ML14251A145

Response to 03/26/2014, Nuclear Energy Institute Letter on Dermal and Ocular Quantitative Exposure Standard

ML14251A145
Person / Time
Site:	Framatome ANP Richland
Issue date:	09/15/2014
From:	Bailey M G NRC/NMSS/FCSS
To:	Schlueter J R Nuclear Energy Institute
Diaz M A
Shared Package
ML14251A150	List: ML14251A145
References
Download: ML14251A145 (3)

Text

September 15, 2014 Ms. Janet R. Schlueter, Director Fuel and Materials Safety Nuclear Generation Division Nuclear Energy Institute 1201 F Street, NW Suite 1100 Washington, DC 20004

SUBJECT:

RESPONSE TO MARCH 26, 2014, NUCLEAR ENERGY INSTITUTE LETTER ON DERMAL AND OCULAR QUANTITATIVE EXPOSURE STANDARD

Dear Ms. Schlueter:

The U.S. Nuclear Regulatory Commission (NRC) staff has reviewed your letter dated March 26, 2014, and its enclosure, arguing that the Integrated Safety Analysis (ISA) need only consider inhalation pathways when analyzing for acute chemical exposures to NRC-licensed material, or chemicals produced from such material. You state that developing dermal and ocular exposure standards for use in demonstrating compliance with the performance requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 70, Subpart H, "is impractical, unnecessary and constitutes an unanalyzed backfit." The staff has reviewed the NRC documentation supporting the development of the Subpart H rule, and finds that the rule's requirements for analyzing chemical hazards (specifically, hazards arising from acute chemical exposures) are not limited to consideration of the inhalation pathway. The staff concludes that failure to consider all reasonable worker exposure pathways would create a regulatory gap in the oversight of chemical hazards that are under NRC's jurisdiction.

Neither the relevant Subpart H requirements, nor the NRC's interpretation of these requirements, have changed. However, even if the staff's position on dermal and ocular exposure pathways is deemed to be the imposition of a new regulatory position that falls within the definition of backfitting, the compliance exception stated in 10 CFR 70.76(a)(4)(i) would be applicable. The enclosure to this letter provides a detailed evaluation of the compliance backfit exception.

Accordingly, the staff will evaluate ISA summaries to ensure that the licensee has considered all reasonable exposure pathways in the ISA chemical hazard analysis. For all credible event consequences as defined in 10 CFR 70.61(b)(4) and (c)(4), the staff will review the ISA summary "description of the proposed quantitative standards used to assess the consequences to an individual from acute chemical exposure to licensed material or chemicals produced from licensed materials," as stated in 10 CFR 70.65(b)(7). For license amendments, renewals or new applications such staff evaluations do not constitute backfitting.

The NRC is developing an Interim Staff Guidance (ISG) that addresses chemical exposures at fuel cycle facilities subject to Subpart H. The ISG will discuss the criteria staff will apply when reviewing event consequences and proposed quantitative standards used to assess the consequences to an individual from acute chemical exposure in the ISA. The ISG will provide

guidance on the staff review of all credible exposure pathways to demonstrate compliance with 10 CFR 70.61. Development of this ISG should help promote a common understanding of proposed quantitative standards for non-inhalation pathways supporting chemical safety analyses in the ISA. The NRC will engage stakeholders, as appropriate, to discuss an implementation plan.

In accordance with 10 CFR 2.390 of the NRC's "Agency Rules of Practice and Procedure," a copy of this letter will be available electroni cally for public inspection in the NRC Public Document Room or from the Publicly Av ailable Records component of NRC's Agencywide Documents Access and Management System (ADAMS). ADAMS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. Sincerely, /RA/

Marissa G. Bailey, Director A.Blamey-for Division of Fuel Cycle Safety and Safeguards Office of Nuclear Material Safety and Safeguards

Docket: 70-1257 License: SNM-1227

Enclosure:

Documented Evaluation for Compliance Backfit Exception

ML14251A145 Pkg.: ML14251A150 OFFICE FCSS/FMB FCSS/FMB/LAFCSS/FMB/BCOGC FCSS/DD NAME MDiaz TBrockington RJohnson JHull MBailey DATE 09/08/14 09/12/14 09/08/14 09/15/14 09/15 /14