do you require records from your suppliers?

do you require records from your suppliers?.

do you require records from your suppliers?

[04/28/08] 
Using ScoringAg’s unique SSI-EID traceback product codes, RFID codes, or 2-D barcodes printed on each clamshell or product, handlers at all levels of the distribution chain including buyers can learn about each product’s Country of Origin.

ScoringAg runs a web-based computer database system that offer’s all retailers access to extensive traceback records, pictures, and or video information for origin traceability, of individual item’s, clamshell’s, case’s, bins, containers, fruits, vegetables, meats, and all other grocery products and ingredients. This gives retailers Country of Origin (COOL) law compliance labeling, traceability, and consumer’s peace of mind with the speed of a mouse click to search for each unique SSI-EID item’s code that displays real time product data for required audit traceback.

Using ScoringAg’s unique SSI-EID traceback product codes, RFID codes, or 2-D barcodes printed on each clamshell or product, handlers at all levels of the distribution chain — including buyers — can learn about each product’s Country of Origin, certifications, good agricultural practices performed, and audits via a store or home computer or internet cell phone in real time. There is no need to wait for audit or certification information for traceability from producers or food chain suppliers and handlers as information can be recovered within seconds by each store. ScoringAg records enable wholesalers, retailers, restaurant chefs, and buyers to decide what country of origin, and quality of purchases they want. As the records can’t be falsified or changed once data is entered into the worldwide database, as there is documentation and a source verification of all movement and document records using the principals of the US . code 21 CFR part 11.

ScoringAg is the only worldwide standardized record keeping system where the records move with the product through its coded PIDC location and labeling code system.

HACPP, GAP’s, BMP’s, FDA Bio-Terrorism rules, field and handling audits, and other food safety quality control systems, helps conventional, natural, and organic grown products with all kinds of certifications, mostly at the producer, processor levels, but doesn’t prevent recalls as recent events have shown. Certifications, lot numbers, and branded labels do not provide an item level traceback of documents for products from shelves to the field or the original source production site in real time. Third party certification’s, BMP and GAP field audit’s with the ScoringAg’s audit trail verification record-keeping system has regained consumer confidence while providing full item level traceability in seconds to retailers no matter the number of mixed lots in produce bins.

Recalls if needed are site-specific, time-specific, handler-specific and item-specific as to not disrupt the total food chain supply as to what happened in the spinach, melon, and the latest meat and food product recalls. This record-keeping and database system allows all trade buyers to purchase anywhere with safety and to use the recall system anytime it’s deemed necessary. The web-based recordkeeping system can also archive records as equired by the COOL law by retailers for 1 year after the sale of all covered commodities sold within the regulatory requirements.

The industry does not need more food safety laws, government regulations and inspectors, what is needed is ScoringAg’s time stamped activity database with daily documentations by each food handler to prove compliance throughout all the complete food supply chain of activities, including transportation as built and provided by ScoringAg for COOL. The secure barcode and SSI-EID label system can be printed directly from the database in real time anywhere. Field stickers on product can be printed where ever product is located or handled using standard label printers whether RFID or not from plain sticker tape directly from the web-based database.

Having a traceback record keeping system in place provides traceback information within seconds by knowing the audit path of handlers whether from the initial production field or from commingling other fields or products in retailers display cases to the final package that the consumer buys. Food growers, buyers, importers, and processors with retailers will now face the toughest questions of food origin and quality, and their biggest challenges now is the Country of Origin Labeling requirements and renew loyalty in their customers food purchases by having full traceability to prove COOL on each packaged or loose product.

ScoringAg’s traceback and trace up system for all agriculture products, featuring Site-Specific Recordkeeping and PIDC location codes, is one of the many divisions of ScoringSystem, Inc., located in Bradenton , Florida USA . The company specializes in providing solutions with mobile data, via wireless PDA’s, laptops, and Semacode programmed internet ready Nokia, Siemens, and Sony Ericsson cell phones. SSI-EID Food code searches can be done thru these other web sites, Traceback.com and ScoringRestaurants.com to display product origin records and also directly from grocery store websites. ScoringAg.com and ScoringContainers.com makes managing data easier and does it in an extremely low cost effective manner.

Public Involvement in Food Safety Modernization Act

The public should not hesitate to be more involved in the food safety policymaking process, Dr. Elisabeth Hagen and Michael Taylor, the nation’s two leading food safety officials, told an audience at the Food Safety Summit in Baltimore late last week.

Dr. Hagen is Under Secretary for Food Safety at the U.S. Department of Agriculture and Taylor is Deputy Commissioner for Foods and Veterinary Medicine at the U.S. Food and Drug Administration. Both Hagen and Taylor encouraged stakeholders of all kinds to get involved and comment on regulations.

“Never underestimate how important your voices are,” said Dr. Hagen, when asked about the lengthy process required to move forward on food safety policies.

That process now regularly includes a months-long review by the White House Office of Management and Budget, which is where the most critical Food Safety Modernization Act Rules were recently stuck for more than a year, a move that frustrated industry stakeholders and public health advocates. A handful of food safety rules, including the foreign supplier verification program set to overhaul import safety, which was required by FSMA, and a rule that would require mechanically tenderized meat products be labelled, have now also been in limbo at OMB for many months.

“If you want to know why something is still sitting [at OMB], I suggest that you ask [OMB],” said Hagen, during a food safety town hall, attended by several hundred food industry professionals and health officials. Hagen reminded the audience that while she and Taylor lead food safety initiatives at the agencies, they “don’t control the entire process” and it helps to hear feedback on what the public wants.

Both officials said the OMB review process was necessary, but admitted that the delays can be frustrating.

“It’s a necessary part of the process. OMB is there for a reason,” said Dr. Hagen, who said there was a lot of constructive “back and forth” that happens between the agency and the OMB’s Office of Information and Regulatory Affairs, which oversees the reviews. “Sometimes we need to be able to step back and look at the questions that might be raised, that we might not be considering.”

“But it can be frustrating, because it’s hard to get anything done in Washington, DC,” she said. “When we make something a priority and we say, this is important, we think it’s going to protect consumers, we want it to happen right away, but there are checks and balances, I think, in any system we work in and we can’t just push things through because we think that they’re supposed to happen.”

What about that rule to label mechanically tenderized meats, specifically? “We look forward to getting that rule out as soon as possible,” said Hagen.

“There is frustration,” admitted Taylor, explaining that he has a long perspective on the process because has been involved with federal rulemaking, on and off, for more than three decades.

“There’s just no question that OMB has an important role to play. It works under executive order…. but it’s a fact of life that there is an accumulation of analytical requirements and box-checking requirements for rulemaking that have made it far more cumbersome and time-consuming than it has been historically. What that means is that the process is heavy, it’s weighty.”

“What that means to me, and I’ll be frank about this, is that we need to all work as part of this process, and that has a public dimension to it. You shouldn’t hesitate to engage in this. I think the government needs to know that there’s strong public support to get stuff done,” Taylor told the audience. “We need to all keep working hard, be unrelenting, and let that frustration be motivating rather than debilitating. That’s the spirit we’re pushing forward with at FDA.”

Taylor said the public should expect the foreign supplier verification rule, which is being anxiously anticipated by the food industry and especially by importers, to be released “soon.”

“We’re right at the last stages of the administration’s review we’re hoping for clearance very soon,” he said. “We’ve given people plenty to chew on already and there will plenty more to come soon. Don’t plan any long vacations this summer.”

New deadline ordered for FDA food safety reforms

New deadline ordered for FDA food safety reforms.

New deadline ordered for FDA food safety reforms

A federal judge is siding with two California advocacy groups in ruling that the Food and Drug Administration must set a new timetable to implement delayed food safety reforms.

U.S. District Judge Phyllis Hamilton in Oakland, Calif., handed down the decision Monday.

The case stems from the Food Safety and Modernization Act passed by Congress in 2011. The act created a sweeping set of rules that will allow the FDA to order recalls and make it easier to trace contaminated food.

Congress mandated the FDA enact the new rules within 18 months.

Two nonprofits, the Center for Food Safety and Center for Environmental Health, alleged the agency failed to meet the deadlines and sued in 2012.

FDA spokeswoman Shelly Burgess said she could not comment on pending litigation.

Getting to the CORE of Foodborne Illness

Kathleen Gensheimer, M.D., MPH, Chief Medical Officer and FDA’s Director of Outbreak Investigation and Response

Peanut butter. Cantaloupe. Dog food. Tuna. Cheese. Any of these products might show up on your weekly grocery list. Each was found to be the source of a foodborne illness outbreak over the past two years.

In the first 17 months after it was launched in August 2011, FDA’s Coordinated Outbreak Response and Evaluation Network (CORE)evaluated 211 incidents of illnesses that were possibly related to FDA-regulated products.

The highlights of CORE’s work are outlined in a new report entitled“FDA’s CORE: A Food Safety Network 2011-2012.” 

Read the entire blog at FDA Voice.

 

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User Fees to Fund 94% of Proposed FDA Budget Increase

by David Acheson on April 18, 2013 in Food Safety

The President’s proposed fiscal year (FY) 2014 budget has been published, including an FDA request for $4.7 billion. As shown on the pie chart below, about 24% of this is to be directed toward foods. While this is an increase of $821 million over FY 2012 for the whole of FDA, 94%, about $770 million, of the funding is to come from industry user fees, including new FSMA fees, a Food Facility Registration, and an Inspection User Fee. (See User Fee chart in next section for detail.)In the opening message of FDA’s Justification of Estimates for Appropriations Committees, FDA Commissioner Margaret Hamburg noted that the budget would include investments to accelerate implementation of FSMA and strengthen the agency’s global oversight capacity, with a particular emphasis on China: “to strengthen FDA’s global oversight capacity and enhance trade with China, by improving the safety of foods and medical products imported into  the United States.”   New User Fees With the acceleration of FSMA implementation is to be funded primarily through user fees, the FDA budgetincludes +$295.8 million ($252.4 million in User Fees / $43.4 million in budget authority) above the FY 2012 level. The budget proposes a food facility registration and inspection fee and a food importer fee and new user fees to support its cosmetic and food contact substance notification programs. The President’s budget proposes a fee to be paid by food importers. The Food Facility Registration and Inspection Fee would support food and feed safety modernization activities required by FSMA, including targeting improvements to FDA’s inspection system, enabling the Agency to increase effectiveness through adoption of preventive controls, training of personnel to inspect against the new prevention standards, and developing new ways to educate and inform industry. It would also support improvements in food and feed safety science and risk analysis. The import fees are intended to target activities associated with the improvements to the import process, including enhancing the safety protections for imported food and feed while improving the efficiency and speed of entry decisions by FDA inspectors to smooth the flow of international trade in safe food and feed. It appears that this is totally separate from any fee associated with the Voluntary Qualified Importer Program Additionally, FDA will implement a Food Contact Substance Notification User Fee, focused on the premarket notification process for food contact substances, known as the Food Contact Notification (FCN) Program established by the Food and Drug Administration Modernization Act (FDAMA) of 1997. The program has been operational since 2000, but according to Section 409(h)(5) of the FD&C Act, the FCN Program can operate only if adequately funded. Thus, the justification states, “The user fees proposed in this initiative will assure that the FCN Program operates more predictably by providing a stable, sustainable, long-term source of funding to supplement budget authority appropriations. The addition of user fees will add predictability for FDA and the regulated industry.”

Transforming Food Safety Budget Authority: +$43,410,000/59 FTE User Fees: +252,269,000/548 FTE The following table displays the budget authority and user fees for the Transforming Food Safety Initiative in the FY 2014 Congressional Budget Justification:

(Dollars in Millions)

Program	FY 2012 Enacted	FY 2013 CR	FY 2014 Request	+/- FY 2012
Budget Authority:   Foods Center Field Activities Animal Drugs and Feeds Center Field Activities   National Center  for Toxicological Research FDA Headquarters Other Rent and Rent Related GSA Rental Payments	$858.315 257.488 600.827 $107.989 57.450 50.539   $10.207 $64.188 $30.175 $73.833	$863.568 259.064 604.504 $108.650 57.802 50.848   10.269 64.581 30.360 74.285	$882.817 266.408 616.409 $112.892 31.711 51.181   10.233 70.331 36.503 75.341	$24.502 8.920 15.582 $4.903 4.261 0.642   0.026 6.143 6.328 1.508
Total, Budget Authority, Salaries and Expenses	$1,144.707	$1,151.713	$1,188.117	$43.410
Food Export Certification User Fee   Food Reinspection User Fee Food and Feed Recall User Fee International Courier User Fee Food Facility Registration and Inspection Fee Food Import Fee Cosmetics User Fee Food Contact substance Notification User Fee	$0.000 $14.700 $12.364 $0.000 $0.000 $0.000 $0.000 $0.000	$1.267 $14.790 $12.440 $0.000 $0.000 $0.000 $0.000 $0.000	$1.267 $15.367 $12.925 $1.175 $58.936 $165.690 $19.074 $4.999	1.267 0.667 0.561 1.175 58.936 165.690 19.074 4.999
Total, Program level	$1,171.771	$1,180.210	$1,467.550	$295.779

The China Initiative

To support the FDA’s capacity to detect and address the risks of products and ingredients manufactured in China and to help assure that these products do not result in harm to Americans, FDA is proposing +$10 million above the FY 2012 for Food and Drug Safety Inspections in China. This emphasis on improving trade withChina, termed the China Initiative, includes:

• Food Manufacturing Inspections in China (+$3,675,000 /7 FTE) — including additional inspections in China, focusing on facilities that produce higher-risk foods and food ingredients for export to the U.S., and training with Chinese food authorities and outreach and education activities for Chinese manufacturers.
• Risk Modeling and Risk Analysis (+$1,000,000 /3 FTE) — expanded risk modeling and risk analysis to improve its ability to target inspection resources to high-risk foods and manufacturing that originate inChina.
• Program Support (+$600,000 / 0 FTE) — resources to ensure that FDA import safety activities in China receive the support necessary to achieve their public health outcomes, including finance and budgeting, human resource assistance, contracting, billing, legal counsel, communication, ethics, headquarters coordination and related support functions.

According to the justification, “The result will be fewer import safety emergencies, less foodborne illness and earlier identification of safety problems associated with foods, drugs and ingredients manufactured inChina.”   USDA ImpactsThe presidential FY2014 budget is also having its impacts on USDA, with one of the proposed cuts withdrawing funding for USDA catfish inspections. We have covered this topic in a number of previous newsletters, noting that with catfish already being regulated by FDA, there is not only no reason to move it, but it is a waste of time and resources to even be spending the time talking about it – particularly with estimations of the program amounting to about $14 million per year, according to a GAO report. So we see this as a very positive proposal of the budget. An additional positive note for USDA is the avoidance of a provision in a spending bill passed by the Senate that would have furloughed USDA inspectors for 11 days beginning this summer. Instead, an amendment has been approved allowing USDA to shift funds among programs to avoid pulling inspectors from plants that require FSIS oversight during operation. Another USDA cost-savings, that is, however, raising some controversy, is its proposed rule to reduce the number and duties of poultry inspectors, allowing for more self-regulation in those plants, . The proposal would move USDA inspectors up the line so that they are inspecting only carcasses that the establishment has deemed likely to pass inspection; requiring establishments to regularly test for Salmonella and Campylobacter; and focusing FSIS inspection resources on the areas of the poultry production system that pose the greatest risk to food safety. Perhaps this move is a baby step in aligning the inspection approaches of FDA and USDA FSIS? FDA does not put inspectors in every plant, but instead focuses on plants/products of highest risk and requires facilities to have food safety plans. With USDA FSIS plants required to have HACCP plans, could this agency also take a step back to expect that the plants under their jurisdiction should be following their HACCP plans, without continuous on-site oversight? As in the past with some of these new user fees, the devil will be in the details; and it raises question around what authority FDA has to collect registration fees. This is clearly a space that we will continue to watch closely and provide updates as the programs become more granular.