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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

Food Safety Bill Leaves Senate with Unanimous Consent, House Vote Tuesday

Perhaps the President will bring the Bill with him to Hawaii for Christmas – It’s a short flight from Seattle.  Thanks to Republican and Democratic Staff for this great Summary of the House and Senate version of the Bill:

Noteworthy

· S. 510 is intended to respond to several food safety outbreaks in recent years by strengthening the authority of the Food and Drug Administration (FDA) and redoubling its efforts to prevent and respond to food safety concerns.

· The legislation expands current registration and inspection authority for FDA, and re-focuses FDA’s inspection regime based on risk assessments, such that high-risk facilities will be inspected more frequently. The bill also requires food processors to conduct a hazard analysis of their facilities and implement a plan to minimize those hazards.

· The bill requires FDA to recognize bodies that accredit food safety laboratories domestically and third-party auditors overseas. The bill enhances partnerships with state and local officials regarding food safety outbreaks, and establishes a framework to allow FDA to inspect foreign facilities.

· The bill does NOT change the existing jurisdictional boundaries between FDA and the Department of Agriculture, and includes protections for farms and small businesses.

· The bill gives the FDA the power to order mandatory food recalls, in the event that a food company cannot or does not comply with a request to recall its products voluntarily.

Title I – Prevention

Records Inspection: Expands and clarifies FDA’s records inspection authority, such that FDA can inspect records regarding an article of food “and any other article of food that [FDA] reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals.”

Registration: Requires facilities to renew registration with the FDA every two years, and to agree to potential FDA inspections as a condition of such registration. Gives the FDA Commissioner the power to suspend facilities’ registration in the event FDA determines the facility “has a reasonable probability of causing serious adverse health consequences or death.” A suspended facility shall not be able to “introduce food into interstate or intrastate commerce in the United States. A hearing would occur within two business days on any suspension. If the suspension is found warranted, the facility must submit a corrective action plan before its suspension could be lifted. The bill also states that the commissioner cannot delegate to other officials within FDA the authority to impose or revoke a suspension.

Small Entity Compliance Guides: Requires FDA to develop plain language small entity compliance guides within 180 days of the issuance of regulations with respect to registration, hazard analysis, safe production, and recordkeeping requirements.

Hazard Analysis: Requires facilities to analyze at least every three years their potential hazards and implement preventive controls at critical points. Further requires facilities to monitor the effectiveness of their preventive controls, take appropriate corrective action, and maintain records for at least two years regarding verification of compliance. The bill gives FDA the authority to waive compliance requirements in certain instances, and allows FDA to exempt facilities “engaged only in specific types of on-farm manufacturing, processing, or holding activities that the Secretary determines to be low risk.” The language also delays implementation for smaller establishments for up to three years.

Performance Standards: Requires FDA to review evidence on food-borne contaminants and issue guidance documents or regulations as warranted every two years.

Produce Safety: Establishes a process to set standards for the safe production and harvesting of raw agricultural commodities (i.e. fruits and vegetables). Requires FDA to promulgate regulations regarding the intentional adulteration of food—applying to food “for which there is a high risk of intentional contamination”—within two years, and issue compliance guidance as appropriate. Includes delayed implementation of up to two years for smaller establishments.

Fees for Non-Compliance: Imposes fees on facilities only in cases where a facility undergoes re-inspection to correct material non-compliance, or does not comply with a recall order and thereby forces FDA to use its own resources to perform recall activities. Importers would be subject to fees for annual re-inspections or for participation in the voluntary qualified importer program established under title III of the bill. Requires FDA appropriations funding to keep pace with inflation in order for fees to be collected. The bill gives FDA the authority to lower fee levels on small businesses through a notice-and-comment process.

Safety Strategies: Requires FDA, the Department of Agriculture, and the Department of Homeland Security to coordinate to create an agriculture and food defense strategy, focused on preparedness, detection, emergency response, and recovery. Requires reports from FDA on building domestic preventive capacity—including analysis, surveillance, communication, and outreach—and requires FDA to issue regulations on the sanitary transportation of food within 18 months of enactment.

Food Allergies in Children: Requires FDA to work with the Department of Education to develop voluntary guidelines to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs. Authorizes new grants of up to $50,000 over two years for local education agencies to implement the voluntary guidelines.

Dietary Ingredients and Supplements: Requires FDA to notify the Drug Enforcement Administration if FDA believes a dietary supplement may not be safe due to the presence of anabolic steroids.

Refused Entry: Requires FDA to notify the Department of Homeland Security, and by extension the Customs and Border Protection Agency, in all cases where FDA refuses to admit foods into the United States on the grounds that the food is unsafe.

Title II – Detection and Response

Targeted Inspections: Requires FDA to prioritize inspection of high-risk facilities, based on a risk profile that includes the type of food being manufactured and processed, facilities’ compliance history, and other criteria. Requires FDA to inspect high-risk facilities once in the five years after enactment, and every three years thereafter; low-risk facilities would be inspected once in the seven years after enactment, and every five years thereafter. Foreign facility inspections would be required to double every year for five years.

Laboratory Testing: Requires FDA to establish within two years a process to recognize organizations that accredit laboratories testing food products, and to develop and maintain model standards for accrediting bodies to use during the accreditation process. Requires food testing for certain regulatory purposes to be conducted in federal laboratories or those accredited by an approved accrediting body, with results sent directly to FDA. Includes reporting and other provisions designed to support early detection among laboratory facilities.

Traceback and Recordkeeping: Establishes a series of pilot projects within nine months of enactment on “methods to rapidly and effectively identify recipients of food to prevent or mitigate a foodborne illness outbreak.” Requires FDA to issue within two years a notice of proposed rulemaking regarding recordkeeping requirements for high-risk foods. Permits FDA to request that farm owners “identify immediate potential recipients, other than consumers,” in the event of a foodborne illness outbreak. Delays implementation of regulations for up to two years for smaller establishments.

Surveillance: Directs FDA to enhance foodborne illness surveillance systems to improve collection, analysis, reporting, and usefulness of data on foodborne illnesses, and establishes a multi-stakeholder working group to provide recommendations. Reauthorizes an existing program of food safety grants through fiscal year 2015.

Mandatory Recall Authority: Provides FDA the authority to order recall of products if the products are adulterated or misbranded “and the use of or exposure to such article will cause serious adverse health consequences or death.” Requires FDA to provide an opportunity for voluntary recall by the manufacturer or distributor prior to ordering a recall and provides the responsible party the opportunity to obtain a hearing within two days regarding any FDA order for a mandatory recall. Requires federal agencies to establish and maintain a single point of contact regarding recalls, and requires FDA to take appropriate actions to publicize mandatory recalls through press releases, an internet Web site, and other similar means. Also gives FDA authority to order the administrative detention of food products when the agency has “reason to believe” they are adulterated or misbranded. Directs that only the commissioner has the authority to order a mandatory recall, a power that may not be delegated to other FDA employees.

State and Local Governments: Directs FDA, working with other federal departments, to provide support to state and local governments in response to food safety outbreaks. Requires the Department of Health and Human Services to set standards and administer training programs for state and local food safety officials. Creates a new program of food safety centers of excellence, and amends an existing program of food safety grants to fund food safety inspections and training, with an extended authorization through fiscal year 2015.

Food Registry: Permits FDA to require the submission of reportable food subject to recall procedures (excepting fruits and vegetables that are raw agricultural commodities). Requires grocery stores with more than 15 locations to post information about reportable foods prominently for 14 days.

Title III – Food Imports

Foreign Supplier Verification Program: Requires importers to undertake a risk-based foreign supplier verification program to ensure that imported food meets appropriate federal requirements and is not adulterated or misbranded. Requires FDA to establish regulations for the foreign supplier verification program within one year of enactment. Importers’ records relating to foreign supplier verification would be maintained for at least two years.

Voluntary Qualified Importer Program: Directs FDA to establish within 18 months a voluntary program of “expedited review and importation” for importers. Eligibility would be determined by FDA using a risk assessment based on such factors as the type of food being imported, the compliance history of the foreign supplier, and the compliance capacity of the country of export.

Import Certification: Permits FDA to require as a condition of importation a certification “that the article of food complies with some or all applicable requirements” under the Food, Drug, and Cosmetic Act. Requires FDA’s determination of certification requirements to be made based on risk assessments. Requires notices for imported food to list any country that previously refused entry for that food. Permits FDA to review foreign countries’ controls and standards to verify their implementation.

Foreign Government Capacity: Requires FDA to “develop a comprehensive plan to expand the technical, scientific, and regulatory capacity” of foreign entities exporting food to the United States. Permits FDA to inspect foreign food facilities, and requires the refusal of imported food if a registered exporter refuses entry of FDA inspectors into an overseas facility. Directs FDA to establish a system to recognize bodies that accredit third-party auditors to certify eligible foreign food facilities meet federal compliance requirements. Requires FDA to establish overseas offices in countries selected by FDA to “provide assistance to the appropriate governmental entities of such countries with respect to measures to provide for the safety of articles of food.”

Smuggled Food: Requires FDA to work with the Department of Homeland Security and Customs officials to develop a strategy to identify smuggled food and prevent its entry.

Title IV – Other Provisions

Funding and Staffing: Authorizes such sums in funding for fiscal years 2011 through 2015. The bill also sets staffing goals of 4,000 new field staff in fiscal year 2011, and a total of 17,800 through fiscal year 2014.

Employee Protections: Creates a new process intended to prevent employment discrimination against individuals reporting food safety violations. The Department of Labor is directed to review and investigate complaints of such discrimination through an administrative process, subject to appeal in federal court.

Jurisdiction: The bill notes that nothing within its contents shall be construed to alter the division of jurisdiction between the Department of Health and Human Services and the Department of Agriculture. Likewise, the bill notes that it shall not be construed in a manner inconsistent with American obligations under the World Trade Organization and other relevant international treaties.

Summary of Tester Amendment as Modified (Included in Harkin Substitute Amendment as passed the Senate):

· Clarifies that a “retail food establishment” shall not include the sale of food products at a roadside stand or farmer’s market, the sale of food “through a community supported agriculture program,” or the sale of food through any other “direct sales platform” designated by the Secretary.

· Exempts from recordkeeping and hazard analysis requirements a “very small business” as defined by the Secretary, as well as those facilities whose direct sales (to consumers and local restaurants) exceed their sales to distributors AND whose annual sales total fewer than $500,000 (adjusted for inflation). Requires such facilities receiving exemptions to submit documentation to FDA that the owners have identified potential food hazards OR are in compliance with state and other applicable food safety laws. Permits FDA to revoke exemptions in the event of a food outbreak directly linked to the facility or to protect the public health.

· Requires a study by FDA and the Department of Agriculture to help define the terms “small business” and “very small business” for purposes of the statute’s regulatory requirements.

· Requires facilities receiving exemptions under the amendment to “include prominently and conspicuously…the name and business address of the facility where the food was manufactured or processed,” either on food labels or at the point of purchase.

· Amends the timeline for the new hazard analysis requirements to specify that small businesses will have an additional six months to comply with the hazard control regulatory requirements (down from two years in the base bill) and very small businesses will have an additional 18 months to comply (down from three years in the base bill).

· Exempts from new produce safety guidelines those farms whose direct sales (to consumers and local restaurants) exceed their sales to distributors AND whose annual sales total fewer than $500,000 (adjusted for inflation). Requires farms receiving exemptions under the amendment to “include prominently and conspicuously…the name and business address of the facility where the food was manufactured or processed,” either on food labels or at the point of purchase. Permits FDA to revoke exemptions in the event of a food outbreak directly linked to the facility or to protect the public health.

  • http://www.squidoo.com/mandala-art dreaming_lucid

    I’m glad I found your site. Thanks for condensing the info in the bill into this post. I have heard both pros and cons in regard to S 510, and I was hoping you might be able to answer a few questions.
    First of all, I think it’s perfectly natural to be suspicious of this bill, given the fact that Michael Taylor, who has been in and out of government and has worked in a law firm representing Monsanto, now holds a prominent position in the FDA. I am familiar with Monsanto’s use of lawsuits to bankrupt farmers whose farms have been contaminated by the genetic drift from farms using Monsanto’s seed. Monsanto has been engaged in many other unethical practices I won’t go into here. I think these issues raise alarm bells for a lot of people who understand the power of these corporations, and their desire to eliminate competitors and maximize profit. Given this record, how can the American people feel confident that this bill is in their best interest, or in the best interest of small businesses/local/organic food?
    Further, why would the bill “require a study by FDA and the Department of Agriculture to help define the terms “small business” and “very small business” for purposes of the statute’s regulatory requirements.” Shouldn’t small farmers be concerned about the effects of this bill if the definition hasn’t been established before it is being voted on? How can you wait to define crucial terms until after the bill is passed?
    The bill uses 500,000 dollars in sales as a benchmark for exemption, but this seems to potentially mask some important numbers, as farming has considerable overhead. Wouldn’t it make more sense to also base exemption on adjusted income? I realize that the concept of a small farm has to take in consideration both volume of sales as well as the monetary factor, but do you think 500,000 dollars is a realistic number in defining a small farm across the board, as I have seen suggestions to the contrary?
    Thanks in advance

  • http://www.marlerclark.com/wmarler.htm Bill Marler

    Regarding Mike Taylor – despite that fact he worked for Monsanto, I have a great deal of respect for him and I have know of him, and known him of him for nearly 16 years. In my opinion, he nearly by himself, did more to improve the safety of the beef supply in this country than anyone in history. You see, Mr. Taylor had the guts in 1994 to go up against all the big packers in this country when he declared E. coli O157:H7 an adulterant. This was a very big deal. It has saved lives.
    Regarding the Tester Amendment and small farms. More has to be worked out to encourage small, local, sustainable Ag. This amendment is a start, but more needs to be done during rule making. Stay engaged.

  • Gabrielle Meunier

    To Dreaming Lucid. The part in the legislation where the definition of small farm is still to be determined is a good thing. What I think it means is that where there is no need to monitor food production due to small output, the FDA has no need to spend time and money doing so. However the exact size of this is yet unknown and time will tell. In terms of choosing the $500,000 gross number, after spending most of my life as an Accountant, I can tell you that most people know their gross sales, but to determine your actual net can vary by so many factors that it would be too difficult to make this a measurement for all producers as some would have some deductions and others would have very different deductions. Many people don’t understand their true “net income”, however most people/businesses do know that they produce Gross in a year. In order to make systems work, my motto has always been KISS (Keep it Simple Stupid)

  • http://www.healthyfoodcoalition.org Harry Hamil

    Bill,
    The Republican and Democratic Staff’s first point under the Tester summary has it backwards. Strike the word “not” and it is correct.
    Interestingly, this clarification was necessary because the FDA wouldn’t make it and the FDA definition of “farm” under the registration requirement doesn’t include most farmers in the local, healthy food movement. In addition, though farms are clearly excluded in the statute, they are exempted in the regs only if they also qualify as a retail food establishment. Also, the FDA wouldn’t give the clarification that a business could be both a farm and a retail food establishment.
    How are those for good examples of why it is foolish to ratify the way the FDA does business, as the FSMA does?
    The 4th point under the Tester amendment summary is also wrong. The consumer notification is required only “if the facility “does not prepare documentation under paragraph (2)(B)(i)(I).”
    The 5th point is completely wrong and appears to say that Tester shortened the implementation time. All the Tester amendment did was change the wording of the effective date provision NOT the timeline. 18 months + 6 months is still 2 years and 18 months + 18 months is still 3 years.
    The 6th point is incorrect, too. The calculation for exemption also includes sales to retail food establishments not just consumers and restaurants. In addition, the second sentence uses the language from the consumer notification requirements for facilities under the new Sec. 418 rather than for farms under the new Sec. 419. The last sentence is correct but has nothing to do with farms and Sec. 418. It is about facilities and Sec. 418. For clarity, it would be better as a separate point further back up.
    I didn’t take the time to read the summary of the rest of the FSMA carefully because it has taken long enough just to correct what it says about Tester. I hope the earlier summary is more accurate.
    As for Mike Taylor, that’s a nice gloss over of his record and clear hyperbole about his place in history. I regard him as the poster child for the revolving door between regulators and those being regulated. Plus, it will be interesting to see how long he stays with the FDA and where he goes afterward. I’ll bet he works in one more stint in private industry or follows David Acheson into very lucrative consulting.
    As for encouraging small, local, sustainable ag, Bill, the greatest encouragement would have been the defeat of the FSMA so that FDA wouldn’t be modernized to the late 20th century when it needs to modernize its thinking to the mid 21st century.
    Any time you want to bring your road show to NC and participate in a public discussion of the actual provisions of the FSMA, I’ll happily work on making the arrangements. How about next December in conjunction with Carolina Farm Stewardship Assn’s 26th Sustainable Ag Conference?

  • http://www.kilpatrickfamilyfarm.com Michael Kilpatrick

    First the good. Requires FDA to work with the Department of Education to develop voluntary guidelines to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs. Authorizes new grants of up to $50,000 over two years for local education agencies to implement the voluntary guidelines. As a person who has a sister who has many food allergies and many customers and friends who are highly allergic to different foods I applaud this provision. Especially after this- http://huff.to/fl5lBf

    A major problem I see with the bill is the $500,000 exemption. I know many very small farms that have a overhead well over $500,000. We run a small vegetable and livestock farm and within 2-3 years will probably exceed that exemption limit. The problem is farming has very high overhead. A pig which grosses 900-1000 will net us less than 100 when you take off feed, fencing, marketing, trucking, labor, and processing.

    This bill, while seeming to protect the small farmer, doesn’t. (Permits FDA to revoke exemptions in the event of a food outbreak directly linked to the facility OR to protect the public health. That “OR” is bigger than you think. It means that “if by chance” the FDA thinks that your farm “might” be a public safety hazard by not chorine bathing your chickens after processing or irradiating your produce (remember, they are being given the authority to say what is safe and what is not) then they can shut you down. Also,“and any other article of food that [FDA] reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals.” What is this “Reasonably belief” that they have going on? Basically a loophole to terrorize and shut down every raw milk producer in the country (we already know the FDA thinks that raw milk causes serious adverse health consequences). -http://bit.ly/atxhl2

    This bill while a slight step in the right direction really just pads the bigs guys hind end. Why are the BIG food companies so excited about this and should we really be excited about the government (which approved DDT, GMO’s and Agent Orange and doesn’t want you to get anywhere close to raw milk) playing a bigger role in how, where, what, and why you eat. At a cost of 1.4 billion dollars and over 17 thousand new federal jobs, it seems that there is a much better use of that money. Seeing that all of our food illness outbreaks have come from multi-state farms and involve produce being shipped thousands of miles, wouldn’t it be better if we spent 1.4 billion dollars decentralizing our food system, plowing money into local food infrastructure such as processing plants (for meat and produce alike), cooler space (for winter storage of vegetables) and education on how to store and can the summer’s bounty? Wouldn’t it be better if we spent 1.4 billion dollars on grants and loans to young farmers to get them up and running, so they can produce a local, sustainable, good-for-you product?