Regulatory Developments

TSCA Work Plan for Chemical Assessments: EPA Adds and Removes Chemicals Based on New Data

October 23, 2014 PRINT

The U.S. Environmental Protection Agency (EPA) announced on October 23, 2014, that it has updated its Toxic Substances Control Act (TSCA) Work Plan for Chemical Assessments. According to EPA, the updated TSCA Work Plan reflects updated data submitted to EPA on chemical releases and potential exposures that EPA received as part of the Chemical Data Reporting (CDR) Rule and the Toxics Release Inventory (TRI) Program. EPA removed or consolidated 16 chemicals, most of which are believed to be no longer in commerce in the U.S. EPA added another 23 chemicals, stating that many were previously considered of "moderate" concern. EPA reportedly will consider the 23 chemicals added to the TSCA Work Plan for Chemical Assessments for assessment after 2017. The updated TSCA Work Plan contains 90 chemicals. More information is available on TSCA Work Plan Chemicals on EPA's website.

Chemicals Added to the TSCA Work Plan for Chemical Assessments

Action Plan Chemicals

Prior to developing the TSCA Work Plan for Chemical Assessments, EPA published ten chemical Action Plans. EPA states that five chemicals or groups of chemicals that scored "high" under the methodology developed for the TSCA Work Plan for Chemical Assessments for which EPA has Action Plans are now included in the TSCA Work Plan:

  • Bisphenol A (BPA);
     
  • Decabromodiphenyl ether (decaBDE);
     
  • Hexabromocyclododecane (HBCD);
     
  • Nonylphenols and nonylphenol ethoxylates (NP/NPE); and
     
  • Group of phthalates (dibutyl phthalate (DBP), butyl benzyl phthalate (BBP), di-(2-ethylhexyl) phthalate (DEHP), di-n-octyl phthalate (DnOP), di-isononyl phthalate (DINP), di-isodecyl phthalate (DIDP), and di-isobutyl phthalate (DIBP)).

EPA notes that, although a July 2014 report provided to the U.S. Consumer Product Safety Commission (CPSC) by the Chronic Hazard Advisory Panel (CHAP) on Phthalates and Phthalate Alternatives provided a risk assessment for the eight phthalates described in EPA's Action Plan, EPA is adding only seven of these chemicals to the TSCA Work Plan for Chemical Assessments to determine whether any additional assessment is needed to supplement the report and address any TSCA-specific uses or exposure scenarios. According to EPA, it is not adding di-n-pentyl phthalate (DnPP) because it is no longer in commerce.

EPA states that it is not adding the five remaining Action Plan chemicals, and provides the following information:

  • Benzidine dyes are only moderately persistent and bioaccumulative, and have not been found to be present in human biomonitoring. EPA will propose a significant new use rule (SNUR) for these chemicals so that it can review any new uses before they are introduced into commerce.
     
  • EPA has already begun risk management actions for long-chain perfluorinated chemicals (PFC), which rank high for hazard due to chronic and developmental toxicity. Use of one subgroup of PFCs (sulfonates) was discontinued in the U.S. from 2002 to 2006; additionally, under the 2010/15 PFOA Stewardship Program, eight companies committed to reduce global facility emissions and product content of PFOA and related chemicals by 95 percent by 2010, and to work toward eliminating emissions and product content by 2015. EPA remains concerned about PFCs being produced by companies not participating in the Stewardship Program, however, and is interested in gathering additional data regarding use of PFCs in imported articles before determining if these chemicals should be candidates for the assessment process.
     
  • The diisocyanates methylene diphenyl diisocyanate (MDI) and toluene diisocyanate (TDI) are not persistent and bioaccumulative, due to their reactivity, and are not found in house dust (factors considered in the Work Plan Methodology). EPA intends to issue a SNUR for TDI. Given the toxicity and potential exposure of these chemicals, EPA states that it will consider if other risk management actions are needed for these chemicals.
     
  • Short chain chlorinated paraffins are no longer domestically produced or imported into the U.S.

Other Chemicals Added

In addition to the five Action Plan chemicals EPA added to the TSCA Work Plan for Chemical Assessments, EPA added ten chemicals that it considered of moderate priority in 2012, and two chemicals that are part of a widely-used flame retardant. Ten of the chemicals added are part of a group of 345 chemicals EPA screened in 2012 during the development of the TSCA Work Plan for Chemical Assessments. They are:

  • 1,3-Butadiene;
     
  • 2,5-Furandione;
     
  • 2-Dimethylaminoethanol;
     
  • 2-Hydroxy-4-(octyloxy)benzophenone;
     
  • 3,3'-Dichloro-benzidine;
     
  • 4,4'-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA);
     
  • Barium carbonate;
     
  • Dicyclohexyl phthalate;
     
  • Molybdenum and molybdenum compounds; and
     
  • Pentachlorothiophenol.

When EPA scored these chemicals for the 2012 TSCA Work Plan for Chemical Assessments, these ten chemicals received a score of "moderate." According to EPA, recently submitted CDR and TRI data (in 2012 and 2011, respectively) indicate that these chemicals are being domestically produced or imported in greater quantities and are being used in a larger variety of consumer and children's products, leading to an increase in their exposure score and a subsequent increase in their final score to "high" under Step 2 of the screening process.

EPA states that it is adding the flame retardants triphenyl phosphate (TPP) and isopropylated phenol, phosphate (iPTPP), although EPA did not screen them in 2012. According to EPA, they came to EPA's attention as part of its analysis of flame retardant chemicals. Because TPP and iPTPP meet the screening criteria detailed in the methodology developed for the TSCA Work Plan for Chemical Assessments, EPA is adding them to the TSCA Work Plan for Chemical Assessments: 2014 Update.

Chemicals Removed from or Consolidated in the TSCA Work Plan for Chemical Assessments

Chemicals No Longer in Commerce

According to EPA, of the original 83 chemicals in the TSCA Work Plan for Chemical Assessments, 67 had no change or had an increase in their potential exposure to people and the environment, and most continue to be in the TSCA Work Plan for Chemical Assessments. EPA is removing 13 chemicals from the TSCA Work Plan for Chemical Assessments because they are not currently in commerce based on recent CDR and TRI data. EPA notes that though these chemicals may be toxic, persistent, and bioaccumulative, and may have been detected in human or environmental biomonitoring, they no longer present exposure potential from current consumer or commercial use. The chemicals being removed are:

  • 1,2,4,5-Tetrachloro-benzene;
     
  • 4-Chloro-2-methylaniline (p-Chloro-o-toluidine);
     
  • Benz(a)anthracene;
     
  • Dibenz(a,h)anthracene;
     
  • Dibromochloromethane;
     
  • Dichloroacetic acid;
     
  • Hexabromobiphenyl;
     
  • Hexachlorocyclohexane;
     
  • N-Nitroso-ethylamine;
     
  • N-Nitrosodimethylamine;
     
  • Pentabromophenol;
     
  • Polychlorinated naphthalenes; and
     
  • Tris(2,3-di bromopropyl) phosphate (TBP).

EPA states that it will continue to review data submitted for these chemicals. If new data indicate that these chemicals have returned to commerce, EPA will update the TSCA Work Plan for Chemical Assessments.

Special Cases

EPA states that it is removing mercury and mercury compounds from the TSCA Work Plan for Chemical Assessments "because their hazards are already well characterized and EPA has a strong risk reduction effort in place." EPA is also removing quartz from the TSCA Work Plan for Chemical Assessments "because it presents a hazard only in the context of silicosis from the inhalation of very fine crystalline dust particles, which might occur only during such occupational activities as sandblasting or stone cutting; these potential exposures are specifically controlled under regulations issued by the Occupational Safety and Health Administration."

Polycyclic Aromatic Hydrocarbons

EPA states that it believes benzo[a]pyrene and other polycyclic aromatic hydrocarbons (PAH) should be assessed as a category rather than as individual chemical substances. According to EPA, the exposure and release information EPA receives about PAHs is generally reported as a mixture of several PAHs, and not as individual chemicals. EPA intends to evaluate several PAHs, including benzo[a]pyrene, as part of an assessment of creosote under the TSCA Work Plan for Chemical Assessments. EPA is removing additional individual PAHs previously on the TSCA Work Plan for Chemical Assessments since they are no longer in commerce.

Commentary

This is EPA's first update to the TSCA Work Plan for Chemical Assessments. Bergeson & Campbell, P.C.'s March 2, 2012, memorandum concerning EPA's announcement of the TSCA Work Plan Chemicals is available online. In light of the recent collapse of TSCA reform efforts, EPA's continued efforts to use its current authority to regulate existing chemicals should be noted.

EPA has been faithful to its commitment to progress the Work Plan Chemicals approach and has demonstrated once again that the approach is effective. New chemicals have been added to the TSCA Work Plan based on CDR and TRI data, and other chemicals have been removed from the TSCA Work Plan for Chemical Assessments either based on new data or special circumstances in the case of mercury, mercury compounds, and quartz. This reflects a certain nimbleness and elasticity in the program, features that are essential to the success of any chemical assessment process. The update also speaks favorably of the Work Plan's ability to accommodate new information and recalibrate on an ongoing basis. It also demonstrates a fact that we all know to be true, but sometimes overlook, namely the utility of EPA databases such as the CDR and TRI, and the role these data place on influencing EPA's regulatory priority setting process.

Although TSCA reform legislation was not in the cards for this Congressional session, it is good to see EPA administratively making good progress on the TSCA Work Plan for Chemical Assessments.


 
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