MD
Maryland House Bill HB97

Maryland 2024 Regular Session

Maryland House Bill HB97 Compare Versions

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1- WES MOORE, Governor Ch. 953
21
3-– 1 –
4-Chapter 953
5-(House Bill 97)
62
7-AN ACT concerning
3+EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
4+ [Brackets] indicate matter deleted from existing law.
5+ Underlining indicates amendments to bill.
6+ Strike out indicates matter stricken from the bill by amendment or deleted from the law by
7+amendment.
8+ Italics indicate opposite chamber/conference committee amendments.
9+ *hb0097*
810
9-Baby Food – Toxic Heavy Metals – Testing and Labeling
10-(Rudy’s Law)
11+HOUSE BILL 97
12+J1 (4lr1369)
13+ENROLLED BILL
14+— Health and Government Operations/Finance —
15+Introduced by Delegates Taveras and Pasteur, Pasteur, Pena–Melnyk, Cullison,
16+Alston, Bagnall, Bhandari, Chisholm, Guzzone, Hill, Hutchinson,
17+S. Johnson, Kaiser, Kerr, Kipke, R. Lewis, Lopez, Martinez, M. Morgan,
18+Reilly, Rosenberg, Szeliga, White Holland, and Woods
1119
12-FOR the purpose of requiring, beginning on a certain date, manufacturers of baby food to
13-conduct certain testing on baby food for toxic heavy metals before packaging
14-individual units of baby food for sale or distribution in the State; requiring, beginning
15-on a certain date, manufacturers of baby food to include certain information related
16-to toxic heavy metals on the manufacturer’s website and on the baby food product
17-label; requiring a consumer to report baby food to the Maryland Department of
18-Health if the consumer believes, based on certain information, that the baby food is
19-being sold in the State with toxic heavy metals that exceed limits established by the
20-U.S. Food and Drug Administration; and generally relating to baby food and toxic
21-heavy metals.
20+Read and Examined by Proofreaders:
2221
23-BY adding to
24- Article – Health – General
25-Section 21–330.4
26- Annotated Code of Maryland
27- (2023 Replacement Volume)
22+_______________________________________________
23+Proofreader.
24+_______________________________________________
25+Proofreader.
2826
29- SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
30-That the Laws of Maryland read as follows:
27+Sealed with the Great Seal and presented to the Governor, for his approval this
3128
32-Article – Health – General
29+_______ day of _______________ at ____________ ____________ o’clock, ________M.
3330
34-21–330.4.
31+______________________________________________
32+Speaker.
3533
36- (A) (1) IN THIS SECTION THE F OLLOWING WORDS HAVE THE MEANINGS
37-INDICATED.
34+CHAPTER ______
3835
39- (2) (I) “BABY FOOD” MEANS FOOD PACKAGED IN A JAR, POUCH,
40-TUB, OR BOX SOLD SPECIFIC ALLY FOR BABIES AND CHILDREN UNDER THE A GE OF 2
41-YEARS.
36+AN ACT concerning 1
4237
43- (II) “BABY FOOD” DOES NOT INCLUDE INF ANT FORMULA , AS
44-DEFINED IN 21 U.S.C. § 321(Z).
38+Baby Food – Toxic Heavy Metals – Testing and Labeling 2
39+(Rudy’s Law) 3
4540
46- (3) “MANUFACTURER ” INCLUDES A FOOD MANU FACTURER, FOOD
47-PROCESSOR, AND FOOD PACKER .
48- Ch. 953 2024 LAWS OF MARYLAND
41+FOR the purpose of requiring, beginning on a certain date, manufacturers of baby food to 4
42+conduct certain testing on baby food for toxic heavy metals before packaging 5
43+individual units of baby food for sale or distribution in the State; requiring, beginning 6
44+on a certain date, manufacturers of baby food to include certain information related 7
45+to toxic heavy metals on the manufacturer’s website and on the baby food product 8
46+label; requiring a consumer to report baby food to the Maryland Department of 9
47+Health if the consumer believes, based on certain information, that the baby food is 10
48+being sold in the State with toxic heavy metals that exceed limits established by the 11 2 HOUSE BILL 97
4949
50-– 2 –
51- (4) “PRODUCTION AGGREGATE ” MEANS A QUANTITY OF PRODUCT
52-THAT IS INTENDED TO HAVE UNIFORM COMPOSITION , CHARACTER , AND QUALITY
53-AND IS PRODUCED ACCO RDING TO A MASTER MA NUFACTURING ORDER .
5450
55- (4) (5) “PROFICIENT LABORATORY ” MEANS A LABORATORY THAT:
51+U.S. Food and Drug Administration; and generally relating to baby food and toxic 1
52+heavy metals. 2
5653
57- (I) IS ACCREDITED UNDER THE STANDARDS OF THE
58-INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
59-STANDARDIZATION /INTERNATIONAL ELECTROTECHNICAL COMMISSION
60-17025:2017;
54+BY adding to 3
55+ Article – Health – General 4
56+Section 21–330.4 5
57+ Annotated Code of Maryland 6
58+ (2023 Replacement Volume) 7
6159
62- (II) USES AN ANALYTICAL ME THOD AT LEAST AS SEN SITIVE AS
63-THE ANALYTICAL METHO D DESCRIBED IN SECTION 4.7 OF THE U.S. FOOD AND DRUG
64-ADMINISTRATION ELEMENTAL ANALYSIS MANUAL FOR FOOD AND RELATED
65-PRODUCTS; AND
60+ SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 8
61+That the Laws of Maryland read as follows: 9
6662
67- (III) DEMONSTRATES PROFICIE NCY IN QUANTIFYING E ACH
68-TOXIC ELEMENT TO AT LEAST 6 MICROGRAMS OF THE TO XIC ELEMENT TO KILOG RAM
69-OF FOOD THROUGH AN I NDEPENDENT PROFICIEN CY TEST BY ACHIEVING A Z–SCORE
70-THAT IS LESS THAN OR EQUAL TO PLUS OR MINUS TWO.
63+Article – Health – General 10
7164
72- (5) (6) “QR CODE” MEANS A MACHINE –READABLE CODE ,
73-CONSISTING OF AN ARR AY OF SQUARES, USED FOR STORING AN INTERNET WEBSITE
74-IN ORDER TO ACCESS A WEBPAGE.
65+21–330.4. 11
7566
76- (7) “REPRESENTATIVE SAMPLE ” MEANS A SAMPLE THAT CONSISTS
77-OF A NUMBER OF UNITS THAT ARE DRAWN BASED ON R ATIONAL CRITERIA , SUCH AS
78-RANDOM SAMPLING , AND INTENDED TO ENSU RE THAT THE SAMPLE A CCURATELY
79-PORTRAYS THE MATERIA L BEING SAMPLED .
67+ (A) (1) IN THIS SECTION THE F OLLOWING WORDS HAVE THE MEANINGS 12
68+INDICATED. 13
8069
81- (6) (8) “TOXIC HEAVY METAL ” MEANS ARSENIC , CADMIUM, LEAD,
82-OR MERCURY .
70+ (2) (I) “BABY FOOD” MEANS FOOD PACKAGED IN A JAR, POUCH, 14
71+TUB, OR BOX SOLD SPECIFIC ALLY FOR BABIES AND CHILDREN UNDER THE A GE OF 2 15
72+YEARS. 16
8373
84- (B) (1) EXCEPT AS PROVIDED IN PARAGRAPH (2) OF THIS SUBSECTION ,
85-ON OR AFTER JANUARY 1, 2025, A PERSON MAY NOT SEL L, DISTRIBUTE, OR OFFER
86-FOR SALE BABY FOOD I N THE STATE THAT CONTAINS T OXIC HEAVY METALS TH AT
87-EXCEED THE LIMITS ES TABLISHED BY THE U.S. FOOD AND DRUG ADMINISTRATION .
74+ (II) “BABY FOOD” DOES NOT INCLUDE INF ANT FORMULA , AS 17
75+DEFINED IN 21 U.S.C. § 321(Z). 18
8876
89- (2) A PERSON MAY SELL , DISTRIBUTE, OR OFFER FOR SALE BA BY
90-FOOD MANUFACTURED BE FORE JANUARY 1, 2026.
77+ (3) “MANUFACTURER ” INCLUDES A FOOD MANU FACTURER, FOOD 19
78+PROCESSOR, AND FOOD PACKER . 20
9179
92- (B) (C) (1) BEGINNING JANUARY 1, 2025, EACH MANUFACTURER OF
93-BABY FOOD SHALL TEST A REPRESENTATIVE SAMPLE OF EACH PRODUCTION WES MOORE, Governor Ch. 953
80+ (4) “PRODUCTION AGGREGATE ” MEANS A QUANTITY OF PRODUCT 21
81+THAT IS INTENDED TO HAVE UNIFORM COMPOSITION , CHARACTER , AND QUALITY 22
82+AND IS PRODUCED ACCO RDING TO A MASTER MA NUFACTURING ORDER . 23
9483
95-– 3 –
96-AGGREGATE OF THE MANUFACTURER ’S FINAL BABY FOOD PRODU CT FOR EACH
97-TOXIC HEAVY METAL BEFORE PACKAGING IND IVIDUAL UNITS OF BAB Y FOOD FOR
98-SALE OR DISTRIBUTION IN THE STATE.
84+ (4) (5) “PROFICIENT LABORATORY ” MEANS A LABORATORY THAT: 24
9985
100- (2) THE TESTING REQUIRED UNDER PARAGRAPH (1) OF THIS
101-SUBSECTION SHALL BE CONDUCTED BY A PROFI CIENT LABORATORY AT LEAST ONCE
102-PER MONTH.
86+ (I) IS ACCREDITED UNDER THE STANDARDS OF THE 25
87+INTERNATIONAL ORGANIZATION FOR STANDARDIZATION 26
88+STANDARDIZATION /INTERNATIONAL ELECTROTECHNICAL COMMISSION 27
89+17025:2017; 28
10390
104- (3) A MANUFACTURER MAY TES T THE FINAL BABY FOO D PRODUCT IN
105-ACCORDANCE WITH PARA GRAPH (1) OF THIS SUBSECTION B EFORE PACKAGING
106-INDIVIDUAL UNITS OF BABY FOOD FOR SALE O R DISTRIBUTION.
91+ (II) USES AN ANALYTICAL ME THOD AT LEAST AS SEN SITIVE AS 29
92+THE ANALYTICAL METHO D DESCRIBED IN SECTION 4.7 OF THE U.S. FOOD AND DRUG 30
93+ADMINISTRATION ELEMENTAL ANALYSIS MANUAL FOR FOOD AND RELATED 31
94+PRODUCTS; AND 32
95+ HOUSE BILL 97 3
10796
108- (C) (D) ON THE REQUEST OF THE DEPARTMENT , A MANUFACTURER OF
109-BABY FOOD SHALL PROV IDE THE RESULTS OF T HE TESTING CONDUCTED UNDER
110-SUBSECTION (B) (C) OF THIS SECTION TO A N AUTHORIZED AGENT O F THE
111-DEPARTMENT .
11297
113- (D) (E) BEGINNING JANUARY 1, 2026, EACH MANUFACTURER OF BABY
114-FOOD SHALL:
98+ (III) DEMONSTRATES PROFICIE NCY IN QUANTIFYING E ACH 1
99+TOXIC ELEMENT TO AT LEAST 6 MICROGRAMS OF THE TO XIC ELEMENT TO KILOG RAM 2
100+OF FOOD THROUGH AN I NDEPENDENT PROFICIEN CY TEST BY ACHIEVING A Z–SCORE 3
101+THAT IS LESS THAN OR EQUAL TO PLUS OR MINUS TWO. 4
115102
116- (1) MAKE PUBLICLY AVAILABLE ON THE MAN UFACTURER ’S WEBSITE
117-FOR EACH BABY FOOD P RODUCT SOLD , MANUFACTURED , DELIVERED, HELD, OR
118-OFFERED FOR SALE IN THE STATE:
103+ (5) (6) “QR CODE” MEANS A MACHINE –READABLE CODE , 5
104+CONSISTING OF AN ARR AY OF SQUARES, USED FOR STORING AN INTERNET WEBSITE 6
105+IN ORDER TO ACCESS A WEBPAGE. 7
119106
120- (I) THE NAME AND LEVEL OF EACH TOXIC HEAVY MET AL
121-PRESENT IN THE FINAL BABY FOOD PRODUCT AS DETERMINED BY THE TE STING
122-CONDUCTED UNDER SUBS ECTION (B) (C) OF THIS SECTION; AND
107+ (7) “REPRESENTATIVE SAMPLE ” MEANS A SAMPLE THAT CONSISTS 8
108+OF A NUMBER OF UNITS THAT ARE DRAWN BASED ON RA TIONAL CRITERIA , SUCH AS 9
109+RANDOM SAMPLING , AND INTENDED TO ENSU RE THAT THE SAMPLE A CCURATELY 10
110+PORTRAYS THE MATERIA L BEING SAMPLED . 11
123111
124- (II) SUFFICIENT INFORMATIO N, SUCH AS THE PRODUCT NAME,
125-UNIVERSAL PRODUCT CO DE, OR LOT OR BATCH NUMB ER, TO ENABLE CONSUMERS
126-TO IDENTIFY THE FINA L BABY FOOD PRODUCT ; AND
112+ (6) (8) “TOXIC HEAVY METAL ” MEANS ARSENIC , CADMIUM, LEAD, 12
113+OR MERCURY . 13
127114
128- (II) (III) A LINK TO THE U.S. FOOD AND DRUG
129-ADMINISTRATION ’S WEBSITE THAT INCLU DES THE MOST RECENT U.S. FOOD AND
130-DRUG ADMINISTRATION GUIDAN CE AND INFORMATION A BOUT THE HEALTH
131-EFFECTS OF THE TOXIC HEAVY METALS ON CHIL DREN; AND
115+ (B) (1) EXCEPT AS PROVIDED IN PARAGRAPH (2) OF THIS SUBSECTION , 14
116+ON OR AFTER JANUARY 1, 2025, A PERSON MAY NOT SEL L, DISTRIBUTE, OR OFFER 15
117+FOR SALE BABY FOOD I N THE STATE THAT CONTAINS T OXIC HEAVY METALS TH AT 16
118+EXCEED THE LIMITS ES TABLISHED BY THE U.S. FOOD AND DRUG ADMINISTRATION . 17
132119
133- (2) INCLUDE IF THE BABY FOOD IS T ESTED FOR A TO XIC HEAVY
134-METAL SUBJECT TO AN ACTION LEVEL , REGULATORY LIMIT , OR TOLERANCE
135-ESTABLISHED BY THE U.S. FOOD AND DRUG ADMINISTRATION UNDER 21 C.F.R. §
136-109, INCLUDE ON THE BABY FOOD PRO DUCT LABEL:
137- Ch. 953 2024 LAWS OF MARYLAND
120+ (2) A PERSON MAY SELL , DISTRIBUTE, OR OFFER FOR SALE BA BY 18
121+FOOD MANUFACTURED BE FORE JANUARY 1, 2026. 19
138122
139-– 4 –
140- (I) THE FOLLOWING STATEME NT: “FOR INFORMATION ABOUT
141-TOXIC HEAVY METAL TESTING ON THIS PRODUCT , SCAN THE QUICK RESPONSE (QR)
142-CODE.”; AND
123+ (B) (C) (1) BEGINNING JANUARY 1, 2025, EACH MANUFACTURER OF 20
124+BABY FOOD SHALL TEST A REPRESENTATIVE SAMPLE OF EACH PRODUCTION 21
125+AGGREGATE OF THE MANUFACTURER ’S FINAL BABY FOOD PR ODUCT FOR EACH 22
126+TOXIC HEAVY METAL BEFORE PACKAGING IND IVIDUAL UNITS OF BAB Y FOOD FOR 23
127+SALE OR DISTRIBUTION IN THE STATE. 24
143128
144- (II) A QR CODE OR OTHER MACHIN E–READABLE CODE THAT
145-ALLOWS CONSUMERS TO ACCESS ON THE MANUFA CTURER’S WEBSITE OR THE BAB Y
146-FOOD PRODUCT INFORMA TION PAGE:
129+ (2) THE TESTING REQUIRED UNDER PARAGRAPH (1) OF THIS 25
130+SUBSECTION SHALL BE CONDUCTED BY A PROFI CIENT LABORATORY AT LEAS T ONCE 26
131+PER MONTH. 27
147132
148- (I) 1. THE TEST RESULTS FOR THE TOXI C HEAVY METALS ;
149-OR AND
133+ (3) A MANUFACTURER MAY TES T THE FINAL BABY FOO D PRODUCT IN 28
134+ACCORDANCE WITH PARA GRAPH (1) OF THIS SUBSECTION B EFORE PACKAGING 29
135+INDIVIDUAL UNITS OF BABY FOOD FOR SALE O R DISTRIBUTION. 30
150136
151- (II) 2. A QR CODE OR OTHER MACHIN E–READABLE CODE
152-THAT LINKS TO A PAGE ON T HE MANUFACTURER ’S WEBSITE CONTAINING THE TEST
153-RESULTS FOR THE TOXI C HEAVY METALS LINK TO THE WEBPAGE ON THE U.S. FOOD
154-AND DRUG ADMINISTRATION WEBSITE THAT INCLUDES THE MOST RE CENT
155-GUIDANCE AND INFORMA TION ABOUT THE HEALT H EFFECTS OF THE TOX IC HEAVY
156-METAL ON CHILDREN .
137+ (C) (D) ON THE REQUEST OF THE DEPARTMENT , A MANUFACTURER OF 31
138+BABY FOOD SHALL PROV IDE THE RESULTS OF T HE TESTING CONDUCTED UNDER 32
139+SUBSECTION (B) (C) OF THIS SECTION TO A N AUTHORIZED AGENT O F THE 33
140+DEPARTMENT . 34
141+ 4 HOUSE BILL 97
157142
158- (F) IF A CONSUMER BELIEVE S, BASED ON INFORMATION GATHERED
159-THROUGH THE USE OF T HE CODE INCLUDED ON THE BABY FOOD PRODUC T LABEL
160-UNDER SUBSECTION (E)(2) OF THIS SECTION , THAT BABY FOOD IS BE ING SOLD IN
161-THE STATE WITH TOXIC HEAV Y METALS THAT EXCEED LIMITS ESTABLISHED B Y THE
162-U.S. FOOD AND DRUG ADMINISTRATION , THE CONSUMER SHALL R EPORT THE BABY
163-FOOD TO THE DEPARTMENT .
164143
165- SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect
166-October 1, 2024.
144+ (D) (E) BEGINNING JANUARY 1, 2026, EACH MANUFACTURER OF BABY 1
145+FOOD SHALL: 2
167146
168-Approved by the Governor, May 16, 2024.
147+ (1) MAKE PUBLICLY AVAILAB LE ON THE MANUFACTUR ER’S WEBSITE 3
148+FOR EACH BABY FOOD P RODUCT SOLD , MANUFACTURED , DELIVERED, HELD, OR 4
149+OFFERED FOR SALE IN THE STATE: 5
150+
151+ (I) THE NAME AND LEVEL OF EACH TOXIC HEAVY MET AL 6
152+PRESENT IN THE FINAL BABY FOOD PRODUCT AS DETERM INED BY THE TESTING 7
153+CONDUCTED UNDER SUBS ECTION (B) (C) OF THIS SECTION; AND 8
154+
155+ (II) SUFFICIENT INFORMATIO N, SUCH AS THE PRODUCT NAME, 9
156+UNIVERSAL PRODUCT CO DE, OR LOT OR BATCH NUMB ER, TO ENABLE CONSUMERS 10
157+TO IDENTIFY THE FINA L BABY FOOD P RODUCT; AND 11
158+
159+ (II) (III) A LINK TO THE U.S. FOOD AND DRUG 12
160+ADMINISTRATION ’S WEBSITE THAT INCLU DES THE MOST RECENT U.S. FOOD AND 13
161+DRUG ADMINISTRATION GUIDAN CE AND INFORMATION A BOUT THE HEALTH 14
162+EFFECTS OF THE TOXIC HEAVY METALS ON CHIL DREN; AND 15
163+
164+ (2) INCLUDE IF THE BABY FOOD IS T ESTED FOR A TOXIC HE AVY 16
165+METAL SUBJECT TO AN ACTION LEVEL , REGULATORY LIMIT , OR TOLERANCE 17
166+ESTABLISHED BY THE U.S. FOOD AND DRUG ADMINISTRATION UNDER 21 C.F.R. § 18
167+109, INCLUDE ON THE BABY FOOD PRO DUCT LABEL: 19
168+
169+ (I) THE FOLLOWING STATEMENT: “FOR INFORMATION ABOUT 20
170+TOXIC HEAVY METAL TE STING ON THIS PRODUC T, SCAN THE QUICK RESPONSE (QR) 21
171+CODE.”; AND 22
172+
173+ (II) A QR CODE OR OTHER MACHIN E–READABLE CODE THAT 23
174+ALLOWS CONSUMERS TO ACCESS ON THE MANUFA CTURER’S WEBSITE OR THE BAB Y 24
175+FOOD PRODUCT INFORMATION PAGE : 25
176+
177+ (I) 1. THE TEST RESULTS FOR THE TOXIC HEAVY META LS; 26
178+OR AND 27
179+
180+ (II) 2. A QR CODE OR OTHER MACHIN E–READABLE CODE 28
181+THAT LINKS TO A PAGE ON T HE MANUFACTURER ’S WEBSITE CONTAINING THE TEST 29
182+RESULTS FOR THE TOXI C HEAVY METALS LINK TO THE WEBPAGE ON THE U.S. FOOD 30
183+AND DRUG ADMINISTRATION WEBSIT E THAT INCLUDES THE MOST RECENT 31
184+GUIDANCE AND INFORMA TION ABOUT THE HEALT H EFFECTS OF THE TOX IC HEAVY 32
185+METAL ON CHILDREN . 33
186+ HOUSE BILL 97 5
187+
188+
189+ (F) IF A CONSUMER BELIEVE S, BASED ON INFORMATION GATHERED 1
190+THROUGH THE USE OF THE CODE INCLUDED ON THE BABY FOOD PRODUCT LABEL 2
191+UNDER SUBSECTION (E)(2) OF THIS SECTION , THAT BABY FOOD IS BE ING SOLD IN 3
192+THE STATE WITH TOXIC HEAV Y METALS THAT EXCEED LIMITS ESTABLISHED B Y THE 4
193+U.S. FOOD AND DRUG ADMINISTRATION , THE CONSUMER SHA LL REPORT THE BABY 5
194+FOOD TO THE DEPARTMENT . 6
195+
196+ SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 7
197+October 1, 2024. 8
198+
199+
200+
201+Approved:
202+________________________________________________________________________________
203+ Governor.
204+________________________________________________________________________________
205+ Speaker of the House of Delegates.
206+________________________________________________________________________________
207+ President of the Senate.