The FDA recently established a docket to obtain comments from the public in order to conduct a risk assessment which will establish regulatory thresholds for the top 8 food allergens (as defined in FALCPA – Food Allergen Labeling and Consumer Protection Act of 2004 – namely milk, eggs, fish, crustacean shellfish, wheat, tree nuts, peanuts and soybeans).
The Docket Name is: Risk Assessment for Establishing Food Allergen Thresholds, Establishment of Docket, Request for Comments
The public may submit comments on safe food allergen threshold levels through Feb. 7, 2013, at http://www.regulations.gov by entering the keyword “docket number FDA-2012-N-0711.” in the blue SEARCH box.
According to the FDA, the docket was established to “provide an opportunity for interested individuals to submit comments (including data) that we can use to design and carry out a quantitative risk assessment for establishing regulatory thresholds for major food allergens. In particular, we invite comments on the following matters:
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?”
For written submissions:
– Fax 301.827.6870
– Mail: Division of dockets Management (HFA-305) Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852
Instructions for submissions: 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 this document.
For more information contact: Steven M. Gendel, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, Tel: 240-402-1056
For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number(s), and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Source: www.regulations.gov
