II 

117TH CONGRESS 

1ST SESSION S. 2546 

To require the Commissioner of Food and Drugs to develop standards for 

‘‘Reef Safe’’ and ‘‘Ocean Safe’’ labels for sunscreen. 

IN THE SENATE OF THE UNITED STATES 

JULY 29, 2021 

Mr. MERKLEY (for himself and Mr. RUBIO) introduced the following bill; 

which was read twice and referred to the Committee on Commerce, 

Science, and Transportation 

A BILL 

To require the Commissioner of Food and Drugs to develop 

standards for ‘‘Reef Safe’’ and ‘‘Ocean Safe’’ labels for 

sunscreen. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Reef Safe Act of 

5 2021’’. 

6 SEC. 2. LABELING CRITERIA FOR ‘‘REEF SAFE’’ AND ‘‘OCEAN 

7 SAFE’’ SUNSCREEN. 

8 (a) IN GENERAL.—As soon as practicable, but not 

9 later than 2 years after the date of enactment of this Act, 


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1 the Secretary, acting through the Commissioner, shall de2 velop labeling criteria for ‘‘Reef Safe’’ and ‘‘Ocean Safe’’ 

3 designations for nonprescription sunscreen, in consulta4 tion with the Administrator of the Environmental Protec5 tion Agency and the Administrator of the National Oce6 anic and Atmospheric Administration. 

7 (b) REEF SAFE LABEL.— 

8 (1) IN GENERAL.—Not later than 2 years after 

9 the date of enactment of this Act, the Secretary, act10 ing through the Commissioner, shall develop stand11 ards for use of the term ‘‘Reef Safe’’ on the labeling 

12 of nonprescription sunscreen, which shall conform 

13 with the requirements of section 502 of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 352). 

15 (2) CRITERIA AND CONSULTATION.—In devel16 oping the standards described in paragraph (1), the 

17 Secretary shall— 

18 (A) consider the impacts of active sun19 screen ingredients on the mortality of, and de20 velopmental or reproductive disruptions to, 

21 ecologically- or economically-valuable marine 

22 species, including fish, fish larvae, sea urchins, 

23 coral, crustaceans, sea grasses, and macroalgae; 

24 (B) consult with appropriate heads of Fed25 eral agencies, including the Administrator of 


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1 the Environmental Protection Agency and the 

2 Administrator of the National Oceanic and At3 mospheric Administration, with respect to stud4 ies on the impacts of active sunscreen ingredi5 ents on living components of coral reef eco6 systems; and 

7 (C) consider the findings of the National 

8 Academies of Sciences, Engineering, and Medi9 cine report titled ‘‘Environmental Impact of 

10 Currently Marketed Sunscreens and Potential 

11 Human Impacts of Changes in Sunscreen 

12 Usage’’. 

13 (c) OCEAN SAFE LABEL.— 

14 (1) IN GENERAL.—Not later than 2 years after 

15 the date of enactment of this Act, the Secretary, act16 ing through the Commissioner, shall develop stand17 ards for use of the term ‘‘Ocean Safe’’ on the label18 ing of nonprescription sunscreen, which shall con19 form with the requirements of section 502 of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

21 352). 

22 (2) CRITERIA AND CONSULTATION.—In devel23 oping the standards described in paragraph (1), the 

24 Secretary shall— 


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1 (A) consider the impacts of active sun2 screen ingredients on the mortality of, and de3 velopmental or reproductive disruptions to, 

4 ecologically- or economically-valuable marine 

5 species, including fish, fish larvae, sea urchins, 

6 coral, crustaceans, sea grasses, and macroalgae, 

7 and ecologically- or economically-valuable ma8 rine and coastal ecosystems including estuaries, 

9 wetlands, tidal marshes, mangroves, kelp for10 ests, seagrass meadows, lagoons, salt marshes, 

11 and intertidal zones; 

12 (B) consult with appropriate heads of Fed13 eral agencies, including the Administrator of 

14 the Environmental Protection Agency and the 

15 Administrator of the National Oceanic and At16 mospheric Administration, with respect to stud17 ies on the impacts of active sunscreen ingredi18 ents on living components of marine and coastal 

19 ecosystems; and 

20 (C) consider the findings of the National 

21 Academies of Sciences, Engineering, and Medi22 cine report, titled ‘‘Environmental Impacts of 

23 Currently Marketed Sunscreens and Potential 

24 Human Impact of Changes in Sunscreen 

25 Usage’’. 


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1 (d) REVIEW AND REVISION.—Not less frequently 

2 than once every 10 years, the Secretary, acting through 

3 the Commissioner and in consultation with the Adminis4 trator of the Environmental Protection Agency and the 

5 Administrator of the National Oceanic and Atmospheric 

6 Administration, and taking into consideration scientific 

7 studies of the Food and Drug Administration, the Envi8 ronmental Protection Agency, and the National Oceanic 

9 and Atmospheric Administration, shall— 

10 (1) review the labeling standards in effect under 

11 subsections (b)(1) and (c)(1); 

12 (2) if appropriate, revise the criteria under sub13 sections (b)(2) and (c)(2); and 

14 (3) in accordance with such criteria, as revised 

15 under paragraph (2) as applicable, update the label16 ing standards under subsections (b)(1) and (c)(1). 

17 (e) NON-PREEMPTION.—Nothing in this section shall 

18 be construed to prevent a State from establishing, enforc19 ing, or maintaining a requirement with respect to labeling 

20 criteria for a ‘‘Reef Safe’’ or ‘‘Ocean Safe’’ designation 

21 for nonprescription sunscreen, provided that any such 

22 State law is at least as restrictive as the requirements es23 tablished under this section. 


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1 (f) RULE OF CONSTRUCTION.—Nothing in this Act 

2 shall be construed as prohibiting or limiting the sale of 

3 any sunscreen product. 

4 (g) DEFINITIONS.—In this section— 

5 (1) the terms ‘‘active sunscreen ingredient’’, 

6 ‘‘nonprescription’’, and ‘‘sunscreen’’ have the mean7 ings given such terms in section 586 of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 360fff); 

9 (2) the terms ‘‘coral’’ and ‘‘coral reef eco10 system’’ have the meanings given such terms in sec11 tion 210 of the Coral Reef Conservation Act of 2000 

12 (16 U.S.C. 6409); 

13 (3) the term ‘‘Commissioner’’ means the Com14 missioner of Food and Drugs; and 

15 (4) the term ‘‘Secretary’’, unless specified oth16 erwise, means the Secretary of Health and Human 

17 Services. 

Æ 


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