By Sphera’s Editorial Team | February 22, 2017

Who? U.S. – Federal

There have been two recent Federal Register notices issued—one from the U.S. Environmental Protection Agency and one from the U.S. Occupational Safety and Health Administration—that have delayed the effective dates of dozens of rules because of a “Regulatory Freeze Pending Review” order issued by the Trump administration on Jan. 20, 2017. All the regulatory changes in the affected Federal Register notices will now have an effective date of March 21, 2017.

Under 82 FR 8499, the affected sections are from the EPA—40 CFR Parts 22, 51, 52, 61, 68, 80, 81, 124, 147, 171, 239, 259, 300 and 770.
Under 82 FR 8901, the revisions to exposure limits for beryllium (OSHA – 29 CFR 1910) have been delayed
Implication: Effective dates moved to March 21, 2017 pending review for EPA and OSHA regulations.

EPA Alerts to Know

The EPA released a notice under the Toxic Substances Control Act regarding the statutory requirements for substantiating Confidential Business Information (CBI) claims. In addition, the EPA has published a rule amending the hazard categories for reporting under the Superfund Amendments and Reauthorization Act, better known as SARA 311/312.

Alert #1: EPA Notice Regarding CBI Claims

Under the Toxic Substances Control Act, or TSCA, newly amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act in June 2016, the EPA has published a notice stating that under the revised TSCA, the EPA will review all CBI claims for chemical identity as well as review a representative sample of at least 25 percent of other nonexempt claims.


Substantiation of CBI claims under the TSCA will be more difficult after March 17, 2017. Those submissions that contain information claimed as CBI must provide substantiation for all information claimed as confidential. Submissions submitted without the substantiation will be deemed deficient. Any business that submitted a CBI claim between June 22, 2016 and March 20, 2017 must also provide substantiation for any information claimed as confidential by Sept. 18, 2017.

Alert #2: Hazard Categories Revised for Reporting Under Emergency Planning and Community Right-to-Know Act Tier II (SARA 311/312)

The EPA published a final rule that revises the hazard categories used in filing Emergency Planning and Community Right-to-Know Act, or EPCRA, Tier II reports to align with OSHA’s Hazard Communication Standard and Globally Harmonized System, or GHS.


The rule applies to data collected during the 2017 calendar year for reports due on March 1, 2018. As of this posting, the revised forms were still not available but regulated entities can watch for them >here.

European Union (EU) – 1 Alert

Commission Directive (EU) 2017/164 of Jan. 31, 2017, establishing a fourth list of indicative occupational exposure limit values pursuant to Council Directive 98/24/EC, and amending Commission Directives 91/322/EEC, 2000/39/EC and 2009/161/EU will be effective Feb. 21, 2017.


Member States are required to establish national occupational exposure limit values for the chemical agents listed in the Annex by Aug. 21, 2018 at the latest.

European Union (ECHA) – 1 Alert

The Candidate List of substances of very high concern (SVHCs) had four new substances added in January 2017, as follows:

4,4’-isopropylidenediphenol (bisphenol A; BPA)
Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts
4-heptylphenol, branched and linear [substances with a linear and/or branched alkyl chain with a carbon number of 7 covalently bound predominantly in position 4 to phenol, covering also UVCB- and well-defined substances that include any of the individual isomers or a combination thereof].

The Candidate List of substances of very high concern (SVHCs) had four new substances added in January 2017, as follows: