Some of these questions require semi-detailed responses, so I will respond with a few different comments. Richard had some examples/anecdotes about the level of impact policy comments could have:
“A good recent example of FDA making major changes as a result of public comment is the Food Safety Modernization Act (FSMA) Produce Safety rule. This rule was extensively changed as a result of feedback from the public, mostly the affected farmers. Some of the comments were merely self-interested lobbying, but some pointed out where FDA’s lack of understanding of specific situations would have led to an inefficient regulation. The changes were so extensive that FDA had to publish a reproposal of the rule.
This is a large and complex rule, so you can choose how much detail you want to look into. The overview is here:
You can do a text search in the Federal Register document for the phrase “Relevant Comments” to see the FDA responses to comments on various subjects and how those comments changed the regulation.
This is a link to the economic analysis of the reproposal, which has details on the costs and benefits of the changes in the reproposal:
Some of these questions require semi-detailed responses, so I will respond with a few different comments. Richard had some examples/anecdotes about the level of impact policy comments could have:
“A good recent example of FDA making major changes as a result of public comment is the Food Safety Modernization Act (FSMA) Produce Safety rule. This rule was extensively changed as a result of feedback from the public, mostly the affected farmers. Some of the comments were merely self-interested lobbying, but some pointed out where FDA’s lack of understanding of specific situations would have led to an inefficient regulation. The changes were so extensive that FDA had to publish a reproposal of the rule.
This is a large and complex rule, so you can choose how much detail you want to look into. The overview is here:
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm
and it has links to further information. The full Federal Register notice is here:
https://www.federalregister.gov/articles/2014/09/29/2014-22447/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption
You can do a text search in the Federal Register document for the phrase “Relevant Comments” to see the FDA responses to comments on various subjects and how those comments changed the regulation.
This is a link to the economic analysis of the reproposal, which has details on the costs and benefits of the changes in the reproposal:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM442801.pdf
Another rule where public comments led to major changes and a repropsal is the FSMA Preventative Controls rule:
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm
However, understanding the issues in that rule requires a bit more specialized knowledge.”