
FOR EACH BABY FOOD P RODUCT SOLD , MANUFACTURED , DELIVERED, HELD, OR 4
OFFERED FOR SALE IN THE STATE: 5
(I) THE NAME AND LEVEL OF EACH TOXIC HEAVY MET AL 6
PRESENT IN THE FINAL BABY FOOD PRODUCT AS DETERM INED BY THE TESTING 7
CONDUCTED UNDER SUBS ECTION (B) (C) OF THIS SECTION; AND 8
(II) SUFFICIENT INFORMATIO N, SUCH AS THE PRODUCT NAME, 9
UNIVERSAL PRODUCT CO DE, OR LOT OR BATCH NUMB ER, TO ENABLE CONSUMERS 10
TO IDENTIFY THE FINA L BABY FOOD P RODUCT; AND 11
(II) (III) A LINK TO THE U.S. FOOD AND DRUG 12
ADMINISTRATION ’S WEBSITE THAT INCLU DES THE MOST RECENT U.S. FOOD AND 13
DRUG ADMINISTRATION GUIDAN CE AND INFORMATION A BOUT THE HEALTH 14
EFFECTS OF THE TOXIC HEAVY METALS ON CHIL DREN; AND 15
(2) INCLUDE IF THE BABY FOOD IS T ESTED FOR A TOXIC HE AVY 16
METAL SUBJECT TO AN ACTION LEVEL , REGULATORY LIMIT , OR TOLERANCE 17
ESTABLISHED BY THE U.S. FOOD AND DRUG ADMINISTRATION UNDER 21 C.F.R. § 18
109, INCLUDE ON THE BABY FOOD PRO DUCT LABEL: 19
(I) THE FOLLOWING STATEMENT: “FOR INFORMATION ABOUT 20
TOXIC HEAVY METAL TE STING ON THIS PRODUC T, SCAN THE QUICK RESPONSE (QR) 21
CODE.”; AND 22
(II) A QR CODE OR OTHER MACHIN E–READABLE CODE THAT 23
ALLOWS CONSUMERS TO ACCESS ON THE MANUFA CTURER’S WEBSITE OR THE BAB Y 24
FOOD PRODUCT INFORMATION PAGE : 25
(I) 1. THE TEST RESULTS FOR THE TOXIC HEAVY META LS; 26
OR AND 27
(II) 2. A QR CODE OR OTHER MACHIN E–READABLE CODE 28
THAT LINKS TO A PAGE ON T HE MANUFACTURER ’S WEBSITE CONTAINING THE TEST 29
RESULTS FOR THE TOXI C HEAVY METALS LINK TO THE WEBPAGE ON THE U.S. FOOD 30
AND DRUG ADMINISTRATION WEBSIT E THAT INCLUDES THE MOST RECENT 31
GUIDANCE AND INFORMA TION ABOUT THE HEALT H EFFECTS OF THE TOX IC HEAVY 32
METAL ON CHILDREN . 33
HOUSE BILL 97 5
(F) IF A CONSUMER BELIEVE S, BASED ON INFORMATION GATHERED 1
THROUGH THE USE OF THE CODE INCLUDED ON THE BABY FOOD PRODUCT LABEL 2
UNDER SUBSECTION (E)(2) OF THIS SECTION , THAT BABY FOOD IS BE ING SOLD IN 3
THE STATE WITH TOXIC HEAV Y METALS THAT EXCEED LIMITS ESTABLISHED B Y THE 4
U.S. FOOD AND DRUG ADMINISTRATION , THE CONSUMER SHA LL REPORT THE BABY 5
FOOD TO THE DEPARTMENT . 6
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 7
October 1, 2024. 8
Approved:
________________________________________________________________________________
Governor.
________________________________________________________________________________
Speaker of the House of Delegates.
________________________________________________________________________________
President of the Senate.