Food Safety Laws
At a Glance
At present, federal and state laws addressing the safety of food and beverage packaging and production materials don’t protect our health or the environment from hazardous chemicals. As a result, these materials leach chemicals into our food and beverage and our air, water, and soil.
Existing laws haven’t kept up with emerging evidence regarding hormone-disrupting chemicals and the over 10,000 chemicals used in food production and packaging materials or direct food additives. At federal level, companies are ‘self-regulating’ and keep their chemical use secret, and the resource-starved FDA poorly implements inadequate current laws. Additionally, state laws are an inconsistent and incomplete patchwork.
We are working to address these problems by 1) advocating for health-protective federal food safety laws, 2) joining food safety petitions and litigation of FDA policies, 3) supporting new protective state laws, and 4) urging the FDA to use its authority to protect the public from toxic chemicals in food production and packaging.
Federal Laws on Food Safety
The 1938 Federal Food, Drug, and Cosmetics Act (FFDCA) and the Food Additive Amendment in 1958 are the primary laws governing the safety of chemicals in materials that contact food or that are used directly in food production and packaging (The 2011 Food Safety Modernization Act deals primarily with pathogens.). [1] These laws permit an estimated 5000 chemicals’ use as direct additives (sweeteners, preservatives, nutrients, fat substitutes, texturizers, flavors, colors) and another 5000 in food materials (called indirect additives, or ‘food contact substances’).
Chemicals are commonly used in coatings for metal and plastic lids or cans, new and recycled plastics, paper, adhesives, materials used during irradiation, and food packaging materials for color, antioxidizing, and antimicrobial properties. The number of chemicals in food from environmental pollution sources is unknown. Because of the enormous number of chemicals involved, what the law says—and how the Food and Drug Administration (FDA) implements and enforces it—is critical to protecting public health and environmental safety.
Chemicals used as direct food additives and in production and packaging materials have entered the market via several routes. Some have been ‘grandfathered in,’ with others expressly authorized by the FDA. Other chemicals have been ‘self-regulated’ by manufacturers themselves:[2]
- ‘Grandfathered’ Substances: Also referred to as prior sanctioned substances, these chemicals were grandfathered into the current system before 1958. For most of these chemicals, safety data information requirements are poor, and subsequently, most remain unreviewed with modern scientific techniques and methods. Some substances authorized under this route are the subject of official NGO petitions to the FDA to revoke their market authorizations (see below for the Petition).
- Petition & Review: This process, also known as the “Food and Color Additive Petitions” program, began in 1958 and was replaced by the Food Contact Substance Notification Program in 1997; the FDA authorized substances that went through this route and set specific conditions or limitations on how the substance could be used in food contact materials. The chemicals are listed on an inventory of indirect food additives.[3] While these substances’ scientific safety is not currently subject to modern review, advances in scientists’ understanding of toxicity, low doses, mixtures, and hormone disruption, particularly for hormonal cancers like breast and for reproductive and neurotoxicity, render the continued use of these chemicals suspect.
- Food Contact Substance Notification: This program was established in 1997 by an amendment to the Federal Food Drug & Cosmetic Act for the pre-market review of food contact substances.[4] Chemicals used along this route are published on an inventory (without public access to the safety data companies submitted to the FDA for review).[5] There are two problems with this program, including:
- Regulation Exemption Threshold – refers to chemicals with an estimated cumulative daily exposure below 1.5 micrograms per person daily. These are exempt from FDA review and regulation conducted via the Food Contact Substance Notification process. The exemption threshold is based on antiquated science, particularly concerning hormone disruption, which shows that some chemicals covered under this caveat yield adverse effects even at extremely low levels. For example, BPA’s updated safety level in Europe is 0.0002 micrograms per kg body weight per day; in the U.S., BPA’s threshold is marked at or below 1.5 micrograms per person per day, meaning that this dosage is undoubtedly harmful.
- GRAS or Generally Recognized As Safe –The GRAS program has become an industry ‘self-regulation’ free-for-all. Companies use this program to avoid the standard FDA review processes required under the Food Contact Notification route.
In short, the Food Contact Notification program has several weaknesses, including an insufficient regular review of substances, absent or minimal requirements for studies examining hormone disruption (i.e., actual testing at low doses as opposed to extrapolation from high-dose testing), and a dependence on data generated and provided by the manufacturer, not independent scientists. You can read more about the GRAS loophole here.
Food and Drug Administration
The FDA ensures food safety, including the safety of chemicals used to make food packaging, processing materials, and direct food additives in the food supply. The law defines safety as ‘reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.’ By law, the FDA must consider ongoing and cumulative exposures to chemicals in the food supply when assessing their safety for market approval. [6] Specifically, the 1958 Delaney clause in the Food Additives Amendment requires testing of food additives, both direct and indirect[7], and prohibits the FDA from approving any substance found to cause cancer in humans or animals. These are two critically important, health-protective food safety concepts codified almost 70 years ago that the FDA fails to implement.
Overall, a series of weaknesses both in the law and in FDA practice result in a severe lack of public health protection from harmful chemicals in food, including but not limited to:
- Lack of data: Lack of thorough testing requirements in the law, especially for hormone disruption, compounded by the FDA’s reluctance to use its already insufficient authority to require industry to produce these data. Data should be provided regardless of the amount of the chemical expected to migrate into the food from contact materials. Back in 2013, a study found that eighty percent of the chemicals in food contact materials were not examined by the toxicity data the FDA requires; 73% lacked reproductive or developmental toxicity data.[8]
- Outdated Science: Modern scientific practices like incorporating methods for analyzing a chemical’s impact on behavior, hormones, hypersensitive or vulnerable populations, effects of low dose exposures, and implications of mixtures and cumulative effects remain absent both in FDA guidance and testing requirements and in their assessment of industry data[9]. At the same time, the Delaney Clause’s interpretation could mean that only carcinogens cause cancer, and only carcinogens are prohibited; however, this interpretation ignores modern science’s advancements regarding the role of hormone-disrupting chemicals in hormonal cancers.
- Gaping ‘GRAS’ loophole: Over 98% of new chemicals introduced to the market (since 2000) pass through the outrageously exploited GRAS route, allowing manufacturers to self-determine a chemical’s safety without FDA review.[10] Additionally, manufacturers aren’t required to inform the FDA about the sale and use of toxic and potentially toxic chemicals in food processing and packaging.
- Conflicts of Interest and Bias: The GRAS loophole through which most new chemicals are introduced to the market exploits built-in conflicts of interest and bias because manufacturers can select the ‘experts’ determining the safety of their chemicals. A recent study found that, broadly, companies do not adhere to FDA guidance on the use of expert panels; a small group of experts are disproportionately involved in industry safety decisions.[11]
- Resource-Starved Agency: The relevant FDA department, now restructured under the Human Foods Program (notably the former Center for Food Safety and Applied Nutrition, re-named Office of Food Chemical Safety, Dietary Supplements and Innovation), faces several problems that solidify and intersect with the factors mentioned above. These include:
- Lack of Clout within the larger FDA: Institutionally, the FDA’s food sector overwhelms the drug sector. The recent appointment of the first-ever Deputy Commissioner for Food may help improve communication and decision-making power within the Agency hierarchy. Still, historically, the two sections drastically differ in terms of staffing and budgetary resources.
- Lack of Resources: The Food Chemicals portion of the Agency’s Food purview (previously the Center for Food Safety and Applied Nutrition, now the Office of Food Chemicals Safety, Dietary Supplements, and Innovation) is historically disproportionately small, understaffed and under-funded. As a result, many chemicals have been left unreviewed for over 40 years. With the thousands of chemicals now used as direct and indirect food additives and the CFSAN/OFCSDSI’s current safety review pace of fewer than ten chemicals per year, it would take hundreds of years before the safety of most chemicals currently used in food packaging and processing materials to be evaluated by the FDA.
- Lack of authority or unwillingness to exercise it: The FDA maintains that it does not have the statutory authority to compel companies to thoroughly test their chemicals for safety or to compel them to provide their safety data. NGOs, including BCPP, have legally contested this interpretation, but a court judgment concerning GRAS placed blame on Congress, which is currently responsible for rectifying the situation.[12] The FDA has been markedly passive and unwilling to address industry wrongdoings proactively when issues emerge. (A Politico article noted, “The [CFSAN] division suffers from a deep-seated culture of avoiding hard decisions and a near-paralyzing fear of picking severe fights with the food industry.”)
- Ignorance of actual market conditions and citizens’ real-life dietary exposures: Companies aren’t legally required to tell the FDA if they use toxic chemicals in food packaging or processing materials (see GRAS above). They don’t have to regularly report what nor how much they directly or indirectly add to food. As a result, the FDA is late or in the dark when specific problematic exposures arise or increase.[13] The FDA must laboriously undertake its own dietary surveys and test chemicals migrating from production and packaging materials to identify and approximate the chemical exposures people are getting from food.
A major Politico article published in April 2022 brought many of these real-life problems into the public limelight. Later that year, the Regan Udall report intensified discussions of some of these same problems, after which the agency embarked on a significant restructuring of its food program. However, this restructuring’s impact on the above-mentioned factors remains unseen.
Illegally Legal – Toxic Food Chemicals
All told, toxic chemicals are being used, wholly or quasi-legally, in direct additives, in food production and packaging materials, and these enter our food supply.
Cancer-causing and hormone-disrupting chemicals in food production & packaging:
Examples of these include:
Bisphenol A and other bisphenols
Styrene – Classified as a reasonably anticipated human carcinogen (National Toxicology Program, 2011) based on its link to occupational cancers (leukemia, lymphoma) and rodent cancers (lung).
Antimony Trioxide –Classified as a reasonably anticipated human carcinogen (National Toxicology Program, 2021) based on its link to rodent cancers, including lung, lymphoma, and skin.
Benzene – Known to be a human carcinogen (National Toxicology Program, 1980) due to its role in the development of leukemia, also lymphoma, other blood cancers, and lung cancer.
Ethylene Dichloride – A reasonably anticipated human carcinogen (National Toxicology Program, 1981) based on its link to rodent cancers, including lymphoma, mammary gland, blood vessel, and uterine.
Methylene chloride – A reasonably anticipated human carcinogen (National Toxicology Program, 1989) based on its link to rodent cancers, including mammary gland, liver, and lung cancer.
Trichloroethylene – Known human carcinogen (National Toxicology Program, 2000) with links to kidney cancer and Non-Hodgkin’s Lymphoma.
BHA (Butylated Hydroxyanisole) – A reasonably anticipated human carcinogen (National Toxicology Program, 1991) based on its link to forestomach and liver animal cancers.
We Need Stronger Federal Laws on Food Chemicals
We advocates for reforming antiquated and inadequate federal laws on the safety of food production and packaging chemicals.
We actively support federal legislation that bans carcinogens and hormone disruptors from food packaging and processing materials to close the GRAS loophole and install systematic FDA safety reassessments of ‘food chemicals.’
We support these federal bills:
H.R.6105, The No Toxics in Food Packaging Act of 2023, would ban bisphenol A (BPA), per- and polyfluorinated substances (PFAS), ortho-phthalates, styrene, and antimony trioxide from use in food packaging and processing materials. Scientific evidence shows that these substances are detrimental to human health, causing cancer and disrupting hormones. Author: Rep Jan Schakowsky (D-IL)
H.R. 3927, Food Chemical Reassessment Act of 2023, is a bill that would create an Office of Food Safety Assessment within the Food and Drug Administration (FDA), ensuring that chemicals that have entered the food supply chain through loopholes or that were reviewed by the FDA decades ago are safe to eat. Author: Rep Jan Schakowsky (D-IL)
S. 3387, Ensuring Safe and Toxic-Free Foods Act of 2023, would create an Office of Food Safety Assessment within the Food and Drug Administration (FDA) to ensure that chemicals that have entered the food supply chain through loopholes or those that were reviewed by the FDA decades ago are safe to eat. Author: Sen Edward Markey (D-MA)
FDA Petitions and Litigation
BCPP joins other non-profit partners to file official FDA ‘Petitions’ requesting changes in federal policy decisions. BCPP also files lawsuits against the FDA for policies that allow the use of cancer-causing and other harmful chemicals in food packaging and processing equipment. A few examples of our participation in past petitions and lawsuits include:
- 2023 petition for FDA to stop PFAS-generating fluorination of plastic containers
- 2023 petition for FDA to stop uses of benzene, ethylene dichloride, methylene chloride, and trichloroethylene for varied uses such as decaffeination of coffee, washing sugar beets and inks for marking produce
- 2021 petition for the FDA to stop BPA use in coatings and adhesives and set strict limits on its use in food plastics. FDA is overdue on giving a final response to this petition
- 2020 petition to force the FDA to address the cumulative health effect of all chemicals in the diet when allowing new chemicals in food or in any materials that contact food in production or packaging. FDA is overdue to give a final response to this petition.
- 2018 lawsuit to force an FDA decision on cancer-causing flavor chemicals in popular foods
- 2017 lawsuit for illegally delegating the FDA’s authority to ensure food safety to food and chemical manufacturers
- 2016 petition to stop the use of harmful ortho-phthalates in food processing and packaging materials, now subject of a lawsuit
State Laws On Chemicals In & Around Food
Over the years, many states have stepped up to protect their residents from harmful food production and packaging chemicals. These states lead the way in banning full classes of chemicals from leaching into our food products. The range of chemicals covered in state laws includes heavy metals, bisphenols, ortho-phthalates, styrene, and PFAS.
Examples include:
- California, Colorado, Connecticut, Hawaii, Minnesota, New York, Oregon, Rhode Island, Vermont, and Washington’s ban of PFAS in food production or packaging materials.
- California, Connecticut, Maine, Maryland, Minnesota, Vermont, and Washington’s ban on Bisphenol A or several bisphenols in food production or packaging materials.
Other recent state laws on toxic food chemicals include:
- Bans on polystyrene in food packaging (Rhode Island), polystyrene foam containers (Oregon), and a New York law requiring a warning label on all containers that contain Bisphenol A.
- A 2021 Vermont law bans the manufacture, sale, and distribution of food packaging with additives (coatings, stabilizers, adhesives, pigments, dyes, and inks) to which orthophthalates have been added.
- A 2019 Maine law prohibits the sale of food packaging with intentionally added toxic heavy metals, PFAS, or phthalates. The law also requires the state to publish a list of no more than ten food contact chemicals of high concern to gather information on their use in food packaging available in Maine.[14]
As concern about plastic packaging grows, many more states will deliberate on laws that reduce plastic or phase out toxic chemicals from packaging, which will significantly impact food packaging and food-contact chemicals.
In 2024, we are co-sponsoring AB2761, a bill that will ban PVC and PFAS in all product packaging (including food and other products).
In 2021, we co-sponsored the California Safer Food Packaging and Cookware Act (AB1200, by Phil Ting), banning paper-based food packaging containing PFAS from sale in California as of January 1, 2023, and requires labeling of hazardous chemicals in cookware both online (by January 1, 2023) and on the product label (by January 1, 2024).
Footnotes
[1] The food additives section of the food title of the Federal Food Drug and Cosmetic Act, 21 U.S.C. 348 and 21 CFR 174-189 and seq. Part 175 is for adhesives and components of coatings; 176 for paper and paperboard; 177 for polymers, 178 for adjuvants and production aids, antioxidants, stabilizers, etc.
[2] Mucke et al, 2017, Scientific Challenges in the Risk Assessment of Food Contact Materials; Environmental Health Perspectives doi.org/10.1289/EHP644
[3] See https://www.fda.gov/food/packaging-food-contact-substances-fcs/inventory-food-contact-substances-listed-21-cfr
[4] https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/food-and-drug-administration-modernization-act-fdama-1997
[5] See https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=FCN
[6] Sec. 409. [21 USC §348] Unsafe Food Additives, item c (5) “ In determining, for the purposes of this section, whether a proposed use of a food additive is safe, the Secretary shall consider among other relevant factors—(A) the probable consumption of the additive and of any substance formed in or on food because of the use of the additive; (B) the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet; and(C) safety factors which in the opinion of experts qualified by scientific training and experience to evaluate the safety of food additives are generally recognized as appropriate for the use of animal experimentation data.”
[7] The testing requirements under the Food Contact Substances Notification program are staggered according to the amount of dietary exposure to the chemical, with the majority of chemicals falling into the tier where short term genotoxicity tests for assessing carcinogenicity are recommended. Given modern scientific ability to detect adverse effects at extremely low doses, these testing recommendations are antiquated and unprotected.
[8] Nelter et al., 2013. Data gaps in toxicity testing of chemicals allowed in food in the US, Reproductive Toxicology, (42) 85-94.
[9] See Fixing the Oversight of Chemicals Added to Our Food, 2013, Pew Reports, pp. 10-11.
[10] https://www.ewg.org/news-insights/news/2022/04/ewg-analysis-almost-all-new-food-chemicals-greenlighted-industry-not-fda
[11] See https://blogs.edf.org/health/2023/09/06/broken-gras-companies-ignore-fda-draft-guidance-bias-conflicts-of-interest-prevail-in-safety-determinations/
[12] See section ‘Health and Food Safety Groups Push Back’ here: https://www.bcpp.org/resource/food-safety-loophole-allows-secret-toxic-chemicals-in-our-food/
[13] [1] Pew, pp. 10.
[14] https://www.politico.com/interactives/2022/fda-fails-regulate-food-health-safety-hazards/ The investigation found that the food division has structural and leadership problems; it has made little progress on keeping toxicants out of baby foods; that despite congressional mandate over a decade earlier, the FDA failed to establish safety standards to prevent pathogens in water used to grow fresh produce; and that FDA has not taken timely action to help cut sodium consumption.
[15] https://reaganudall.org/operational-evaluation-fdas-human-foods-programs
[16] The list published in February 2022 has criteria for identification includes carcinogens, reproductive and developmental toxicants, endocrine disruptors, or chemicals that are ‘Persistent, Bioaccumulative and Toxic’ or ‘very Persistent and very Bioaccumulative.’ It includes:
* Bisphenols A, B, S and F
* 4-octyl phenol
* Octamethyl cyclo tetra siloxane (D4)
* Toluene
* Styrene
* Benzene
* Methylenedianiline
* Paraben Structure (includes propyl, butyl, methyl, and ethyl)
* Benzophenone
* Nonylphenol
Types: Article