It is clear that most of the people chattering across the Internet on either side have never read the bill (arguably, many who voted on did not either). Below is a summary as I read the bill. In order to effectively read it, you have the Food, Drug and Cosmetic Act, Chapter IV open to track the amendments and changes – especially the definitions. So, here we go – H.R. 2749 – Food Safety Enhancement Act 2009:
State Law not preempted.
USDA Regulated Food products exempt from the requirements of the Act if the facility is regulated exclusively by the USDA. This includes Farms that are regulated by the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act. Read the following carefully, it should help explain that farms; private residences of individuals; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer are exempt. (1) DEFINITION OF FACILITY.—Paragraph (1) of section 415(b) (21 U.S.C. 350d(b)) is amended to read as follows:
(1)(A) The term ‘facility’ means any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food.
“(B) Such term does not include farms; private residences of individuals; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing as defined in section 123.3(k) of title 21, Code of Federal Regulations, or any successor regulations).
“(C)(i) The term ‘retail food establishment’ means an establishment that, as its primary function, sells food products (including those food products that it manufactures, processes, packs, or holds) directly to consumers (including by Internet or mail order).
“(ii) Such term includes—
“(I) grocery stores;
“(II) convenience stores;
“(III) vending machine locations; and
“(IV) stores that sell bagged feed, pet food, and feed ingredients or additives over-the-counter directly to consumers and final purchasers for their own personal animals.
“(iii) A retail food establishment’s primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers.
“(D)(i) The term ‘farm’ means an operation in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both.
“(ii) Such term includes—
“(I) such an operation that packs or holds food, provided that all food used in such activities is grown, raised, or consumed on such farm or another farm under the same ownership;
“(II) such an operation that manufactures or processes food, provided that all food used in such activities is consumed on such farm or another farm under the same ownership;
“(III) such an operation that sells food directly to consumers if the annual monetary value of sales of the food products from the farm or by an agent of the farm to consumers exceeds the annual monetary value of sales of the food products to all other buyers;
“(IV) such an operation that manufactures grains or other feed stuffs that are grown and harvested on such farm or another farm under the same ownership and are distributed directly to 1 or more farms for consumption as food by humans or animals on such farm; and
“(V) a fishery, including a wild fishery, an aquaculture operation or bed, a fresh water fishery, and a saltwater fishery.
“(iii) Such term does not include such an operation that receives manufactured feed from another farm as described in clause (ii)(IV) if the receiving farm releases the feed to another farm or facility under different ownership.
“(iv) The term ‘harvesting’ includes washing, trimming of outer leaves of, and cooling produce.
“(E) The term ‘consumer’ does not include a business.”
Alcohol-Related Facilities exempted.
Require yearly registration for domestic facilities and foreign facilities that export to the United States. Much more detailed requirements to explain the type of facility, what is produced and contact information. Registration can be canceled or suspended for violations of the Act.
Fees Relating to Food – Beginning 2010 an annual fee will be collected of $500 from each registered facility, not to exceed $175,000 for multiple facilities. Fee is to offset inspection costs and food safety activities. The fee provision even has a “sunset provision.”
Hazard Analysis, Risk-Based Preventive Controls, Food Safety Plan, Finished Product Test Results From Category 1 Facilities. This includes the facility conducting a hazard analysis, identifying and validating preventive controls and keeping records of such efforts. The HHS Secretary may establish by regulation or guidance preventive controls for specific product types to prevent intentional and unintentional contamination throughout the supply chain. HHS Secretary will review international standards.
HHS Secretary may exempt from compliance facilities that are solely engaged in a) the production of food for animals other than man or the storage of packages foods that are not exposed to the environment, b) the storage of raw agricultural commodities for further processing.
HHS Secretary shall consider the impact on small business in making rules and regulations.
HHS Secretary may take into account the differences between food intended for human or animal consumption.
Finished Product Test Results from Category 1 Facilities will be required to be submitted to HHS Secretary.
HHS Secretary will review and review and evaluate epidemiological on significant food-borne contaminants.
HHS Secretary shall establish scientific-based regulations for growing, harvesting, processing, packing, sorting, transporting, and holding raw agricultural commodities, and shall take into consideration, consistent with ensuring enforceable public health protection, the impact on small-scale and diversified farms, and on wildlife habitat, conservation practices, watershed protection efforts and organic production methods.
Inspection of domestic and foreign manufacturers will be pursuant to a risk-based schedule. Category 1 – high – risk facilities – inspected once every 6-12 months. Category 2 – low – risk facilities – inspected once every 18 months to 3 years. Inspections can occur more frequently depending on the type of food and facility compliance.
Each person who produces, manufactures, processes packs, transports, distributes, receives, or holds an article of food in the US or for import to the US shall produce records (paper or electronically) bearing on whether the food may be adulterated. Records must be kept for 6 months to 3 years.
HHS Secretary shall by regulation establish a tracing system for food that is located in the US and for imports to the US. Direct sales by farms to consumer, restaurant or grocery store are exempted.
HHS Secretary can assess fees for violations and costs of additional inspection during recalls.
Imported food must be certified as complying with the Act.
Auditors and Laboratories must all be certified and audited. Test results of food items and environmental testing must be reported.
A facility shall recall an article of food, or ingredient, that presents a reasonable probability that it is a threat to human health. HHS Secretary may request a recall if the secretary has reason to believe the food is adulterated or misbranded. HHS Secretary my order a facility to cease distribution of a food product. HHS Secretary may order a recall.
Additional requirements on infant formula manufacturers to keep records and for additional clinical studies that the formula supports normal physical growth in infants. HHS Secretary must also report to Congress on Bisphenol A in food and beverage containers. Also, a lead warning on ceramics was added.
The CDC shall enhance food-borne illness surveillance by coordinating Federal, State and Local food-borne systems.
HHS Secretary shall design and implement a national public education program on food safety.
HHS Secretary shall conduct food safety research.
HHS Secretary may seize food likely to have serious adverse health consequences and quarantine any geographic are of the US where the food originated after notification.
Criminal penalties increased to 10 years the penalties for selling misbranded or adulterated food.
Civil penalties now range from $20,000 to $7,500,000 for violating or knowingly selling misbranded or adulterated food.
Country of origin and disclosure of ingredients required.
A facility, including a farm, is prohibited against delaying, limiting or refusing inspections. HHS subpoena authority clarified.
Creation of a dedicated foreign inspectorate.
Whistleblower Protections – protections to employees who refuse to violate the Act or who disclose violations.
My suggestions as this moves to the Senate, Conference Committee and the President’s Desk:
1. Raise more money – have a sliding scale based upon risk of contamination and size of operation. Frankly, I would require registration of all who produce and sell food, but charge little, if anything, to farms that sell directly to consumers. Raise enough money to actually fund all of this.
2. Clearly excluded are all direct sales between farmer and customer (including direct sales to consumer, restaurant and farmer’s markets) from the necessity of most, if not all, the provisions of this legislation. However, I would recommend and give resources so that State and Local Health and Agriculture authorities can work with farmers to produce safe food.
3. Bottom line, regardless of size, if food is produced and put into the larger stream of commerce, the producer, small or large, must play by the same food safety rules.
4. Perhaps not in this bill or the Senate version at this time, but we need to start dealing with creating a sustainable and regionalized agriculture. We need to balance safety with environmental policy – both energy/global warming and protection of biodiversity. We need a food policy that helps create healthy humans.