Attachment M

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

NOV 1 ( 2018

MEMORAN DUM

SUB.ffiCT:

Response to Comments Received on Proposed Renewal o f In formation Collection
Request for Premanufacturc Review Reporting and Exemptio
equiremcnts for New
Chemical Substances and Significant New Us(\Reportir ~ Re u rements for Chemical
Substances

.

\ \

FROM:

Lance Wormell, Acting Di rector
Chemical Control Division
Office of Pollution Prevention and Toxic

TO:

Angela Hofmann, Director
Regulatory and lnfom1ation Coord inatio n Staff
O ffice of Chemical Safety and Po llution Prevention

Background
On J uly 25, 20 18, EPA pub lished a notice in the Federal Register proposing to renew an lnfomiatio n
Collection Request ()CR) for Premanufacture Review Repo11ing a nd Exemption Requirements for New
C hemical Substances and Significant New Use Reporting Requirements for Che mical Substances to the
Office o f Manageme nt and Budget (0MB), and requesting public comment. 83 Fed . Reg. 35269, July 25,
201 8. The public comme nt period c losed on September 24 , 2018. EPA received two comments.

Public Comment
EPA received two comments: one substantive comment related to the ICR and one comment unrelated to
the ICR and in support ofEPA' s m ission. T he substantive comment comes from the American Chemistry
Counc il ( ACC) and asks the EPA to increase the estimates o f burden re lated to the pre-submission
consultation process as well as the burden required for industry to review EPA 's " Po ints to Consider
When Preparing TSCA N ew Chem ical Notifications" document released in June 201 8.
Response to Comments
In response to the comment expressing a general support of the Agency, EPA appreciates the commenter
taking time to offer her support.
With regard to the ACC comme nts, EPA appreciates the thoughtful comments subm ined by ACC
concerning the burden associated with the voluntary activities o f reading the " Points to Consider"
docume nt and engaging with EPA in a pre-notice consultation o n the PMN review process. T hough a
voluntary activ ity, EPA d id estimate the burden to respondents w ith regard to the " Po ints to Consider"
document. As noted in its Suppo rting Statement attached to the IC R, EPA estimated that it could take
submitte rs 1.4 manageria l and technical hours per notice to famil iarize themselves w ith the document.
T his burden estimate is based upon the average time it took several volunteers w ho were generally
knowledgeable about T SCA activ ities to review the actua l document. S imilarly, EPA did describe the
availability of a voluntary pre-subm ission consultat ion process in its Suppo rt Statement to the IC R. S ince
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pre-submission consultation is voluntary, can vary bel:\veen submitters, and is not an option that all
submitters take advantage of, EPA is hesitant to further adjust the burden on s ubm itters in this !C R s ince
the subject ICR is for the purpose of assessing required reporting burden associated with PMN
subm ission.
EPA believes that to adjust the current estimate of the burden ho urs in this IC R to account for time
associated w ith an activity not required by statute and not routinely used by s ubmitters would create an
inaccurate estimate of the burden o n s ubmitters for this process. Therefore, EPA finds no compelling
reason to change its current IC R burden estimates for the pre-submission activ ities associated w ith the
TSCA New Chemicals review program in this IC R.