EPA Chemical Data Reporting Rule Published

Submitted by dee.woodhull on August 24, 2011 - 4:50pm

 

The Environmental Protection Agency (EPA) August 16 published several revisions to its Inventory Update Reporting Rule (IUR), a requirement of the Toxic Substances Control Act (TSCA), that expand reporting of production volume, use, and exposure data for a wide range of chemicals, and make mandatory electronic data reporting.  
 
Those affected include commercial manufacturers or importers of chemical substances listed on the TSCA Inventory:
 
  • Chemical substance manufacturers and importers in NAICS codes 325 and 324110; e.g., chemical substance manufacturing and processing and petroleum refineries
  • Chemical substance users and processors in NAICS codes 22, 322, 331, and 3344; e.g., utilities, paper manufacturing, primary metal manufacturing, and semiconductor and other electronic component manufacturing, who, may also manufacture a by-product chemical substance
 
EPA has changed the name of the IUR rule to the Chemical Data Reporting (CDR) rule, in response to comments it received during the rulemaking process.  A brief listing of the primary amendments to the rule is as follows:
 
1.      The method for determining whether a manufacturer or importer is subject to CDR reporting is changed. Following the 2012 submission period, reporting will be required if the production volume of a chemical substance meets or exceeds the 25,000 pound (lb) threshold in any calendar year since the last principal reporting year (e.g., 2011). 
 
2.      The reporting frequency is changed from every five years to every four years.
 
3.      EPA will require electronic reporting of the CDR data, using an Agency-provided, web-based reporting tool (e-CDRweb) to submit reports to EPA’s Central Data Exchange (CDX).  After the final rule’s effective date, paper submissions will no longer be accepted.
 
4.      A new definition section has been added, revising the definition for manufacture and site; and making other needed definitional modifications and additions.
 
5.      EPA has lowered the 300,000 lb. reporting threshold for processing and use information for the 2012 submission period.  In 2010, the threshold for reporting processing and use information is 100,000 lb.  In subsequent submission periods, the reporting threshold will be 25,000 lb.
 
6.      The 25,000 lb. threshold for specific chemical substances that are the subject of particular TSCA rules and/or orders is lowered to 2,500 lb, which will be effective for the 2016 submission period and subsequent submission periods.
 
7.      Chemical substances for which an enforceable consent agreement (ECA) to conduct testing has been made under 40 CFR part 790 are now ineligible for exemptions from CDR.  A full exemption from CDR requirements is given for water; and polymers which are already fully exempt from the partially exempt list of chemical substances, are removed from CDR.
 
8.      The reporting requirements for certain manufacturing data elements have been modified. Specifically, manufacturers (including importers) are required to report: 
a.      The name and address belonging to the parent company
b.      The current Chemical Abstracts (CA) Index Name, as used to list the chemical substance on the TSCA Inventory, as part of the chemical identity
c.       For the 2012 submission period only, the production volume for calendar year 2010
d.      The production volume for each of the years since the last principal reporting year.  This requirement will be effective after the 2012 reporting cycle (i.e., for the 2016 submission period and subsequent submission periods)
e.      The volume of a manufactured (including imported) chemical substance used at the reporting site
f.        Whether an imported chemical substance is physically present at the reporting site
g.      The volume directly exported and not domestically processed or used
h.       When a manufactured chemical substance, such as a byproduct, is being recycled, remanufactured, reprocessed, or reused
 
9.      The “readily obtainable” reporting standard used for the reporting of processing and use information has been replaced with the “known to or reasonably ascertainable by” reporting standard.
 
10.  Up-front substantiation is required when processing and use information is claimed as confidential business information (CBI).
 
11.  Confidentiality claims for processing and use data elements identified as not “known to or reasonably ascertainable by” will be disallowed.
 
12.  The list of industrial function categories for the reporting of processing and use information has been revised.  The 5-digit NAICS codes have been replaced with 48 Industrial Sector (IS) codes.
 
13.  The list of consumer and commercial product categories for the reporting of consumer and commercial use information has been revised.  Also, EPA is requiring separate reporting for consumer or commercial categories and the reporting of the number of commercial workers reasonably likely to be exposed to the subject chemical substance.
 
14.  The gaps in the ranges used to report concentration have been eliminated.
 
Modification of the IUR rule has been made to meet four primary goals, which are supported by a TSCA policy that “adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment, and that the development of such data should be the responsibility of those who manufacture and those who process such chemical substances and mixtures”. The goals are to:
 
1.      Tailor the data to better meet the Agency’s overall information needs
 
2.      Increase EPA’s ability to effectively provide public access to the information.
 
3.      Obtain new and updated information relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory.
 
4.      Improve the usefulness of the information reported.  
 
EPA believes that expanding the range of chemical substances for which more in-depth processing and use information is to be reported; and adjusting the specific reported information, the method and frequency of collecting the information, and CBI requirements will accomplish these goals. In addition, these changes will enable EPA and other Federal agencies to improve their risk screening capabilities, enabling them to better assess and manage risk, and improve public awareness of basic information about a large number of chemical substances.
 
The first reporting period under the new rule will be from February 1 to June 30, 2012.