delivron
01-17-2013, 01:15 AM
There are is no known exception base on size. They have more to do how you sell your product.
There is a current comment period about what constitutes a small business and how inspections will be conducted.
But the rules are not currently enforce.Effective and Compliance Dates and Definitions for Small and Very Small Businesses
FDA is proposing the following effective and compliance dates for businesses subject to the proposed rule. Recognizing that small and very small businesses may need more time to comply with the requirements, the compliance dates are adjusted accordingly.
• Effective Date: 60 days after the final rule is published
• Compliance Dates:
o Small Businesses—a business that employs fewer than 500 persons and that does not qualify for an exemption would have to comply two years after publication of the final rule.
o Very Small Businesses—Three options are being proposed for the definition of a very small business:less than $250,000, less than $500,000, and less than $1,000,000 in total annual sales of food, adjusted for inflation. Very small businesses, which would be considered “qualified facilities” and subject to modified requirements for preventive controls, would have to comply three years after publication of the final rule.
o Other Businesses—a business that is not small or very small and does not qualify for an exemption would have to comply one year after publication of the final rule.
Economic Impact of the Proposed Rule
The proposed rule is aimed at reducing the public health burden of foodborne illness. FDA estimates that close to 1,000,000 illnesses each year are attributable to food that would fall under the scope of this proposed rule. The economic cost of illnesses avoided is $2 billion a year. The proposed rule has a first-year cost to industry of $701 million and an annualized cost of $472 million using a 7 percent discount rate according to Office of Management and Budget guidelines. The proposed rule would cover an estimated 97,600 domestic and 109,200 foreign facilities
More information at: http://www.fda.gov/Food/FoodSafety/FSMA/ucm334115.htm
There is a current comment period about what constitutes a small business and how inspections will be conducted.
But the rules are not currently enforce.Effective and Compliance Dates and Definitions for Small and Very Small Businesses
FDA is proposing the following effective and compliance dates for businesses subject to the proposed rule. Recognizing that small and very small businesses may need more time to comply with the requirements, the compliance dates are adjusted accordingly.
• Effective Date: 60 days after the final rule is published
• Compliance Dates:
o Small Businesses—a business that employs fewer than 500 persons and that does not qualify for an exemption would have to comply two years after publication of the final rule.
o Very Small Businesses—Three options are being proposed for the definition of a very small business:less than $250,000, less than $500,000, and less than $1,000,000 in total annual sales of food, adjusted for inflation. Very small businesses, which would be considered “qualified facilities” and subject to modified requirements for preventive controls, would have to comply three years after publication of the final rule.
o Other Businesses—a business that is not small or very small and does not qualify for an exemption would have to comply one year after publication of the final rule.
Economic Impact of the Proposed Rule
The proposed rule is aimed at reducing the public health burden of foodborne illness. FDA estimates that close to 1,000,000 illnesses each year are attributable to food that would fall under the scope of this proposed rule. The economic cost of illnesses avoided is $2 billion a year. The proposed rule has a first-year cost to industry of $701 million and an annualized cost of $472 million using a 7 percent discount rate according to Office of Management and Budget guidelines. The proposed rule would cover an estimated 97,600 domestic and 109,200 foreign facilities
More information at: http://www.fda.gov/Food/FoodSafety/FSMA/ucm334115.htm