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New Turn for Asbestos Reporting Under TSCA

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A court ruling in the final days of 2020 for asbestos reporting under the Toxic Substance Control Act (TSCA) may finally steer the EPA’s review of asbestos back in the right direction.

How the incoming Biden Administration responds to these developments will impact whether asbestos is finally labeled a toxin under TSCA and the extent of new asbestos reporting requirements for continued industry use of asbestos.

Background

A 2016 bipartisan amendment to TSCA created an agency review standard that seemed likely to result in asbestos finally being identified by the EPA as a toxin.  However, the EPA under the Trump Administration created a very narrow analysis based on too little information.  Legal challenges to that approach, coupled with the COVID-19 pandemic, slowed the final scope and status of the EPA’s asbestos risk analysis. Though the EPA released the first part of its risk evaluation on December 30, 2020, a federal district court decision handed down on December 22, 2020 could force the EPA to drastically change its assessment.    

Court ruling involving asbestos reporting

The federal district court ruling involved two cases – one brought by the Asbestos Disease Awareness Organization (ADAO) and a second filed by several states attorney generals.  Judge Edward Chen, in his 36-page ruling, found that the asbestos-containing products identified by the agency during the rule making process “appear to be only the tip of the iceberg.” Chen also held that gaps in the agency’s information create risk evaluation models which don’t have the ability to “make accurate assessments that capture all ‘reasonably available’ data.”

The Court ordered the EPA to make significant changes to its TSCA Chemical Data Reporting (CDR) Rule to close several loopholes. These include considering more in-depth information about potential uses of asbestos for its risk evaluation.  Judge Chen’s order also addressed closing two additional loopholes:  ending the reporting exemption for products with “impurities” (like asbestos contaminated talc products) and requiring current processors of asbestos products to report those uses. 

What happens next?

Assuming the Biden Administration chooses not to appeal Judge Chen’s order,  the district court’s opinion will require EPA to amend its TSCA Chemical Data Reporting (CDR) Rule to require additional asbestos reporting from companies using asbestos and raw material that may be contaminated with asbestos – such as talc-based cosmetics. The data gathered through additional reporting may require the EPA to revise its conclusions or conduct yet another evaluation.  

This will impact not only the EPA’s Part 1 – risk evaluation of current asbestos uses, but Part 2 as well – risk evaluation for legacy uses of asbestos. Safer consumer products and cosmetics could also be the upshot of more stringent asbestos reporting requirements.

Industry Methods of Screening Talc for Asbestos Are Lacking

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The Environmental Working Group (EWG) found by using electron microscopy, the cosmetic industry methods of screening talc for asbestos are lacking. Of the myriad cosmetics tested by the Scientific Analytical Institute (SAI), nearly 15% showed the presence of asbestos.

Methods of screening talc for asbestos are lacking

Incredibly, the Food and Drug Administration (FDA) doesn’t require testing for asbestos in talc. Though it may be “only” in trace levels there is no safe level of asbestos exposure.

Sean Fitzgerald, who leads the SAI based in Greensboro, NC, said, “It is critical that the FDA develop a rigorous screening method for talc used in personal care products. The lab repeatedly finds asbestos in products made with talc, including cosmetics marketed to children. Last year several children’s cosmetic products at Claire’s and Justice were found to contain asbestos. This includes products beyond cosmetics: children’s toys, crayons, chewing gum, and feminine hygiene as a few samples. It’s outrageous that a precise method for testing personal care products for the presence of asbestos exists, but the cosmetics industry isn’t required to use it.”

Why is asbestos often found in talc?

Rather than perform rigorous testing to verify there is no asbestos, the government promotes careful selection of mines to avoid asbestos contamination.

The talc and asbestos are often mined in close proximity and for industrial, cosmetic and a wide variety of other uses. This leads to potential intertwining in veins and a high possibility of cross-contamination. 

Why is asbestos a problem?

Science confirms there is no safe level of exposure to asbestos. The fibers contained in the asbestos are released into the air when the material holding them is disturbed. Inhaling these fibers can lead to serious diseases, such as lung and ovarian cancer, asbestosis, and the deadly mesothelioma. Talc products are often distributed as loose powders, a sure way to allow inhalation to anyone using them or in the vicinity.

Approximately 15,000 Americans die each year because of exposure to asbestos according to Scott Faber, Senior Vice President of the Environmental Working Group.

What’s next?

In March of 2019, Representatives Debbie Dingell (D-MI) and Jane Schakowsky (D-IL), introduced The Children’s Product Warning Label Act. This act required products marketed to children have a warning label declaring the product was not evaluated for asbestos content. To avoid the label, the product would require a written certification from the HHS Secretary that the product is from an asbestos-free mine and include proof to the FDA that the product is asbestos-free through testing by an electron microscopy method. At this time, there has been no action on the bill.

No other bills to increase testing for asbestos in talc products are pending. 

Talc Safety Topic of Congressional Hearings

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Talc safety has been a concern for years. More recently, the clear possibility of asbestos contamination in talc has led to heightened concern about critical diseases, such as mesothelioma and ovarian cancer being caused by use of talc based products.  

Why is asbestos connected to talc safety?

Both talc and asbestos are minerals found in underground mines. Geologists know that these two minerals are often found intertwined in veins, making cross-contamination a real risk.

Talc everyday uses

Aside from baby powder, talc is used in a wide range of cosmetics for its moisture absorption and silkiness. Recently asbestos was found in four cosmetic products from Claire’s and Justice – both catering to makeup for children. It was also used for feminine hygiene, crayons, children’s toys, chewing gum, and a plethora of common products. There is no safe level of asbestos as its microscopic fibers can infiltrate lungs and harbor the potential for developing into lung cancer, asbestosis, and the deadly mesothelioma for fifty years or more.

Congressional hearings on talc safety

Concerns recently grew when the FDA found asbestos in several products, including baby powder. An initial hearing was conducted in March of 2019 over cosmetic talcum powder’s safety. This hearing specifically focused on talc’s connection with ovarian cancer.

The second hearing was launched when the FDA found asbestos in a sample of Johnson & Johnson’s (J&J) baby powder in October 2019. Under consideration may be the use of warning labels or regulation of talc products.

Congress speaks

The hearing questioned the testing methods used.  William Longo, founder of Materials Analytical Service, stated, “Independent labs throughout the country and over the course of several decades have documented the presence of asbestos in consumer talc products, including Johnson & Johnson’s baby powder. The methods used in the past and today by the industry are not sensitive enough to detect trace levels of asbestos.”

While Longo once denied the presence of asbestos in talc, he stated there is now more sensitive testing. He also received access to thousands of internal J & J documents showing their knowledge of small amounts of asbestos in their talc for decades. There is no safe level, yet J&J kept this information from regulators and the public. Protecting the J&J brand and the public trust of their products was their focus. They now have paid out billions of dollars in thousands of lawsuits with thousands more in process.

The House of Representatives Subcommittee on Economic and Consumer Policy tried to convince the CEO of Johnson & Johnson, Alex Gorsky, to testify at the hearing. He turned down the invitation.

Charles M. Elson, director of the John L. Weinberg Center for Corporate Governance at the University of Delaware, said Gorsky’s refusal made sense as the “CEO and his advisers probably figured that the downside was greater to testifying than not.”

Claire’s Finally Pulled Their Products Containing Asbestos

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Claire’s finally pulled their products containing asbestos when the FDA affirmed the presence of asbestos after testing in 2017 and 2018. Though the removal was voluntary, it occurred only after the FDA issued a warning against the three contaminated products. Since the FDA does not have jurisdiction, they believed this was warranted since Claire’s initially “refused to comply with the FDA’s request, and the agency does not have authority to mandate a recall.” Claire’s steadfastly refuted the FDA’s findings, asserting “the products were “extensively tested by multiple independent accredited laboratories” and “all products were found to be compliant with all relevant cosmetic safety regulations.”

Meanwhile, Frank Pallone, Jr, Energy and Commerce Chairman, stated, “Examples like Claire’s’ refusal to voluntarily recall their asbestos-tainted products demonstrates the need to modernize the current regulatory framework for cosmetic and personal care products to ensure that the FDA can act to protect consumers when industry fails to do so.”

Claire’s finally pulled their products

Claire’s sold the affected products between October 2016 and March 2019. While they are no longer in the stores, some households possibly continue to harbor the three products pinpointed. To check your home, the products are:

• Claire’s Eyeshadows, UPC #888711847165, SKU #84716, Lot No. 08/17
• Claire’s Compact Powder, UPC #888711839153, SKU #83915, Lot No. 07/15
• Claire’s Contour Palette, UPC #888711401947, SKU #40194, Lot No. 04/17

The identifying numbers are found on the price stickers on the product. Batch numbers are found beneath the ingredient lists on the back panels.

The original products pulled from stores in December of 2017 were Ultimate Mega Make Up Set, Metallic Hot Pink Glitter 48-Piece Makeup Set, Bedazzled Rainbow Heart Makeup Set, Rainbow Bedazzled Star Make Up Set, Rainbow Glitter Heart Shaped Makeup Set, Mint Glitter Make Up Set, Rainbow Bedazzled Rectangle Make Up Set, and Pink Glitter Palette with Eyeshadow & Lip Gloss. Again, if these still remain in your home, dispose of them or return the item to the Claire’s store.

For more information

If you want more information, contact Claire’s at 800-252-4737, option 2, from 9:30 AM – 7 PM EDT.

FDA Affirms Asbestos Found in Cosmetics Targeting Teens

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Asbestos found in cosmetics targeting teens and preteens continues to be a problem in a statement from the Food and Drug Administration (FDA) this week. This affirmation is the result of testing performed by U.S. PIRG, a consumer advocate group, in both 2017 and 2018. These three branded cosmetic products from Claire’s and one sold by Justice, were among those tested in 2017 and again in 2018. The Claire’s products tested positive for tremolite asbestos in 2018 as did the Justice product.

Why is asbestos found in cosmetics harmful?

After years and decades of testing, it is proven than there is no safe level of exposure to asbestos. Asbestos that is in solid form, such as shingles, left untouched is a potential danger, but asbestos that is loose, as found in powders and other cosmetics, is definitely dangerous. These products are easily inhaled or ingested which can lead to lung cancer and even mesothelioma – a deadly disease. In addition, these products targeted young girls, still growing and developing.

Claire’s rebuttal

In all testing, Claire’s contends there is no danger and that the U.S. PIRG report is faulty and misleading. In their independent testing, no asbestos fibers were found, however they have not disclosed their testing methodologies or results.

Claire’s spokeswoman, Melanie Berry said in a statement, “The FDA test reports have mis-characterized fibers in the products as asbestos, in direct contradiction to established EPA and USP criterion for classifying asbestos fibers.” “Despite our efforts to discuss these issues with the FDA, they insisted on moving forward with their release. We are disappointed that the FDA has taken this step, and we will continue to work with them to demonstrate the safety of our products.”

Claire’s filed for bankruptcy in the US in March 2018 and came out of it in October of 2018

FDA response

“Our lab is accredited by the U.S. National Institute of Standards and Technology NVLAP program. The FDA used a lab on this accredited list for their cosmetics testing for asbestos (AMA Analytical Services) as well as another lab on the list, STAT Analysis Corporation.”

Why are cosmetic companies allowed to sell these products?

The FDA cannot force a company to remove asbestos-laden products because there are no laws requiring testing cosmetic products for safety. “The FDA is today announcing the results of these tests. Those tests confirmed the presence of asbestos in three of the product samples collected from Claire’s and one of the product samples collected from Justice. All suspect Justice products, including the one testing positive for asbestos, were previously recalled from the market in 2017. The FDA issued a Safety Alert today warning consumers to discontinue use of three Claire’s products: Claire’s Eye Shadows – Batch No/Lot No: 08/17; Claire’s Compact Powder – Batch No/Lot No: 07/15; and, Claire’s Contour Palette – Batch No/Lot No: 04/17 because they tested positive for asbestos.

In an FDA press release published on March 5, 2019, the following statement was made, “The FDA requested that Claire’s recall the products because they should not be used by consumers. Claire’s has refused to comply with the FDA’s request, and the agency does not have authority to mandate a recall. The FDA is therefore warning consumers not to use these products and will continue to communicate our safety concerns about them.“

Until laws requiring testing are enacted, the FDA requests cosmetic firms to take voluntary measures to register in the FDA’s Voluntary Cosmetic Registration Program (VCRP.) The FDA also asks manufacturers to voluntarily report any negative effects involving cosmetic products.

While the FDA was told there are no more asbestos-tainted products in the Claire’s stores, they caution anyone who has them in their homes should stop using them.