EDF Health

Top 10 cities with the most lead pipes

By Roya Alkafaji and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 6, 2023

Note: This blog has been updated and adapted. For the most up-to-date information, please visit our new page, Top 10 Cities with the Most Lead Pipes.

 

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

EDF identified 10 cities in the U.S. with the most lead service lines (LSLs) based on numbers reported in 2021.[1] These cities collectively have over one million LSLs, representing 12% of the 9.2 million EPA estimates are in the country.

Below we rank each city from most LSLs to fewest, and briefly describe the progress each city has made toward LSL replacement. Some have robust programs, while others have yet to start addressing the problem.

The List

1. Chicago, IL

Chicago Department of Water Management reported 387,095 LSLs in 2021, more than twice as many as the next city on this list. Three-quarters of its service lines are LSLs, and virtually all the rest are of unknown material. City ordinance actually mandated that LSLs be installed until the federal government banned them in 1986.

Decades later, Chicago is struggling to pull itself out of a deep hole relative to most other large cities that took earlier action against lead pipes. Chicago has a small LSL replacement program but applied for a $336 million loan from EPA in 2020[2] and $8 million in state revolving funds (SRF) from Illinois EPA in 2023 to accelerate the effort.

2. Cleveland, OH

Cleveland Water reported 185,409 LSLs in 2021, about 43% of all its service lines.

The utility has a small LSL replacement program but is seeking more than $63 million in federal infrastructure funding from Ohio EPA in 2023 to accelerate the effort.

3. New York, NY

New York City reported 137,542 LSLs in 2021 and an additional 230,870 lines that are of unknown material. About 43% of the city’s service lines are lead or of unknown material.

It has a small LSL replacement program and is seeking more than $58 million in federal infrastructure funding from New York State DEP in 2023 to accelerate the effort.

Read More »

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

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

Broken GRAS: Secret GRAS determinations may outnumber those reviewed by FDA

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 13, 2023

What Happened?

FDA estimates that, each year, food companies designate 82 new food chemicals as “GRAS” (Generally Recognized as Safe) for use in food. On average, FDA reviews only 64 of those new chemicals for safety. For the remaining 18 chemicals in FDA’s estimate, the companies making and marketing them for use in food or in the food-production process choose not to seek a voluntary review by FDA.

In comments to the agency, we said we think FDA’s estimate may be too low – and the number of new chemicals added to food that bypass FDA review may be as high as 130 new food chemicals a year (significantly higher than 18). This is based on searches of company marketing claims. In an 8-week period, we identified 10 chemicals claimed as GRAS without a submitted notice to FDA seeking voluntary review. (Please see our comments for a full explanation of our estimate.)

Why It Matters

I want to throw in chemical safety as another really, really important area for the future – for humankind, really – and where science is evolving rapidly.—Robert Califf, MD, FDA Commissioner

FDA’s review of GRAS safety determinations is critical to ensure food chemicals are safe. When agency scientists receive GRAS notices, they closely review them and ask notifiers tough questions about the safety of the chemical alone—and the potential consequences when that chemical is combined with other chemicals on the market.

But FDA allows companies to withdraw their notices – which they do in about 17% of cases. Sometimes companies fix the problems and resubmit the notice. FDA does not require companies to do this, however. Too many simply continue to market the chemical for food uses as GRAS without seeking further FDA review. That is in addition to the GRAS safety determinations companies choose never to file, which leads to chemicals entering our food system without any FDA notice or review at all.

Our Take

While the GRAS system is clearly broken (something we’ve blogged about at length and the Washington Post covered in-depth back in 2014), FDA does retain the ability and the duty to monitor the marketplace to ensure unsafe chemicals that food companies claim as GRAS are kept off the market. Unfortunately, the agency appears to lack any system to ensure that monitoring takes place. The only examples of agency action to pull industry-certified GRAS products off the market have been caffeinated alcoholic beverages and partially hydrogenated oils (aka artificial trans fat). Both were prompted, in part, by state and media calls for action.

Examples of inaction, however, are numerous and include: tara flour, COZ corn oil, Apocynun ventron, gamma aminobutyric acid (GABA), aquaequorin/Prevagen, and many more.

One of the key breakdowns that contributes to FDA’s failure to monitor is the lack of coordination between the regulatory programs in the Center for Food Safety and Applied Nutrition (CFSAN) and the inspection/enforcement programs in the Office of Regulatory Affairs (ORA).

Next Steps

In January 2023, FDA Commissioner Califf announced a proposal to reorganize the food safety program in response to stakeholder calls for action after the infant formula debacle and to a recent review of the agency by the Reagan-Udall Foundation. This review noted that one key step is to appoint a new Deputy Commissioner for Human Food. This person would have greater responsibility to coordinate efforts between CFSAN and ORA. The Commissioner’s proposal has been strongly criticized since there would be no clear line of authority between the new Deputy Commissioner and ORA.

But Commissioner Califf has stated that chemical safety is a priority, telling a reporter that “I want to throw in chemical safety as another really, really important area for the future – for humankind, really – and where science is evolving rapidly.”[1]

Fixing GRAS is an important step to rebuild consumer confidence and reduce the ongoing risk to public health. Until the broken GRAS system is fixed, FDA will continue to be hamstrung in preventing health risks posed by chemicals of unknown safety. Until the system is fully fixed—which includes ensuring that no chemicals enter our food system without notice to, and review by, the agency—FDA needs to be coordinating with ORA and CFSAN to proactively monitor and enforce GRAS evaluations on chemicals entering the market to ensure they are actually safe.

Go deeper: You can learn more from these resources:

 

NOTES

[1] FoodFix, January 31, 2023, edition.

Posted in Deep Dives / Authors: , / Comments are closed

Alternative Figures: FDA’s food chemical reports to Congress don’t add up

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 10, 2023

In its annual justification of budget estimates to Congress, FDA describes its activities and tracks its performance. One of those performance measures is the percentage of food- and color-additive petitions (FAPs/CAPs) the agency has reviewed and completed within 360 days of receipt.[1]

We analyzed FDA’s reports to Congress published from 2016 to 2023 and found that FDA told Congress it had completed 100% of its reviews within 360 days in every year but one. The exception was FY2020, when the rate dropped to 89%. During that 7-year period, the agency reported that it had filed a total of 51 petitions. (See Table 1.)

Why It Matters

FDA’s impressive claims about the percentage of FAP/CAP reviews it completed run contrary to our experience and the available evidence:

  • FDA’s own webpage describes seven petitions that have been under review for over 360 days. (See Table 2.) Five of those overdue petitions were filed in FY2021, when the agency claimed it had reviewed and completed 89% of them. The agency reports filing and reviewing only two petitions in that year.
  • Four of five petitions submitted by food safety advocates for which the agency has made a decision were in FDA’s review pipeline for over 360 days.[2] For three of those overdue petitions, FDA acted only after petitioners sued in court for unreasonable delay. (See Table 3.)
  • FDA’s guidance for industry on these petitions says, “the average time between submission until a final rule is published for a direct food additive petition is 24 months and for color additive petitions, the approval process varies significantly.”

Our Take

Accurate and transparent reporting empowers Congress to:

  • See that the agency is having difficulty meeting its deadline for reviewing FAPs/CAPs; and
  • Set priorities and evaluate FDA’s funding requests more effectively.

Our Research Findings

Table 1 summarizes those findings. We excluded years where we did not have data for both petitions filed/reviewed in the fiscal year and the percent of petitions reviewed within 360 days.[3]

Table 1: FDA’s Reporting of Office of Food Additive Safety Activity

(Year of Budget Justification Reports)
Fiscal Year FAPs/CAPs

Filed/ Reviewed*

 FAPs/CAPs Percent Reviewed within 360 days
FY2015

10 / 11
(2016 report, p. 61)

100%

(2017 report p. 57 &

2016 report p. 59)
FY2016 7 / 7

(2017 report, p. 60)

100%

(2018 report p. 54 &

2017 report p. 57)
FY2017 10 / 10

(2018 report p. 57)

100%

(2019 report p. 67 &

2018 report p. 54)
FY2018 10 / 10

(2018 report p. 57)

100%

(2021 report p. 80 &

2020 report p. 68 &

2019 report p. 67)
FY2019 5 / 5

(2021 report p. 82 &

2020 report p. 70)

100%

(2022 report p. 96 &

2021 report p. 80 &

2020 report p. 67)

FY2020

 7 / 7

(2021 report p. 82)

89%

(2023 report p. 66)
FY2021

 

 2 / 2

(2022 report p. 98)

100%

(2023 report p. 64 &

2022 report p. 96)

* Reviewed includes approved, withdrawn, or placed in abeyance due to deficiencies during the fiscal year.

 

Table 2 identifies all food and color additive petitions that FDA’s website reported as under review (and not in abeyance or decided) as of April 7, 2023. “Days Under Review” is calculated as of that date.

Table 2: Status of Food and Color Additive Petitions
Under Review as of April 7, 2023
Substance and Requested Action Petition No. Filing Date Days Under Review
Revoke BHA FAP 0A4216 6/22/90 11,977
Allow jagua (genipin-glycine) blue CAP 0C0317 7/31/20 980
Allow Vitamin D3 FAP 1A4827 2/3/21 793
Allow Gardenia Blue Powder CAP 1C0319 4/20/21 717
Allow vitamin D2 mushroom powder FAP 1A4828 6/8/21 668
Allow blue Galdieria (Galdieria sulphuraria) extract CAP 1C0320 7/27/21 619
Allow vitamin D2 heat-killed (“inactive”) baker’s yeast FAP 1A4829 9/28/21 556
Allow myoglobin CAP 2C0322 12/13/21 480
Revoke bisphenol A (BPA) FAP 2B4831 5/2/22 340
Revoke Red Dye No. 3 CAP 3C0323 11/15/22 143

 

Table 3 reviews the timing of FAPs/CAPs submitted by food safety advocates since 2014. Where available, FDA’s decision on the petition is noted, as well as whether petitioners went to court asking a judge to issue a writ of mandamus to order the agency to act. For each of those lawsuits, FDA agreed relatively quickly to a schedule to make a final decision on the petition.

Table 3: Timing of Review for Advocates’ Petitions
Seeking Revocation of Food and Color Additive Approvals (as of April 7, 2023)
Substance and Requested Action Filing Date Decision Date Days Under Review Decision Lawsuit Filing Date
Perchlorate as FCS 12/31/14 4/28/17 849 Denied 3/31/16
Long-chain PFAS (non-sulfonated) as a food contact substance (FCS) 1/7/15 12/29/15 356 Accepted None
Carcinogenic flavors as food ingredient 8/17/15* 10/2/18 963 Accepted for 6 of 7 5/17/18
Ortho-phthalates as FCS 4/12/16** 5/20/22 1516 Denied 2/7/21
Lead acetate as cosmetic color additive 2/24/17 10/25/18 618 Accepted None
Bisphenol A as FCS 5/2/22 Pending
Red Dye No. 3 11/15/22 Pending
* Revised to 2/12/16 due to substantive amendments provided by petitioner.

** Revised to 3/26/18 due to substantive amendments provided by petitioner.

 

Next Steps

The agency should explain to Congress and stakeholders how it came up with its numbers and ensure accurate and transparent reporting.

NOTES

[1] The statutory deadline for a final decision on a food or color additive petition is 90 days, with an option to extend for an additional 90 days for a total of 180 days. See 21 U.S.C. §§ 348(c)(2) and 379e(d)(1). We do not know why FDA’s performance measure gives the agency twice as much time to complete a review than is allowed by the law.

[2] Long-chain PFAS food additive petition was processed in 356 days. See Table 3.

[3] FDA reported 100% for FY2014 in the 2016 report(p. 59) but did not include the number of FAPs/CAPs reviewed. In its 2023 report, the agency reported reviewing five FAPs/CAPs (p. 61) but did not provide the percentage of reviews that had been approved, withdrawn, or placed in abeyance in 360 days.

Posted in Deep Dives, FDA / Authors: / Comments are closed

Broken GRAS: FDA’s half-step to limit bias and conflicts of interest in GRAS determinations may backfire

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 15, 2023

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

What Happened? FDA finalized a long awaited guidance for industry in December to help reduce conflicts of interest and bias when a chemical manufacturer chooses to convene an expert panel to assess whether a new chemical additive is generally recognized as safe (GRAS).

Why It Matters: As written, FDA’s Best Practices for Convening a GRAS Panel guidance is excellent. If food companies convene GRAS panels consistent with the guidance, the panels’ evaluations will be more credible because they should have less of the pervasive bias and conflicts of interest that plague the current system and all too often result in unsafe chemicals being added to food. But that’s a big if.

Our Take: Unfortunately, we think the guidance is likely to backfire because of the limited scope — FDA explicitly makes GRAS panels optional – a choice the agency made when it finalized the GRAS rule in 2016. Chemical manufacturers will simply avoid convening GRAS panels, relying solely on their employees or a consulting firm they hire to conduct these safety evaluations. These employees and consultants typically have significant bias and conflicts of interest because positive opinions help their employer or client. We raised this issue in comments to FDA, calling for the best practices to apply to everyone involved in the safety evaluation process. FDA did not address our comments in their recommended best practices in the revised final guidance.

While making GRAS panels optional is a serious problem, a more fundamental concern is that FDA may not have an opportunity to review the GRAS safety evaluations made by employees or hire consultants because the company chooses not to notify the agency. FDA’s Office of Food Additive Safety fails to consider just how often companies choose not to tell the agency that a new chemical is being added to food. In our Broken GRAS series, we provided six examples of the serious risk posed by the GRAS system, the most public being hundreds of people sickened due to consumption of tara flour, an ingredient in a Daily Harvest frozen meal. Last November, using marketing materials we showed FDA that the number of new chemicals bypassing its review likely outnumber those voluntarily submitted to the agency.

We see no evidence that the agency systematically investigates or even audits the GRAS determinations that bypass their review despite promises made by the agency over the years and a scathing 2010 report by the U.S. Government Accountability Office calling for action.

Next Steps: In his effort to reform FDA’s dysfunctional food safety program, FDA Commissioner Califf told a reporter that “I want to throw in chemical safety as another really, really important area for the future – for humankind, really – and where science is evolving rapidly.”[1] If he follows through, fixing GRAS is an important step to rebuild consumer confidence and reduce the ongoing risk to public health. If he fails, the agency will continue to be hamstrung in preventing health risks posed by chemicals of unknown safety.

Go deeper: Broken GRAS series, Neltner et al (2013) Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe: Out of Balance; Toxic Free Act; Food Chemical Reassessment Act.

[1] FoodFix, January 31, 2023 edition.

Updated April 9, 2023 to add link for Broken GRAS series.

Posted in Broken GRAS, Conflict of interest, FDA, GRAS / Tagged , , , | Authors: / Read 1 Response

Unleading Baby Food: FDA’s proposed limits are a positive step, but…

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 1, 2023

Tom Neltner, Senior Director, Safer Chemicals

What Happened: FDA recently released draft action levels for lead in foods intended for babies and young toddlers.1 Action levels represent the point above which FDA is likely to regard food as adulterated – essentially unsafe – and seek a recall. This is a key step in implementing FDA’s Closer to Zero Action Plan.

  • Lead limits would be 10 parts per billion (ppb) for most foods.
  • Limits would be 20 ppb for dry infant cereals and single-ingredient root vegetable products, because these products may have greater lead contamination levels. (Root vegetables are primarily carrots and sweet potatoes.)

The new action levels do not apply to juices; FDA proposed limits on those in April 2022.

Why It Matters: There is no safe level of lead in the diet.

For young children living in homes without lead pipes or lead paint, diet is the primary source of their lead exposure. FDA makes clear in the proposal that:

“Even low lead exposure can harm children’s health and development, specifically the brain and nervous system. Neurological effects of lead exposure during early childhood include learning disabilities, behavior difficulties, and lowered IQ. Lead exposures also may be associated with immunological, cardiovascular, renal, and reproductive and/or developmental effects. Because lead can accumulate in the body, even low-level chronic exposure can be hazardous over time.”

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.

Our Take: We applaud FDA’s proposed limits, which are more protective than the European Union’s 2021 standards. BUT…on the flip side:

  • FDA failed to set action levels for popular grain-based snacks, like teething biscuits and snack puffs. The agency needs to rectify this failure with all deliberate speed.
  • More protective action levels are achievable, especially for non-rice cereals and for foods that don’t contain rice or root vegetables.
  • Proposed action levels do not apply to multiple categories of foods, including:
  • FDA’s justification for the draft action levels lacks transparency—undermining both credibility of the levels and the likelihood industry will comply with them.

In addition, USDA and industry need to expand their support for research on the methods for growing, harvesting, and processing root vegetables, rice, and quinoa to further reduce lead contamination in these important foods. Research should include both store-bought and homemade baby foods.

Go Deeper: Visit our new Deep Dives blog to see our 3-part series, which provides a more detailed analysis of FDA’s proposal—including our recommendations for setting more protective limits and improving the transparency and credibility of the agency’s process of setting action levels.

NOTES
1 FDA’s guidance refers to babies and young children. Younger than two is a very narrow definition of young children, especially since children up to age six are particularly vulnerable to the harm that lead causes to their brains. 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 “young toddlers” to avoid confusion.

Revised on March 21 to correct quote.

Posted in Deep Dives, FDA, Health policy, Health science, Public health, Unleaded Juice / Read 1 Response