Regulatory Thresholds For Major Food Allergens?

Regulatory Thresholds For Major Food Allergens?*

In December 2012, the Food and Drug Administration (FDA) published a notice requesting comments “relevant to conducting a risk assessment to establish regulatory thresholds for major food allergens.”  Please take the time to submit your comments to the FDA, since this is the only way the food allergic community’s voice will be heard. Please also take a moment to share this article with your friends and in any allergy forums and communities you visit.

The notice invites interested individuals to submit comments (including data) on the following issues:

1         How should we define “an allergic response that poses a risk to human health?”

2         Which major food allergens are of greatest public health concern and what is the size of the at-risk population?

3         How should clinical dose distribution data be used when establishing regulatory thresholds for the major food allergens?

4         What approaches exist for using biological markers or other factors related to the severity of allergic responses in a threshold risk assessment?

5         What data and information exist on dietary exposure patterns for individuals on allergen avoidance diets?

6         What data or other information exist on current levels of exposure associated with the consumption of undeclared major food allergens in packaged foods?

7         What other information or data should we consider in establishing regulatory thresholds for major food allergens?

Why is the establishment of regulatory thresholds important? Currently undeclared major food allergens are one of the major causes of reportable food incidents, which also lead to recalls. With established thresholds, the FDA can determine the appropriate type of enforcement action, when specific problems are identified.

DATES: Submit either electronic or written comments by February 12, 2013.

You may submit comments, identified by Docket No. FDA–2012–N–0711, by any of the following methods:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:

• Fax: 301–827–6870.

• Mail/Hand delivery/Courier (for paper or CD–ROM submissions):

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

Instructions: All submissions received must include the Agency name and Docket No. FDA–2012–N–0711. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of the notice.

Link to the FDA notice http://www.gpo.gov/fdsys/pkg/FR-2012-12-14/pdf/2012-30123.pdf

Link to share this article: http://blog.onespotallergy.com/2013/02/regulatory-thresholds-for-major-food-allergens/

* Thank you to Jennifer Ng, a Onespot Allergy Blog reader, who contributed this article.