[montanafood_ag] FW: PSA-FDA Q & A Series on FSMA Proposed Produce Safety Rule

Reid, Howard hreid at mt.gov
Wed Mar 6 08:33:32 MST 2013

More on the Proposed Produce Safety Rule. Looks like a good opportunity to participate in the discussion with FDA.

Howard Reid, R.S., Manager
Food, Drug & Cosmetics Program
Cogswell Building
1400 Broadway Street, RM C214
PO BOX 202951
Helena, MT 59620-2951
Ph: (406) 444-5306
Fax: (406) 444-5055

From: bounce-75461621-20624842 at list.cornell.edu [mailto:bounce-75461621-20624842 at list.cornell.edu] On Behalf Of *Wall, Gretchen L.
Sent: Tuesday, March 05, 2013 3:27 PM
To: Reid, Howard
Subject: PSA-FDA Q & A Series on FSMA Proposed Produce Safety Rule

March 5, 2013

Hello Produce Safety Alliance Members:

The Produce Safety Alliance, in collaboration with the FDA, will be hosting a series of Q & A teleconferences to discuss specific sections of the Food Safety Modernization Act (FSMA) Proposed Produce Safety Rule. This is a great opportunity for you to ask questions directly to the FDA staff. Dr. Jim Gorny, Senior Advisor for Produce Safety, and Dr. Erick Snellman, Policy Analyst, will be available to answer questions.

Each teleconference will have a different focus; please refer to the schedule below.We ask that you keep your questions for each Q & A session relevant to the topic.  Though Dr. Gorny and Dr. Snellman may not be able to answer every question, they will be able to direct and review specific sections of the proposed rule to enhance your understanding of what is being proposed.  If specific details are not available or addressed in the proposed rule or through this Q & A series, we encourage you to write and submit a comment or question to the docket regarding issues that FDA should clarify or address in the final rule or in companion guidance documents.  Comments must be submitted BEFORE May 16, 2013.

There are two ways to comment:
1.) Comment electronically at http://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0921

2.) Written comments may be faxed to the FDA at 301-827-6870 or mailed to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD  20852

Q & A Session with the FDA

Time (EST)


Mar 18, 2013

11 AM

Understanding Exemptions

Mar 25, 2013

11 AM

Agricultural Water

Apr 22, 2013

11 AM

Soil Amendments

Apr 25, 2013

11 AM

Domestic and Wild Animals


Growing, Harvesting, Packing, & Holding Activities


Equipment, Tools, Buildings, & Sanitation


Health, Hygiene, and Training of Workers


Recordkeeping, Compliance, & Enforcement

The full proposed produce rule and codified sections are attached to this message for your review.  In addition, the links below will take you to other documents that may help clarify the proposed rule.  We recommend reviewing this information before the teleconference.

Proposed Produce Safety Rule at a Glance:

Proposed Produce Rule Subpart Fact Sheets:

Call-in Information and Instructions

To participate in the teleconference, dial the toll-free number below 5 minutes prior to the presentation. No registration is required. All participants will be placed on mute upon entering the conference; however, the Q & A will be moderated by an operator who will provide instructions for how to ask questions using your telephone and individually unmute the lines of those who have questions. We ask that you call into the teleconference 5 minutes prior to the event start to ensure that all participants are available to receive instructions for the Q & A process at the beginning.

*Dial toll-free: 866-906-9888
*Enter passcode: 8140591
*These numbers will remain the same for ALL scheduled Q & A sessions.

We hope you can join us for one or more of the series! If you have any questions about this series, please contact Gretchen Wall at 607-255-6806 or glw53 at cornell.edu<mailto:glw53 at cornell.edu>.

Betsy Bihn, PSA Director                           Gretchen Wall, PSA Coordinator
eab38 at cornell.edu<mailto:eab38 at cornell.edu>                                      glw53 at cornell.edu<mailto:glw53 at cornell.edu>
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