S3354-118

1. Short title This Act may be cited as the Stephen Hacala Poppy Seed Safety Act.

2. Findings; purpose Congress finds as follows: Stephen Hacala was a 24-year-old from Fayetteville, Arkansas, who was dearly loved by family and friends when he died from morphine intoxication caused by consumption of contaminated poppy seeds. At least 19 people in the United States have been confirmed to have died from morphine overdoses from contaminated poppy seeds. Women in the United States have tested positive for opiates in hospitals at childbirth due to poppy seed consumption in food, leading to unwarranted scrutiny from child welfare officials. In 2023, the Department of Defense issued a warning to all servicemembers to avoid poppy seed consumption due to opiate contamination and the risk of positive drug tests. Studies of pharmaceutical opiates have found that a dose of just 20 to 50 morphine milligram equivalents per day increases the risk of overdose and death among patients prescribed morphine for pain treatment. Poppy products purchased in the United States have been found to have up to 2,788 milligrams of morphine per kilogram of seeds after extraction. Cleaning processes are available that have proved effective at reducing morphine contamination from 50 to 220 milligrams per kilogram down to 4 milligrams per kilogram or less. While poppy seeds are excluded from the definition of opium poppy and poppy straw under the Controlled Substances Act (21 U.S.C. 801 et seq.), that definition does not exclude unwashed poppy seeds that have been contaminated with opium alkaloids from the latex of the plant. The opium alkaloids (inclusive of morphine, codeine, and thebaine), if present as contaminants on poppy seed material, are also not exempted from control under that Act. It is the purpose of this Act to prohibit the distribution and sale of contaminated poppy seeds in order to prevent harm, addiction, and further deaths from morphine-contaminated poppy seeds.

3. Unsafe poppy seeds as adulterants in food Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following: Selling, or offering to sell, directly to consumers a food that is or contains poppy seeds, including concentrates, metabolites, constituents, or extracts of poppy seeds, that contain levels of morphine, codeine, or other alkaloid compounds that may render the food injurious to health. The Secretary of Health and Human Services shall— not later than 1 year after the date of enactment of this Act, issue a proposed rule establishing a maximum level for contamination under section 301(jjj) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) by morphine, codeine, and any other alkaloid compound which the Secretary may designate; and not later than 2 years after the date of enactment of this Act, finalize such rule. (jjj)Selling, or offering to sell, directly to consumers a food that is or contains poppy seeds, including concentrates, metabolites, constituents, or extracts of poppy seeds, that contain levels of morphine, codeine, or other alkaloid compounds that may render the food injurious to health..

4. Poppy seeds as an adulterant Nothing in this Act and the amendment made by this Act shall be construed as preventing the Secretary of Health and Human Services from— determining that poppy seeds contaminated with morphine, codeine, or another alkaloid compound that may render food injurious to health are adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 342), in violation of section 423 of such Act (21 U.S.C. 350l), or in violation of any other provision of such Act; or exempting such contaminated seeds from regulation under the Controlled Substances Act (21 U.S.C. 801 et seq.).