The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

Monday, September 12, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time

Register Today

Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®) and Chemical Watch have collaborated to present a series of complimentary webinars on the reformed Toxic Substances Control Act (TSCA). Webinar 3 -- Inventory, CDR, and CBI will cover:

  • Section 8 Reporting and Retention of Information
     
    • Small Manufacturer Definition;
       
    • Reporting by Processors;
       
    • Byproduct Rulemaking and Reporting;
       
    • TSCA Inventory; and
       
    • Nomenclature.
       
  • Section 14 Confidential Business Information (CBI)
     
    • Information Not Protected;
       
    • Asserting CBI;
       
    • Presumptive CBI;
       
    • Requirements for CBI Claims;
       
    • Exemptions to Protection from Disclosure;
       
    • Review and Resubstantiation;
       
    • Duties of Administrator; and
       
    • Criminal Penalties.

Previous webinars in the series:

Webinar 1 -- The New TSCA -- Overview and Summary of Major Changes: What to Expect and When to Expect It, June 13, 2016; and

Webinar 2 -- Impacts on New and Existing Chemicals Programs (TSCA Sections 4, 5, and 6), July 14, 2016.

To request materials from previous webinars, please contact .(JavaScript must be enabled to view this email address).


 

Bergeson & Campbell, P.C. (B&C®) is pleased to offer a complimentary webinar that will include a review of the Chemical Data Reporting (CDR) rule elements, a highlight of changes that will come into play for 2016, and some helpful hints on how to get prepared. Kathleen M. Roberts, Senior Regulatory Consultant at B&C; and Executive Director of the Biobased and Renewable Products Advocacy Group (BRAG®), and Richard E. Engler, Ph.D., Senior Chemist at B&C, will discuss the basic requirements of CDR reporting that apply to manufacturers and importers of chemical substances subject to the Toxic Substances Control Act (TSCA), as well as new changes, which include:

  • Expansion of years to report on production volume information;
     
  • Varied reporting thresholds for subject chemicals;
     
  • Potential exclusion of reporting exemptions; and
     
  • Utility of CDR data for Next Generation Compliance initiatives.

The webinar will be presented on May 3, 2016, from 1:00 p.m. - 2:00 p.m. (EDT), and will consist of 45 minutes of presentation, followed by a 15 minute Q&A period. Registration is available online. Please contact .(JavaScript must be enabled to view this email address) with any questions.


 

In less than two months, renewable fuel and biobased chemical companies that have successfully moved from research and development to commercialization will be required to respond to the U.S. Environmental Protection Agency's (EPA) Chemical Data Reporting (CDR) rule under the Toxic Substances Control Act (TSCA). This may come as a surprise to some biobased chemicals companies that are under the misperception that they are not regulated under TSCA. This is simply wrong. Unless otherwise regulated as a pesticide, food, food additive, drug, cosmetic, or nuclear material, biobased chemicals used for a commercial purpose, including fuels regulated under the Renewable Fuel Standard program, are subject to the rules and requirements under TSCA. Companies that do not comply are subject to enforcement actions and significant fines of up to $37,500 per violation, per day.

The reporting window for the 2016 CDR is June 1, 2016, to September 30, 2016. CDR reporting includes detailed information on volumes of chemicals produced, imported, used on site, and exported. It also requires information on amounts and functions for downstream uses in industrial, commercial and consumer applications. CDR reporting is further complicated with numerous potential exemptions that must be carefully analyzed for applicability. Bergeson & Campbell, P.C. (B&C®) is hosting an informational webinar on CDR reporting on May 3, 2016, from 1:00 p.m. - 2:00 p.m. (EDT). All impacted stakeholders are invited to participate, but companies new to the TSCA arena and CDR reporting are urged to attend.


 

As reported in last week's Update, EPA published its final rulemaking expanding the list of chemicals partially exemption from certain additional chemical data under the CDR. This action, which formally amended the list of chemicals that do not have to report the onerous downstream processing and use information under the CDR Form U, Part III, occurred because of the forward thinking actions of the Biobased and Renewable Products Advocacy Group (BRAG®). In October 2014, recognizing an advocacy opportunity to equalize what had been an uneven regulatory reporting field for biodiesel products, BRAG submitted a petition to EPA outlining the reasons why the six biodiesel chemicals listed below should be afforded reduced reporting requirements under the CDR:

  • Fatty acids, C14-18 and C16-18 unsaturated, methyl esters (Chemical Abstracts Service (CAS) No. 67762-26-9);
     
  • Fatty acids, C16-18 and C-18 unsaturated, methyl esters (CAS No. 67762-38-3);
     
  • Fatty acids, canola oil, methyl esters (CAS No. 129828-16-6);
     
  • Fatty acids, corn oil, methyl esters (CAS No. 515152-40-6);
     
  • Fatty acids, tallow, methyl esters (CAS No. 61788-61-2); and
     
  • Soybean oil, methyl esters (CAS No. 67784-80-9).

EPA quickly concurred with BRAG's view and issued a direct final rule to add the listed chemicals to the partial reporting list in January 2015. Unfortunately, due to one adverse comment submitted, which did not provide information pertinent to EPA's planned actions, the listing process under the direct final rule was halted. Instead, EPA had to proceed with a proposed rulemaking under the Administrative Procedures Act, a significantly more time and resource consuming approach. At that time, BRAG members were very concerned that EPA may not complete the rulemaking process to add the biodiesel chemicals to the partial reporting exemption list in time for the 2016 reporting cycle.

Knowing the industry's concerns with the upcoming reporting cycle, EPA staff worked diligently to issue the proposed rulemaking in July 2015. No adverse comments were submitted, and the final rulemaking was issued six months later, which is lightening fast action within a regulatory context.

While BRAG members took the initiative to request the partial reporting exemption and worked with EPA to ensure the listing occurred, any company that manufactures or imports the listed biodiesel products can take advantage of the listing. Thus, for the 2016 reporting cycle, companies that produce or import the above-listed six biodiesel chemicals do not have to report the following information elements for the exempted chemicals:

  • Top ten combinations of industrial process, industrial sector, and industrial functions;
     
  • Production or importation volumes associated with each combination;
     
  • Number of industrial sites using the chemical within each combination;
     
  • Number of workers potentially exposed within each combination;
     
  • Top ten consumer and/or commercial downstream applications;
     
  • Indication of whether reported consumer or commercial categories result in products intended for children;
     
  • Production or importation volumes associated with each reported consumer or commercial category;
     
  • Maximum concentration within each reported consumer or commercial category; and
     
  • Number of workers potentially exposed within each reported consumer or commercial category.

Per EPA's estimate, companies that utilize this reporting exemption will save 65.63 hours or almost 1.5 weeks of staff time, per report. Companies that produce more than one of the listed chemicals or have more than one reporting site will save even more.


 

On March 29, 2016, the U.S. Environmental Protection Agency (EPA) published the Partial Exemption of Certain Chemical Substances from Reporting Additional Chemical Data final rule in the Federal Register. This final rule amends the list of chemical substances that are partially exempt from additional reporting requirements under the Chemical Data Reporting (CDR) rule. The rule applies to six biodiesel chemicals that are very similar to petroleum based biodiesel chemicals that are already on the exempt list. EPA determined that CDR processing and use information for these chemical substances is of low current interest and, while the chemical substances can be removed from the exempt list in the future, manufacturers are now exempt from submitting processing and use information for:

  • Fatty acids, C14-18 and C16-18 unsaturated, methyl esters (Chemical Abstracts Service (CAS) No. 67762-26-9);
     
  • Fatty acids, C16-18 and C-18 unsaturated, methyl esters (CAS No. 67762-38-3);
     
  • Fatty acids, canola oil, methyl esters (CAS No.129828-16-6);
     
  • Fatty acids, corn oil, methyl esters (CAS No. 515152-40-6);
     
  • Fatty acids, tallow, methyl esters (CAS No. 61788-61-2); and
     
  • Soybean oil, methyl esters (CAS No. 67784-80-9).

This exemption was created after the Biobased and Renewable Advocacy Group (BRAG®) petitioned EPA in 2014 to create an equivalent exemption for six biodiesel versions of petroleum based chemicals that were already exempt from submitting processing and use information under the CDR rule.


 

On March 23, 2016, Bloomberg BNA Daily Environment Report announced that EPA signed a final rule exempting manufacturers of six biodiesel chemicals from reporting processing and use information under the Chemical Data Reporting (CDR) rule under Section 8(a) of the Toxic Substances Control Act (TSCA). In 2014, BRAG filed a regulatory petition to exempt the chemicals, requesting the same exemption that EPA currently provides to manufactures of petroleum-based versions of the chemicals. The rule was originally issued as a direct final rule in February 2015 before being withdrawn due to a single comment. This final rule is consistent with the original proposed rule that was issued on July 22, 2015, and applies to manufacturers of:

  • Fatty acids, C14-18 and C16-18 unsaturated, methyl esters (Chemical Abstracts Service (CAS) No. 67762-26-9);
     
  • Fatty acids, C16-18 and C-18 unsaturated, methyl esters (CAS No. 67762-38-3);
     
  • Fatty acids, canola oil, methyl esters (CAS No.129828-16-6);
     
  • Fatty acids, corn oil, methyl esters (CAS No. 515152-40-6);
     
  • Fatty acids, tallow, methyl esters (CAS No. 61788-61-2); and
     
  • Soybean oil, methyl esters (CAS No. 67784-80-9).

As with all the chemicals currently afforded partial exemption status, the biodiesel chemicals would no longer be eligible for the partial reporting exemption if they were to become the subject of a TSCA Sections 4, 5(a)(2), 5(b)(4), or 6 rule (proposed or final), an enforceable consent agreement, a Section 5(e) order, or relief granted under a civil action under Section 5 or 7. BRAG is pleased that EPA was able to complete the rulemaking process in time for the CDR reporting cycle starting in June 2016. The partial CDR exemption will save manufacturers about two weeks of time that would typically be spent preparing processing and use data for Form U.


 

On July 22, 2015, EPA announced a proposed rule for the Partial Exemption of Certain Chemical Substances from Reporting Additional Chemical Data. If enacted, this rule will exempt the following six biobased chemicals from reporting additional information under the Chemical Data Reporting (CDR) rule:

Fatty acids, C14-18 and C16-18 unsaturated, methyl esters (Chemical Abstracts Service Registry Number (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).

EPA originally proposed this exemption as a direct final rule in February 2015 in response to a 2014 petition by the Biobased and Renewable Products Advocacy Group (BRAG®), but was forced to withdraw the rule due to a single comment EPA determined was "adverse," although that was far from clear. In any event, BRAG is thrilled the proposed rule has been issued, and hopes it will be issued in final soon. Comments on the newly proposed rule, including the single adverse comment from the previous rule, will be considered after the 60-day comment period has expired. Comments are due by September 21, 2015.


 

On March 30, 2015, the U.S. Environmental Protection Agency (EPA) withdrew a Direct Final Rule for Partial Exemption of Certain Chemical Substances from Reporting Additional Chemical Data. The direct final rule, issued in January 2015, would have exempted manufacturers of six biobased diesel chemicals from reporting processing and use information for the compounds under the Chemical Data Reporting (CDR) rule. It resulted from a regulatory petition filed by the Biobased and Renewable Advocacy Group (BRAG®). The EPA decision to withdraw the rule was in response to a single comment posted during the short comment period.

Kathleen Roberts, BRAG's Executive Director, stated: "Albeit disappointing, the response is not unexpected given the strict procedures associated with direct final rules. EPA has stated it plans to proceed with a proposed rulemaking to list the chemicals soon and we will urge them to move as quickly as possible. Our hope is EPA can complete the rulemaking process in time for the next reporting CDR cycle, which starts in June 2016."

Until the new rule is completed, manufacturers of the six affected biobased diesel chemicals should be prepared to submit processing and use information under the CDR in 2016.

 

 

On January 16, 2015, the U.S. Environmental Protection Agency (EPA) granted a petition from the Biobased and Renewable Products Advocacy Group (BRAG®) to add "biodiesel" as a chemical category for partial reporting exemption at 40 C.F.R. Section 711.6(b)(2)(iv) under the Chemical Data Reporting (CDR) rule and will be proceeding with a direct final rule to be published later in January. The approved biodiesel category on the partial reporting exemption list will include the following chemicals:

  • Fatty acids, C14-18 and Cl6-18-unsatd., Me esters (Chemical Abstract Services Registry Number (CASRN) 67762-26-9);
     
  • Fatty acids, Cl6-18 and C-18-unsatd., Me esters (CASRN 67762-38-3);
     
  • Fatty acids, canola oil, Me esters (CASRN 129828-16-6);
     
  • Fatty acids, com oil, Me esters (CASRN 515152-40-6);
     
  • Fatty acids, tallow, Me esters (CASRN 61788-61-2); and
     
  • Soybean oil, Me ester (CASRN 67784-80-9).

As a result of EPA's decision to grant the petition, manufacturers and importers of these chemicals will not have to compile and report the processing and use information under Part III of the CDR Form U for the upcoming 2016 CDR reporting cycle, or future CDR reporting cycles. By EPA's estimate, this equates to a savings of more than 80 hours and $5,500 per report. More importantly, this action results in equitable regulatory reporting burdens of chemical substances of comparable release and exposure potential, and avoids EPA providing regulatory relief to one subset of diesel products over another.

BRAG's Executive Director Kathleen M. Roberts stated: "I am pleased that BRAG's quick and decisive actions in identifying the diminished CDR reporting obligations that the rules allow proved successful. Knowing the TSCA regulatory landscape was key to our success. We will continue to identify other opportunities to leverage favorable regulatory outcomes that our clear understanding of the rules makes possible."

As with all the chemicals currently afforded partial exemption status, the biodiesel chemicals would no longer be eligible for the partial reporting exemption if they were to become the subject of a Section 4, 5(a)(2), 5(b)(4), or 6 rule (proposed or final), an enforceable consent agreement, a Section 5(e) order, or relief granted under a civil action under Section 5 or 7.

For more information or to join BRAG, contact Kathleen M. Roberts at .(JavaScript must be enabled to view this email address) or (443) 964-4653. BRAG is managed by B&C® Consortia Management, L.L.C. (BCCM).

 

 

On October 21, 2014, the Biobased and Renewable Products Advocacy Group (BRAG®) submitted two petitions to the U.S. Environmental Protection Agency (EPA) requesting that biodiesel fuel manufacturers be granted the same Chemical Data Reporting (CDR) exemptions that petroleum-based diesel manufacturers already receive.


The Bloomberg BNA Daily Environment Report covered the petitions in an October 22, 2014, feature story that stated "[t]he Biobased and Renewable Products Advocacy Group (BRAG) filed the petitions in an attempt to be exempted through either of two mechanisms allowed under Toxic Substances Control Act rules. Petroleum-derived diesel already is exempt from certain Chemical Data Reporting (CDR) rule requirements, BRAG wrote in both petitions. That means the EPA's current rule provides regulatory relief to petroleum-derived diesel but not to the biobased chemicals that are used in conjunction with or as replacements for the petroleum-based compounds, BRAG's petitions say. If the EPA rejects the petitions, biodiesel manufacturers will be subject to certain Chemical Data Reporting Rule requirements while manufacturers of the petroleum-derived versions of these fuels are not, Kathleen Roberts, BRAG's executive director, told Bloomberg BNA. That means biodiesel producers would have to spend a significant amount of time and money gathering information and providing it to the EPA, she said. The chemicals both types of manufacturers make are very similar, serve the same purpose and are managed in equivalent ways, BRAG's petitions said."


Copies of the two petitions submitted by BRAG are available on the BRAG website:


* Section 21 Petition for Section 8(a) Partial Exemption in Chemical Data Reporting for Biodiesel Products

* Petition for Partial Exemption of Biodiesel Products
 


 
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