Food Safety Modernization Act
Recent Regulatory Activities - The Food Safety Modernization Act
The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. Visit FDA's FSMA website.
NMPF has submitted a series of comments on FSMA proposed rules. Most recently, on July 30, 2014, NMPF submitted two sets of comments on FDA's proposed rule on Sanitary Transportation of Human and Animal Food. One set of comments, on the impact of the proposed rule on the dairy industry in general, was submitted jointly with the International Dairy Foods Association. The other comments, specific to the issue of animal feed on dairy farms, were submitted by NMPF alone.
Earlier, on June 30, 2014, NMPF asked the FDA not to impose addtional regulations on dairy farmers under FSMA because milk destined for further processing, into products like butter, cheese and bottled milk, is not a high-risk concern.
NMPF also issued comment in May 2014 on the matter of high-risk foods.
NMPF also submitted the following comments in November 2013:
- General comments on the preventive controls for human food as applied to dairy processing facilities
- Comments that, for Grade "A" facilities, FDA recognize compliance with the PMO as compliance with FSMA
- Comments that FDA not exempt farms selling raw milk for direct consumption from FSMA regulations for preventive controls for human food
- For the produce rule, comments that FDA not include milk sales toward the threshold for exempting farms from produce regulations (addendum)
NMPF Submits Comments on Burden of FDA FSMA Fee Amounts on Small Businesses: November 30, 2011
FSMA recognizes the role of small businesses in the food industry and provides for various ways to assist small businesses in meeting the new food safety requirements of the law. FDA established a docket for comments on the impact of FDA FSMA fees on small businesses. NMPF submitted comments to FDA about consideration that should be given to small businesses with respect to collection of fees for various activities (domestic/foreign facility reinspections, recalls, importer reinspections).
NMPF urged FDA to use the Small Business Administration's standard to define dairy processing facilities (500 employees or less). However, with respect to dairy farms, the SBA standard of less than $750,000 per year in sales is outdated. NMPF urged FDA to apply the SBA employee-based standard to dairy farms, or to use a roughly equivalent-based revenue standard for dairy farms.
NMPF Submits Comments on FDA Fee Structure: November 30, 2011
FSMA specifically authorizes new fees to give FDA resources necessary to implement specific activities (see FDA's topic page on FSMA fees). NMPF and the International Dairy Food Association submitted comments to FDA about the proposed Facility Reinspections, Recall and Importer Reinspection User Fee Rates for FY 2012.
NMPF and IDFA urged FDA to reconsider their fee structure incorporating direct costs only, and posed several questions for clarification of FDA's proposed fee structure. They also urged FDA that reinspection fees under FSMA should not apply to State inspections/reinspections conducted through the Pasteurized Milk Ordinance (PMO) under the umbrella of the National Conference on Interstate Milk Shippers (NCIMS), and asked FDA to reaffirm this in their upcoming guidance.
NMPF Submits Comments on Preventive Controls for Facilities: May 20, 2011
FDA opened a docket to obtain information about preventive controls and other practices used by food facilities that manufacture, process, pack, or hold human food to identify and address hazards associated with specific types of food and specific processes. The National Milk Producers Federation submitted comments with the International Dairy Foods Association (IDFA).
The comments from NMPF and IDFA encouraged FDA to consider the Pasteurized Milk Ordinance (PMO) in developing preventive controls regulations for the dairy industry, emphasized that food safety can not be built into a process through finished product testing, and encouraged FDA to modify the requirement for warehouses to have food safety plans.
FDA Launches Webpage on Recalled Foods: April 4, 2011
As of April 4, 2011, consumers can search for food and other product recalls easier and quicker on FDA’s website than previously. The FDA Food Safety Modernization Act (FSMA) signed into law in January by President Obama called for a more consumer-friendly recall search engine.
To provide greater ease of use for consumers, the search results provide data from news releases and other recall announcements in the form of a table. That table organizes information from news releases on recalls since 2009 by date, product brand name, product description, reason for the recall and the recalling firm.
Under FSMA, FDA was required to provide a consumer-friendly recall search engine within 90 days after the law went into effect. Further, for recalls conducted under FSMA, it requires FDA to indicate whether the recall is ongoing or completed. Prior to passage of FSMA, FDA did not have mandatory recall authority for food and feed products other than infant formula.
Legislative Timeline - The Food Safety Modernization Act
President Signs Food Safety Legislation: January 4, 2011
On January 4, 2011, President Obama signed into law the Food Safety Modernization Act, landmark legislation that represents the first major overhaul of the nation's food-safety infrastructure since 1938.
The bill moves the Food and Drug Administration (FDA) away from its early-20th-century role of responding to adulterated food to a more modern one of requiring companies to stop contamination before it happens by looking for the places where things can go wrong and fixing them. It also allows the agency to issue mandatory recalls and hire more food-safety inspectors.
Supporters of the new law are gearing up to fight for the estimated $1.4 billion to implement the provisions.
Food Safety Bill Heads to President's Desk: December 21, 2010
The House approved major food safety legislation (HR 2751, underlying bill S. 510) by a vote of 215-144. The FDA Food Safety Modernization Act, the first significant reform since 1938 of the U.S. Food and Drug Administration's oversight of the food supply, is expected to be signed by President Obama before Christmas.
The bill survived a near-fatal constitutional snafu, filibuster threats, fierce debate over controversial amendments, and managed to gain ground amidst a jam-packed legislative agenda in one of the most productive Congresses in recent history. In the last 18 months, food safety legislation cleared the Senate twice and the House three times.
Food Safety Bill Passes Senate: December 19, 2010
The Senate passed a long-delayed comprehensive food safety bill by voice vote on the evening of December 19, 2010, sending it back to the House to clear for the president’s signature. The action resurrected legislation some supporters had begun to write off as a casualty of a technical error and shifting partisan sentiments after the Nov. 2 elections.
The food safety measure — which would expand Food and Drug Administration regulatory authority and empower the agency to order mandatory recalls — enjoys broad bipartisan support in both chambers. The Senate passed its bill last month with 73 votes, and clearing it in the House appeared to be a formality. But the Senate bill included user fees that ran afoul of a constitutional requirement that revenue measures originate in the House.
Read more from The Washington Post (December 19, 2010).
House Advances Food Safety Bill: December 9, 2010
Food safety legislation inched forward on December 8, 2010, as the House passed the Senate version of the bill as part of a larger resolution to fund the federal government for the next several months. The bill, which passed the House 212-206 with 35 Democrats joining Republicans to vote "no," must now be re-approved by the Senate.
The controversial Tester-Hagan amendment, a provision added to the Senate bill to exempt small farms and producers under certain conditions, is part of the legislation going back to the Senate for consideration.
Read more from Food Safety News (December 9, 2010).
NMPF, AG and Food Groups Oppose Tester/Hagan Language as a part of Food Safety Bill: December 7, 2010
As the House considers how to proceed on S. 510, the “Food Safety Modernization Act” as passed by the Senate, 17 food and agricultural groups, including NMPF, sent a letter to Speaker Pelosi and Minority Leader Boehner expressing concerns with language added that exempts small entities.
"What matters for food safety is that the operation implements prudent product safety practices, regardless of whether the product is purchased at a roadside stand, a farmers’ market,or a large supermarket," the letter read. "Consumers should be able to rely on a federal food safety framework that sets appropriate standards for all products in the marketplace, no matter the size of the producing entity."
Senate Passes Food Safety Bill: November 30, 2010
The Food Safety Modernization Act, S.510, passed the Senate on November 30th, after overcoming procedural hurdles. The vote was 73-25.
The bill, which sought to improve food-borne illness prevention, detection and response, will provide the Food and Drug Administration (FDA) with more resources for inspection, mandatory recall authority, and the technology to trace an outbreak back to its source, among other things.
The House passed the Food Safety Enhancement Act in July 2009, but despite the Senate version’s passage with a bipartisan 73-25 vote, there is little time available in the current congressional lame-duck session for the two chambers to wrangle over the details of a final version.
Here's a summary of what's in the Senate food safety bill, from sponsor Sen. Dick Durbin (D-IL), as well as what's needed to reconcile it with the House version, from the Congressional Research Service (Food Safety News, December 1, 2010).
NMPF, Food and Ag Groups Rally Against Tester Amendment: November 15, 2010
As the Senate gears up to vote on a motion to limit debate and move the pending food safety bill forward on Wednesday, interest groups are kicking into high gear to lobby for and against key amendments.
On November 15, 2010, a group of 30 meat, pet food, and fresh produce industry groups, including NMPF, sent a letter to the Health, Education, Labor, and Pensions Committee chairman and ranking members, Senators Tom Harkin (D-IA) and Michael Enzi (R-WY), respectively, urging key staff and lawmakers working on the bill to oppose a measure to exempt small farms and producers from the crux of the legislation.
"We believe an operation's size, the growing practices used, or its proximity to customers does not determine whether the food offered is safe," read the letter. Read the full letter.