By Cassie Huang, MPH, Project Manager, Consumer Health
Note: This blog is cross-posted from the EDF + Business blog.
EDF Health
New updates to understanding packaging scorecard spur a safer & more sustainable foodservice industry
Posted in BPA, Food, Food contact materials, Food packaging, Markets and Retail
Tagged Chemicals in food, Food contact substance, Food packaging, Safer packaging
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Time for a new age for new chemicals
By Maria Doa, PhD, Senior Director, Chemicals Policy, Samantha Liskow, Senior Counsel, and Colin Parts, Legal Fellow
NOTE: This is the first of a series about EPA’s regulation of new chemicals.
What Happened?
EPA recently proposed regulations to govern how it reviews companies’ pre-manufacture notifications for new chemicals before those chemicals can go on the market.
Why It Matters
Unfortunately, as we noted in our comments to EPA [PDF, 721KB], the proposal falls significantly short of implementing the fundamental changes needed to ensure the safety of any new chemicals allowed onto the market.
Posted in Chemical regulation, Industry influence, TSCA
Tagged Chemical testing, EPA, New chemicals, regulation
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Alternative Figures: FDA’s food chemical reports to Congress don’t add up
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]
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Table 1: FDA’s Reporting of Office of Food Additive Safety Activity (Year of Budget Justification Reports) |
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| Fiscal Year | FAPs/CAPs
Filed/ Reviewed* |
FAPs/CAPs Percent Reviewed within 360 days |
| FY2015 |
10 / 11 |
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. |
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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.
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Table 2: Status of Food and Color Additive Petitions |
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| 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.
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Table 3: Timing of Review for Advocates’ Petitions |
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| 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
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National Teflon Day—Seriously?!
What’s National Teflon Day?
According to National Day Calendar, yesterday (April 6th) was “National Teflon Day”—a day to “celebrate” the accidental discovery in 1938 of a chemical called polytetrafluoroethylene (PTFE for short)—better known by the product it became associated with, Teflon™.
Teflon™ is PFAS Wrapped in a Bow
PTFE, the main component of Teflon™, is a fluorinated polymer that belongs to the PFAS chemical class—aka “forever chemicals.” PTFE is extremely heat- and stick-resistant—properties that lend themselves to a variety of uses, ranging from nonstick pans to semiconductors.
While some argue that PTFE itself does not present a health risk when used properly, the harms of PTFE become clear when you look across the chemical’s lifecycle—particularly the ways it’s produced and how it’s disposed of.
The Harms of PTFE Production
Harmful PFAS are used to produce PTFE and are also byproducts of the production process—exposing workers and surrounding communities.
PFOA—a notoriously toxic PFAS linked to cancer and heart disease—was used to manufacture PTFE for decades. In response to public pressure to phase out PFOA due to its harms, companies created other PFAS to replace PFOA—such as GenX, which has similar health effects as its predecessor. In addition to these harmful inputs, toxic PFAS byproducts are also created and released during the manufacturing of PTFE.
Decades of manufacturing PTFE have led to widespread PFAS contamination of our environment and our bodies.
The Harms of PTFE Disposal
At the end of the chemical lifecycle, fluoropolymers like PTFE may end up in a landfill—say, when you throw away your old Teflon™ pan. Over time, particles begin to disintegrate, leading to contamination of landfill liquids with PFAS that can then make their way into soil and drinking water.
Waste containing PTFE may also be incinerated. Burning of any type of PFAS is known to generate many other harmful PFAS—including potent greenhouse gases, such as tetrafluoromethane (which has a warming potential 6,500 times that of carbon dioxide).
Next Steps
Given the public health and climate effects of PTFE throughout its lifecycle, the next steps are clear: 1) Stop producing PTFE and other fluoropolymers for uses where there are clear alternatives; and 2) Stop celebrating the discovery of Teflon™ and the explosion of PFAS products (and pollution) that followed.
Posted in Environment, Public health
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Toxic Chemicals: Regulatory exemptions prioritize industry wants over safety needs
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 EPA, Industry tactics, New chemicals, Persistent Bioaccumulative and Toxic (PBT), PFAS, Risk assessment, Risk evaluation, TSCA reform
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Anti-androgenic chemicals as a class of related substances with cumulative toxicological effects
Maricel Maffini, consultant, and Tom Neltner, Chemicals Policy Director
Scientists and regulators have known for decades that certain chemicals disrupt the actions of male hormones—identified collectively as androgens—in the body. Because of their effects, these chemicals are called anti-androgens or anti-androgenic chemicals.
During gestation, fetal testes begin producing testosterone, the critical hormone required to develop reproductive organs and genitalia. Insufficient production of testosterone leads to malformation of the genital tract that may need corrective surgery in infant boys and may result in reproductive health problems later in life. Ortho-phthalates (aka phthalates), known to interfere with the production of fetal testosterone, are considered anti-androgenic chemicals.
Although phthalates are perhaps the most recognizable group of anti-androgenic chemicals in the diet, there are others, including bisphenol A (BPA), propyl paraben, and certain pesticides used in food crops. Because they cause similar harmful effects, namely adverse health outcomes for male reproductive system, their safety assessment must take into account the cumulative effects of similar substances in the diet as established by law. But what does “cumulative effect” mean? Below, we use a recent study to explain what it means, why it is important, and why FDA is failing.
Biology is not math and the concept of something from nothing Read More
Posted in Adverse health effects, FDA, Phthalates
Tagged Chemicals in food, Cumulative effect, Cumulative exposure, FDA, Food chemicals
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