EPA grants partial exemption from Chemical Data Reporting rule for six biodiesel chemicals.

Today, EPA announced that six biodiesel chemicals will be partially exempt from certain reporting requirements of the Chemical Data Reporting (CDR) rule, under section 8(a) of the Toxic Substances Control Act (TSCA). The Final Rule amends the list of chemical substances exempt from submitting processing and use information by adding the six chemicals, all of which are involved in the production of biodiesel. These chemicals will still be subject to other CDR reporting requirements, on facility and manufacturing and import volume information.

The affected chemicals and their Chemical Abstract Services Registry Numbers (CASRNs) are:

  • Fatty acids, C14-18 and C16-18 unsaturated, methyl esters (CASRN 67762-26-9);
  • Fatty acids, C16-18 and C-18 unsaturated, methyl esters (CASRN 67762-38-3);
  • Fatty acids, canola oil, methyl esters (CASRN 129828-16-6);
  • Fatty acids, corn oil, methyl esters (CASRN 515152-40-6);
  • Fatty acids, tallow, methyl esters (CASRN 61788-61-2); and
  • Soybean oil, methyl esters (CASRN 67784-80-9).

This partial exemption was granted as part of the petition process for “Low Current Interest” chemicals developed in 2003. Under this process, EPA considers the “totality of information” available for a particular substance and certain considerations, defined in the regulations, including the availability of other risk screening information and whether potential risks of the substance are adequately managed, in determining the agency’s “current assessment of the need for collecting CDR processing and use information.” The agency stresses that this process is not necessarily based on potential risks, and interest may increase in the future, in which case the agency would reconsider the applicability of the partial exemption.

In this case, EPA determined that it had low current interest in processing and use information for the six substances. The analyses (“Review Reports”) for the individual chemicals are available at docket number EPA-HQ-OPPT-2014-0809.

These chemicals were requested to be added to the partial exemption list in a petition submitted by a biofuels industry group in October 2014. EPA initially granted the petition in a Direct Final Rule published in January 2015, but withdrew the rule in March 2015 after receiving an adverse comment to the Direct Final Rule. The agency proposed to make the same additions to the partial exemption list in a Proposed Rule published July 22, 2015; the Final Rule announced today makes no changes from that Proposed Rule. However, the Final Rule does discuss comments submitted by the petitioner arguing that these biodiesel chemicals should be treated similarly to comparable “petroleum process” chemicals, which the EPA has designated partially exempt because the agency “believes worker exposure is diminished.” The agency made “no determination” on the petitioner’s argument that the biodiesel chemicals should be partially exempt because they share similar manufacturing conditions, properties, and uses as petroleum process chemicals, since the issue is “moot” as the agency is now granting equivalent partial exemption under the “Low Current Interest” process.

The EPA signed the Final Rule on March 22, 2016. The partial exemption goes into effect when the rule is published in the Federal Register, which should be well before the June 1 start of the 2016 CDR reporting cycle.

EPA and others weigh in on TSCA reform, but no reconciliation in sight.

Although both chambers of Congress approved legislation in 2015 to modernize the Toxic Substances Control Act (TSCA), there has been little proof of progress towards reconciling the two bills, while stakeholders, including the United States Environmental Protection Agency (EPA), have been active in providing feedback and recommendations to legislators. However, Senator James Inhofe (R-OK), Chairman of the Senate Environment and Public Works Committee, recently told Bloomberg BNA that an agreement on merging the bills could happen before the next Congressional recess.

Overall, the EPA prefers the Senate version of legislation to update TSCA, according to a letter [PDF] sent earlier this year to Congressional leaders. EPA Administrator Gina McCarthy provided the Agency’s most comprehensive comments to date on the TSCA modernization bills passed by both houses of Congress in a letter dated January 20, 2016 but not made public until the beginning of March. The letter stops short of expressly recommending that the Senate bill be adopted as the framework for final legislation, but voices the EPA’s preference for various aspects of the Senate version while also approving certain provisions found in both bills. The EPA’s comments are based on the Administration’s previously discussed principles for TSCA reform, and were submitted to help negotiators reconcile the two bills, emphasizing that “[t]he lack of a workable safety standard, deadlines to review and act on existing chemicals, and a consistent source of funding are all fundamental flaws in TSCA that should be addressed.”

In particular, the EPA expressed support for the following aspects of the Senate bill:

  • Deadlines for chemical assessments and a requirement to repopulate the high-priority list until all chemicals on the TSCA Inventory have been evaluated;
  • Considerations EPA must assess in choosing a risk management measure, including costs and benefits of alternative ways to achieve the safety standard, based on reasonably available information;
  • Prioritizing chemicals for review based on manufacturer requests, subject to a cap on the number of manufacturer-initiated evaluations and funding from requestors;
  • Authorizing fee collection for the cost of reviewing confidential business information (CBI) claims, section 5 notices, prioritization decisions, safety assessments, and rulemakings;
  • Regulatory flexibility under a new section 6(d), providing “catch-all” regulatory authorities;
  • Affirmative safety determinations for new chemicals;
  • Strengthened civil and criminal enforcement authorities; and
  • Clarifying the types of state laws that are intended to be protected from federal preemption.

However, the EPA also wrote that it “strongly prefers the House bill” on the matter of implementation, because the Senate version’s deadlines and procedural requirements “may unnecessarily slow progress on more substantive issues, limit the EPA’s flexibility to allocate resources appropriately, and lead to burdensome litigation.” The letter also identifies some areas where both bills need improvement, or where the Senate version was not singled out as preferable, such as new use notification requirements for chemicals in articles.

The Hill reported that, after receiving the letter and incorporating suggestions from it, leaders of the House Energy and Commerce Committee Fred Upton (R-MI) and Frank Pallone Jr. (D-NJ) “sent an offer to the Senate …as the first formal step in negotiating toward a bill.” This offer addressed EPA’s main concerns by, for example, capping the number of industry-initiated risk evaluations, increasing funding for the program, and providing for safety determinations for new chemicals. The offer was reportedly made at the end of February but there have not been any public reports on whether the Senate responded or whether any other progress has been made since early March.

Plans to merge the competing bills might have been thrown off track earlier this month following reporting from the New York Times on a provision in the House legislation that “could help shield [Monsanto] from legal liability” related to its manufacture of polychlorinated biphenyls (PCBs). The article has drawn criticism of the House bill from some NGOs and even Presidential candidate Hillary Clinton.

Meanwhile, even more stakeholders have weighed in with their concerns and priorities. Environmental regulators from eight states, including California and New York, submitted a letter in early February focusing on the bills’ approaches to preemption issues. In late February, the American Alliance for Innovation, an umbrella group of dozens of trade associations, outlined its priorities for consideration in conference discussions.

Although Congress is perhaps closer than ever to passing a TSCA modernization bill, there has been little indication that legislators are making progress in getting legislation to the President’s desk. These most recent stakeholder comments may be just what Congress needs to speed up the process.

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