Tag Archive for: Phthalates

EPA to Release Phthalate Cumulative Risk Assessment

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On December 10, 2024, EPA announced its schedule for completing Toxic Substances Control Act (TSCA) risk evaluations for five phthalates: BBP, DBP, DEHP, DIBP and DCHP.  In the next few weeks, EPA expects to release a draft risk evaluation for DCHP and a slew of supporting documents—including a first-of-its-kind cumulative risk assessment (CRA) for six phthalates as a class.

The CRA will mark the first time EPA has evaluated the combined risk to health from multiple chemicals with similar effects under TSCA section 6.  It is intended to inform, rather than replace, individual risk evaluations for each phthalate.

EPA justified the CRA in a draft proposal released in February 2023.  According to the agency, studies have shown “widespread exposure to some phthalates and that humans may become co-exposed to multiple phthalates at the same time,” possibly due to their use in food contact materials.  A particular concern is “phthalate syndrome,” a collection of adverse effects on the developing male reproductive system.

In the draft proposal, EPA announced the agency’s plan to address phthalate syndrome by focusing on the most sensitive effect rather than assessing the syndrome as a whole.  EPA also proposed to consider exposures to these substances from “non-TSCA exposures,” such as dietary intake, and to assess the phthalates “under an assumption of dose addition” using “a relative potency factor approach.”

Meanwhile, final risk evaluations for two additional phthalates, DIDP and DINP, are nearing release.  The risk evaluations for these substances were initiated at the request of the companies that produce them.  EPA intends to include DINP—but not DIDP—in its cumulative risk analysis.

Draft risk evaluations for BBP, DBP, DEHP, and DIBP are expected in the first quarter of 2025.  According to the December 10 announcement, final risk evaluations “will be released by December 2025.”

EPA’s Draft Risk Evaluation of DINP Finds Minimal Risks, but Determines That the Phthalate Presents an Unreasonable Risk

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On August 30, 2024, EPA released its draft risk evaluation for diisononyl phthalate (DINP).  The draft risk evaluation determined that most uses of DINP under the Toxic Substances Control Act (TSCA) “do not pose risk to the environment or the general population.”

The draft only identified three uses that “raise concerns” out of 47 evaluated conditions of use.  However, EPA preliminarily found that DINP presents an unreasonable risk of injury to human health due to the agency’s “single risk determination” approach to risk evaluations.

Two of these three uses were found to raise concerns for workers: industrial use of adhesives and sealants and industrial use of paints and coatings, specifically in scenarios in which unprotected workers used high-pressure sprayers.  According to the draft, these uses could create high concentrations of DINP in mist that an unprotected worker could inhale.

The other use—use of DINP in construction and building materials that cover large surface areas—was found to raise concerns for consumers.  This use could result in young children inhaling DINP-containing dust that settles “onto vinyl flooring, in-place wallpaper, and carpet backing and [is] resuspended into the indoor environment,” the draft says.

The draft risk evaluation identified developmental toxicity and liver damage as potential health effects of these types of exposures.  DINP also has the potential to cause “phthalate syndrome,” a collection of adverse effects on the developing male reproductive system, EPA said.

According to EPA, DINP is primarily used as a plasticizer to manufacture flexible polyvinyl chloride, better known as PVC.  Data from the Chemical Data Reporting rule indicates that hundreds of millions of pounds of DINP are manufactured annually.

EPA initiated the risk evaluation process after a 2019 request from ExxonMobil Chemical Company to review DINP and its chemical relative diisodecyl phthalate (DIDP).  EPA only found one concerning condition of use in DIDP’s draft risk evaluation, which was released this May.

DINP is a category of chemical substances which include 1,2-benzene-dicarboxylic acid, 1,2-diisononyl ester (CASRN 28553-12-0) and 1,2-benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich (CASRN 68515-48-0).

Amended TSCA requires EPA to issue a risk management rule to address any unreasonable risks found by the final evaluation.  Comments on the draft risk evaluation are due on November 4, 2024.

FDA Reaffirms Softening Chemicals are Okay for Food Packaging

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FDA recently denied a citizen petition requesting that the Agency prohibit the use of eight ortho-phthalates and revoke prior sanctioned uses for five additional ortho-phthalates in food packaging. Ortho-phthalates are used to soften plastics. They can be found in plastic film wrap on foods, cap gaskets used on the metal lids of glass jars, beverage caps, and other packaging.

The original petition was submitted by Earthjustice in 2016. FDA responded in May 2022, denying the petition; Earthjustice submitted a petition for reconsideration in June of that same year. Earthjustice stated that it filed the petition for reconsideration because FDA needed to consider the “mounting scientific evidence that phthalates in food cause serious harm,” evidence that has been developed since the petition was originally submitted.  According to Earthjustice, there is now significant scientific evidence that links phthalates to fibroid tumors in women and preterm births.

The petition for reconsideration alleged that FDA ignored the scientific information presented within the original petition, did not take new information into consideration when denying the petition, and failed to take action on the use of phthalates. In its response to the petition for reconsideration, FDA maintained that it did, in fact, assess the scientific information presented in the original petition, which it did not find persuasive enough to change its position on phthalate regulation at this time.

Further, under 21 CFR § 10.33, FDA is only required to grant a petition for reconsideration if all the following criteria apply:

(1) The petition demonstrates that relevant information or views contained in the administrative record were not previously or not adequately considered.

(2) The petitioner’s position is not frivolous and is being pursued in good faith.

(3) The petitioner has demonstrated sound public policy grounds supporting reconsideration.

(4) Reconsideration is not outweighed by public health or other public interests.

The Agency holds that no information was presented in the petition that has not already been presented and is, therefore, in the administrative record. Because all of the above requirements must be met for reconsideration without the presentation of new relevant information in the petition, FDA has no further obligation at this time.

FDA Rejects Phthalate Petition

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On May 19, 2022, the US Food and Drug Administration (FDA) announced that it has denied two petitions to ban phthalates in food packaging.  In conjunction with denying the petitions, the FDA accepted a petition requesting that the Agency stops authorizing 23 phthalates for use in food containers as they are no longer used by industry.

In addition to being in food containers, phthalates are used as additives in cosmetics, detergents, and shower curtains.  Industry often uses them to soften plastics.  Although allowed in many products, the 2008 Consumer Product Safety Improvement Act bans a concentration of more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP); dibutyl phthalate (DBP); or benzyl butyl phthalate (BBP) in all children’s toy and childcare articles.  Being exposed to concentrated amounts of phthalates can cause reproductive and developmental issues.

Multiple groups, including the Environmental Defense Fund and Earthjustice, have petitioned the FDA in the last decade to block the authorization of phthalates in food packaging, but the petitions have always failed, with the FDA citing a lack of information to justify blocking authorization of phthalates.

FDA’s acceptance of the petition to stop authorizing certain phthalates was due to the industry no longer using those substances. As the industry has abandoned use of those phthalates, the FDA found it appropriate to stop their authorization.  Currently, there are eight phthalates that the FDA still authorizes.  Shortly after the FDA’s announcement, they issued a request for information regarding current uses, levels, dietary exposure, and safety data for those phthalates.

CPSC Settles with NRDC Regarding the Restriction of Phthalates in Children’s Toys

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The U.S. Consumer Product Safety Commission (CPSC) and the Natural Resources Defense Council (NRDC) have reached an agreement in principle for the federal agency to issue a rule banning five chemicals, known as phthalates, that may cause reproductive harm from their exposure in children’s products. Those five phthalates are: diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DnPP), di-n-hexyl phthalate (DnHP), dicyclohexyl phthalate (DCHP); and diisononyl phthalate (DINP). While the CPSC reached a tentative agreement with the NRDC on the timetable for issuing a rule, the contents of the final rule will be made by a vote of the CPSC Commission.

Phthalates are a class of chemicals used to soften plastics and are commonly found in children’s toys. Three phthalates, di-(2-ethylhexly) phthalate (DEHP), dibutyl phthalate (DBP), and benzyl butyl phthalate (BBP), were banned from use in toys and other children’s products in concentrations above 0.1 percent in 2009 under the Consumer Product Safety Improvement Act, and three more were banned on an interim basis based on the same concentration limit the same day. The 2009 interim banned substances include diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), and di-n-octyl phthalate (DnOP).

The CPSC published a proposed rule in December 2014 and was supposed to issue a final order within 180 days to continue an interim ban on the five phthalates, DIBP, DnPP, DnHP, DCHP, and DINP, within children’s toys, however, the 180-day period stretched to 950 days as of last week.

The NRDC, along with the Environmental Justice Health Alliance for Chemical Policy Reform and the Breast Cancer Fund, filed a complaint in December of 2016 seeking injunctive and declaratory relief to force the CPSC to regulate the five phthalates in children’s products.

A consent decree is expected to be finalized within the month.

The case is Natural Resources Defense Council et al. v. U.S. Consumer Product Safety Commission, case number 1:16-cv-09401, filed in the U.S. District Court for the Southern District of New York.

CPSC proposes new ban on phthalates in children's products.

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Regular readers know that in terms of domestic, national regulation, we usually focus on developments coming out of the Environmental Protection Agency (EPA). In the U.S., the EPA is the principal federal agency that regulates chemicals in products, but it’s not the only one. Last month, the U.S. Consumer Product Safety Commission (CPSC) approved for publication a proposed rule prohibiting the use in children’s toys and child care articles of certain phthalates, a type of plasticizer used in teethers, plastic toys, home furnishings, and cosmetics.

The rule expands the existing “permanent ban” on phthalates at levels greater than 0.1% in accessible plasticized components of toys and child care products. Diisononyl phthalate (DINP) is shifted from the “interim ban” list and di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and butyl benzyl phthalate (BBP) remain on the “permanent ban” list. The rule also adds to the “permanent ban list” the following: diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP) in concentrations greater than 0.1%. Two other phthalates, diisodecyl phthalate (DIDP) and di-n-octyl phthalate (DnOP), were removed from the “interim ban” list.

The Commission proposed the rule under § 108 the Consumer Product Safety Improvement Act (CPSIA), which requires promulgation of regulations in response to the Chronic Hazard Advisory Panel’s report and recommendations on the health effects of phthalates in children’s toys and child care articles. Under the CPSIA, a “child care article” is “a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething.”

The Commission is accepting public comment on the proposed rule through March 16, 2015.