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Avoiding The Pitfalls Of FSMA’s Recordkeeping and Sanitation Rules

By Pamela Sweeten, Owner & Founder, P. Sweeten Consulting

Two cornerstones of FSMA’s final rule on Preventative Controls for Human Food are record keeping and sanitation. Food manufacturers and processors, along with companies importing goods into the U.S., are now being held to a much higher standard of sanitation, documentation, and compliance to better protect the health of the U.S. public.

Food Safety Records
It is not just that demand for record keeping has increased dramatically in scope, the FDA now has more legal authority to access and audit your records. This makes knowing and following the changes to Part 117 of the Current Good Manufacturing Practice (cGMP), Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food essential.

Record Requirements
There are general requirements for all records that must be followed. All records must:

  • Be kept as original or electronic records or true copies
  • Contain factual observations and values
  • Be legible, permanent, and accurate
  • Must be done in real time
  • Include the detail required to create a history of performed work
  • Standard details including identifying the facility or plant, date/time of the activity being documented, signatures and initials of the person who performed the activity, and when applicable the identity and lot code of the product

Record Retention Requirements

  • You must store and retain your records for a minimum of two years
  • Any documentation relating to supporting the status of a facility as being a qualified facility should be kept as long as necessary to support the status of the facility
  • Records that have been discontinued (records related to changes) must be kept for a minimum of two years
  • Records, other than the Food Safety Plan, must be able to be present at the facility within 24 hours of being requested by an official for review.
  • The Food Safety Plan may only be transferred to another accessible location only if the facility is closed for an extended period. The document still must be able to be obtained and given to an official at the facility within 24 hours of an official review request

Food Safety Plan

  • Must be kept on-site at the plant or facility
  • Upon completion of the food safety plan, the owner, operator, or agent in charge of the plant or facility is required to sign and date the plan. Any changes to the plan must also be signed and dated by this person of authority.

Three Categories Of Records To Keep
There are three categories of records you may need to keep, depending on your hazard evaluation. The records needing to be kept reflect the entire supply chain process and potential hazards from prior to receiving at the facility through to the customer carrying the product.

First are hazards controlled by the supplier (prior to delivery to the receiving facility). Once the hazard evaluation has been completed, if it is determined that a hazard will be controlled by the supplier, then a written supply chain program (or Foreign Supplier Verification Program for facilities that are importers) is required.

Documentation in this program includes but is not limited to:

  • Approval of the supplier
  • Supplier verification
  • Sampling and testing
  • Suppliers food and safety records
  • Procedure for receiving ingredients and raw materials
  • Reanalysis documentation

Next come hazards controlled at the receiving facility. If the receiving facility will control the hazards, then the receiving facility will be required to develop, implement, and document preventative controls.

Documentation requirements include, but are not limited to:

  • Preventative control monitoring and verification of monitoring
  • Any corrective measures that were taken and verification of actions taken
  • Environmental monitoring
  • Product testing
  • Training documentation
  • Reanalysis documentation

Finally, there are hazards controlled by the customer. If the receiving facility relies on a customer or another first receiver to control a hazard, then there are some records that must be developed and kept.

Documentation requirements include but are not limited to:

  • Written disclosure (included in the food’s shipping documents) that an identified hazard was not controlled by the facility
  • A written assurance (submitted annually) that contains the established procedures the customer must follow to prevent (or drastically reduce) the identified hazard

Sanitation Controls
A large part of controlling hazards is creating sanitation regulations that will drastically reduce or prevent hazards before they can occur. The environment, equipment, and employees should all be part of the sanitation control solution. Sanitation controls should include:

  • Food contact surfaces (including utensils, equipment, and food packaging)
  • Food handling
  • Cross contamination
  • Food allergens

Sanitation can be costly, but you could lose so much more if your product quality or shelf life is affected by unsanitary facility conditions. The best sanitation departments audit their facility and then create a structure for consistency. When creating this structure, a facility should consider the type of soil that needs to be cleaned, what the chemical needs to do when used (dissolving, emulsification, wetting agents etc.), and the state of the plant’s water.

There are many products designed to properly manage each type of sanitation control. Depending on the type of food a facility is working with or the equipment utilized, the needs may be different. For example, facilities handling meat, poultry, or seafood should include in their sanitation controls antimicrobial treatments to maintain product quality and yield. And, depending on the type of conveyor a facility has, a wet or dry lubrication system is required to both lubricate and sanitize the conveyor.

Working with an experienced cleaning and sanitation company can ensure that a company’s unique needs are covered. Working with the sanitation department to identify the hazards, a sanitation company will implement a customized program and routinely test to ensure you are meeting food safety standards. These results should be kept in your records as evidence your facility has taken preventative measures and taken steps to control the environment.

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Consistent with recent years, the Food and Drug Administration inspected just less than 2% of food and feed imports in 2012, according to a new report.

The report said the agency examined 1.9%, or 207,839, of more than 11.1 million food import shipments in fiscal year 2012.

In fiscal year 2012, the FDA reports that imported fresh fruit and vegetables totaled 2.189 million shipments out of a total 11.13 million U.S. imported food shipments, or 19.7% of the total. That compares with 1.92 million shipments of imported fresh fruits and vegetables in fiscal year 2011, which represented 18.5% of total imported food shipments of 10.44 million that year, according to the FDA. FDA defines food shipments to include human food, infant formula/food, animal feed, dietary and food and color additives.

The FDA’s 2012 inspection rate of 1.9% of food import shipments compares with a rate of 2.3% in fiscal year 2011, when the FDA said it examined 243,000 food import shipments out of total imports of 10.43 million. For fiscal year 2010, the FDA physically examined 2.1% of food import shipments, or 206,723 lots out of a total of 9.94 million shipments imported.

However, this year’s report said the FDA’s reach was greater than the percent of imports inspected.

“All import entries are electronically screened using an automated system, which helps field inspectors determine which products pose the greatest risk and, therefore, should be physically examined,” according to the report.

When needed, the report said the FDA can issue import bulletins which trigger greater scrutiny for a product or range of products from a supplier.

The average cost of physically inspecting/sampling is about $160 per field exam and $3,100 per sample analyzed, according to the report.

The FDA also provided statistics on the number of inspections the agency performed on domestic and foreign food facilities. In fiscal year 2012, FDA and the states under contract with FDA inspected (or tried to inspect) 24,462 domestic food facilities, according to the report; FDA officials inspected 1,342 foreign food facilities.

As of October 2012, the FDA said there 172,969 registered domestic food facilities and 285,977 foreign food facilities.

The FDA has identified 22,325 domestic food firms as high-risk. Of that total, the FDA said 11,007 were inspected in fiscal year 2011. In fiscal year 2012, another 8,023 high-risk facilities were inspected (or inspection was attempted), totaling 19,030 or 85% of the total high risk domestic food firms. In addition, another 3,736 firms inspected in fiscal year 2011 were re-inspected (or inspection was attempted) in fiscal year 2012.

In fiscal year 2012, the average FDA inspection cost for a high-risk domestic food facility was $15,500, according to the report. while the non high risk domestic food facility inspection average cost was $9,200. Foreign facility inspections were more expensive, the report said; foreign-high risk food facility inspections averaged $23,000 in fiscal year 2012.

Food facility inspections performed by the Food and Drug Administration cost nearly $200 million in fiscal year 2012 according to the FDA’s annual report to Congress on food imports and food facilities.

The report said the total budgeted money for inspections totaled $198.5 million in fiscal year 2012. Of that total, the FDA said $145.2 million was used for FDA inspections of domestic facilities and $34.7 million for FDA inspection of foreign facilities. In addition to those amounts, the FDA said $18.6 million was provided to state agencies, through contracts, to perform domestic inspections on behalf of FDA. Those figures don’t include the cost of inspections at the border, the FDA said, since those inspections are not performed in registered facilities, according to the report. The agency devotes more than 1,300 full time equivalent staff to conduct inspections and food safety investigations, according to the report.

– See more at: http://www.thepacker.com/fruit-vegetable-news/FDAs-report-shows-2-inspection-rate-for-imports-233635361.html?view=all#sthash.1qs6LwAU.dpuf

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Thank You AMERICA’S FARMERS!!! “

If your eating a meal today then you need to see this.

http://bit.ly/1cscoxp 

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DENVER (AP) — Two Colorado cantaloupe farmers who pleaded guilty to charges related to a deadly listeria outbreak personally apologized Tuesday to some of the family members of people who got sick or died, an attorney said.

The meeting with Eric and Ryan Jensen, the two brothers who owned and operated Jensen Farms in Holly, Colo., was part of an agreement with prosecutors.

The brothers apologized during what William Marler, an attorney representing victims in lawsuits against Jensen Farms, described as a sober meeting at the federal courthouse in Denver. In turn, some of the victims told the Jensens about their loved ones who fell ill, he said.

“Everybody — prosecutors, the FDA — none of us had ever had a meeting like this,” Marler said. “It’s a tragedy for everybody.”

By agreement with prosecutors, the Jensens’ statements at the meeting cannot be used against them either in their misdemeanor criminal case or in numerous civil lawsuits that are pending, Marler said.

The listeria outbreak traced to tainted fruit from the Jensens’ farm caused 33 deaths and sent scores of people to hospitals. Officials have said people in 28 states ate the contaminated fruit and 147 were hospitalized.

Eric and Ryan Jensen have pleaded guilty to six misdemeanor counts of introducing adulterated food into interstate commerce. The federal charges carry penalties of up to six years in prison and $1.5 million in fines. A sentencing hearing has been set for Jan. 28.

Marler said stores that sold the tainted fruit and inspectors who approved it should have also been at Tuesday’s meeting, but they weren’t invited.

“This isn’t just about the Jensens,” Marler said.

Eric Jensen refused to comment when reached by phone Tuesday.

A statement from the Jensens’ attorneys after the guilty pleas said the brothers were shocked and saddened by the deaths, but the guilty pleas do not imply any intentional wrongdoing or knowledge that the cantaloupes were contaminated.

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Suppy Chain

Our system allows you to track inputs and output gaining an understanding of data will make you more efficient and profitable.

Gather the data.

Gain control of practices.

See Return on Investment.

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CA border stations are vital to our food supply; a small inconvenience to reduce pest risks. #bees http://t.co/mWU698OHFD.
http://m.youtube.com/watch?v=k3DJOOv4sjg&desktop_uri=%2Fwatch%3Fv%3Dk3DJOOv4sjg
http://www.trackmycrop.com
http://www.tracethefood.com

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It’s that time of year again … for the third time, FDA has announced its fiscal year FSMA User Fees for domestic and foreign facility reinspections. These fees focus on failures to comply with a recall order and reinspection fees, as authorized by the Act. The fees are effective October 1, 2013, through September 30, 2014. The challenge around the fees is that, so far, FDA does not appear to have collected any, and for an Agency that needs resources, this is an odd disconnect.

The focus of the fees is in two areas:
Reinspection Fee – This fee will be assessed when FDA must conduct a reinspection, subsequent to an inspection which identified non-compliance materially related to a food safety requirement of the FD&C Act, to determine whether corrective actions have been implemented and are effective and compliance has been achieved. In such cases, FDA will assess and collect fees from the responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection to cover reinspection-related costs. The fiscal year in which a reinspection occurs dictates the fee rate to be applied.
Non-compliance with Recall Order – This fee will be assessed for not complying with an FDA recall order and would cover food recall activities associated with such order Non-compliance may include: (1) not initiating a recall as ordered by FDA; (2) not conducting the recall in the manner specified by FDA in the recall order; or (3) not providing FDA with requested information regarding the recall, as ordered by FDA.
The user fees were initially introduced for the 2012 fiscal year to help pay for the implementation of FSMA, with the FY 2013 user fees for food reinspection and recall non-compliance intended to generate $15.367M and $12.925M respectively, none of which has been collected as far as we are aware.
Not a lot has changed since these fees were first introduced in 2013. The fee is based on an hourly rate, including not just the FDA’s time for the reinspection, but any preparations, arrangements, travel, reports, or other activity associated with the reinspection; or the hours spent on taking action in response to a firm’s failure to comply with a recall order.
Although the hourly rates actually decreased from FY 2012 to FY 2013, they will increase for FY 2014, but the foreign travel rate is still below that of FY 2012.

FSMA Fee Schedule

Fee category FY 2014
Fee rates FY 2013
Fee rates FY 2012
Fee rates
Hourly rate if domestic travel is required $237 $221 $224
Hourly rate if foreign travel is required $302 $289 $335

So the catch here is that, with all the talk of budget woes, as far as we know, FDA has not yet collected any user fees. If they have, we’ve not heard talk of it, or heard talk from anyone who has had to pay. This is most likely because a process has not yet been established to do so – which could, in fact, be a Catch 22 … FDA needs the user fees to pay for resources, but it doesn’t have the resources to develop the process by which to collect the user fees.
FDA does intend to consider reducing fees for some small businesses for whom the full cost could impose severe economic hardship, and the Agency is developing a guidance document on the process by which firms may request a reduction. FDA’s current publication also notes that it does not intend to issue invoices for reinspection or recall order fees until this guidance document has been published—supporting our notion that fees have not yet been collected.
Which brings us full circle to our February 2012 newsletter: Get Ready to Pay New Registration Fees – FDA FY2013 Budget Request Relies Heavily on Establishment of User Fees, in which we stated:
What impact will that have on FSMA implementation? As we have said before, writing regulations is cheap; enforcing them is expensive, so we should expect enforcement and inspections to stay at current levels and not meet the goals outlined in FSMA. Overall I see FDA as being in for a tough ride since a flat line budget is, in reality, quite a hefty cut in operating budget.
And without the user fee income that makes up a significant portion of the Agency’s FSMA budget, I don’t see this changing in the near future.
This is all very unfortunate for FDA – they need resources and appear to be held up on collecting $10 million+ each year through lack of a guidance document and a process to collect the fees. Makes me wonder if Congress can “lend” the cash to FDA to get this program going rather than continue to allow the current lack of progress on this front. But I guess Congress does not work that way!
Thus, as with much of FSMA, headway continues to be made, but with the pace of that headway, it is incumbent on the industry to do all it can for food safety – with or without regulation.

Did You Know…?
Don’t miss Melanie Neumann and David Acheson on Food Safety Tech.com’s FoodFlix – How Much Gets Recalled Don’t Make Me Mad
You can also catch an interview with David Acheson after his Keynote address at IAFP 2013 by Food Safety News

New User Fee Assessment – But It Creates Catch 22 for FDA by David Acheson is licensed under a Creative Commons Attribution 3.0 Unported License.
– See more at: http://leavittpartners.com/2013/08/new-user-fee-assessment-but-it-creates-catch-22-for-fda/#sthash.FUGKoF9V.dpuf

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“Coming down like a ton of bricks.”

“Complicated and interwoven.”

“Costly.”

“The end of many small- and mid-size farms and food processors.”

“Never heard of it.”

“A work in progress.”

When asked about FDA’s new proposed rule for food processing facilities, that’s how a sustainable-agriculture advocate, a food-safety expert for a large fresh produce association, the Office of Management and Budget, a small-scale farmer who owns a processing facility, a farm commodity official and an FDA food safety expert — in that order — described it.

Referred to as HARPC (pronounced “harp sea”), the acronym stands for Hazard Analysis Risk-based Prevention Controls. Mandated by the Food Safety Modernization Act, signed into law in 2011, HARPC embraces a strategy that focuses on preventing foodborne illness and other risks make food unsafe to eat. As such, it would apply to certain unintentional hazards such as microbiological, chemical, physical and radiological hazards, as well as to allergens.

According to estimates from the U.S. Food and Drug Administration, 951,000 million cases of foodborne illnesses can be attributed each year to the pathogens that this rule is designed to eliminate or reduce. The economic cost of illnesses avoided comes to $2 billion a year.

A big player in the food safety arena, FDA regulates about 80 percent of U.S. food supply—$602 billion in domestic food and $64 billion in imported food each year. That accounts for nearly everything consumers in the United States eat except for meat, poultry and some egg products, which are regulated by the U.S. Department of Agriculture.

HARPC’s focus

While HARPC is intertwined with the FDA’s proposed produce rule, which focuses primarily on preventive controls on the farm, HARPC puts the spotlight on what’s happening in food processing facilities.

For the most part, HARPC would apply to facilities that manufacture, process, pack or hold human food. These would include manufacturers, processors, warehouses, storage tanks and grain elevators, although there are some exceptions. Bottom line – HARPC would apply to facilities that are required to register with FDA under the agency’s current food facility registration regulations, which went into effect under the 2002 Bioterrorism Act.

When looking at the numbers, the proposed rule would cover an estimated 97,600 domestic and 109,200 foreign facilities. (According to FDA, in 2011 about 50 percent of the fresh fruit consumed in the U.S. was imported.)

What triggers HARPC on a farm?

Not surprisingly, there’s a lot of confusion, and even alarm, about the activities conducted by a farm that might cause it to fall under the FDA’s definition of a processing facility.

According to detailed-but-straightforward information about who would be affected by HARPC supplied by the National Sustainable Agriculture Coalition, the key distinction between a farm and a facility “seems to be whether you are transforming a product in any way.”

Farms, as defined by FDA, won’t be subject to HARPC, said FDA’s Jenny Scott. According to FDA’s definition, a farm is an agricultural operation in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood) or both. It can also include facilities that pack or hold food, as long as all of that food is grown or raised on that farm or on another farm under the same ownership.

Farms that grow and harvest their own food crops are exempt from the facility registration rule. But if the farm purchases product from another farm to sell at its own retail operation and/or through wholesale transactions, it is then considered a facility and therefore required to register with FDA as a processing facility.

If a farm doesn’t grow a crop but sells it, HARPC also kicks in. Likewise, if a farm is growing fruits and vegetables and then doing anything beyond standard practices to prepare that fruit or vegetable to sell it as a whole product, HARPC would kick in. Drying, baking, cutting, and mixing products all trigger HARPC.

Manufacturing and processing always includes these activities:

– Irradiation

– Cutting, coring, chopping, slicing

– Canning

– Coating with things other than wax, oil, or resin

– Drying that creates a distinct commodity

– Artificial ripening

– Cooking

– Pasteurizing, homogenizing

– Infusing

– Distilling

– Salting

– Smoking

– Grinding, milling

– Freezing

– Slaughtering animals or post-slaughter operations

Going beyond what’s already expected

Although HARPC is similar to HACCP, Hazard Analysis and Critical Control Points, a food-safety system already in place for juice, seafood, and some produce processing plants when commercial buyers require it, it goes a bit further than HACCP.

The main difference between the two systems, said Jenny Scott, senior advisor in FDA’s Office of Food Safety, is that under HARPC, preventive controls may be required at points other than at critical control points, and critical limits (such as temperature and time requirements) would not be required for all preventive controls.

In a recent Food Safety News article about this risk-based preventive approach to food safety, Scott said that facilities that already have HACCP plans in place may need to make some changes, but for the most part, they “will be well on their way toward complying with preventive control rules.”

Pull out a pen and paper

During a presentation about HARPC, David Gombas, food safety expert at United Fresh Produce Association, called up images of a pen and paper — in other words, a lot of paperwork — when he described the proposed provisions of HARPC:

-Written food safety plan

– Written preventive controls for identified hazards

– Written monitoring procedures and frequencies

– Written corrective actions

– Written verification procedures, including validation of most preventive controls

– Written recall plan

The specter of additional paperwork and the time and expense involved in gathering the necessary information for the paperwork always rises up to haunt small- and mid-sized businesses. And with that specter come fears that HARPC will push food processors of this size off the map.

“These businesses don’t have much, if any, room to raise food costs to cover the added expenses,” said Kristen Wilmer, program assistant at Community Involved in Sustaining Agriculture.

According to the White House Office of Management and Budget, the proposed rule has a first-year cost to the industry of $701 million and an annualized cost of $472 million, using a 7 percent discount rate.

Trevor Suslow, food safety expert at University of California, Davis, told Food Safety News that it’s the mid-level and smaller-scale food processors consolidating product from multiple farms that will face the greatest challenges.

“Bottom line, it will take some work,” Suslow said, pointing out that most of the large food processors “are already about there,” in meeting HARPC’s requirements.

But Suslow also said that the FDA recognizes that different scales of operations need to be considered. He also warned about becoming polarized over specific sections of HARPC.

“At a reasonable, commonsense level, these smaller food processors can implement what’s expected of them,” he said. “There are ways for people to put something in place. I certainly hope this won’t push people out of business.”

Along those same lines, the FDA describes the preventive controls as science- and risk-based and points out that the proposed rule would require controls only where necessary to prevent hazards to public health and would exempt certain facilities from requirements or modify requirements for certain low-risk activities.

In addition, the requirements are flexible in that food processors could develop preventive controls that fit their products and operations, as long as they are adequate to significantly minimize all food-safety hazards that are reasonably likely to occur, according to FDA.

Exemptions

Size does come into play when it comes to exemptions. With certain stipulations and requirements, “small” and “very small” processors, as well as those with a previous 3-year average product value of less than $500,000, would qualify for an exemption, but they would not be exempt from following food-safety rules and good handling practices.

For more information about HARPC and exemptions from HARPC, visit FDA’s FAQ page. FDA also offers a chart showing exemptions and modified requirements for Preventive Controls for Human Food.

What about CSAs and farm stands?

FDA’s Jenny Scott said that farm stands and CSAs (Community Supported Agriculture) organizations, which are similar to subscribing for baskets or boxes of food on a regular basis from a farm or group of farms) would likely be classified as “exempt retail establishments.” That would mean they wouldn’t be subject to HARPC, although food-safety practices would need to be followed. But since this is a proposed rule, there’s no saying how the final rule, which is expected to be released late next year, will actually treat these sort of farming operations.

What about current Good Manufacturing Practices?

According to an article in Food Processing, for the past several decades, current Good Manufacturing Practices (CGMP) have provided the primary food safety framework for most foods regulated by the FDA. As such, they cover practices that need to be followed to ensure that food is manufactured, processed, packed and held under sanitary conditions and that the food is safe, clean and wholesome.

While HARPC embraces the same goals, it goes in a different direction, pointing the way to preventing food from being contaminated with harmful pathogens such as E. coli, Salmonella and Listeria, which can sicken or kill people. The goal is to make sure that specific potential threats to the food supply can be identified so that effective measures can be taken to counter them before any harm can occur.

Make sure to send in written comments

FDA’s Jenny Scott said that it’s extremely important for people to send in written comments, primarily because the agency needs to know what people are concerned about and what they would like to see changed and why.

“We really want to hear about specific situations and concerns and how people would be impacted by the proposed rule,” she said. But she emphasized that it’s only when the agency gets a written comment that it can be considered.

Comments can be submitted on the Federal Register. To read already-submitted comments about HARPC, enter docket #FDA-2011-N-0920 on the Federal Register’s site.

Due to requests from many people in the ag industry, the comment period was extended to Sept. 16, 20013.

The first year of enforcement will likely be 2016, although the dates are staggered for small facilities (3 years) and for “very small” facilities (4 years).

I need help with this

Scott said that people can ask their county extension agents for help figuring out whether their farm or processing facility needs to comply with HARPC requirements. During office hours (Eastern Standard Time), they can also call this toll-free number: 1-888-SafeFood (723-3366).

In the meantime, the Food Safety Preventive Controls Alliance is developing FDA-approved training materials for implementing HARPC. Guidance on the best way to implement the requirements is also being developed.

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The Pew Charitable Trusts commended Congressman Tom Latham (R-IA) last week for his leadership in securing approximately $27 million in additional food safety funding for the U.S. Food and Drug Administration in the appropriations bill that is moving through the House.

As Food Safety News reported Friday, the food safety funding boost was approved as part of a $19.5 billion agricultural appropriations bill that cleared the full House Appropriations Committee Thursday.

“We’re delighted that Rep. Latham, a senior member of the House Appropriations Committee, continues to make food safety a clear priority. He understands that food safety programs are crucial to consumers and to the hardworking farm families who grow our crops,” said Erik Olson, senior director of Pew’s food programs. “Outbreaks of foodborne illnesses, such as the salmonella in cantaloupe that sickened 15 Iowans last year, can shake consumer confidence and cost agricultural producers millions. This new funding would help strengthen prevention efforts and protect consumers and producers alike.”

In polling they conducted last year, Pew found that 73 percent of Iowans favored an increase in funding for FDA food safety programs for 2013, indicating that support was bipartisan.

Pew has also highlighted foodborne illness victims in Iowa to make the case for more funding for food safety.

“My daughter died at the age of 14 after being sickened by E. coli poisoning, and as a result, I know the horrors of foodborne illness all too well,” said Dana Boner of Monroe, IA. “This funding increase is a step in the right direction, and I appreciate Rep. Latham’s continued commitment to food safety.”

In a release, Pew noted that although the Senate version of the bill has included increased food safety funding for the past three years, this increase in the House bill marks the first time in three years the House Appropriations Committee has initiated significant new dollars for FDA food safety.

The House bill is expected to see floor action as early as next week. The Senate version of the appropriations bill is scheduled for committee markup next week.

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HR 1332  Costa  House Agriculture

Safe Food Enforcement, Assessment, Standards, and Targeting Act of 2009 – Expands the authority of the Secretary of Health and Human Services to regulate food, including by authorizing the Secretary to: suspend the registration of a food facility; and order a cessation of distribution, or a recall, of food. Requires each food facility to evaluate hazards and implement preventive controls. Directs the Secretary to assess and collect fees related to: food facility re-inspection; food recalls; and the voluntary qualified importer program.

HR 2749  Dingell  Senate Health, Education, Labor and Pensions 

Requires each food facility to conduct a hazard analysis; implement preventive controls; and implement a food safety plan. Requires the Secretary of HHS to minimize the hazards from food-borne contaminants; inspect facilities at a frequency pursuant to a risk-based schedule; establish a food tracing system; assess fees relating to food facility re-inspection and
food recall; 

HR 875  DeLauro  House Agriculture – Subcommittee on Livestock, Dairy and Poultry

Directs the Administrator to: administer a national food safety program; and ensure that persons who produce, process, or distribute food prevent or minimize food safety hazards. Sets forth requirements for the Administrator to carry out such duties, including: requiring food
establishments to adopt preventive process controls; enforcing performance standards for food safety; establishing an inspection program; requiring imported food to meet the same standards as U.S. food; and establishing a national traceability system for food.

S 510  Durbin  Senate Health, Education, Labor and Pensions (Passed 11/18/09) 

FDA Food Safety Modernization Act – Expands the authority of the Secretary of Health and Human Services (the Secretary) to regulate food, including by authorizing the Secretary to suspend the registration of a food facility. Requires each food facility to evaluate hazards and implement preventive controls. Directs the Secretary to assess and collect fees. Requires the Secretary to: identify preventive programs and practices to promote the safety and security of food; promulgate regulations on sanitary food transportation practices; allocate inspection resources based on the risk profile of food facilities or food; and improve the capacity of the Secretary to track and trace raw agricultural commodities.

S 2819  Feinstein  Senate Nutrition, Agriculture and Forestry

Processed Food Safety Act of 2009 – Requires processors of food products to certify to the applicable Secretary that the processed food products are not adulterated. Would require each facility registered under section 415 to apply pathogen reduction treatments to each food, as the Secretary determines appropriate, that such facility manufactures, processes, packages, or holds for consumption in the U.S.

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