FDA to Assess Safe Food Allergen Levels

[LinksEtc]

http://supermarketnews.com/food-safety/fda-assess-safe-food-allergen-levels

The public can submit comments on safe food allergen threshold levels through Feb. 7, 2013, at http://www.regulations.gov by using the keyword "docket number FDA-2012-N-0711." 

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Thread also about FSMA

[Jessica]

I'm curious if this will ultimately affect food labeling. For example, if they determine a level is not going to cause a reaction in a large percentage of the population, will some companies stop using advisory labeling at that level even though it may still cause reactions in some people? This is the article I read earlier, which mentions labeling.

http://foodpoisoningbulletin.com/2012/fda-requests-input-on-allergen-threshold-levels/

[CMdeux]

The problems with the establishment of NOAEL for any super-potent food allergen have NOT been resolved since 2006.

In other words, the same exact limitations exist NOW that did then for things like peanut, tree nuts, sesame, etc.

• persons with greatest sensitivity (lowest threshold doses) have disproportionately severe reactions
• persons with a history of very severe reactions are systematically excluded from formal studies by IRB's who approve study protocols, so the only way to study such individuals is via uncontrolled histories.
• such histories indicate VERY strongly that such individuals have reaction thresholds which fluctuate substantially depending upon allergen load, hormonal status, stress and illness.
• problems with analysis of heterogeneous foodstuffs and inherent LOD being higher than threshold doses for highly sensitive allergic individuals have not been resolved adequately

When you put all of that together, what you come up with is that the population which is at GREATEST risk of fatality from cross-contamination are probably still more sensitive than the methods that the industry has at their disposal-- any reproducible analytical methodology is going to exceed a permissible threshold for some of those people-- at least some of the time.

  Yes, this means that people with HIGH thresholds are going to be seeing labels that reflect risk that doesn't apply to them.  But the alternative is to aim at the median, and those aren't the people who are MOST likely to die from exposures to begin with.

[twinturbo]

Just adding that IRBs are also more hesitant on any experiment involving children because the single largest tenet of human subject protection is the ability to opt out of the experiment. This is why many of the studies, including those on children, anxiety and FA is strictly observational. It can't be induced because someone wants data to see how severe the results are.

[LinksEtc]

http://www.gpo.gov/fdsys/pkg/FR-2013-02-04/pdf/2013-02319.pdf

The Food and Drug Administration (FDA or we) is extending to May 13, 2013, the comment period for the notice entitled ''Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of Docket,'' that appeared in the Federal Register of December 14, 2012 (77 FR 74485).

We are extending the comment period in response to a request from an industry association.

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Survey on Thresholds from FARE

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"Are Food Allergen Thresholds on the (Far) Horizon?"
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/12/are-food-allergen-thresholds-on-the-far-horizon.html


"FDA Allergen Controls"
http://www.qualityassurancemag.com/qa1212-regulations-food-allergens.aspx

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Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food
March 2006 (FDA)

http://tinyurl.com/a2fwbu7

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"Deliberately Adding Allergens to Reduce Risk: A Good Idea or Bad Idea?"
http://leavittpartnersblog.com/2013/01/deliberately-adding-allergens-to-reduce-risk-a-good-idea-or-bad-idea/

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"Two FSMA Proposed Rules Published ... But What Does This Really Mean?"
http://leavittpartnersblog.com/2013/01/two-fsma-proposed-rules-published-but-what-does-this-really-mean/

http://leavittpartners.com/wp-content/uploads/2013/01/Proposed-Rule-On-Preventive-Controls-Key-Provisions.pdf

[LinksEtc]

Just FYI on the related FSMA topic ...

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Constituent Updates are also available on the web at
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/default.htm
[This is a correction to a previously sent message. More detailed information on the planned public meetings has been added.]

FDA to Hold Additional Public Meetings on Two Major FSMA Proposed Rules

Chicago, IL
March 11, 2013 from 8:30 am -5:00 pm & March 12, 2013 from 8:30 am -12:00 pm
The Westin-Michigan Avenue
909 North Michigan Avenue
Chicago, IL 60611

Portland, OR
March 27, 2013 from 8:30 am - 5:00 pm & March 28, 2013 from 8:30 am – 12:00 pm
Crown Plaza Portland Downtown
Convention Center
1441 NE 2nd Avenue
Portland, OR 97232

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http://www.gpo.gov/fdsys/pkg/FR-2013-02-13/pdf/2013-03316.pdf

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http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/default.htm?source=govdelivery

Extension of Comment Period (to May 16, 2013) for Information Collection Provisions Associated with Two FSMA Proposed Rules

[ajasfolks2]

Update from FARE:

FARE CEO Offers Public Comment at FDA Meeting on Preventive Controls
On Friday, March 1, FARE CEO John L. Lehr appeared at an FDA public meeting in Washington, D.C., concerning proposed rules for preventive controls that will be required by the Food Safety Modernization Act, signed into law in 2011. The meeting, attended by a number of senior level FDA officials, was called to give the public an opportunity to comment on the proposed rules for risk-based preventive controls. These proposed rules call for specific requirements for preventing the unintended presence of allergens. In his comments, Lehr reiterated the importance of recognizing food allergens as hazards with potentially life-threatening consequences and of addressing the issue of allergen control plans as an important part of the manufacturing process. FARE will be providing written comments to the official docket regarding preventive controls in coming weeks.

I don't have time this morning, but if someone else does, please try to grab link to gov website to see official video/digital audio or transcript of this public meeting, if available.  Would be interesting and possibly beneficial to hear/read ALL comments.

[rebekahc]

http://www.gpo.gov/fdsys/pkg/FR-2013-01-31/html/2013-02089.htm

Information and data submitted voluntarily to FDA during the public
meeting will become part of the administrative record for the relevant
rulemaking and will be accessible to the public at http://www.regulations.gov. The transcript of the proceedings from the public
meeting will become part of the administrative record for each of the
rulemakings. Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov and at
FDA's FSMA Web site at http://www.fda.gov/Food/FoodSafety/FSMA/. It may
also be viewed at the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. A transcript will also be available in either hardcopy or on CD-
ROM, after submission of a Freedom of Information request. Written
requests are to be sent to the Division of Freedom of Information
(ELEM-1029), 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Additionally, FDA will be video recording the public meeting. Once the
recorded video is available, it will be accessible at FDA's FSMA Web
site at http://www.fda.gov/Food/FoodSafety/FSMA/.

[ajasfolks2]

Thank U!

[LinksEtc]

This is a little off the topic of this thread, but I think it's worth posting here ...

"FDA Seeks Input on Improving Food Traceability to Help Craft Future Rule"
http://www.foodsafetynews.com/2013/03/fda-seeks-input-on-improving-food-traceability-to-help-craft-future-rule/#.UTZZARG9KSM

FDA could one day visualize food supply chains and actually see how they interconnect and overlap during a foodborne illness outbreak, enabling investigators to hone in on the problem quickly.

This could maybe help with tracing allergen cross-contam

FDA invited those interested in submitting comments to do so over the next 30 days. To submit comments electronically, go to http://www.regulations.gov and enter docket number FDA-2012-N-1153.

[LinksEtc]

Tweeted by @NutFreeWok

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"Allergen Proteins: Plant Sanitation's Biggest Challenge"
http://www.foodprocessing.com/articles/2014/plant-sanitations-biggest-challenge/#.U2n1Rq56z-g.google_plusone_share

Preventive controls rules in the Food Safety Modernization Act (FSMA) specify plants must have an allergen control program, making allergen control a fundamental prerequisite for safe processing.

[LinksEtc]

FDA to Hold Food Safety Modernization Act Supplemental Notices of Proposed Rulemaking Public Meeting

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm418931.htm

The U.S. Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed changes to four rules originally proposed in 2013 to implement the FDA Food Safety Modernization Act (FSMA). In response to the comments received on these foundational FSMA proposed rules, FDA issued supplemental notices of proposed rulemaking that propose changes and updates to four of the proposed FSMA rules: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventive Controls of Human Food); Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety); Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Preventive Controls for Animal Food); and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Foreign Supplier Verification Programs).

The meeting will be held November 13, 2014, 8:30 am – 5:00 pm at the Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740.

November 7, 2014: Closing date for Advanced Registration
December 15, 2014: Closing date to submit either electronic or written comments to FDA's Division of Dockets Management.
For Preventive Controls for Human Food, see Docket No. FDA-2011-N-0920.
For Produce Safety, see Docket No. FDA-2011-N-0921.
For Preventive Controls for Animal Food, see Docket No. FDA-2011-N-0922.
For Foreign Supplier Verification Programs, see Docket No. FDA-2011-N-0143.

[ajasfolks2]

I keep thinking about allergen cross-contact and seeing the peanut fields in Georgia . . . and the shared harvesting equipment (I think some for soy?) . . . and then the packing houses for pecans and peanuts . . .

This (cross contact potential) just goes so darned deep.

[LinksEtc]

Tweeted by @foodsafetynews

"Revised FSMA Provisions Need More Tweaks"
http://www.foodsafetynews.com/2014/11/revised-fsma-provisions-need-more-tweaks/#.VGZu13-9KSN

In the supplemental proposals, FDA decided to define a "very small business" producing human food as one with less than $1 million in annual sales and a small business as producing animal food as one with less than $2.5 million in annual sales. Several commenters expressed opposition to the $1 million threshold, arguing that it conflicts with the statutory framework of the legislation by expanding exemptions beyond what Congress had intended.

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Tweeted by @US_FDA

"Progress on FSMA: Getting Down to Implementation"
http://blogs.fda.gov/fdavoice/index.php/2014/12/progress-on-fsma-getting-down-to-implementation/?utm_source=FDA.Twitter&utm_medium=social