EDF Health

Unleading Baby Food: FDA needs to tighten its proposed action levels

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 28, 2023

Tom Neltner, Senior Director, Safer Chemicals Initiative

Note: This is the first of three blogs in this series. Click here for Blog 2 or Blog 3.

On January 24, 2023, FDA released draft action levels1 for lead in foods intended for babies and young toddlers.2 This proposal is a key step in implementing the agency’s Closer to Zero Action Plan.

For most of these foods, the lead limit would be 10 parts per billion (ppb). FDA proposed a 20-ppb limit for dry infant cereals and single-ingredient root vegetable products (i.e., carrots and sweet potatoes), because these products may have greater lead contamination levels.

The action levels do not apply to five types of foods that young children frequently eat:

  • Grain-based snacks such as teething biscuits, sandwich cookies, and puffs—despite FDA’s finding that the biscuits and cookies were two of the three foods with the highest mean lead concentrations that the agency tested for its Total Diet Study from 2018-2020.
  • Fruits, cereals, and vegetables that parents use to make homemade foods for their babies and young toddlers—despite those products being likely to be more contaminated, whether or not it was labelled as organic.
  • Food marketed for a general audience (e.g., raisins, applesauce, canned food) that parents commonly feed to children —especially families on tight budgets.
  • Food marketed to young children over age 2, including kids’ meals and some snack bars.
  • Juices, since FDA proposed limits on those in April 2022 and should finalize them this year.

FDA has not set—or even proposed—action levels for lead for any of these foods (except juice). Based on the current Closer to Zero Action Plan schedule, the agency has no plans to establish action levels for the foods listed in items 2 and 3, above.

Do Food Companies Have to Comply with Action Levels?
The short answer is technically and legally “No”—but in practice, “Yes”…with important caveats. As with all guidance, FDA makes clear that:

[G]uidance documents do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

As a practical matter, action levels serve as limits that companies meet to decrease the risk of having FDA deem their products adulterated and subject to a recall. In addition, FDA expects food facilities to use their Hazard Analysis and Preventive Control Program to achieve action levels by managing their facilities and suppliers to ensure compliance and taking action if problems are revealed through testing or other efforts.

FDA’s Criteria for Setting Action Levels
There is no safe level of lead in the diet. Lead can enter the food chain through multiple sources, including crops grown in contaminated soil and/or irrigated with contaminated water, atmospheric deposition from industrial activities, and old food-processing equipment that contains lead. The objective is to get exposure closer to zero.

In its proposed guidance, FDA said:

[W]hen evaluating possible action levels under 21 CFR 109.6 for lead in foods intended for babies and young children less than two years old, we took into account several considerations, including:

  • the action level should minimize the likelihood that a consumer will be exposed to lead levels exceeding the IRL (interim reference level);
  • as appropriate, there should be a limited number of unique action levels for simplicity;
  • the action levels should result in a reduction in exposure to lead; and
  • for those baby foods where lead levels are already relatively low, the action levels should be established where achievability is in the 90th-95th percentile range.

EDF’s Recommendations for Making FDA’s Proposed Action Levels More Protective
We did a deeper dive into FDA’s proposal and the three datasets3 it published to support its decision. We applied FDA’s achievability target of 90th percentile to develop four recommendations to improve the action-level proposal and reduce dietary exposure to lead for babies and young toddlers, even though we think FDA should use a stricter target for infants and babies—as it did for inorganic arsenic in infant rice cereal.4 For the sake of simplicity, we also sought to minimize the number of unique action levels:

  1. The 20-ppb action level for dry infant cereals should be limited to rice cereals; other grains should have a 10-ppb action level. For the 299 rice cereal samples, the 90th percentile was 21 ppb of lead, and 28% had levels of 10 ppb or more. By contrast, only 1 of 85 samples (1.2%) for non-rice or multigrain cereals had 10 ppb or more of lead, and the 90th percentile was 8 ppb—so a 10-ppb level can be met and is justified. Note that rice cereal is also high in inorganic arsenic.
  2. Beyond dry infant cereals, foods that contain no root vegetables as ingredients should have an action level of 5 ppb instead of 10 ppb. For 478 samples without root vegetables5, the 90th percentile was 3.3 ppb of lead, while 6% had 5 ppb or more. Note that half of those over 5 ppb had quinoa as an ingredient. Based on these results, foods other than dry cereals that do not have root vegetables should have an action level of 5 ppb. For 110 samples of food with root vegetables as one of multiple ingredients, the 90th percentile was 11 ppb of lead and 22% had 5 ppb or more. For foods whose only ingredient is a root vegetable, a 20-ppb action level is justified.
  3. Grain snacks, such as teething biscuits, puffs, snack bars, and cookies should have an action level of 20 ppb; they are some of the most contaminated baby foods. For 123 samples of these foods collected in 2013-14, the 90th percentile was 18 ppb of lead and 26% had 5 ppb or more. While the samples are old, there are sufficient samples of these popular products with high enough levels that the agency should set a level of 20 ppb.
  4. Quinoa, an increasingly popular ingredient for baby food, requires greater scrutiny, starting with increased sampling, since almost half of the samples with quinoa as the sole or main ingredient have lead levels of 20 ppb or more. The levels of lead in quinoa were worse than rice cereal, grain snacks, or root vegetables. While the data set is older (from 2014) and much smaller (29 samples), the 90th percentile was an astounding 90 ppb of lead. In addition, 41% had 20 ppb or more of lead and 58% were over 10 ppb.6 Without more data, FDA should maintain a limit of 20 ppb for dry cereal and 10 ppb if that cereal is combined with other ingredients.

We made these recommendations in our formal comments (PDF) on the proposal that we submitted on March 27, 2023 . In subsequent blogs, we identify significant problems with the process FDA uses to establish action levels for lead and to describe specific research needs. (Updated on 3/28/23 to reflect submission of our comments to FDA and link to the document.)

Up Next: Unleading Baby Food: FDA needs to improve how it sets action levels to be more transparent and credible

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NOTES

1 FDA’s guidance refers to babies and young children. However, the action levels only apply to foods intended for children younger than 24 months, a very narrow definition of young children, especially since children up to six years of age are particularly vulnerable to the harm to their brain from lead. Other federal agencies set standards for this broader age range. Toddlers are generally considered to be between 1 and 3 years of age. Therefore, we use the term “toddlers” to avoid confusion.

2 Action levels represent levels at which FDA may regard food as adulterated and seek a recall.

3 In its 2018 sample results, 29% of the 149 samples exceeded 100 ppb of inorganic arsenic in infant rice cereal.

4 1) Toxic Element Program consisting of 356 samples of dry infant cereals, fruits, mixtures and vegetables collected from 2008-2021; 2) FDA Survey 1 consisting of 147 samples of dry infant cereals and mixtures collected from 2013 to 2014; and FDA Survey 2 consisting of 360 samples of fruits, mixtures, vegetables, yogurts, custards/puddings, and single-ingredient meats collected in 2021.

5 Excluding dry infant cereals.

6 We included all 29 samples that FDA identified as quinoa, even if the agency did not also identify them as  dry cereal.

Posted in Deep Dives, FDA, Food, General interest, Health policy, Health science, Lead / Authors: / Comments are closed

EPA Should Address Cumulative Risks from New Chemicals

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: January 11, 2023

Names of blog authors: Maria Doa, PhD, Sr. Director, Chemicals Policy, and Lariah Edwards, PhD, Associate Research Scientist, Columbia University

What’s Happening? EPA’s current safety assessments of new chemicals proposed for market entry often fall short of effectively protecting all members of the public from risk because they don’t consider that we may be exposed to closely related chemicals that cause similar harms.

Recent Example: EPA proposed rules requiring notification of significant new uses for a group of new chemicals. Two of these chemicals, known as trimellitate esters, are very closely related, and would be expected to cause very similar harms and have very similar uses—so that people exposed to one chemical would likely be exposed to the other. Despite this, EPA did not consider the chemicals together or even use the information it had on one to inform its understanding of the safety of the other.

This doesn’t make sense.

Even though EPA said that one chemical was intended to be used as a lubricant and the other as a plasticizer (a chemical that makes plastics more flexible), it is likely that both could be used as a plasticizer or a lubricant. They may be used together or turn up in similar consumer products, such as a car’s dashboard. Further, both chemicals are very closely related to yet another plasticizer used in the auto industry, but it appears that EPA considered these nearly interchangeable chemicals in isolation from one another.

Items that require plasticizers for production. They include seats in cars, rain boots, a garden hose, medical gloves, an exercise ball, and rolls of wallpaper.

In fact, under the Toxic Substances Control Act (TSCA), EPA is required to identify such “reasonably foreseen uses,” such as ending up in the same product.

Why It Matters: Evaluating chemicals in isolation likely underestimates the exposures and risks workers, consumers, and frontline communities face. Doing so also fails to make use of all the best available science, since information on each of these two chemicals (as well as the one already being used) could inform the safety determination for the other.

Considering the combined risks from similar chemicals is not new. EPA is already doing this for another group of closely related chemicals—phthalates. Phthalates have long been widely used in a range of consumer products and are detected in almost all our bodies. Phthalates are known to impact male reproductive health. EPA is joining the ranks of other federal agencies that have considered the cumulative risks they pose.

Our Take: EPA should not stop at phthalates. They can and should be incorporating cumulative approaches from the very beginning of a chemical’s regulatory life. Considering the impact of combined exposures does not need to be complicated and EPA could make such a consideration without much extra effort.

EPA can take a first step toward doing this by considering the potential for cumulative risks when finalizing its regulation on the significant new uses for these two new closely related chemicals.

Go Deeper: Read EDF’s response to EPA’s proposed new SNURs. And check out our Cumulative Risk Assessment Framework.

Posted in Environment, Health science, Industry influence, Public health, TSCA / Comments are closed

Denver Water proves its Lead Reduction Program is a national model

By Lindsay McCormick / Published: January 3, 2023

Tom Neltner, Senior Director, Safer Chemicals and Lindsay McCormick, Senior Manager, Safer Chemicals

What’s New: After an extensive review process, EPA approved Denver Water’s request to extend the variance to allow the utility to administer their Lead Reduction Program for the full 15-year term. EPA touts Denver Water’s Lead Reduction Program as an “innovative and aggressive approach” to lead service line replacement (LSL) in a letter approving the variance.

Denver Water will continue to:

  • replace all lead service lines at no cost to homeowners,
  • provide residents with filters to help reduce their exposure in the short-term, and
  • use an alternative approach to water treatment that still ensures effective corrosion control.

We applaud their emphasis on environmental justice and commitment to ensure that the program continues to prioritize disproportionately impacted neighborhoods – and EPA’s new requirement to track this progress.

This fall, we visited Denver Water’s field operations to see for ourselves how it is successfully replacing more than 4,500 lines per year. We were impressed by what we saw, and sent a letter to EPA’s Regional Administrator expressing our full support for Denver Water’s March 2022 request to continue their program. Read More »

Posted in Drinking water, Lead / Tagged , , , | Authors: / Comments are closed

Mapping Lead: Powerful tool helps communities find underground hazards

By Roya Alkafaji / Published: December 13, 2022

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

We have all come to expect access to information at our fingertips. To meet this demand, water utilities are increasingly posting interactive maps online to help residents identify whether their homes are connected to lead service lines (LSLs).[1] These are the pipes that deliver water from the main under the street to homes and buildings. In homes built before 1986, this pipe could be made of lead.

With this information, people can:

  • Better assess their risk of lead exposure from drinking water and take steps to reduce possible exposure (e.g., water filters);
  • Make decisions when renting or purchasing a new home, and/or;
  • Demand that their water utility and community invest in effective LSL replacement programs to reduce harmful exposure to lead, particularly for children who are most vulnerable.

Given the importance and growing popularity of LSL maps, we are launching a new blog series, Mapping Lead, that will explore how utilities are approaching maps, evaluate which map features are most and least effective, and share best practices to help guide future efforts.

EPA recognized the value of interactive maps in its August 2022 guidance on developing service line inventories. The agency recommended utilities of all sizes consider making information available through interactive maps using commonly available tools, like GIS software. The guidance references EDF’s 2019 study for evidence of the power of these interactive maps and spotlights LSL replacement programs in Cincinnati and Denver as examples of best practices.[2]

We wholeheartedly agree with EPA’s recommendations. As a result of the agency’s guidance, we anticipate that the number of online maps is likely to grow dramatically as utilities meet an October 2024 deadline to make their inventory of service line materials publicly accessible to comply with EPA’s revised Lead and Copper Rule (LCR).

Top 100 Cities: Who Has Maps – And Who Doesn’t

We identified over 50 interactive LSL maps that utilities have made publicly available to residents across the United States. Looking at the utilities that serve the 100 largest cities in the country, we found that 15 have LSL maps—a positive step that leverages existing asset-management tools such as GIS, while increasing public transparency. Together, these 15 utilities provide drinking water to more than 16 million people.

Throughout this blog series we’ll take a closer look at maps; in some cases, we’ll be critical of those that don’t meet the criteria for an effective map. Nonetheless, we recognize these utilities have taken a step in the right direction and should be applauded for their efforts.

We discovered that 12 large utilities were notably absent from the list of those with online maps. Given their size and location, these utilities presumably have LSLs in their distribution areas and the in-house resources to develop effective maps. We hope that by shining a light on the cities that are leading the way and addressing the contrast with those cities without maps, we can help spur action so residents of large cities served by these utilities will have access to this crucial information. For a list of the 12 utilities without maps and 15 with maps, see the tables below. We’ll continue to revise these lists as more large cities publish interactive maps online.

By the Numbers

It’s important to understand the broader landscape as we track cities that are choosing interactive maps as a key tool for communicating about LSLs to the public. Using estimates from EPA’s Regulatory Impact Analysis for the revised LCR, the figure below shows the number of community water systems that fall under the purview of the LCR and subsequent requirements based on presence of LSLs and population served.

By October 2024, more than 50,000 utilities[3] will either submit an initial service line inventory or demonstrate the absence of LSLs in their distribution area.[4] EPA estimates that more than 12,000 utilities will find LSLs and thus will be required to make their inventory publicly accessible; those that serve over 50,000 people will also be required to post the inventory online.

More to Come

Follow along as we explore interactive maps and the role they play in LSL replacement.

Utilities Serving Top 100 Largest Cities With Online Interactive Maps

UtilityPopulation Served†Estimated # of LSLs‡
New York City, New York (Map)8.3 million360,000
Boston, Massachusetts (Map)2.6 million3,900**
Denver, Colorado (Map)1.4 million64,000**
Columbus, Ohio (Map)1.3 million28,000*
Seattle, Washington (Map)956,0002,000*
San Francisco, California (Map)884,0001,600*
Cincinnati, Ohio (Map)750,00040,000
Memphis, Tennessee (Map)700,00014,000*
Tucson, Arizona (Map)675,000600
Washington, D.C. (Map)632,00042,000**
Pittsburgh, Pennsylvania (Map)520,00016,000**
Toledo, Ohio (Map)480,00030,000**
St. Paul, Minnesota (Map)400,00027,000
Newark, New Jersey (Map)295,00024,000**
Jersey City, New Jersey (Map)262,00016,000
*Map and/or estimated number of LSLs reflects public side only.
**Active or completed LSL replacement program. The number listed reflects the estimated number of LSLs prior to the start of the program.
†Source is SDWIS, 2022.
‡Source available upon request.

 

Select Utilities Serving Top 100 Largest Cities That Lacked Online Interactive Maps

UtilityPopulation Served†Estimated # of LSLs‡
Chicago, Illinois2.7 million380,000
Baltimore, Maryland1.6 millionNot reported
Philadelphia, Pennsylvania1.6 million20,000
Cleveland, Ohio1.3 million200,000
Charlotte, North Carolina1.1 millionNot reported
Indianapolis, Indiana (Citizens Energy – Water)837,00055,000-75,000
Nashville, Tennessee722,000Unknown
Detroit, Michigan714,00080,000
Milwaukee, Wisconsin590,00066,000
Omaha, Nebraska554,00016,000-17,000
Minneapolis, Minnesota424,00049,000
New Orleans, Louisiana291,000Unknown
†Source is SDWIS, 2022.
‡Source available upon request.

 

[1] For this blog series, LSLs includes service lines that are “galvanized requiring replacement” per 40 CFR § 141.2.

[2] See Section 7.2 of EPA’s service line inventory guidance.

[3] For purposes of this blog series, community water suppliers as defined by EPA are referred to as utilities.

[4] Per 40 CFR 141.84(4), CWSs must categorize each service line, or portion of the service line where ownership is split, as lead, galvanized requiring replacement, non-lead, or lead status unknown. In order to declare that the system only contains non-lead service lines, this must be “determined through an evidence-based record, method, or technique.”

 

Revised May 2, 2023 to update blog series title and link.

Posted in Drinking water, Lead, Mapping Lead / Tagged , , , | Authors: / Comments are closed

Toxic Chemicals: Regulatory exemptions prioritize industry wants over safety needs

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: December 2, 2022

A rubber stamp lies on its side to the right of the photo. To the left, you see the stamped image of a skull and crossbones and the words Toxic Substances

By Maria Doa, PhD, Senior Director, Chemicals Policy

What’s the Issue?

EPA grants exemptions from full safety reviews for approximately half the new chemicals submitted by the chemical industry. Once those exemptions are granted, EPA very rarely revises or revokes them—even in the face of new information.

The Toxic Substances Control Act allows EPA to grant an exemption from a full safety review only if it determines that the chemical will not present an unreasonable risk. That’s a high standard—and one that many exemptions do not meet.

Why it Matters:

  • The chemical industry takes maximum advantage of exemptions given the abbreviated safety review and the industry’s ability to keep their use of new chemicals under the radar. For example, the chemicals that get exemptions don’t go on the national inventory of chemicals that are in use.
  • For years, EPA has granted exemptions for chemicals that can have long-term negative impacts on human health and the environment. They include hundreds of exemptions for PFAS, “forever chemicals” known to contaminate our water supplies and farmland. And it’s not just PFAS. EPA has granted exemptions for other types of persistent, bio-accumulative, toxic (PBT) chemicals that can have lasting impacts on people and the environment.
  • These exemptions often contradict TSCA’s requirement that EPA consider the risks from a chemical throughout its lifecycle. That includes the risks for vulnerable groups who may be more susceptible to the chemical or who are more highly exposed, such as frontline communities.
  • EPA does not typically consider the cumulative impacts of multiple exempted chemicals on frontline communities, consumers, or the environment.

Our Take: EPA has an important opportunity to address overuse of TSCA exemptions.

Next Steps:

  • EPA should revisit the exemptions it has already granted. The agency should determine that chemicals truly do not present an unreasonable risk—particularly to vulnerable populations—throughout their lifecycles. EPA should focus first on chemicals that can have long-lasting impacts on health and the environment, like PFAS and other PBTs.
  • Before granting any new exemptions, EPA should consider the combined impacts throughout the lifecycle of these chemicals on all stakeholders, especially frontline communities. EPA Administrator Regan recently said EPA would be embedding environmental justice into the DNA of EPA. This is another opportunity for EPA to do just that.
Posted in Frontline communities, Industry influence, Public health, TSCA / Tagged , , , , , , , | Authors: / Comments are closed

EPA greenlights 21 states’ SRF plans to fund LSL replacement projects

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 16, 2022

Tom Neltner, Senior Director, Safer Chemicals

What’s New: EPA announced it has awarded $1.16 billion to the State Revolving Fund (SRF) programs in 21 states, the District of Columbia, and three territories to support lead service line (LSL) replacement projects. In order to secure funding, these states developed and submitted Intended Use Plans (IUPs), which included LSL replacement projects that met EPA’s requirements.

Why It Matters: These 25 programs can now begin distributing their share of the first of five years of funding from the $15 billion Congress included in the 2021 Infrastructure Investment and Jobs Act (IIJA) specifically for full LSL replacement projects. The remaining states are working to get their IUPs submitted to EPA.

Read More »

Posted in Drinking water, Lead, Public health / Tagged , , , , , , | Comments are closed