EDF Health

Representatives Call For FDA Public Hearing on Phthalates

By Joanna Slaney and Maricel Maffini, PhD, Consultant / Published: June 6, 2023

By. Joanna Slaney, Senior Director, Federal Affairs, and Maricel Maffini, PhD, Consultant

U.S. Capitol dome framed by trees

Source: A. Paige Baker, ShutterSights.com©

What Happened?

On May 19, Reps. Katie Porter, Steve Cohen, Nanette Diaz Barragán, Earl Blumenauer, and Raúl Grijalva issued a letter [PDF, 300KB] to FDA Commissioner Robert Califf calling on FDA to “act expeditiously to protect the public from the health risks posed by phthalates in food and food packaging.”

They asked the FDA to hold a public hearing on ortho-phthalates (phthalates), chemicals associated with disruptions to the development of the male reproductive system and neurodevelopment, among other health effects.

Why It Matters

In 2021, Reps. Porter and Lieu led a letter with 12 colleagues urging FDA to take action on phthalates in food and cosmetics. That letter, in part, called on FDA to take action on a 2016 petition filed by EDF and allied environmental health organizations asking FDA to revoke its approval for all uses of phthalates in food packaging and processing equipment.

In May 2022, after the petitioners sued, FDA denied the petition. The petitioners formally objected to the decision and requested a public hearing pursuant to FDA’s regulations. The agency has not provided any timeline for acting on the objections.

Request for a Public Hearing

The Representatives stated in the letter submitted last month that  FDA’s decision denying the petition was flawed. “[W]e are deeply concerned about the denial, which was made without deciding whether the remaining approved uses of phthalates in food and food packaging are safe.” (Emphasis original)

They reminded Commissioner Califf of his recent statement that chemical safety is a “really, really important area for the future – for humankind, really – and where science is evolving rapidly,” urging FDA to hold a public hearing on two areas of concern:

  • The agency’s failure to evaluate the safety of phthalates as it was legally required to do before denying the 2016 petition. The letter stated, “failing to evaluate the safety of phthalates is an abdication of the FDA’s continuing obligation to oversee the safety of the food supply.”
  • FDA’s failure to address new toxicity information that raises significant questions about the safety of phthalates. Phthalates are associated with numerous health issues, including reproductive and developmental toxicity, endocrine disruption, immune toxicity, and epigenetic alterations. The letter stated, “the denial of the petition fails to acknowledge, let alone analyze, the dozens of peer-reviewed studies that underscore the toxicity of the phthalates that remain approved for food contact use.”

Next Steps

EDF and our allies will continue to press FDA to hold a public hearing on the safety of phthalates used in food packaging and processing equipment.

Go Deeper

EDF blogs on phthalates

Posted in Congress, Developmental toxicity, Endocrine disruptors, FDA, Food, Food packaging, Health science, Phthalates, Public health, Public hearing, Regulation, Reproductive toxicity / Tagged , , , , , | Authors: , / Comments are closed

Mapping Lead: Ohio issues map of properties with known lead hazards

By Roya Alkafaji / Published: May 25, 2023

Tom Neltner, Senior Director, Safer Chemicals Initiative, and Roya Alkafaji, Manager, Healthy Communities

What Happened: The Ohio Department of Health published an interactive map showing almost 1,200 properties whose owners have refused to comply with an order to correct known lead-based paint hazards. As a result, the Department has declared these properties are unsafe to live in until the hazards have been remediated.

Why It Matters: The availability of address-specific information is important to engage residents, potential home buyers, and renters so they can make better informed decisions about protecting their families from harmful lead exposure. Ohio is the second state after New Jersey that we’re aware of to move beyond neighborhood-level mapping of lead risks to provide specific information at the address level.

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Posted in Lead, Mapping Lead, Public health / Tagged , | Authors: / Comments are closed

Mapping Lead: New Jersey State map as a backbone for real progress on lead

By Roya Alkafaji / Published: April 28, 2023

Tom Neltner, Senior Director, Safer Chemicals Initiative and Roya Alkafaji, Manager, Healthy Communities

What Happened: The State of New Jersey published an interactive map showing potential sources of lead exposure for any given address in the state. Currently, the map specifically looks at lead-based paint in housing, though the State has plans to expand this to include other sources of lead, including drinking water from lead service lines (LSLs).

Why It Matters: The availability of address-specific information is important to engage residents, potential home buyers, and renters so they can make better informed decisions about protecting their families from harmful lead exposure. New Jersey is the first state to move beyond neighborhood-level mapping of lead risks to provide specific information about lead at the address level.

The map uses housing age as an indicator to assess risk to lead exposure, which is an excellent place to start because it is relevant to the prevalence of both lead-based paint and lead in drinking water.

As more information is added on lead pipes, lead-contaminated soil, and nearby commercial operations that release lead, as well as details on lead poisoning prevention requirements, the map will become a critical tool in the effort to comprehensively consider lead risks and drive exposure closer to zero.

Source: New Jersey Department of Environmental Protection Potential Lead Exposure Mapping (click on Lead-based paint tab at the top and zoom in until you see parcel-level detail with color overlays)

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Lead Pipe Replacement: EPA changes state shares of funding

By Roya Alkafaji / Published: April 21, 2023

Lindsay McCormick, Senior Manager, Safer Chemicals, Tom Neltner, Senior Director, Safer Chemicals and Roya Alkafaji, Manager, Healthy Communities

What Happened?

Earlier this month, EPA announced an updated formula it will use to allocate federal funds for lead service line (LSL) replacements. This new formula will be based on each state’s expected needs, as determined by a 2021 survey of state and water utility estimates.

Why It Matters

EPA’s distribution of the first of five years of the historic $15 billion dedicated to LSL replacement from the Infrastructure Improvement and Jobs Act (IIJA) was not necessarily going to states and communities that needed it most.

Many water utilities rely on the State Revolving Fund (SRF) program to build and maintain their drinking water infrastructure. EPA funds SRF programs each year and their previous formula to determine allocations was based on a 2015 survey of estimated drinking water infrastructure funding needs including LSL replacement – putting populous states like California at the top of the list. However, a 2016 article by the American Water Works Association (AWWA) showed LSLs are most heavily concentrated in the Midwest and Northeast, in states like Illinois, Ohio, Michigan, Missouri, New York, and New Jersey.

With EPA’s new formula, each state’s need, based on its estimated number of LSLs, will be used to distribute the next four years of IIJA funding for LSL replacement. This is a critical step to ensure that the system for distributing federal funds is functioning equitably and funds go to those communities with the greatest needs.

Projected Number of Lead Services Lines by State–2023

But wait…what’s going on in Florida and Texas?

When we dug into the details, there was one surprise in particular. Florida’s level of funding has increased a whopping 228%, based on a new estimate that the state has 1.2 million LSLs – more than any other state – and that about one in every six of its service lines is an LSL. Based on the age of infrastructure in the state, we think that this number is a gross overestimate. If we’re right, other states will get shorted on their share of LSL-replacement funding.

At first blush, data from Texas also caught our eye. The state reported almost 650,000 LSLs – up from 270,000 in the AWWA survey. But in contrast to Florida, this means Texas is claiming that only 5% of all its services lines are LSLs. Overall, Texas’ funding under the new formula will decrease by one-third.

What’s Next?

Starting this federal fiscal year (October 1, 2023), states will receive their new allocations of IIJA funding for LSL replacement. We’ll continue to monitor the funding flowing into each state for the critical task of getting the lead out, especially in communities that need it most. For states like Florida that may be in line for more than their fair share, we’ll be monitoring where those dollars are going.

Want to learn more?

Check out EPA’s detailed factsheet: 7th Drinking Water Infrastructure Needs Survey and Assessment

Posted in Mapping Lead, Public health / Tagged , , , , , | Authors: / Comments are closed

PFAS: EPA’s proposed notification requirements are a positive step, but exemptions will cause harm

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: April 20, 2023

Maria Doa, PhD, Senior Director, Chemicals Policy

The Good News

Using its authority under the Toxic Substances Control Act, EPA proposed a rule that would require companies to notify the agency before they produce or import a PFAS “forever chemical” that has not been used commercially since 2006.

These notifications are crucial because resuming production or import of these toxic chemicals would expose people to harm. The notification gives EPA an opportunity to evaluate these PFAS to determine if exposure during their lifecycle—production or import, distribution in commerce, industrial, commercial and/or consumer use, and disposal—is likely to pose an “unreasonable risk” to people or the environment.

The Not-So-Good News

EPA is proposing to exempt some parts of the PFAS lifecycle from the notification requirement if the PFAS are:

  • Part of certain types of products EPA designates as “articles”—such as carpets.
  • Impurities.
  • Byproducts used as fuels or disposed of as waste, including in a landfill or for enriching soil.

EPA also asked if it should go a step further by broadening the exemption and completely exempting the PFAS if they are byproducts with no commercial purpose on their own.

Why It Matters

Exempting any part of the PFAS lifecycle from EPA’s evaluation will result in PFAS exposure—no ifs, ands or buts. This is a big problem because small amounts of these chemicals can cause harm, and many PFAS remain in our bodies for months—or even years.

Our Take

In our comments on the proposed rule, Environmental Defense Fund said that because of the well-documented harms caused by PFAS, EPA should not allow exemptions.

The impurities and articles exemptions could have a significant impact. PFAS impurities can end up in both commercial and consumer goods (like cleaning products), leading to exposure when people use them, or unintentionally release them into the environment. PFAS can also leach out of articles through handling or weathering—exposing us and our environment.

The byproduct exemptions could have an even more significant impact. The broader exemption for PFAS produced “as a byproduct with no commercial purpose” is basically the same exemption that allowed the notorious Gen-X to be produced and released for years without any controls—contaminating the Cape Fear River and impacting the health and welfare of its residents. EPA should not allow this to happen with other PFAS.

In addition, EPA should not allow a narrower byproduct exemption either, as it would still exempt PFAS applied to soil for “enrichment” or burned as fuel. “Enriching” soil with PFAS-contaminated waste can pollute the land (including farmland), affecting the livelihood of farmers, the animals that graze on the land, and the food we eat. Burning it as a fuel is also likely to release PFAS into the air because the chemicals are so difficult to destroy.

These exemptions also are at odds with other EPA actions to address PFAS contamination, such as its recent strong and scientifically robust proposed drinking water standards.

What’s Next?

EPA should not allow any exemptions for these PFAS. EPA should ensure that it has the opportunity to review these PFAS and identify any unreasonable risks before they reenter the marketplace. Only by addressing PFAS early in the lifecycle can we limit the contamination and health harms they cause.

Posted in Frontline communities, Health hazards, Public health, TSCA / Authors: / Read 1 Response

European Food Safety Authority reaffirms that BPA uses for food are not safe. Where is FDA?

By Tom Neltner, Senior Director, Safer Chemicals Initiative and Maricel Maffini, PhD, Consultant / Published: April 19, 2023

Tom Neltner, Senior Director, Safer Chemicals, and Maricel Maffini, consultant

Warning message written in bold red letters with words Bisphenol A Exposure. 3d illustration.

What Happened?

Today, the European Food Safety Authority (EFSA) finalized its Re-evaluation of the Risks to Public Health Related to the Presence of Bisphenol A (BPA) in Foodstuffs report. After considering public comments on its November 2021 draft, the agency reaffirmed its conclusion that Europeans of all ages are exposed to BPA at levels 100 to 1,000 times greater than EFSA considers to be safe.

Why It Matters

EFSA found that consumers’ dietary exposure should be less than 0.2 nanograms of BPA per kilogram of body weight per day (ng/kg-bw/day) to protect their immune systems from harm.1 Although EFSA didn’t analyze the reality for U.S. consumers, we used FDA’s 2014 estimated dietary exposure for BPA (the most recent available) to calculate that Americans’ exposure is 1,000 times greater than what EFSA deems safe.

Our Take

EFSA’s analysis is primarily based on scientific evidence that FDA had not considered in previous reviews. With the final report in place, EFSA has completed a rigorous, transparent, and comprehensive risk assessment. FDA now has no excuse for delaying action on a food additive petition submitted by EDF and our partners that the agency agreed to consider on May 2, 2022. That petition requested that FDA revoke its approvals for using BPA in adhesives and can coatings and set strict limits on using it in plastic that contacts food. FDA has not yet responded.

EFSA’s Conclusions

EFSA found that extremely low exposures to BPA can lead to an overactive immune system producing out-of-control inflammation. BPA was also associated with disrupting the endocrine system, harming reproduction, and reducing learning and memory. The immune system was most sensitive to BPA exposure.

After calculating a safe level of BPA—known as TDI (tolerable daily intake)—that would prevent anticipated harm, EFSA compared it against the estimated dietary exposure of the European population. The agency concluded that “both the mean and the 95th percentile dietary exposures in all age groups exceeded the TDI by two to three orders of magnitude.”

Putting BPA New Safe Level in Context

EFSA’s safe dose of 0.2 ng/kg-bw/day is extremely low. It may be useful to compare it to exposure from drinking water. For an adult weighing 120-pounds who drinks 2 liters of water a day, it would take only 1.2 parts per trillion of BPA to exceed the safe level.2

Next Steps

We will press FDA to act with greater urgency on our overdue petition. We are also looking at whether there is increased risk to communities near where BPA is made or processed.

NOTES

1 The limit was 0.04 ng/kg-bw/day in the draft EFSA report.

2 0.2 ng/kg-bw/day * 60 kg / 2 liters = 1.2 ng/L = 1.2 ppt. This does not account for other sources of BPA in the diet.

 

 

Posted in BPA, EFSA, Emerging science, Emerging testing methods, Environment, FDA, Health science, Public health / Tagged , , , | Authors: , / Read 1 Response