Petfood Industry - January 2018 - 46
46 | www.PetfoodIndustry.com
Relevant FDA links
I also recommend someone with specific knowledge of the
substance or class of substances in question to serve on the
panel. Particularly for a substance that has been produced
by use of genetic engineering, an expert in that field is
FDA draft guidance https://goo.gl/FahbwE
To submit comments to FDA https://goo.gl/YUshHD
Limits on data and information shared with
FDA recommends organizers to minimize the amount of
non-public information made available to the panel, unless
that information itself raises question as to the safety of the
substance (then it definitely should be provided). With appreciation that the scientific community at large may not have
easy or full access to that same information, in my experience
that restriction could inadvertently impair the panel's deliberations. Certainly, data not in the public domain cannot be used
as pivotal evidence of safety, as anything critical in reaching a
conclusion of GRAS needs to be publicly available. However,
FDA regulations expressly allow for corroborative data from
unpublished scientific studies and other sources to be considered in a determination of GRAS status. It appears contradictory
to say that same data shouldn't be shared with the panel.
As the FDA guidance is a draft document, public comment
is welcome. Comments can be made at any time, but to ensure
that FDA considers your comment on this draft guidance before
a final version is issued, comments should be sent by May 15,
2018. The most convenient means to submit comments is electronically, via the regulations.gov website (refer to Docket No.
Control of potential bias and conﬂicts of interest
Bias can come in many forms (e.g., confirmation bias,
outcome bias) and strategies to control that in selection of
panelists and during the panel's deliberations are suggested. A
panelist's conflict of interest could seriously damage the credibility of the entire panel. The proponent or organizer of the
panel, its lawyer, agent or employee, or others that have a financial or other vested interest in the outcome (either directly or
through relatives or other close associations) should be excluded
from service. In my opinion, someone that has consulted for
For more insights by Dr. Dzanis
a company on other matters but does not rely on that business relationship as a major source of income could potentially
qualify. Regardless, documentation of any potential conflicts or
appearances of conflicts prior to panel deliberation is prudent.
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