Food Safety Magazine - June/July 2013
Food Safety Magazine - June/July 2013
Food Safety Magazine - June/July 2013
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REGULATIONS<br />
uled and held a series of Public Meetings to receive feedback<br />
from food industry representatives and consumers. FDA<br />
initially stated in the proposed rules that it would consider<br />
written comments received by May 16, <strong>2013</strong>. However, FDA<br />
received numerous requests for an extension to provide written<br />
comments given the complexity of these rules as well<br />
as the fact that they are highly intertwined with three other<br />
major rules (foreign supplier verification program, preventive<br />
controls designed to reduce the likelihood of contamination<br />
in animal food and certification of third-party audits) that<br />
have yet to be published. Based on these requests, the agency<br />
extended the comment period by another 120 days to give industry<br />
and consumers a chance to fully comment on the rules,<br />
so now the new date for filing written comments is September<br />
16, <strong>2013</strong>.<br />
The final regulations may include changes requested by<br />
commenters and will likely have variable, effective compliance<br />
dates for different provisions and for different categories or<br />
sizes of businesses (small and very small businesses will likely<br />
have longer to come into compliance than larger companies).<br />
Given the impact FDA’s regulations will have on companies<br />
large and small, however, it is crucial for any and all affected<br />
companies to understand the proposed rules and to make<br />
their views, objections and constructive suggestions known to<br />
FDA as part of the rulemaking process.<br />
The issuance of these proposed rules marks the start of<br />
what will be a lengthy and challenging rulemaking proceeding.<br />
There are many issues within the rules, and industry may want<br />
FDA to modify or relax its proposals around them. FDA may<br />
be flexible on some issues, but on others, the agency’s views<br />
will be difficult or impossible to change.<br />
•<br />
Sonali Gunawardhana is a member of Wiley Rein’s food and<br />
drug law practice group. She worked for nearly 10 years as an<br />
attorney at FDA and also served in FDA’s Center for <strong>Food</strong> <strong>Safety</strong><br />
and Applied Nutrition. She can be reached at 202.719.7454 or<br />
sgunawardhana@wileyrein.com.<br />
James N. Czaban is a member of Wiley<br />
Rein’s food and drug law practice group. He has extensive experience<br />
in government regulation of food, pharmaceutical, biotechnology,<br />
medical device and healthcare-related companies. He can<br />
be reached at 202.719.7411 or jczaban@wileyrein.com.<br />
References<br />
1. Taylor, M.R. 2012. Progress on FSMA, Changes within the FDA <strong>Food</strong>s<br />
Program, and on Partnerships. FDA Science Writers Symposium, Silver<br />
Spring, MD.<br />
2. FDA Warning Letter issued to Lucky Taco, April 2, 2012.<br />
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