Dear President Biden: BCPP Federal Policy Agenda for Breast Cancer Prevention
At a Glance
We recommend these actions to the Biden administration to prevent and stem the rising tide of breast cancer in America.
These solutions address the toxic chemical exposures Americans face every single day that are contributing to increasing rates of breast cancer and other diseases.
This agenda includes:
- Recommended Executive Orders
- Recommended reversals of regulatory rollbacks issued by the Trump Administration
- Recommended FDA policy initiatives needed for cosmetic and food safety
- Recommended EPA policy initiatives needed for chemical safety
- Recommended OSHA policy initiatives for worker safety
- Research recommendations for NIEHS, NIH, CDC, NIOSH, and DOD
Breast Cancer Prevention Partners (BCPP) is the only national science-based organization focused solely on preventing breast cancer by eliminating our exposure to toxic chemicals and radiation linked to the disease. We work to connect the dots between breast cancer and chemical exposure by translating the growing body of scientific evidence linking environmental exposures to breast cancer into public education and advocacy campaigns that protect our health and reduce risk of breast cancer. Since 1992, because of our work, stronger laws are now requiring a higher level of ingredient transparency and protecting the public from toxic chemical exposures.
- We translate the science linking breast cancer to chemical exposures: We’ve published 33 major studies, including our landmark “Paths to Prevention,” a first-of-its-kind comprehensive report providing a roadmap to the primary prevention of breast cancer; and 8 “State of the Evidence” reports that have been instrumental in educating the public, business leaders, and policymakers about the relationship between chemicals and radiation exposures in our products and environment and increased breast cancer risk.
- We champion laws that strengthen chemical regulation and ingredient disclosure: We played a central leadership role in securing passage of 15 local, state, and federal laws that have banned toxic chemicals from baby bottles, infant formula, kids toys, and cosmetics; forced full disclosure of ingredients in cleaning products, professional salon products, and beauty and personal care products; and created the nation’s first biomonitoring program to measure the “pollution in people,” all of which are playing a part in reducing chemical exposures linked to increasing rates of breast cancer and other diseases.
- We run market-based campaigns that have helped create a market where fewer toxic products are now produced and purchased: BCPP’s Campaign for Safe Cosmetics has pressured major multinational cosmetic companies to stop using phthalates (DBP and DEHP), formaldehyde, long-chain parabens, triclosan, and other chemicals of concern. We have secured commitments from 3 cosmetic giants to voluntarily disclose the secret fragrance ingredients in their personal care products. Our work on bisphenol A (BPA), a hormonally active chemical linked to breast cancer and a host of other diseases, has driven BPA out of baby bottles, sippy cups, and infant formula packaging and resulted in the canned food industry’s voluntary removal of BPA from 9 out of 10 canned foods on store shelves today.
Background on Breast Cancer
Breast cancer has touched us all, whether we have been diagnosed ourselves or have a friend, family member, or coworker facing this complex and devastating disease. Today, a U.S. woman’s lifetime risk of breast cancer is 1 in 8.1
After skin cancer, cancer of the female breast is the most common type of cancer in the U.S. According to estimates, breast cancer will cause more deaths of U.S. women under the age of 45 than any other cancer in 2020.2
This year in the U.S., an estimated 280,000 women and 2,600 men will be diagnosed with breast cancer, and more than 42,000 women and 500 men will die from it. In California alone, an estimated 30,650 women will be diagnosed, and more than 4,000 will die. Across racial and ethnic groups, Black women have the highest breast cancer mortality rate, 42% higher than the comparable rate for White women;4 and among women younger than 45, breast cancer incidence is higher among Black women than White women.5 Breast cancer affects women of all ages, ethnicities, and races. The majority of these individuals have no inherited risk or family history of the disease: According to the American Cancer Society, 8 out of 10 women who are diagnosed with breast cancer do not have a family history of the disease.6 And the incidence of breast cancer is on the rise, up 40% over the last four decades.
What the Science Says about Chemicals and Breast Cancer
Only 10% of all breast cancers can be attributed to a genetic history of the disease. More and more scientific evidence is pointing to our environment—mammary carcinogens, endocrine disrupting compounds, and ionizing radiation—to explain what is contributing to much of the remaining breast cancer risk. Every one of us is exposed to chemicals linked to breast cancer from the moment we wake up in the morning to when we go to bed from the water we drink, the food we eat, the air we breathe, and from the beauty and personal care, cleaning, and other consumer products we use. For many people, their workplace and the community they live in also contributes to their breast cancer risk.
Our scientific understanding of breast cancer has taught us that low doses of some chemicals may increase risk of disease, combinations of chemicals (mixtures) have different effects than single chemicals alone and there are distinct subtypes of breast cancer. Scientific evidence shows that endocrine-disrupting compounds can exert negative effects at extremely low levels of exposure, sometimes with more serious or different effects than at higher doses. While it is important to limit exposure at every stage of life, it is even more important during critical periods of development, including gestation, childhood, and pregnancy.
In fact, a large body of research demonstrates that the timing of exposures across the lifespan can have an enormous influence on whether, how, and how much an environmental exposure might influence the risk for later development of breast cancer. Mammary gland cells are more susceptible to the carcinogenic effects of hormones, chemicals, and radiation during the early stages of development, from the prenatal period through puberty and adolescence, and on until the first full-term pregnancy. Particular concerns have been demonstrated for exposure during prenatal and early childhood periods. Much of this data comes from the use of animal models, but there also are several sources of data that support this claim from the human clinical literature. Specific timing and duration of exposures, especially when they happen early in development, may cause more detrimental effects than later exposures. When we consider breast cancer prevention, we need to consider interventions throughout a woman’s lifespan, from prenatal development to old age.
Breast Cancer’s Impact
In the U.S., women’s lifetime risk of breast cancer increased steadily and dramatically from the 1930s, when the first reliable cancer incidence data was established, through the end of the 20th century.13
As cancer incidence data have become more nuanced over the past decade, it has become clear that the incidence of breast cancer varies by several factors, including age and ethnicity. Across racial and ethnic groups in the U.S., Black women have the highest breast cancer mortality rate of any racial/ethnic group (28.4 deaths per 100,000 women, age-adjusted and normalized to the 2000 standardized U.S. population). Asian, Native-Hawaiian, and Pacific Islander women have the lowest mortality rates (11.4), with White (20.3), Latina (14), and Native-American (14.6) women having intermediate mortality rates based on cancer registry data.11 Younger women in general and younger Black women are more likely to present with the triple-negative subtype of the disease. This diagnosis is both more aggressive and associated with higher mortality.9,10
Despite the universal drop in mortality rates across the past two decades and the similarity in incidence rates over the same period, the disparities between mortality rates for White and Black women have grown significantly. The mortality rate for Black women diagnosed with breast cancer is 42% higher than the comparable rate for White women.12
Aside from the physical and emotional suffering women and their families experience when facing a breast cancer diagnosis, additional challenges often include long-term economic impacts from medical debt, absence from work or extended periods of under-employment while going through and recovering from treatment, insecurity about needing to explain extended unemployment to potential employers, and fear of employment discrimination due to their health history. Women may also face enduring side effects from treatment, such as pain, cognitive impairments, and physical limitations. The toll of this disease can be devastating in many ways and often hits the people with fewer economic resources the hardest.
Developing prevention recommendations in the context of numerous types of breast cancer, combined with differences in the way specific groups of women are impacted by breast cancer, is complex. There is no straightforward way to predict where interventions can have the greatest impact. But given the deep, systemic barriers to health and wellbeing that many women of color—especially Black women—face, the recommendations in this Plan prioritize opportunities to disrupt and counter the myriad ways that legacy and existing racist policies disadvantage women of color.
Racial and Social Inequities that Contribute to an Increased Breast Cancer Risk
We strongly urge the President-Elect, his cabinet and other appointees, to prioritize looking at breast cancer prevention strategies through a lens that addresses the racial and social inequities and obstacles that prevent people of color and other marginalized communities from accessing the primary prevention that would also reduce their risk of breast cancer.
Breast cancer risk is a complex web of interrelated factors. Some are better established, such as radiation exposure, tobacco smoke (first- and secondhand), alcohol consumption, and lack of physical activity. Other risk factors are still emerging but no less compelling—for example, environmental exposures, the stress of poverty and racism, immigrating to the U.S. from countries with lower breast cancer rates, and others. All communities face multiple risk factors simultaneously, but marginalized communities often have increased exposures to risk factors with fewer resources or opportunities to mitigate those factors. It is common to see the same communities facing higher exposure to industrial pollution, poor air quality, lack of access to healthy food, limited opportunities for physical activity, and other concerns that can increase risk of breast cancer.
Key Actions the Biden Administration Can Take to Prevent Breast Cancer
While we do not know everything about the causes of breast cancer, we do know enough to act. The following recommendations are divided into actions the President-Elect can take immediately through executive orders and reversals of regulatory rollbacks initiated through the previous Administration as well as key research and policy initiatives, all of which will help to stem the tide of breast cancer.
I. Recommended Executive Orders
- Make the EPA Administrator a Cabinet Level position.
- Create a New Position: EPA Assistant Administrator for Children’s Environmental Health.
- Create a multi-agency task force on Environmental Health and Justice made up of relevant federal agencies including NIEHS, CDC, FDA, EPA, and NIOSH to share new science, resources, strategies for public outreach, and information about the impact of unsafe chemical exposures on human health.
- Increase federal support for state biomonitoring by: i) increasing CDC state biomonitoring grants; and ii) instructing the Department of Homeland Security to provide state agencies with access to bioterrorism biomonitoring labs—when they are not being otherwise used—to analyze biospecimens collected through state biomonitoring activities.
- Recreate the EPA Office on Green Chemistry to support research in environmentally benign chemistry and promote green chemistry through educational activities, international activities, conferences and meetings, and tool development, via partnerships with academia, industry, other government agencies and non-government organizations. Issue a green chemistry challenge to identify and fund the creation of green chemistry alternatives to chemicals of concern in cosmetic products marketed to women of color and used by professional salon workers.
- Issue an Executive Order that unlocks the stranglehold on the ability of federal agency staff to work with congressional staff on policy and regulatory matters, including drafting and reviewing proposed legislation. Allow free access for federal agency scientists to advise and consult with Members of Congress and their staff.
- Issue an Executive Order that directs relevant federal agency heads to develop a plan to implement an expanded approach to risk and exposure assessments that includes an analysis of cumulative exposures, low dose exposures, timing of exposures, additive effects and the special vulnerability of highly exposed populations, workers, children, and pregnant women to harmful chemical exposures.
- Direct the National Toxicology Program to screen more reproductive toxicants and carcinogens, particularly breast carcinogens.
- Direct NIEHS to develop a list of chemicals known or suspected to have endocrine-disrupting
- Direct the FDA to create a new Office to reassess the safety of existing chemical additives to food, including GRAS chemicals (generally recognized as safe food additives), which will complement the current Office of Food Additive Safety that focuses on the safety reviews of new chemicals added to food.
- Create an EPA Office on Environmental Justice to review agency-wide decisions for their impact on communities of color and low-income communities, who often experience a level of chemical exposure that puts their health at risk.
- Issue an Executive Order requiring all federal advisory committees to incorporate diverse perspectives of women and people of color.
- Instruct the National Institutes of Health to ensure their websites and public education materials include information on the contribution of environmental chemicals to breast cancer and other chronic health concerns. The NIH should specifically acknowledge, on its website, the large body of scientific evidence establishing a link between chemical exposures and an increased risk of breast cancer and other adverse health effects.
II. Recommended Reversal of Regulatory Rollbacks Issued by the Trump Administration
- Recommendation: We recommend the EPA issue an outright ban on Chlorpyrifos, a pesticide closely linked to breast cancer, to protect farmworkers, nearby communities, and schools experiencing pesticide drift, and anyone consuming products grown with this extremely toxic pesticide.In 2017, the Trump Administration’s Environmental Protection Agency rejected the scientific conclusion of the agency’s own chemical safety experts who, under the Obama Administration, recommended that chlorpyrifos be permanently banned from use by farms nationwide because of the harm it potentially causes children and farm workers.
- Recommendation: We recommend that all EPA risk assessments be conducted considering cumulative exposures and taking into consideration impacts experienced by the most sensitive/vulnerable populations.The Trump Administration has significantly narrowed the scope of exposures it will consider when conducting risk assessments that are required under the 2016 Lautenberg Chemical Safety Act. While the Obama Administration suggested considering the broad range of exposures evaluated, including exposures from air and water contamination from the chemical under consideration, the Trump Administration excluded these exposures, thereby significantly limiting the ability of the EPA to evaluate public health and environmental risks presented by the chemical exposures it evaluates for safety. One example is the recently released EPA final risk assessment for Tricholoroethylene, which the new Administration should reject.
- Recommendation: The EPA must re-amend its chemical facility risk management rules to improve safety at sites that use hazardous chemicals.In 2019, the EPA released its final facility risk management rulings, which rolled back most of the Obama Administration’s early 2017 requirements for risk management programs under the Clean Air Act: rescinding third-party audits, incident investigations, and accident reporting requirements.
- Recommendation: The EPA should return to a “no net loss of wetlands” rule. The current “Navigable waters protection rule” should be replaced with “Waters of the US (2015).” The EPA’s 2020 Navigable Waters Protection ruling stripped the protection on ephemeral waters, leaving them unprotected from development and farmers.
- Recommendation: We recommend the EPA issue new and more effective emission standards for POTWs, including rules aimed at reducing pollutants, including air pollution at sewage treatment plants. In 2017, the EPA finalized emission standards for Publicly Owned Treatment plants (POTW), which did not include substantive changes approved at the end of the Obama Administration in 2016.
- Recommendation: We recommend that the EPA require mine operators to monitor groundwater before, during, and after uranium extraction to prevent contamination and to improve “health and environment protection standards from uranium and thorium mill tailings.” The Trump Administration shrunk Utah’s Bears Ears national monument by 85%; green lighting hundreds of uranium mining claims that, if mined, can pollute water with chemicals from the “mill tailings.”
- Recommendation: We recommend requiring coal plants to upgrade their wastewater system to treat arsenic, mercury, and other heavy metals. The Trump Administration’s EPA weakened pollution limits for two of the largest and most toxic power plant waste streams. A 2015 ruling required zero discharge of fly ash and bottom ash wastewater and set strict limits on discharges in scrubber sludge wastewater.
- Recommendation: We call for a return to the Lead Copper Rule of 1991. Service lines containing lead must be mandated to be replaced with urgency and under a specific timeframe.The Trump Administration significantly loosened the Lead Copper Rule of 1991, allowing service lines containing lead to no longer be mandated for replacement. The changes now require some lead to be present in tests before replacement would be required. There is no safe level of lead in water for children.
- Recommendation: We recommend the EPA allow California to reinstate its federal waiver to limit hazardous tailpipe emissions.In 2019, the Trump Administration revoked a waiver previously granted to California, which allowed the state to set stricter tailpipe emissions than what was required by the federal Clean Air Act. Thirteen states followed California’s more stringent standard.
- Recommendation: We recommend the EPA mandate power plants limit mercury emissions from coal power plants.The new (2020) EPA method to calculate costs and emissions from mercury pollution undermine the legal underpinnings of controls on mercury and other hazardous air pollutants.
- Recommendation: We call for limits on toxic emissions from major industrial polluters by returning to the “maximum achievable control technologies” set by the Clean Air Act of 1995.The Trump Administration allowed major polluters to opt out of the Agency’s “Maximum Achievable Control Technologies” (MACT) standards which led to weaker or no standards in some cases.
- Recommendation: We recommend a stricter NSR interpretation and return to the EPA’s oversight of industrial emissions of harmful pollutants. Since December 2017, EPA has implemented significant changes to the agency’s administration of major National Source Review (NSR) permits. These changes reduce EPA’s oversight of industry actions and create a more lenient NSR regime, which could result in increased emissions of harmful pollutants from industrial facilities across the United States.
- Recommendation: We recommend the EPA adopt a larger and more health-protective AEZ for schools and residential areas near agricultural fields. The EPA recently weakened safeguards that prevent farmworkers and rural residents from being accidentally sprayed with pesticides but gutting the Application Exclusion Zone (AEZ) requirements, which are a key provision of the Agricultural Worker Protection Standard (WPS).
III. Policy Recommendations
A. Food and Drug Administration
1. Food Safety
The safety of our food is currently not assured by the existing system that regulates the over 10,000 chemicals used in food processing or packaging. Many hazardous or untested chemicals are used to make the materials that come into contact with food and these chemicals migrate into the food we eat, and then into people. An increasing amount of scientific evidence illustrates that exposure to hazardous food chemicals increases the risk of breast cancer and other chronic and lethal diseases, and more recently, increased susceptibility to COVID-19. Examples of food processing or packaging chemicals that are present in food in the U.S. and that are scientifically linked to breast cancer include phthalates, bisphenol A, and per and poly-fluoroalkyl substances (PFAS).
A new study and related database published in a peer-reviewed scientific journal paints a troubling picture of the hidden dangers of many food processing or packaging chemicals, whether FDA approved or industry self-certified. The database holds 12,285 chemicals potentially used in the manufacture of materials and articles that come into contact with food compiled from over 67 global regulatory and industry lists. Of the chemicals in this database:
- 29% of these chemicals lack openly accessible toxicity data.
- 608 chemicals were identified as most hazardous and, therefore, should be high priority for substitution in food contact materials (FCM). 235 of these are present on FDA lists.
- Another 1,411 chemicals are also of concern, based on predictive hazard data, although they do not yet have official hazard classifications. 531 of these chemicals are present on FDA lists.
These are chemicals used in food processing and packaging throughout the world but provide a troubling snapshot of the problem here in the U.S., given the global reach of multinational food manufacturers and their share of the U.S. food market.
Policy Recommendations for Strengthened Food Safety
i. Close the GRAS Loophole
For decades, food chemical manufacturers have taken advantage of a Generally Recognized As Safe (GRAS) loophole created by the Food Additives Amendment of 1958. The new food safety law amended the federal Food, Drug, and Cosmetic Act of 1938 to prohibit the use of food additives that have not been adequately tested for safety, but also created an exemption for chemicals that are “generally recognized as safe.” The exemption was designed to account for common ingredients with established safety records like vinegar, salt, and flour. Unfortunately, the FDA has abdicated its authority to ensure safe use and implementation of the GRAS program, allowing companies to make their own determinations about whether a chemical is safe for use in food.
As a result, food manufacturers have taken advantage of the GRAS loophole to self-certify the safety of chemicals with known adverse health effects. For example, Butylated hydroxyanisole (BHA), a California Proposition 65-listed carcinogen (among other health concerns, including hormone disruption and male reproductive toxicity) is added to cereals, chewing gum, potato chips, and vegetable oil under the guise of a GRAS designation.
The GRAS route has now become the main process by which food manufacturers introduce any new chemical into use, not just chemicals that would logically be deemed GRAS. Under existing law, companies are not even required to notify the FDA about chemicals they deem as GRAS, allowing chemicals into our food without any FDA oversight or even FDA knowledge of their use. If companies do notify the FDA of their intended use of a GRAS chemical and the FDA expresses concern, companies can and do withdraw their notifications and proceed to use the chemical in secret. The FDA issued a proposed rule in 1997 under which the voluntary GRAS notification program has been operating until an NGO lawsuit filed in February 2014, which forced the FDA to finalize the rule in 2016. The final rule formally institutionalized the GRAS program, including its inherent secrecy and industry conflict of interest in safety determinations.
Recommended GRAS policy solutions:
- Amend the GRAS rule to require companies to immediately report to the agency all chemicals they are currently using and designated as GRAS.
- Establish an FDA process to conduct safety reviews of ‘existing GRAS’ chemicals.
- Immediately revoke GRAS status for and prohibit use of any chemicals that are known or reasonably anticipated to cause cancer.
- Prohibit new chemicals from being marketed as “GRAS” without FDA notification and safety review.
- Ensure transparency and public access to information on all past GRAS chemicals and new chemicals used as direct or indirect additives going forward.
- Create rules prohibiting conflicts of interest when determining the safety of GRAS chemicals, food additives, or food contact substances.
ii. Overhaul of Safety Assessments for Food Chemicals
Alongside the GRAS route, food chemicals can also be approved for use through the Food Contact Substance Notification (FCN) program or the Threshold of Regulation Exemption route. Under the notification program, companies must notify the FDA that they intend to use a new chemical or an already approved chemical in a new way, along with information supporting their claim that it is safe for that use. The FDA has 120 days to object in writing, in the absence of which the new use is approved. The law for the FCN program defines “safe” only as “reasonable certainty in the minds of competent scientists that a substance is not harmful under the conditions of its intended use.” In practice, regardless of which approval route processes the food contact chemical or direct additive, the scientific practices of the Agency to determine safety are out of date and do not conform to best practice in environmental health science. These practices ignore low dose effects, mixtures effects, and ‘cumulative exposures’ from the entire diet that can provoke hormone disruption. Given the increasing scientific recognition that hormone disruption plays an important role in cancers, particularly breast cancer, and other diseases, the existing practices and guidelines that focus only on direct carcinogenicity and genotoxicity are woefully insufficient. Moreover, recent research has shown that the FDA routinely neglects any consideration of cumulative effects in its safety reviews, as prescribed by the law. This neglect is now the subject of an NGO petition to the Agency.
Recommended Policy Solutions for Reliable Safety Assessments:
- Instruct FDA to establish a process by which to modernize the FDA’s scientific practices within a defined period.
- Instruct FDA to organize the review of all previously authorized food contact chemicals, with particular focus on endocrine disruption and with priority assigned to chemicals where there are indications of social and racial inequities of exposure and concomitant health risks.
- Instruct the FDA to respond to the Cumulative Effects Citizens’ petition brought by BCPP, Environmental Defense Fund, American Academy of Pediatrics, American Public Health Association, Center for Food Safety and other NGOs, which requests the FDA adhere to the 1958 Food Additives Amendment. That law requires the FDA to consider “the cumulative effect of such additives in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet” when making safety determinations for new food contact chemicals or direct additives.
- Work with Congress to ensure sufficient funding for the FDA to adequately resource and implement the above policy solutions and conduct open discussions with stakeholders to assess potential legislative reforms.
2. Cosmetic Safety
The average American uses roughly 12 personal care products a day, resulting in exposure to an average of 200 unique chemicals, many of which have been linked to adverse health impacts such as cancer and birth defects. Science has demonstrated that toxic cosmetic ingredients end up in our bodies, drinking water, rivers, and lakes, and even in the sewage sludge spread on our food-producing farm fields. Cosmetics are one of the least regulated consumer products on the market today. Due to gaping holes in federal law, it is perfectly legal for cosmetics companies to use unlimited amounts of virtually any ingredient, including chemicals linked to cancer, reproductive and developmental harm, hormone disruption and other adverse health impacts, with no premarket FDA safety testing or review. The FDA does not have the authority to recall unsafe products to get them off store shelves, nor can it require companies to submit adverse event reports, as is the case for food and drugs. The federal law that governs this enormous industry is 2.5 pages long and has not been amended significantly since it was enacted over 80 years ago. In the absence of government authority and will to act, the safety of personal care product ingredients has been ceded to the industry itself.
Over the past 15 years, BCPP’s Campaign for Safe Cosmetics has released 10 product testing reports on cosmetic safety that reveal the presence of lead in lipstick; secret hormone-disrupting chemicals in fragranced personal care products; perfluorooctanoic acid (PFOA) in anti-aging products; formaldehyde and 1,4 dioxane in baby bath products; heavy metals in kids’ face paints, and volatile organic compounds (VOCs) and other chemicals of concern in make-up and nail products marketed specifically to children. For instance, in September 2018, we released Right to Know: Toxic Fragrance Chemicals Hiding in Personal Care, Beauty and Cleaning Products, which found that most of the toxic chemicals in the products we tested were fragrance chemicals hiding from public view. Our report findings were recently confirmed in testing by nonprofit organization Women’s Voices for the Earth, who analyzed the IFRA (International Fragrance Association) palette of 4,000 fragrance chemicals and found 1/3 of them to be linked to harm to human health or the environment by respected, authoritative, scientific bodies.
Sadly, our testing results illustrate just the tip of the iceberg of the problem. As of December 2020, the California Safe Cosmetics Database—run by the California Department of Public Health—reported that 581 companies disclosed the sale of 86,222 cosmetic products in California containing 94 unique Prop. 65 carcinogens and reproductive toxicants since their online reporting system launched in 2009.
These and other toxic cosmetic ingredients end up inside our bodies and our babies. They go down the drain and pollute our waterways and drinking water. Some are even polluting the air. This problem is compounded by the fact that scientific data from the past two decades and new advancements in science have exposed the health risks of repeated exposures to small doses of hazardous chemicals—especially exposures to hormone disrupting chemicals during critical windows of development such as in utero, childhood, and puberty.
What is needed to respond to the problem is a massive overhaul and modernization of federal cosmetic safety law to address the inadequacies of decades-long self-regulation by the $100 billion cosmetics industry and the $70 billion fragrance industry in order to ensure the most vulnerable populations among us are protected from toxic chemicals in the cosmetic and personal care products they use and are exposed to every day.
Existing law exempt fragrance and flavors from FDA ingredient disclosure, which means the FDA does not receive the information it needs to effectively regulate cosmetic ingredient safety. This is the case even though fragrance ingredients can make up the majority of the ingredients in a cosmetic product. A lack of legislatively mandated supply chain transparency means fragrance and other cosmetic chemicals are also kept secret from manufacturers, making it impossible for them to fully substantiate the safety of all of the ingredients in their products. Because the majority of cosmetic products include fragrance, this means the majority of cosmetic products on the market today have not been fully assessed for safety. Consumers and salon workers have an urgent right to full disclosure of all, and not just some, of the chemicals in their cosmetics and personal care products so that they can make safer, more informed, purchases.
Policy Recommendations for Cosmetic Safety
We urge the President-Elect to work with consumer and industry stakeholders on legislation that would give the FDA Office of Cosmetics and Colors the authority and resources it needs to ensure:
- The FDA and manufacturers utilize a robust safety standard that protects vulnerable populations, including pregnant women, infants, children, workers and other highly exposed populations.
- Pre-market safety assessment of all cosmetic ingredients.
- A ban on ingredients, impurities or products linked to cancer, birth defects, infertility, neurotoxicity, endocrine disruption or other adverse health endpoints.
- Full ingredient listing on product labels and company websites, including disclosure of the ingredients in professional salon products and cosmetic products sold through Internet sales and the disclosure of the constituent ingredients of fragrance and flavor.
- Industry sharing of safety data to avoid duplicative testing.
- Supply chain transparency so manufacturers have the safety data and ingredient disclosure they need to make safer products.
- The public has easy access to adverse event reports related to cosmetic products that are causing real harm to large numbers of consumers.
- The FDA has the ability to recall personal care and cosmetic products causing real, serious harm that might not meet the high bar definition of “serious adverse health events” that your bill sets.
- Women of color and hair and nail salon workers are protected from the toxic chemicals they are exposed to via the toxic products marketed to them and/or from products they work with every day.
- The creation of a grants program to encourage the creation of safer alternatives to toxic chemicals in cosmetics marketed to women of color and used by professional salon products.
- Facilitation of interagency cooperation on cosmetic safety by creating an interagency council on cosmetic safety – to include FDA, NIEHS, CDC, OSHA and EPA – to share existing and new science, exposure and safety data related to the ingredients in cosmetics, and other issues related to cosmetic safety.
- Adequate funding through a sliding scale fee structure so FDA Office of Cosmetics and Colors has the support it needs to provide effective oversight of the cosmetics industry.
B. Environmental Protection Agency
The EPA regulatory rollbacks listed above should immediately be reversed by the new Administration in order to reduce the exposure of millions of Americans to hundreds of harmful chemicals, some of which pose serious health hazards in the water we drink, the air we breathe, the food we eat, and products we use.
Chemicals from industrial processes, agriculture, products, and other sources make their way into air, water, and household dust. Studies have found that indoor air is often more polluted than outdoor air and that household dust can be a major source of exposure. The eroding of environmental protections over the last several years has further diminished the EPA’s responsibility and ability to fulfill its mission “to protect human health and the environment.”
The Toxic Substances Control Act (TSCA), originally passed in 1976, is the federal chemicals management law for industrial chemicals. The law failed miserably in its stated goal of protecting the public from toxic chemicals. The law grandfathered in as “safe” 62,000 chemicals that were on the market at the time, without any review of safety. In fact, the law was so weak that the EPA was not even able to ban the notoriously dangerous chemical asbestos.
In 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) was passed to update and modernize TSCA. The promise of TSCA reform was to give the EPA the authority, responsibility, and resources it needed to truly protect the public from exposure to toxic industrial chemicals. Unfortunately, under the Trump Administration, the interpretation and implementation of the law has favored the chemical industry at every turn. For instance, the EPA has not considered the full scope of potential exposures when determining a chemical’s safety; safety assessments have not adequately incorporated aggregate and cumulative exposures, especially for vulnerable populations; and the agency has not used its new authority to require safety testing for unstudied chemicals already on the market. A much stronger public health lens is needed as the implementation process continues and in reconsidering the industry-skewed decisions that have been made to date.
America has recently come face to face, in a more public and visible way than ever before, to the vast inequities in our country. The dual crises of the COVID-19 pandemic and police brutality toward Black Americans have surfaced the results of centuries of systemic racism, including environmental racism. The disproportionate exposure to toxic chemicals is one of those inequities that undermine the health of communities of color and low-income communities and may contribute to the particularly devastating impact the virus has had on people of color.
Under the Trump Administration, the EPA failed the American people in myriad ways: loosening or not enforcing restrictions on air and water pollution, undermining protection of our public lands and wildlife, failing to adequately and quickly clean up legacy hazardous waste sites, failing to address and counter environmental racism, and more. As with the rest of our society, the EPA has a moral obligation to immediately take steps to begin to mitigate and reverse the policies and practices that have led to the heavy burden of chemical exposures in environmental justice communities across this country.
The recommendations offered here focus specifically on the Office of Chemical Safety and Pollution Prevention (OCSPP), as the EPA’s core office responsible for ensuring the safety of chemicals and pesticides released into commerce and the environment.
Policy Recommendations for EPA
- Address environmental racism by prioritizing Environmental Justice issues, including community engagement in decision making.
- Create an Office for Environmental Justice to review decisions of OSCPP for their impact on communities of color and low-income communities, which often experience a level of chemical exposure that puts their health at risk.
- Issue formal guidance requiring procedures designed to protect Environmental Justice communities, account for past injustices and eliminate racist policies and attitudes in EPA.
- Commit to fulfilling and effectively implementing the requirements of the Frank R. Lautenberg Chemical Safety for the 21st Century Act to consider the cumulative impact of chemical exposures on communities, particularly communities already over-burdened by chemical exposures. Guidelines, based on recommendations from respected scientific bodies such as the National Academies of Sciences, should be issued to provide a blueprint for the consistent inclusion of cumulative chemical exposures in safety assessments and determinations across the agency.
- Provide for authentic community input into regulatory decisions by allowing ample time for public comment, significant advance notice of meetings and hearings, and holding meetings in locations outside the Washington, DC area, specifically in the communities most directly impacted by the decision(s) under consideration.
- Redefine how chemical safety assessments and determinations are conducted as the Lautenberg Chemical Safety Act continues to be implemented.
- Require safety determinations to consider the full scope of exposures, from all sources and routes to the chemical under consideration, as well as the impact from other chemicals with similar health impacts.
- Ensure chemical regulations protect both highly exposed populations, such as environmental justice communities and workers, and very sensitive populations, including pregnant women and young children.
- Restore the integrity of, and public confidence in, the science used by EPA to make safety determinations for chemicals.
- Rescind the EPA policy barring scientists receiving EPA-funding from serving on EPA federal advisory committees. This policy only serves to exclude highly qualified academic scientists, who rely on federal funding to conduct research in the public interest, in favor of industry scientists who come with conflict of interest concerns.
- Institute strong disclosure and conflict of interest policies for all science used in regulatory decisions and all members of advisory boards to prevent undue and unrevealed industry influence.
- Withdraw the so-called “Transparency in Regulatory Science” proposed rule, which serves not to provide transparency, but to eliminate peer-reviewed, and often foundational, epidemiological studies. Industry argues that animal studies do not truly reflect the impact of chemicals on humans yet seeks to severely restrict both the use and creation of epidemiological studies by attempting to require disclosure of study participants’ confidential medical information.
- Restore EPA funding for whole animal testing to provide the most complete and reliable information about the potential health risks posed by chemicals. Alternative non-animal testing can miss critical health impacts, such as endocrine disruption, which acts on the entire biological system and impacts numerous organ systems and is a particularly important mechanism in determining breast cancer risk. Whole animal testing should continue and only be phased out as validated alternatives become available that accurately predict chemical hazards, including increased breast cancer risk.
- Reform the Office of Pesticide Programs to require the use of the most up-to-date and systematically reviewed science in the assessment and registering of pesticides; prioritize protecting farmworkers and communities from pesticide exposures, including pesticide drift; and revoke the registration of pesticides linked to increased breast cancer risk.
- Require that chemical safety testing across EPA programs include evaluation of mammary gland endpoints and incorporate that data into safety determinations. Mammary gland endpoints are often the most sensitive to endocrine disruption and provide a more complete assessment of the breast cancer risk the chemical poses.
- Support and provide adequate resources for EPA’s Safer Choice program, a voluntary program which helps businesses create, and consumers find, products that both perform well and contain ingredients that are safer for human health and the environment.
- Increase funding and focus on designing intrinsically safer chemicals through the EPA’s Green Chemistry program.
C. Occupational Safety and Health Administration (OSHA)
Women’s occupational health risk is significantly understudied, yet existing research suggests that some occupations entail a considerably increased risk of breast cancer. Occupations with the most consistent data for associations with female breast cancer include cosmetologists, medical professionals, flight attendants, sales and retail workers, production workers, and scientists. In addition, occupational exposures to night-shift work, ionizing radiation, some chemicals, job stress, and sedentary work may increase risk of breast cancer. Yet, major research gaps exist, and OSHA does not have the necessary authority or resources to regulate unsafe workplace exposures.
Some of the strongest evidence for concerns about occupational health risks emerges from studies that have examined the potential links between specific occupational exposures and breast cancer risk. Most exposure studies tend to focus on single (or a few) exposures, despite the reality that workers are exposed to mixtures at the worksite and multiple chemicals across the day.
Studies have linked exposures to a number of chemicals with an increased risk of breast cancer, including:
- solvents (such as benzene, styrene, carbon tetrachloride, methylene chloride, formaldehyde,
- freon, isopropyl alcohol, trichloroethylene, gasoline and other petroleum products)
- pesticides (such as aldrin, chlordane, dieldrin, heptachlor, lindane, captan, dichlorvos,
- chlorpyrifos, terbufos, malathion, 2,4,5-TP)
- polychlorinated biphenyls (PCBs)
- polycyclic aromatic hydrocarbons (PAHs)
- aromatic amines
- ethylene oxide
- tobacco smoke.
One example of an occupation with increased risk of harm from workplace exposures is hair and nail salon workers. They experience health hazards from extended exposure to toxic chemicals in the cosmetic products they use every day, ranging from acute reactions such as headaches, dizziness, eye irritation, breathing problems, nausea, vomiting, sleeplessness, and fainting; to long term conditions and diseases including cancer, infertility, respiratory problems, asthma and reproductive harm including harm to the developing fetus.
The International Agency for Research on Cancer lists “occupational exposures as a hairdresser or barber” as a probable carcinogen. Several studies have found elevated rates of breast cancer among hairdressers and both Black and White cosmetologists. Premenopausal breast cancer has different characteristics than post-menopausal breast cancer, and both are elevated in this population of workers, yet OSHA is not setting the kind of permissible exposure limits (PELs) for salon workers that are needed to ensure their health and safety. The Cosmetic Ingredient Review—the cosmetic industry’s safety panel—does not even account for salon worker exposure when substantiating the safety of cosmetic chemicals for industry guidance. In addition, the Federal Food, Drug and Cosmetic Act (FDCA) does little to protect salon workers’ health and safety. As a result, none of these entities are adequately serving and protecting salon workers—another example of how our country’s bifurcated federal approach to chemicals safety threatens worker health.
Federal agencies should collaborate to ensure workers across industries and workplaces are protected from occupational exposures linked to breast cancer and other diseases and chronic conditions. Furthermore, employers should be required to provide financial compensation to workers with illnesses related to workplace chemical exposure. Approximately 97% of workers with occupational illnesses are not compensated, and for those employees who do receive workers’ compensation, only about 20% of work-related medical expenses are covered.
Finally, federal resources should be put into supporting the formation of broad coalitions and collaborations across movements and countries to improve workplace conditions globally. In our increasingly globalized economy, we need to support workers around the world, especially in the manufacturing sector. As these jobs move offshore, workers are faced with lower wages, inconsistent regulation, higher chemical exposures, and increasingly detrimental working conditions.
Policy Recommendations for Worker Safety:
- Ban chemicals linked to breast and other cancers from the workplace to the greatest extent possible.
- Stop regulating chemicals one at a time, use a class approach, and require inherently safer chemicals and chemical processes (in keeping with the Hierarchy of Controls for workplace safety) to reduce harmful chemical exposures.
- Replace chemicals with known health impacts with safer alternatives, using a hazard approach vs. risk approach.
- Consider exposures to mixtures of chemicals and possible low–dose effects of endocrine disruptors when assessing hazards.
- Require transparent, accessible, and clear disclosure of chemicals—related safety data—in products and materials used by all workers. Require justification for any trade secret claims and prohibit confidential business information protection for hazardous chemicals.
- If/while still using a risk approach, increase the safety standard for Permissible Exposures Levels (PELs) from 1 additional cancer death per 1,000 workers to at least 1 additional cancer death per 10,000 workers and strive for 1 per 1,000,000 where feasible.
- Institute meaningful penalties that serve as a true deterrent for companies that violate OSHA rules and put their workers at risk of dangerous chemical exposures.
- Prevent federal preemption of states’ abilities to pass more stringent regulatory requirements.
- Provide adequate funding to NIOSH and OSHA to identify, implement, and enforce truly health-protective regulation of chemical exposures in the workplace.
IV. Research Recommendations
A. National Institutes for Health
National Cancer Institute
The National Cancer Institute (NCI) is the federal government’s principal agency for cancer research and training. NCI is the largest funder of cancer research in the world with an annual budget, which is set by Congress, of approximately $6.25 billion. NCI’s leadership role makes it critically important that they acknowledge and have a public-facing position on the significant body of evidence linking environmental exposures to breast cancer risk.
More than a decade ago, the President’s Cancer Panel concluded that “Public health messages should be developed and disseminated to raise awareness of environmental cancer risks and encourage people to reduce or eliminate exposures whenever possible.”
However, by NCI’s own standards, the agency underrepresents concerns about environmental links to breast cancer. The NCI website states, “While increased risk for some cancers is caused by inherited genetic factors (about 5%–10% of cancer cases), most cancers are caused by environmental and lifestyle factors.” Yet the NCI ignores the large body of science linking breast cancer to chemical exposures, putting all women at risk, but especially women of color and low-income women, who are disproportionately exposed to toxic chemicals and pollution.
We are concerned about the lack of acknowledgment presented by the NCI regarding the increased breast cancer risk associated with environmental exposures and other modifiable risk factors. The breast cancer prevention patient page (i.e. the Physician Data Query patient page (PDQ)) states, “Avoiding risk factors and increasing protective factors may help prevent cancer” and goes on to list breast cancer risk factors like “aging” and “an inherited risk of breast cancer.” Why is aging presented as a risk factor but not chemical exposures? Other federal agencies and working groups clearly state the problem. For example, the National Institute of Environmental Health Sciences concluded: “Most experts agree that breast cancer is caused by a combination of genetic, hormonal, and environmental factors.”
Research Recommendations for NCI:
- NCI should update its publicly available information about breast cancer risk and prevention to include the current science linking an increased risk of breast cancer to environmental exposures.
- 20% of NCI funding should be dedicated to primary prevention focused on environmental factors that increase cancer risk, including chemical exposures, and developing systemic strategies to reduce those risks.
- The NCI’s Screening and Prevention Editorial Board should be expanded to include toxicologists and environmental epidemiologists.
B. National Institute of Environmental Health Sciences
The National Institute of Environmental Health Sciences (NIEHS) plays a unique role within the National Institutes of Health (NIH). NIEHS conducts research to better understand the impact of environmental agents and our genetic susceptibilities on human health. The Institute’s research on the role of environmental factors in the initiation and promotion of chronic diseases and disorders—such as cancer, Parkinson’s disease, Alzheimer’s disease, and developmental disorders—is essential to their prevention. The results of NIEHS research are used by both the public and policy makers to take actions to prevent a broad range of diseases and disorders.
The work of NIEHS to understand the relationship between the environment and breast cancer provides the information necessary to develop primary prevention models to reduce the incidence of this devastating disease. While Congress has prioritized increasing NIH funding, the NIEHS budget has not kept pace. Given the growing scientific understanding and public concern about the impact of environmental factors on our nation’s health and the need to invest in prevention to contain health care costs, the work of NIEHS is more important than ever.
Over its history, NIEHS has specifically focused on the connection between breast cancer risk and environmental exposures, including the now completed Breast Cancer and the Environment Research Program (BCERP), which supported a multidisciplinary network of scientists, clinicians, and community partners around the country investigating the impact of pre-pubertal exposures to environmental chemicals on later-life risk of breast cancer. NIEHS is also conducting the Sister Study, a longitudinal research study of 51,000 women whose sisters have or had breast cancer, to study the interplay of environment and genes in breast cancer risk and to identify preventable risk factors.
NIEHS’s National Toxicology Program (NTP) is a collaborative program, working with two other core federal agencies—the FDA’s National Center for Toxicological Research and the CDC’s National Institute for Occupational Safety and Health—to study the toxicity of environmental substances of public health concern. NTP is responsible for identifying chemicals linked to cancer through its Report on Carcinogens, a congressionally mandated, science-based, public health document. This cumulative report currently includes 248 listings of agents, substances, mixtures, and exposure circumstances that are known or reasonably anticipated to cause cancer in humans.
Another major focus of NTP is endocrine disrupting chemicals (EDCs), substances that act like hormones or disrupt the endocrine system in humans or wildlife. EDCs have been implicated in numerous adverse health effects, including disruptions to pubertal timing, obesity, diabetes, reproductive disorders including infertility, and various cancers including breast cancer. NTP’s high volume throughput screening program is developing the ability to test thousands of chemicals at once, providing a critical tool for initial screening of tens of thousands of chemicals, as well as chemical mixtures, in our environment, about which we know very little. This screening will allow scientists, industry, and federal agencies to prioritize chemicals that need in-depth testing to more fully gauge any potential toxic effects.
We recognize that NIEHS is already supporting and conducting excellent research on the connections between the environment and disease risk, including breast cancer. We encourage NIEHS to continue this groundbreaking research and offer these additional suggestions.
Research Recommendations for NIEHS:
- Continue and expand funding for community-based participatory research which involves the community being studied in all aspects of the research, from design to conducting the research to communication and dissemination.
- Expand research to better understand how various social determinants of health impact breast cancer incidence and risk to address racial and social inequities.
- Invest in research to better understand the role of the social and built environment on breast cancer risk.
- Expand research to identify ways to reduce exposures to ionizing radiation.
- Expand research on the connection between non-ionizing radiation and breast cancer risk.
- Collect occupational histories in cohort studies. Several ongoing cohort studies, including the Sister Study, explore breast cancer risk and other diseases among women. Such longitudinal studies should collect adequate data on occupational history as a factor, which could greatly enhance the scope of knowledge on how occupation impacts breast cancer risk.
C. Centers for Disease Control and Prevention (CDC)
National Institute for Occupational Safety and Health (NIOSH)
The CDC’s National Institute for Occupational Safety and Health’s mission is to develop new knowledge in the field of occupational safety and health and to transfer that knowledge into practice. One of the consistent flaws in occupational research is the dearth of scientific research on women in occupational fields, which in turn means there is very little research on occupational breast cancer risk and the interventions needed to reduce that risk. NIOSH should be directed to conduct the necessary research to fill that knowledge gap.
- Inter-agency, multi-stakeholder collaborations to promote workplace monitoring. NIOSH should launch collaborations among federal agencies, companies, researchers, and workers to develop viable methods to monitor workplace exposures. Environmental monitoring of air, dust, and water, and biomonitoring of biological fluids such as blood and urine can provide important data to help researchers and policymakers better understand which chemicals people are being exposed to in the workplace. Intake forms and electronic health records should include questions about occupation, and healthcare professionals/providers should be provided with training to conduct occupational histories.
- Understand and mitigate the adverse impacts of shift work. The International Agency for Research on Cancer (IARC) classified shift work with circadian disruption as a probable There is a large and growing body of evidence linking night work with increased risks of breast cancer. We recognize that some sectors require work in the middle of the night. Necessity is not permission to ignore health concerns; rather, it conveys a further need to determine how to mitigate adverse health effects associated with nighttime shift work. It is imperative that we invest in understanding the health implications of nightshift work and implement policies that ameliorate the associated increased risk of breast cancer.
- Promote transparency. Workplaces must fully disclose exposures of concern, regardless of trade secrets, and must communicate with workers about their personal exposures when they are measured. Putting an end to trade secrets and confidential business information (CBI) will free the important information needed for chemical safety in the workplace.
- Include workers throughout research. Most occupational studies do not include the workers in the design or implementation of studies. Engaging workers, with their direct knowledge of their working conditions, in the research process is key in shaping an effective and relevant research agenda. The community of workers should be fully involved in all aspects of the research process, including communication strategies generally and full report-back on findings from biomonitoring studies.
- Include women, and specifically women of color, in occupational studies. Women have historically been excluded from occupational studies, which means that health issues that predominantly affect women, including breast cancer, have been, at best, under–studied, and at worst, ignored. People of color, and by extension women of color, have also been largely excluded or overlooked in research studies. This exclusion of women and people of color severely limits the legitimacy and relevance of the research.
- Study young working women and, when possible, their children. Breast cancer is diagnosed much more often in postmenopausal women, but exposures early in life can impact risk of its occurrence later. Studying young workers is important for capturing these exposures and, ideally, research should include enough follow-up time within study designs to observe effects later in life. Women at younger ages may be more vulnerable to effects of toxic exposures, and exposures during a woman’s reproductive years may also impact the next generation.
- Measure exposures directly through biomonitoring and workplace monitoring. Without direct monitoring of occupational exposures, it is exceedingly difficult to capture the environment of the workplace or the level and type of toxicants to which women have been exposed. Good exposure measurements need to be made and retained for long periods of time.
- Understand other characteristics and factors that might affect risk. A person’s risk for developing breast cancer is a reflection of the intersection of many biological, social, lifestyle, and environmental factors. Understanding possible links between workplace exposures and breast cancer risk will require sophisticated modeling exercises and collection of detailed personal and health histories, as well as social determinants of health, for study participants.
- Consider breast cancer subtypes. Breast cancer is not a single disease. There are several subtypes, and the risks of certain subtypes of breast cancer may be influenced more strongly by certain specific exposures. These subtleties may be missed if researchers only consider overall breast cancer incidence or mortality.
- Convene a workshop on occupation and breast cancer. In order to establish a national agenda on worker health and the disease, NIOSH should convene a 2- to 3- day workshop to discuss the current understanding of the links between occupation and breast cancer and to create a national agenda for research and action to reduce risk for, and incidence of, breast cancer in the workplace. Participants should include workers, federal agencies (NIOSH, NIEHS, OSHA, CDC, etc.), academics, breast cancer advocates and industry stakeholders.
D. Department of Defense
Breast Cancer Research Program (BCRP)
The Department of Defense’s Breast Cancer Research Program’s mission is to end breast cancer for Service members, Veterans, and the general public by funding innovative, high-impact research through a partnership of scientists and consumers. BCRP is the second-largest funder of breast cancer research in the U.S. and has funded over $3.6 billion of research from FY92 to FY19, and Congress allocated $150 million in FY 2020. Primary prevention is listed as one of the program goals. However very little of those resources are directed towards reducing risk related to chemical exposures, radiation, and other environmental risk factors.
Dedicate 20% of the BCRP funding to primary prevention focused on environmental factors that increase breast cancer risk, including chemical exposures, and developing systemic strategies to reduce those risks.
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