In the Federal Register issue of 08/13/2010, the Environmental Protection Agency (EPA) released for public comment a proposed rule that would, if adopted, significantly change the TSCA Inventory Update Reporting (IUR).
The first part of the notice, "Supplementary Information", explains the proposed changes to 40 CFR Parts 704, 710, and 711. The text of the proposed rule follows the Supplementary Information.
In the Supplementary Information, EPA states that it is proposing modifications to the IUR
to meet four primary goals:
1. To tailor the information collected to better meet the Agency’s
overall information needs.
2. To increase its ability to effectively provide public access to
the information.
3. To obtain new and updated information relating to potential
exposures to a subset of chemical substances listed on the TSCA
Inventory.
4. To improve the usefulness of the information reported.
EPA believes that expanding the range of chemical substances for which
comprehensive information is to be reported and adjusting the specific
reported information, the method and[[Page 49659]]
frequency of collecting the information, and CBI requirements will
accomplish these goals.
Reading the Supplemental Information reveals a fifth, unstated goal – the creation of uniform reporting standards that will provide EPA with the information it needs to "identify and take follow-up action on chemical substances that may pose potential risks to human health or the environment" in a more efficent and timely manner, cutting the amount of time EPA staff will need to spend reviewing submitted information, determining if EPA action is required and uploading the information to a publicly available databse.
Under the proposed rule, EPA would require information to be submitted via agency supplied web based application
EPA believes the proposed requirement to use e-IURweb to report
electronically would eliminate problems related to the scanning of
paper documents, incorrect chemical identities, and other errors
introduced by the submitter. These errors substantially delayed the
availability of the IUR information to both internal EPA programs, such
as the Existing Chemicals Program, and the public. . . . EPA believes the
required use of e-IURweb and CDX would reduce the reporting burden on
industry by reducing both the cost and the time required to review,
edit, and transmit data to the Agency.
The terms manufacture, manufacturer, and site would be redefined:
with this proposal . . . manufacture would be defined . . . to mean "to manufacture, produce, or import for commercial purpose.
Also with this proposal, manufacturer would be defined . . . to mean "a person who manufactures a chemical substance. "
The term site
would be defined under the IUR
rule to mean “a contiguous property unit. Property divided only by a
public right-of-way shall be considered one site. More than one plant
may be located on a single site.
(a) For chemical substances manufactured under contract, i.e., by a
toll manufacturer, the site is the location where the chemical
substance is physically manufactured.
(b) The site for an importer who imports a chemical substance
described in 40 CFR 711.5 is the U.S. site of the operating unit within
the person’s organization that is directly responsible for importing
the chemical substance. The import site, in some cases, may be the
organization’s headquarters in the United States. If there is no such
operating unit or headquarters in the United States, the site address
for the importer is the U.S. address of an agent acting on behalf of
the importer who is authorized to accept service of process for the
importer.
(c) For portable manufacturing units sent out to different
locations from a single distribution center, the distribution center
shall be considered the site.”
The proposed rule would also modify the definitions of the terms "commercial use", consumer use" "reporting year" "submission period" and add a definition for the term "industrial function".
The method of determining if a manufacturer or importer is subject to IUR reporting would be changed:
EPA is proposing to modify the method used to determine whether a
person is subject to IUR reporting. The proposed method would be to
determine whether, for any calendar year since the last principal
reporting year, a chemical substance was manufactured (including
imported) at a site in production volumes of 25,000 lb. or greater. The
proposed method would be effective after the 2011 IUR submission
period.
EPA is proposing this change because of the mounting evidence that
many chemical substances, even larger volume chemical substances, often
experience wide fluctuations in manufacturing volume from year to year.
Chemical substances coverd by IUR reporting would be changed to exempt water, both naturally occuring and manufactured, fully exempt the polymers starch, dextrin, and maltodextrin, and making chemical substances subject to enforceable consent decrees ineligible for exemption.
Data to be reported would change as well. The company name to be reported would be the name of the parent company, including its Dunns & Bradstreet (DNB) number, the chemical name(s) supplied would be the name as listed on the TSCA Inventory, production volume of chemicals manufactured, exported and/or imported would be reported on one report rather than multiple reports. A check box, to indicate if a chemical substance is to be recycled, remanufactured, reprocessed, reused or reworked would be added.
Among other changes, EPA is proposing to revise and expand the list of industrial function categories and replace the NAICS codes with Industrial Sector Codes based on the European Union’s "Guidance on information requirements and chemical safety assesment". The codes for consumer and commercial product categories would also be revised.
These lists of codes would be revised to bring them into harmony with existing codes used in Canada, to better facilitate the exchange of information between EPA and its Canadian counterpart and to serve as a model for Mexican agencies to develop an inventory of chemical substances.
Manufacturers and importers would be required to report the "total number of commercial workers likely to be exposed while using the reportable chemical substance(s):
iii. Number of commercial workers reasonably likely to be exposed.
EPA is proposing to require that submitters report the total number of
commercial workers, including those at sites not under the submitter’s
control, that are reasonably likely to be exposed while using the
reportable chemical substance, with respect to each commercial use. The
approximate number of workers would be reported using the same
definitions and ranges used for manufacturing and industrial processing
and use workers required by 40 CFR 710.52(c)(3)(v) and (4)(i)(F)
(proposed 40 CFR 711.15(b)(3)(vii) and (4)(i)(F)), respectively. The
ranges are:Fewer than 10 workers.
At least 10 but fewer than 25 workers.
At least 25 but fewer than 50 workers.
At least 50 but fewer than 100 workers.
At least 100 but fewer than 500 workers.
At least 500 but fewer than 1,000 workers.
At least 1,000 but fewer than 10,000 workers.
At least 10,000 workers.Information on the number of commercial workers reasonably likely
to be exposed to the reportable chemical substance would be used to
characterize the commercial population reasonably likely to be exposed
to the subject chemical substance. The population characterization is
important to the development of the overall exposure characterization.
Claims of "Confidential Business Information" – also known more commonly as "trade secrets" – would be required to be substantiated and claimed at the time the IUR is submitted and "should be limited only to those data elements the release of which would likely cause substantial harm to the business’ competitive position. . . . EPA expects that reducing the number of CBI claims would increase the amount of information available to the public and improve the timeliness of its public availability". In a previous section, EPA noted that manufacturers would submit claims for CBI on information that was publicly available from other sources and thus was not CBI at all.
In Unit V of of the Supplemental Information, EPA requests comments on the proposed rule and various other topics, ranging from how best to use IUR data to take action on chemical substances that might pose "unreasonable risks" with particular emphasis on protecting children from exposure to harmful chemical substances to changing the reporting cycle, changes in how EPA should collect the information, and whether IUR reporting requirements should be changed to include processors as well as manufacturers and importers.
Comments must be submitted by October 12, 2010. The notice describes how comments need to be submitted. After receiving and reviewing the comments submitted, EPA hopes to publish a final rule in Spring 2011. As with any proposed rule submitted for public comment by any Federal agency, there may be a "Notice of Further Proposed Rulemaking" (NPRM) or the agency may also issue an interim rule before the final rule is published.
EPA has established a docket (EPA-HQ-OPPT-2009-0187) on www.regulations.gov where documents referenced in the Supplemental Information and comments on the proposed rule may be found.
A shorter discussion of the proposed rule may also be found on the OMB Watch website.
