米国における化学物質管理政策最新動向セミナー（平成 29 年 11 月 13 日開催）

1. Regarding the document below, when was it released? What review did it have? Concern:
International users are not familiar with CDX, and are having trouble. I’m told this guidance
was not available day 1 of the reporting period.
The Central Data Exchange, or CDX, is the Agency's electronic reporting portal. CDX enables EPA
reporting systems to receive legally acceptable data in various formats, including confidential
data. Within CDX, the “Submissions for Chemical Safety and Pesticides Programs” (CSPP) service
provides the software modules and forms for submitting TSCA notices, including the “TSCA
Section 8(b) – e‐NOA” module for submitting Notices of Activity under the TSCA section 8(b)Inventory rule.
https://cdx.epa.gov/ , https://www.epa.gov/reviewing‐new‐chemicals‐under‐toxic‐substances‐control‐act‐tsca/how‐submit‐e‐pmn
The “Section 8(b) e‐NOA User Guide ‐ Primary Authorized Official” was posted in the docket for
the rule on August 11, 2017 (the date of the publication of the rule in the Federal Register). It
was also available in the electronic reporting application on August 14, 2017. Reporting wasscheduled to begin after the publication of the rule in the Federal Register on August 12. As
August 12 was a Saturday, EPA released the electronic reporting application on Monday, August14, in order to assure a smooth rollout and staff available for any troubleshooting. This
document was updated in the docket and reporting application with the “Section 8(b) eNOA
Application User Guide ‐ Primary Authorized Official Updated” on October 11, 2017.
The “Section 8(b) eNOA User Guide ‐ Secondary Support” was available in the docket andapplication on October 11, 2017.
The “Section 8(b) e‐NOA User Guide – Secondary Authorized Official” was available in the docket
and application on October 16, 2017.
These documents underwent internal review prior to finalization.

2. How does one maintain CBI for something that will remain on the inactive inventory, is thatform A?
A CBI chemical substance, identified as an inactive substance on the TSCA Inventory, cannot
have its CBI status altered outside adherence to the forward looking reporting process. That
process provides that when a manufacturer or processor acts to reintroduce the chemical backinto commerce, using the forward looking reporting form (NOA Form B), the CBI claim for thesubstance identity can be maintained (or not) by following the procedures set forth in 40 CFR
710.37(a)(2). Those procedures, in summary, provide that a manufacturer or processor may
request to maintain a CBI claim for chemical identity, and substantiate the same within 30 daysof filing an NOA Form B.

3. Once you have done a Form B, and have a CDX receipt, can you commence activity
immediately?
Yes, activity can commence immediately. The statute and the rule stipulate that, for futurereporting, a Notice of Activity (NOA) Form B is required to be submitted prior to the date that aninactive substance is reintroduced into U.S. commerce for a non‐exempt commerce
purpose. Once a valid NOA Form B is submitted, a company has met its obligation and activity
can commence immediately.

4. Not on inventory, but for PMNs, how are impurities, which are CBI, reported? Is there areporting requirement?
Impurities are exempt from Premanufacture Notification (PMN) requirements under TSCA
section 5 (see 40 CFR 720.30(h)(1)). Although impurities are exempt from separate PMN
reporting, they must be identified in a PMN on a reportable new chemical substance if theimpurities are present in that new chemical substance. The manufacture or processing of achemical substance described in 40 CFR 720.30(h) is also exempt from Notice of Activity (NOA)
reporting under TSCA section 8(b). Impurities are therefore exempt from NOA reporting.

5. Can non‐US companies utilize the CDX application for reporting and include a request that EPA
maintain the company’s confidentiality claim in their Form A or Form B submission?
Non‐U.S. companies can submit a Form A or a Form B via the electronic reporting application
and CDX. Any company submitting an NOA Form for a substance whose chemical identity is
confidential on the TSCA Inventory can request in their Form that EPA maintain theconfidentiality claim.