SOCMA Comments on EPA's Chemical Data Reporting Rule - Pharmaceutical Technology

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SOCMA Comments on EPA's Chemical Data Reporting Rule


ePT--the Electronic Newsletter of Pharmaceutical Technology

The Society for Chemical Manufacturers & Affiliates (SOCMA) commented on EPA’s modifications to the Inventory Update Reporting (IUR) rule, also broadly known as the Chemical Data Reporting (CDR) rule. EPA issued the final rule earlier this month.

The CDR enables EPA to collect and publish information on the manufacturing, processing, and use of commercial chemical substances and mixtures on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory. This information includes current chemical substance production volumes, manufacturing sites, and how the chemical substances are used.

“Our organization believes that the use of IUR rules has been an effective information-gathering tool in the past and is on course to being improved this go around,” said SOMCA in an Aug. 3, 2011, press release. “We have consistently advocated for a prioritization scheme like that under ChAMP [Chemicals Assessment and Management Program]. We trust this CDR rule will help guide that process.”

SOCMA’s main concerns at the time the proposed IUR rule was published last August were with the scope and timing of the rule. Although SOCMA says “the scope of this rule is still broad and some concerns remain, EPA has addressed several of our members’ major concerns with adjusting to the new requirements,” the association said in an Aug. 3, 2011, SOCMA press release. “We are pleased to see that EPA has changed the timing of the reporting year and submission period and plans to phase in certain requirements over time as we called for. The agency has also eliminated retroactive reporting.”

In comments issued in October 2010, SOCMA urged EPA to move the principal reporting year to 2011 with the submission period to occur in 2012, which it did. SOCMA also suggested that for a reporting trigger for processing and use information, the agency keep the 300,000-pound trigger or use the 100,000-pound one if compelled, consistent with one of the triggers for the small-business exemption. The reporting threshold for processing and use information is now 100,000 pounds, but will eventually be 25,000 pounds as the 300,000-pound trigger gets phased out over time, noted SOCMA. SOCMA also supported maintaining the “readily obtainable’” reporting standard in lieu of “known to or reasonably ascertainable by,” although this standard was changed in the final rule. SOCMA said it was pleased to see the small-business exemption intact in the final rule and commented favorably on the use of electronic reporting. “The use of electronic reporting could potentially facilitate the utility of the information being provided. We look forward to better understanding the electronic tool via EPA’s outreach,” said the association.

Overall, SOCMA concluded that, “these changes will move us in the direction of enhanced implementation of TSCA, particularly as it pertains to existing chemicals. Despite improvements, the challenge of gathering exposure information from downstream users will remain.”

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SOCMA Focuses on Concerns of Batch and Custom Manufacturers
SOCMA and EFCG Urge for Reform in FDA Inspections of Foreign Drug-Manufacturing Facilities
SOCMA Offers Support for Free Trade Pacts with South Korea, Panama, and Colombia

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