EPA proposes TRI reporting for the diisononyl phthalate category

The EPA this week proposed a rule to add diisononyl phthalate (DINP) as a category to the list of toxic chemicals subject to the reporting requirements under the Emergency Planning and Community Right to Know Act (EPCRA) and the Pollution Prevention Act (PPA). The EPA concluded that this category met the EPCRA toxicity criterion because it can reasonably be anticipated to cause cancer and serious or irreversible chronic health effects in humans. The proposed rule was published in the Federal Register on August 8, 2022.

BY PATRICIA ISCARO, ESQ. | AUG 11, 2022 7:06 PM EDT

Once finalized, the EPA’s proposed rule would add a new category of chemicals, diisononyl phthalate (DINP) to the Toxics Release Inventory according to the requirements of EPCRA. The new rule must be finalized no later than January 31, 2023.

What is DINP?

  • The diisononyl phthalate (DINP) category is a family of di-ester phthalates that are colorless, oily liquids with high boiling points, low volatilities, and are poorly soluble in water.
  • DINPs are used as plasticizers and in the production of coated fabricselectrical insulation, and vinyl flooring. Multiple identifiers known as Chemical Abstracts Service (CAS) numbers are associated with DINPs. Two common CAS RNs associated with the category are: 28553-12-0 and 68515-48-0.
  • In 2013, California’s Office of Environmental Health Hazard Assessment (OEHHA) classified DINP as a human carcinogen and published a document on the carcinogenicity of DINP by the Carcinogen Identification Committee (CIC) concluding that DINP causes cancer and should be listed under California’s Proposition 65 as a carcinogen.
  • In 2017, the U.S. Consumer Product Safety Commission (CPSC) issued a final phthalates rule prohibiting child care articles and any children’s toys that can be placed in a child’s mouth containing concentrations of more than 0.1 percent of DINP (82 FR 49938), 16 CFR part 1307).
  • Also in 2017, DEHP was classified by the International Agency for Research on Cancer (IARC) as possibly carcinogenic to humans (Group 2B). The EPA classified DEHP, (CAS RN 117-81-7) as a Class B2 (probable human carcinogen) carcinogen.

The EPA first proposed adding DINP to the list of toxic chemicals subject to reporting under the TRI on September 5, 2000.

  • Quick background on TRI: The Toxic Release Inventory (TRI) database was created by Section 313 of the Emergency Planning and Community Right-to-Know Act or ( EPCRA). Under EPCRA, facilities that manufacture, process, or use chemicals listed on the TRI over a specified threshold amount are required to annually report the quantity of the chemicals that are released, emitted, or discharged into the environment, unless an exemption is applicable. The reporting period is the calendar year and the deadline for reporting is July 1 of the year following the reporting year.
  • The EPA’s proposed rule was published in response to a petition submitted in February 2000 by the Washington Toxics Coalition (WTC), now known as ToxicFree Future, to add the DINP to the TRI list as it met the criteria for listing under section 313 of EPCRA.
  • WTC’s argument: EPCRA allows “any person” to petition the EPA to add a chemical to the TRI list because of the chemical’s known or reasonably anticipated adverse effects on human health. EPA may add chemicals to the TRI list which are known to cause or can reasonably be anticipated to cause in cancer or teratogenic effects, or serious or irreversible in humans such as: reproductive dysfunctions, neurological disorders, heritable genetic mutations, or other chronic health effects.
  • Once EPA receives a petition, it must either “[i]nitiate a rulemaking to add or delete the chemical to the list” or “[p]ublish an explanation of why the petition is denied” within 180 days from receipt.
  • Although the EPA proposed a rule to add DINP to the TRI within 180 days, it failed to finalize the rule. The next action EPA took was to publish an updated hazard assessment for DINP on June 14, 2005 (70 Fed. Reg. 34437).

More than twenty years later, the EPA is now proposing to add DINP as a category to the TRI, pursuant to lawsuit filed in September 2021.

  • The plaintiffs, the Breast Cancer Prevention Partners, Sierra Club, Defend our Health, and Texas Environmental Justice Advocacy Services, brought the suit in the U.S. District Court for the Northern District of California, (Case No. 4:21-cv-07360-HSG) declaring the EPA unreasonably delayed taking final action in its proposed rulemaking in 2000 to list DINP on the TRI.
  • In the proposed rule, published in the Federal Register on August 8, 2022, EPA concludes that the available cancer data provides a sufficient basis for listing DINP on the EPCRA section 313 toxic chemicals list because it demonstrates that DINP can reasonably be anticipated to cause cancer in humans.
  • As EPA explained in 1994, EPCRA allows the EPA to add a chemical category to the list in cases where EPA identifies the toxic effect of concern for at least one member of the category and then shows why that effect can reasonably be expected to be caused by all other members of the category.
  • EPA is proposing to add DINP as a chemical category under the name Diisononyl Phthalates (DINP): “Includes branched alkyl di-esters of 1,2 benzenedicarboxylic acid in which alkyl ester moieties contain a total of nine carbons,” due to their structural similarity.
  • The lawsuit resulted in a consent decree signed on June 16, 2022 ordering the EPA to finalize the proposed rule EPA published in February 2000 no later than January 31, 2023, or withdraw the proposed rule.
  • Comments on the proposed rule (EPA-HQ-TRI-2022-0262) may be submitted on or before October 7, 2022.

How this will affect manufacturers or processors of the DINP category of chemicals

  • TRI reporting is required for chemicals that may cause cancer and/or other chronic human health effects; and/or have significant adverse acute human health or environmental effects. Large manufacturing facilities report data to the TRI as well as industries involved in metal mining, electric power generation, chemical manufacturing, and hazardous waste treatment. By requiring information to be reported to the EPA and made public, the EPA hopes to prevent major accident hazards/accidents.
  • EPCRA requires owners/operators of certain facilities that manufacture or process more than 25,000 pounds of DINP-category chemicals per year (or that use more than 10,000 pounds of DINP-category chemicals per year) to report their facilities’ environmental releases and other waste management information on such chemicals annually (42 U.S.C. 11023(d)11023(e)(1) and 11048). These facility owners/operators must also report pollution prevention and recycling data for such chemicals, pursuant to Section 6607 of The Federal Pollution Prevention Act of 1990 (PPA, 42 U.S.C. 13106). The PPA focuses on source reduction of pollution from hazardous substance, and Section 6607 requires that facilities report additional data on waste management and source reduction activities to the TRI.
  • Facilities required to report must have 10 or more employees, fall under one of the required industries and exceed the established threshold imposed for the relevant chemical. A TRI Form R is submitted for each TRI-listed chemical a facility manufactures, processes, or otherwise uses in quantities above the reporting threshold. TRI data and tools are available here.
  • A facility will report data about how they are managing chemical waste through environmental releases (into the air, water, and land); recycling, energy recovery, treatment, and disposal for the calendar year by July 1 of the following year.
  • Facilities also report on prevention and reduction measures taken for waste. Facilities prepare and submit Toxics Release Inventory reporting forms using TRI-MEweb. This software guides facility representatives through the steps for completing, reviewing, and submitting TRI reporting forms on EPA’s Central Data Exchange or CDX. Tutorials and webinars on submitting forms may be reviewed here.

To contact the author of this item, please email  Patricia Iscaro

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