Tuesday, July 22, 2014

Columbus recognized for its breweries.



Columbus Ohio returns to its lager roots.  

Check out the link and description below:

Well, for starters, local stalwart Columbus Brewing, the resurrection of a brewery originally founded in 1830(!), has been delivering rock-solid beers since they emerged in 1988, led by the Gold Standard of Ohio Double/Imperial IPA, “Bodhi”, a pungent, crisp, palate-coating stunner that made me a tad weak in the knees…A brewery named for one my favorite adjectives ever? Yeah! Zaftig Brewing takes its name from the Yiddish-derived, Americanized word for a shapely, round-bodied woman and that’s exactly the aesthetic owners,brewers Jim Gokenbach and Brent Halsey have fiercely embraced: high-gravity, ass-kickin’ BIG beers, led by their spectacular Barleywine/DIPA monster, “Shadowed Mistress”, which can stand toe-to-toe with any American Strong Ale I’ve ever tasted…Smokehouse Brewing goes straight for the DIPA jugular with Double Dog Dare, a spectacular mouthful of citrus, flowers, resins galore, and iron-willed malt core…Barley’s Brewing should, if God is in His Heaven, make a killer Barleywine, wouldn’t ya think? And they do: the imaginatievly named “Barleywine!”, with a built-in exclamation point, both in print and in piehole. Titanic, rich, almost thick BW with flavors that explode on the tongue…Toss in Seventh Son Brewing, with one of America’s great Biere de Gardes, the very promising Zauber BrewingNorth High Brewing with a Black IPA that would stack up strong even Out West. Four String Brewing, Sideswipe Brewing, Wolf’s Ridge, and the delightfully name-conscious Actual Brewing Company, with their towering Wheatwine, “Beau’s Eisenweizen Condensate”, and ya got a crazy-promising culture that’s only getting better, year by year, new brewery by new brewery.


Friday, July 18, 2014

CFPB To Assume A Larger Role In Virtual Currency Initiatives






Consumer Financial Protection Bureau to assume a larger role in virtual currency initiative.


On June 26, 2014, the U.S. Government Accountability Office ("GAO") released a report, entitled "Virtual Currencies: Emerging Regulatory, Law Enforcement, and Consumer Protection Challenges." The report, delivered earlier to the U.S. Senate Committee on Homeland Security and Government Affairs, is the GAO's second report on virtual currencies. In 2013, the GAO released a report on the tax implications of virtual currencies, which led to guidance from the Internal Revenue Service ("IRS") concluding that virtual currencies should be treated by the IRS as property for tax purposes.
The GAO's second report examines the roles, responsibilities and challenges federal agencies face in connection with the regulation of virtual currencies. The report names the Financial Crimes Enforcement Network, the prudential banking regulators, the Securities and Exchange Commission, the Consumer Financial Protection Bureau ("CFPB"), the Department of Justice and the Department of Homeland Security as the federal agencies responsible for overseeing both the legitimate and illegitimate uses of virtual currencies. According to the GAO report, these agencies are responsible for addressing the regulatory, law enforcement, and consumer protection challenges presented by virtual currencies.
The challenges discussed in the GAO report include:
                the high degree of anonymity provided by virtual currencies;
                the cross-jurisdictional nature inherent in virtual currency schemes; and
                the consumer and investor protection risks posed by virtual currency activities.

Recommendation for More CFPB Involvement on Virtual Currencies
The GAO report catalogs and examines the actions federal agencies have taken in response to the challenges presented by virtual currencies, including the establishment of interagency working groups on virtual currencies. The report finds that these groups have not, thus far, emphasized consumer protection issues due to the CFPB's lack of participation in efforts to inform consumers about the potential risks associated with virtual currencies, such as the disruption and subsequent bankruptcy of Mt. Gox, a bitcoin exchange. As a result, the GAO recommended that the CFPB identify interagency working groups that would benefit from the CFPB's participation, and coordinate with other federal agencies to determine the groups in which the CFPB should participate.
In a letter responding to the GAO report, the CFPB identified its involvement in numerous informal discussions and its participation in various interagency working groups on virtual currencies, but nevertheless concluded that it concurs with the GAO's recommendation. Specifically, the CFPB stated that continued federal regulatory efforts "will benefit from a collaborative response" to concerns arising from virtual currencies, and said that it will increase its involvement in interagency working groups "as they engage on specific issues relating to consumer protection." We will continue to follow developments related to virtual currencies and the CFPB's efforts in this regard.
Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
Last Updated: July 16 2014
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Sunday, July 6, 2014

Food safety, pet treats and China-sourced food and China-processed food.


Food safety , China sourced food and China processed food.

Dirksen Senate Office Building, Room 562 Washington, DC 20510 | Tuesday, June 17, 2014 - 3:30pm to 5:00pm

Recently major pet stores have announced they would stop selling dog and cat treats made in China following the deaths of 1,000 dogs which may be linked to pet treats from China. Chickens raised in the United States may now be shipped to China for processing before being sold in the United States. Researchers are also exploring the connection between the domestic outbreak of Porcine Epidemic Diarrhea virus with China. These developments have highlighted concerns over the effectiveness of China’s food safety regulation, the effectiveness of U.S. government regulation of imported foods from China, and the overall safety of such foods. Moreover, they raise questions about whether current labels are adequate in helping American consumers determine when foods or its constituent components come from China. 

Congressional-Executive Commission On China Examines Food Safety


June 17, 2014, statement of Senator Sherrod Brown to Congressional-Executive Commission on China.

As prepared for delivery.

Statement of U.S. Senator Sherrod Brown, Chairman of the Congressional-Executive Commission on China (CECC).

CECC Hearing on “Pet Treats and Processed Chicken from China: Concerns for
American Consumers and Pets” Tuesday, June 17, 2014.

We have called this hearing to seek answers for American consumers, pet owners, farmers, and parents about the safety of pet treats, processed chicken, and animal feed from China.

Americans want to know where their foods come from and want to make sure that everything is being done to keep it safe.

Sixty-two million households in this country have a pet. They are raising 83 million dogs and 96 million cats just like members of their family.

That’s why it’s so troubling that seven years on, we still do not know what’s causing the deaths and illnesses of thousands of dogs. Just last month, the FDA said that reports of illnesses had increased to 5,600 pets, including 1,000 dog deaths, and now three human illnesses. While no cause has been identified despite extensive study, the illnesses may be linked to pet treats from China.

Days later, major pet stores Petco and Petsmart announced they would be phasing out the sale of pet treats from China out of safety concerns.

Many of us still remember the pet food scare and recalls of 2007, the result of melamine-tainted pet food from China.

Given this, pet owners in Ohio and across America are rightfully concerned. When they go to the store to buy treats and food for their pet, they face difficult and confusing questions, just like the ones our family faces for our dog Franklin.

If something says it’s made in China, can we be assured that it is safe? If it says it’s made in the USA, what exactly does that mean? Is everything being done to keep pet treats safe?

Last year, the USDA declared that China is eligible to export processed, cooked chicken to the United States, paving the way for chicken sourced in the United States to be shipped to China for processing and then sold back to American consumers.

While no such chicken has entered our shores yet, it’s possible that very soon this processed chicken could end up on our dinner tables and in our school lunchrooms.
Can we trust our Chinese counterparts to enforce safety up to our own standards, given China’s poor enforcement of their own laws and rampant corruption? Will the label clearly indicate that the chicken was processed in China, so Americans can make an informed choice?

And finally, researchers are exploring a possible link between animal feed from China and the Porcine Epidemic Diarrhea Virus (PEDv) that has wiped out some 10 percent of our pig population. It’s been a year and no definitive cause has been identified.

Americans want and require better answers, clearer labels, and the peace of mind that the foods we import from China are safe.

I appreciate the FDA and USDA being here to shed more light on these issues and to help American consumers better understand them.

In the meantime, I would urge the Chinese government to fully cooperate with our agencies and to make significant improvements in their food safety system.

And I would urge our FDA and USDA to continue devoting every effort to determining the cause of the pet illnesses and PEDv.

I urge companies to ensure the highest safety standards and to put pet and human safety first.

Finally, I would also urge us in Congress to consider whether we need to update our labeling requirements to take into account an increasingly globalized marketplace and to ensure the public health of our citizens.


Witnesses



Dr. Daniel L. Engeljohn, Assistant Administrator, Office of Field Operations, Food Safety and Inspection Service, U.S. Department of Agriculture

Statement of Dan Engeljohn, PhD, Assistant Administrator Food Safety and Inspection Service, Office of Field Operations United State Department of Agriculture Before the Congressional-Executive Commission on China June 17, 2014.

Chairman Brown, Co-Chairman Smith, and members of the Commission, I am Dr. Dan Engeljohn, Assistant Administrator of USDA’s Food Safety and Inspection Service’s Office of Field Operations. I am pleased to appear before you today to explain the current state of U.S. regulatory oversight of poultry exported from the People’s Republic of China (PRC) for human food.


Our Mission:  First, let me take some time to explain FSIS’s mandate. By law, FSIS is required to examine and inspect all slaughtered and processed livestock and poultry, as well as all processed egg products produced for use in commerce for human consumption. Our inspectors and veterinarians monitor the health of the animals brought to slaughter and ensure that livestock are treated humanely. These inspectors also collect the samples that our scientists analyze for the presence of pathogens and illegal drug residues. These dedicated men and women are on the front lines nationwide enforcing regulations and directives backed by scientific evidence to ensure that meat, poultry, and processed eggs in commerce are safe and wholesome.

FSIS also regulates all imported meat, poultry, and processed egg products intended for use as human food through a three part process:

First, (sic) before FSIS-regulated products can enter the country, the agency determines whether the food safety regulatory system of any country that wishes to export to the United States is equivalent to our own system.

Second, once FSIS finds a foreign country’s food safety system to be equivalent, FSIS re- inspects eligible products from that country at U.S. ports-of-entry. During FY 2013,

1FSIS personnel inspected approximately 3 billion pounds of meat and poultry products presented for import by 28 actively exporting foreign countries, as well as about 10 million pounds of processed egg products.

Third and finally, FSIS evaluates an exporting country’s food safety system on an ongoing basis. Each year, FSIS reviews any changes in the foreign country's food safety system.

In addition, FSIS may conduct an in-country audit of the system and will review the country's performance in port-of-entry inspections. Based on these reviews, the Agency decides whether the country is maintaining equivalence, or whether additional Agency action is warranted. This performance-based approach allows FSIS to direct its resources to foreign food regulatory systems that potentially pose a risk to public health and makes our international program more consistent with the U.S. domestic inspection system. Our approach improves the linkage between port-of-entry re-inspection and on-site audits.

Regulatory Oversight:  Again, let me assure you that FSIS follows every mandate given the Agency to ensure that our food supply is safe. FSIS audits any foreign country that wishes to export meat, poultry, or processed egg products to the United States. A foreign country’s inspection system must ensure that establishments preparing to export to the United States comply with requirements equivalent to those in the Federal Meat Inspection Act, the Poultry Products Inspection Act, the Egg Products Inspection Act, and in FSIS regulations. This is true for the PRC as it would be for any other country.

As you know, pursuant to requirements in the fiscal year 2010 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (PL 111-80), the Agency is also required to provide Congress with detailed updates on China’s request for equivalency every six months. However, let me explain briefly where we are in the process for the PRC – a process that began in 2004 with the PRC’s request for on-site FSIS audits of its poultry processing and slaughter system.

First, the United States is not importing any chicken that was slaughtered in China. A March 2013 audit found China’s poultry slaughter system not equivalent to that in the United States; and

Second, FSIS reaffirmed in August 2013 that the PRC’s poultry processing inspection system is equivalent to that of the United States. This means that chicken slaughtered in the U.S. or another country whose poultry slaughter system has been found by FSIS to be equivalent to the U.S. system could be sent to China for processing and then exported to the United States.


Again, the only chicken currently permitted to be imported from China is processed chicken from approved sources. FSIS, in coordination with USDA’s Animal and Plant Health Inspection Service (APHIS), also currently requires that all processed chicken products from China be cooked.

China has provided a list of four plants it has certified as eligible to export processed chicken to the United States. Before any processed chicken can be exported to the United States, a proper export health certificate must be developed by the PRC and approved by FSIS and APHIS. Such a certificate, a draft of which was submitted earlier this month, must demonstrate that the poultry is sourced from the United States or from a country with an inspection system for slaughter that is equivalent to that of the United States and that the poultry was cooked to a proper temperature, among other things. Once FSIS and APHIS approve a certificate, and that certificate is agreed to by the PRC, the PRC will then be able to determine when to begin shipping products from the plants certified to export processed poultry products to the United States. The Agency doesn’t have any information about how much processed product it expects China to ship once certification is up and running.

In addition to carrying a proper certificate, product must be properly labeled. Under Poultry Products Inspection Act regulations at 9 CFR 381.205, immediate containers of poultry products imported into the United States for human consumption must bear a label showing the name of the country of origin. Because processed product from China must be cooked, FSIS believes that it is unlikely that the product would be repacked or further processed in this country. If a product is not repacked or further processed, the label would indicate that the product is from the PRC. If the product were to be repacked or further processed in the United States at an official establishment, it would not include information that such product was from the PRC, but it would be repacked or processed under FSIS inspection. However, I would like to emphasize again that our systems-based approach to equivalence is designed to assure Americans that the food safety systems of other countries that FSIS finds to be equivalent, including the PRC’s, are effective.

Of course, FSIS will also conduct annual on-site audits of the PRC’s inspection system for processed poultry for at least the next 3 years, as we would do for any country that has just been found to be equivalent.

Conclusion:  The dedicated men and women of FSIS work every day toward a common and extremely important goal of preventing food-borne illness. We take our mission seriously and understand the importance of our roles in ensuring the safety of the nation’s food supply – whether from domestic or from foreign establishments.

Thank you for your continued support and the opportunity to report on the work we do to protect public health.




June 17, 2014, statement of Tracey Forfa to Congressional-Executive Commission on China.

Tracey Forfa, J.D., Deputy Director, Center for Veterinary Medicine, U.S. Food and Drug Administration, U.S. Department of Health & Human Services

Good afternoon, Chairman Brown, Co-Chairman Smith, and Members of the Commission. I am Tracey Forfa, Deputy Director of the Center for Veterinary Medicine (CVM) at the Food and Drug Administration (FDA or the Agency), which is part of the Department of Health and Human Services (HHS). Thank you for the opportunity to be here today to discuss FDA’s investigation into reported illnesses in pets that consumed jerky pet treats.

FDA has been receiving reports of pet illnesses associated with the consumption of jerky pet treats since 2007. As of May 1, 2014, FDA has received approximately 4,800 such reports, including 1,800 complaints received since FDA’s website update in October 2013. The reports received involve illnesses in more than 5,600 dogs, 24 cats, three humans, and, sadly, more than 1,000 canine deaths. Most of the reported cases involve chicken, duck, or sweet potato jerky products imported from China. Unfortunately, to date, FDA has not been able to identify a specific cause for the reported illnesses or deaths despite an intensive scientific investigation. Getting to the bottom of this problem is a priority for FDA, and the Agency is continuing its comprehensive investigation into the potential cause of the pet illnesses.

The ongoing global investigation is complex and includes a wide variety of experts at FDA, including toxicologists, epidemiologists, veterinary researchers, forensic chemists, microbiologists, field investigators, state research partners, and senior Agency officials. FDA has collaborated with our colleagues in academia and industry and has reached out to U.S. pet food firms to enlist their help and to share data involving this public health investigation. FDA is updating veterinarians and pet owners about the investigation regularly via the Agency’s website and a webpage dedicated specifically to issues related to jerky treats. This information has been further disseminated to veterinarians by various groups, including the American Veterinary Medical Association (AVMA). Most recently, on May 16, 2014, CVM released an update entitled “FDA Provides Latest Information on Jerky Pet Treat Investigation.” CVM also has a webpage entitled “FDA Progress Report on Ongoing Investigation into Jerky Pet Treats.” In addition, the Agency will continue to remind pet owners that jerky pet treats are not necessary for pets to have a fully balanced diet, so eliminating them will not harm pets since commercially produced pet food contains all of the nutrients that pets need.

Adverse events report:  The 4,800 reports of pet illnesses received by FDA cover many sizes and ages of dogs, and multiple breeds. About 60 percent of the reports are for gastrointestinal illness and about 30 percent relate to kidney or urinary issues. Some dogs with kidney or urinary issues were diagnosed with Fanconi or Fanconi-like Syndrome, a rare kidney disease normally seen primarily in certain breeds as a genetic disease, although Fanconi can also be acquired following exposure to kidney toxins. Affected dogs were reported to involve a wide variety of breeds, which makes genetic Fanconi Syndrome unlikely. The background incidence of Fanconi Syndrome in dogs is currently unknown, but it appears to be increasingly reported in association with jerky treat ingestion. The remaining 10 percent of cases involve a variety of other symptoms, including convulsions, tremors, hives, and skin irritation.

In October 2013, FDA published an update on the Agency’s website which resulted in a surge of 1,800 adverse event reports received by FDA. The Agency has determined that about 25 percent of the 1,800 reported cases were “historic”; that is, the illnesses occurred several months or even years previously. The remaining cases were more recent, but may or may not have received veterinary attention. Of the new cases since October, the Agency has identified about 125 well- documented cases for further investigation, and has continued to correspond with the owners and veterinarians of these pets to track their progress and to obtain test samples of blood, urine, feces, and tissue.

In addition to the October 2013 website update, FDA reached out through the AVMA to solicit information about new or ongoing cases currently under veterinary care. This is a novel approach, and it resulted in the submission of tissue samples (blood, urine, feces, necropsy, etc.) from affected dogs that were associated with jerky pet treat exposure.

FDA has also had the opportunity to perform post-mortem examinations on dogs suspected of having jerky-pet-treat-associated illnesses. As of May 1, 2014, the Agency completed 26 post- mortems on the samples submitted since October 2013. In half of the cases, the dogs’ cause of death was due to a variety of other causes, such as widespread cancer, trauma or infections; in the remaining 13 cases, 11 had kidney disease and two involved gastrointestinal disease. An exact causal relationship between these deaths and jerky pet treats has not been determined, but involvement of jerky pet treats has not been ruled out. We are exceptionally grateful to the owners who consented to allow FDA to perform post-mortem examinations of their beloved pets. We understand this is a difficult decision to make and sincerely appreciate the opportunity to learn more about the potential cause of their pets’ deaths.

Beginning in May 2014, FDA has partnered with the Centers for Disease Control and Prevention (CDC) to collaborate on a study of cases reported to FDA of sick dogs compared with “controls” (dogs that have not been ill). The goal of the study is to compare the foods eaten by the sick dogs (cases) to those eaten by the dogs that did not get sick (controls), in order to determine whether sick dogs are eating more jerky pet treats than healthy dogs.

Investigators have identified about 100 cases of kidney illnesses in dogs reported to FDA to have occurred on or after July 1, 2013. The cases included dogs diagnosed with Fanconi or Fanconi- like illness, or dogs that were five years of age or younger and had kidney failure, regardless of jerky pet treat exposure. Cases were selected solely on this case definition and not on what food they consumed. Data collected during this investigation will allow Federal investigators to better understand what is making pets sick. The study is still ongoing, and FDA will share results when the study is completed.

Pet food sample testing:  Since 2011, in concert with FDA’s Veterinary Laboratory Investigation and Response Network (Vet-LIRN), which partners with state and university veterinary diagnostic laboratories, the Agency has collected approximately 250 jerky treat samples related to more than 165 consumer- related complaints, plus more than 200 retail samples (unopened bags obtained from a store or shipment), and has performed more than 1,000 tests on these samples. In addition, the team at Vet-LIRN ran more than 240 tests on historical samples (those received in 2007-2011).

FDA’s Vet-LIRN program has included intensive testing for numerous contaminants such as: Salmonella; metals or elements such as arsenic; pesticides; antibiotics; antivirals; mold and toxins from mold testing; rodenticides; nephrotoxins such as ethylene glycol and melamine; and other chemicals and poisonous compounds. FDA’s test results of jerky treat product samples for toxic metals, including tests for heavy metals, have been negative.

Testing has also included measuring the composition of jerky pet treats to verify that they contain the ingredients listed on the label and do not contain ingredients that are not listed on the label. FDA is reaching out to private food testing laboratories for help with this work to better allow FDA to focus efforts on other aspects of the investigation. It is important to understand the composition of a product and its ingredients to determine where there might be a potential for problems to occur. For example, during a prior investigation involving contaminated pet food, FDA looked carefully at all the ingredients and it was later discovered that melamine was being used to raise the level of the protein in the products. Currently, FDA is investigating whether potentially contaminated glycerin could be a possible source of the reported illnesses in pets. FDA has tested a limited number of samples of glycerin obtained from inspections and is actively investigating new methodologies for analyzing glycerin for a variety of contaminants or impurities.

Testing of jerky pet treats from China has revealed the presence of the drug amantadine in some samples containing chicken. These samples were from jerky pet treats that were sold a year or more ago. Amantadine is an antiviral medication that is FDA-approved for use in humans. It has also been used in an extra-label manner (using an approved drug in a way that is not listed on the label) in dogs for pain control, but FDA prohibited its use in poultry in 2006.


FDA does not believe that amantadine contributed to the illnesses because the known side effects or adverse events associated with amantadine do not seem to correlate with the symptoms seen in the jerky-pet-treat-related cases. Amantadine, however, should not be present at all in jerky pet treats, and the Agency has notified the Chinese Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) that the presence of amantadine in these products is an adulterant. Chinese authorities have assured FDA that they will perform additional screening and will follow up with jerky pet treat manufacturers. FDA has notified the U.S. companies that market jerky pet treats that were found positive for amantadine of this finding and is testing both imported and domestic jerky pet treats for amantadine and other antivirals. FDA is in the process of conducting a survey assignment of both domestic and imported jerky pet treats for amantadine, as well as other antivirals. Of the 41 samples analyzed thus far, only one has tested positive for antivirals.


FDA’s testing also found various antibiotic residues in chicken jerky pet treats, which were also found by the N.Y. State Department of Agriculture and Markets. Though FDA does not believe the presence of these residues contributed to the reported illnesses in jerky pet treats, they should not be present in the products. These findings led to the temporary removal from the market of two major brands of jerky pet treats.

Interaction with China:  It was just over a year ago that FDA testified before this Commission about FDA’s efforts to ensure global product safety and quality, particularly in our work related to China. China is the source of a large and growing volume of imported foods, drugs, and ingredients. Every product imported from abroad must meet the same standards as those produced here in the United States. Firms always have the primary responsibility to produce safe products, but it is important that governments provide meaningful and robust regulation to ensure public safety. FDA is continuing its work with Chinese officials to help them improve their regulatory system and educate them on the new standards that are being implemented in our regulatory system.

FDA has held regular meetings with the Chinese authority, AQSIQ, about the jerky pet treat issue. These meetings have helped to ensure that AQSIQ is aware of U.S. requirements for pet food safety and to share information in support of FDA’s investigation.

In April 2012, FDA conducted inspections of several facilities in China that manufacture jerky pet treats for export to the United States. FDA selected these firms for inspection because the jerky products they manufacture have been associated with some of the highest numbers of pet illness reports in the United States. These inspections provided valuable information on these firms’ jerky pet treat manufacturing operations, including the ingredients and raw materials used in manufacturing, as well as manufacturing equipment, the heat treatment of products, packaging, quality control, sanitation, and product testing. Although these inspections helped to identify additional areas that FDA may investigate, the Agency found no evidence indicating that these firms’ jerky pet treats are associated with pet illnesses in the United States. FDA, however, did identify concerns about the record keeping practices of several of the inspected Chinese firms. In particular, one firm falsified receiving documents for glycerin, which is a common ingredient in jerky pet treats. As a result of the inspection, the Chinese AQSIQ informed FDA that it had seized products at that firm and suspended exports of the firm’s products to the United States.

As a follow-up to these inspections, FDA sent a delegation to China in April 2012 to express our concerns to AQSIQ about the complaints we continue to receive concerning jerky pet treat products imported from that country. As a result, FDA and AQSIQ agreed to expand the investigation of jerky pet treats. In addition to sharing our epidemiological findings with AQSIQ, FDA initiated a scientific collaboration, and has taken other steps to attempt to identify the root cause of the illness complaints. As noted, FDA and AQSIQ are meeting regularly to share findings and discuss further investigational approaches. FDA has also hosted Chinese scientists at the Agency’s veterinary research facility to further scientific cooperation.

Pet food safety in general:  Pet food safety in general continues to be a priority issue for FDA. In response to section 1002 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA established the Pet Food Early Warning Surveillance System. The goal of the surveillance system is to quickly identify contaminated pet food and illness outbreaks associated with pet food. The system uses data collected by two surveillance resources to collect information about pet-food-related problems: FDA’s Consumer Complaint Reporting System (through the FDA District Consumer Complaint Coordinators) and the FDA-National Institutes of Health Safety Reporting Portal (SRP) (where consumers can submit complaints regarding adverse events in animals associated with the consumption of pet food). Information provided through these reporting mechanisms helps provide early detection of problems with pet food, enabling FDA to respond quickly to prevent or mitigate risks to people and animals.

The SRP launched in May 2010, allowing the public to submit complaints electronically. Using the portal’s pet food questionnaire, consumers can report possible adverse health effects associated with their pets’ food. Veterinarians may also report pet food safety problems on behalf of their clients and provide valuable medical information. Within days of opening the SRP for pet food complaints, veterinarians identified a thiamine deficiency in a cat that only ate one brand of canned food and reported it through the SRP. FDA notified the manufacturer, which promptly initiated a recall.

Another important safety surveillance tool is a new requirement, provided for in section 1005 of FDAAA, that manufacturers, processors, packers, and holders of human or animal food report to FDA if there is reasonable probability that an article of human or animal food will cause serious adverse health consequences or death to animals or humans. In conjunction with that requirement, section 1005 also required FDA to establish the Reportable Food Registry (RFR), an electronic portal to which such reports can be submitted. The intent of the registry is to help FDA better protect public health by tracking patterns of possible food and feed adulteration and to better target inspection resources. By providing early warning signals about potential health risks, it has increased the speed with which FDA, its state and local partners, and industry can remove hazards from the marketplace. For example, in 2011, a pet treat distribution company submitted a report to the RFR that their pig ear dog treats were contaminated with Salmonella. After FDA’s investigation, two lots of the affected pet treats that had been distributed to 18 states were recalled.

In addition, FDA uses a system called the Pet Event Tracking Network (PETNet) to share information about emerging pet-food-related illnesses and product defects. PETNet is a secure network launched in August 2011 that allows the exchange of information between FDA and other Federal and state regulatory agencies. Using the shared information, state and Federal agencies can work together to quickly determine what regulatory actions are needed to prevent or quickly limit adverse effects associated with pet food products.

Finally, section 1002 of the FDAAA required FDA to establish processing standards for pet food. The process controls standards for pet food have been incorporated into the proposed rule, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals,” which, when finalized, will implement, for animal food, section 103 of the FDA Food Safety Modernization Act. The proposed rule, which issued on October 25, 2013, establishes requirements for the safe manufacturing, processing, packing, and holding of animal food to protect animals and humans from foodborne illness.

CONCLUSION:  Thank you for the opportunity to describe FDA’s ongoing efforts to determine a definitive cause of the reported pet illnesses associated with jerky pet treats. The Agency is devoting significant resources to actively investigate the problem and its origin. FDA continues to work in collaboration with a wide variety of experts, including our colleagues in academia and industry, our international counterparts, and Federal, state and university laboratories, on this investigation. If FDA’s investigation leads to the identification of any particular jerky pet treat ingredient or contaminant that is associated with illnesses in pets, the Agency intends to act quickly to notify the public of its findings and take steps, as appropriate, to ensure the affected product is promptly removed from the market.  FDA encourages consumers to check our website for updates on the ongoing investigation. As noted above, we will continue to remind pet owners that jerky pet treats are not necessary for a pet’s healthy diet.

I am happy to answer any questions you may have.




June 17, 2014 statement Shaun Kennedy to Congressional-Executive Commission on China.

Shaun Kennedy, Director of the Food System Institute, LLC; Adjunct Associate Professor, Department of Veterinary Population Medicine, College of Veterinary Medicine, University of Minnesota

Congressional-Executive Commission on China Hearing
“Pet Treats and Processed Chicken from China: Concerns for American Consumers and Pets”
June 17, 2014
Chairman Brown, Chairman Smith and distinguished members of the Commission, I would like to thank you for this opportunity to provide my perspective on current concerns with the safety of the food and feed system and potential steps to make it safer. I am the Director of the Food System Institute, LLC, a food system risk management and research firm and I have been focused on protecting our food system for years in prior positions as Director of the National Center for Food Protection and Defense, as Associate Professor of Food Systems in the Department of Veterinary Population Medicine at the University of Minnesota and as Vice President of Global Food and Beverage Research Development and Engineering for Ecolab.
As is often the case, there are a number of ongoing public and animal health concerns that are related to potential food and feed contamination. The pet deaths that appear to be attributable to jerky treats imported from China have raised concerns among many that we are exposed to unknown risks due to imported food products and food ingredients.
The most commonly identified type of treats are chicken jerky treats, which may also raise concern that the USDA’s designation of China as an “equal to” country for processed poultry will expose consumers to additional unknown risks.
The potential that the ongoing Porcine Epidemic Diarrhea virus (PEDv) outbreak in swine may be attributable, at least in part, to feed is another example of uncertain risk from food and feed. Among many possible solutions to these, and other, food system concerns are demands for increased regulatory inspection and clearer source labeling on consumers’ packages, more commonly known as COOL or Country Of Origin Labeling. 
Before addressing either of those approaches, I would first like to provide a bit of context around our current food and agriculture system and what that implies for how either increased inspection or COOL could be effectively implemented.
Everyone realizes that we are sustained by a global food and agriculture system, but it is often hard to conceptualize how global it really is.  In the first four months of this year, January through April, we imported food and raw agricultural products from more than 179 countries with a total value of over $48 billion and weighing over 26 million metric tons.
When we focus on food items classified as “consumer oriented”, which are products close to the form in which consumers would purchase them and not intermediate products like raw cocoa beans, we imported $23.5 billion and nearly 11 million metric tons of these products in the same four months.  That is roughly 75 pounds per person in the U.S. for the first four months of the year or over half a pound per day.  So at a basic level, we are always eating foods that come from around the world as well as those from around the block, and that is something that has been steadily growing over the last decade.
In 2004, our imports of “consumer oriented” products were only $12 billion and 8 million tons or about 56 pounds per person in the first four months of the year.
Those imports come from a broad range of facilities, with over 6,800 USDA-FSIS approved domestic facilities and over 250 approved foreign facilities while over 81,000 domestic and 115,000 firms are registered with the FDA to supply food to the U.S. 
A significant challenge any consumer faces is figuring out the origin of each ingredient in any particular meal, but it is easier to understand where it could have come from.
If your lunch today was a cheeseburger, French fries and milk, the last two are
fairly straightforward.  We are a big producer of both fluid milk and frozen French fries, with only five countries exporting frozen French fries to the US and five  countries exporting fluid milk In both cases the dominant source is Canada.
That doesn’t necessarily mean that all components of these food items are domestically sourced, however, as Canada, Chile and Mexico have historically been exporters of salt to the U.S. that may be on the French Fries and the vitamins added to the milk are primarily imported from China and a few other countries.  The cheeseburger is a bit more complicated as the bun, burger, cheese, tomato, lettuce, pickle, onion, ketchup, mustard and seasoning, ten consumer level items, can contain 75 or more individual ingredients.   Last year those ingredients were imported to some degree from over 55 countries.
That means that, including domestic sourcing, the burger has billions of possible combinations of country of origin for its various ingredients.
While any specific burger obviously has a dramatically smaller range of sourcing options, this simple lunch illustrates both the complexity of the food system and the hurdles of country of origin labeling. If it is winter, the lettuce and tomato are usually imported from Mexico and Central America. The ground beef is often a mix of domestic and imported sources, from Australia and other sources, to meet quality demands. The bun, ketchup, mustard and seasoning usually include imported ingredients from a number of countries, especially since many spices don’t grow in our climate. While a company could verify what the country of origin was for each ingredient, under COOL the challenge becomes how to label and where to put this information?
This is further complicated by the fact that sources, especially for seasonal ingredients, may change several times a year. Ingredients may also be comingled in entirely different ways in a relatively short time frame based on availability, cost or quality parameters.
Clearly, accurate and informative labeling on country of origin is thus a challenge.
With the increasing use of web based solutions, the only reasonable option might be to provide the information in something like a QR Code that you see on many consumer products that would take the consumer to a website for details that cannot be reasonably provided on the label.
Whatever the solution, including the potential of reducing sourcing complexity to make COOL more easily achievable, there is an additional expense that would have to be added to the retail cost of the product, and consumers will ultimately bear the burden of the increased cost of foods reaching their table.



Patty Lovera, Assistant  Director, Food  &  Water  Watch


June 17, 2014,  testimony  before  the U.S.  Congressional-­Executive  Commission  on China, Pet  Treats  and  Processed  Chicken  from  China:  Concerns  for  American Consumers  and  Pets
My name  is  Patty  Lovera,  and  I  am  the  assistant  director  of  Food  &  Water Watch,  a  nonprofit  consumer  advocacy  organization.  Thank  you  for  the  opportunity  to  present  testimony  on  this  important  topic.
Introduction
The  United  States  is  increasingly  reliant  on  imported  food.  The  U.S.  Government Accountability  Office  (GAO)  reports  that  from  2000  through  2011,  the  percentage of  food consumed  in  the  United  States  that  was  imported  rose  from  9  percent  to over  16  percent, and  food  imports  increased  by  an  average  of  10  percent  each year for  seven  years.
China  is  a  growing  supplier  of  the  United  State’s  food  imports.  China  is  the largest  agricultural  economy  in  the  world  and  one  of  the  biggest agricultural exporters.
It is  the  world’s  leading  producer  of  many  foods  Americans  eat:  apples, tomatoes, peaches,  potatoes,  garlic,  sweet  potatoes,  pears,  peas  —the  list goes  on  and  on.
It is  also  a  leading producer  of  many  of  the  inputs  used  to  make processed food, for  example  ascorbic  acid,  or  vitamin  C,  producing  about  80  percent of  the  world supply.
But  the  poorly  controlled  expansion  of  China’s  economy  has  often  been fueled  by excess  pollution,  treacherous  working  conditions,  and  foods  and products  that  pose significant  risks  to  consumers  in  China  and  worldwide.  
China is  often  described  as  home  to a  Wild  West  business  environment that  allows food  manufacturers  and  processors  to  cut  corners,  sell  tainted food  products  and rely  on  adulteration  to  maximize  their  competitive advantage.  
Food safety problems in China have  been  making  headlines  around  the world for quite a  while,  especially  after  several  rounds  of  publicity  concerning  contamination  of foods  with  a  chemical,  normally  used  to  make  plastic,  called  melamine.  The chemical has  been intentionally  added  to  different  food  products  in  China, usually  to try  to  artificially increase the  nitrogen  content  in  attempt  to  pass  tests  for protein  levels.  
In  2007,  the  U.S.  Food  and  Drug  Administration  (FDA)  received  reports 17,000 pet illnesses,  including  4,000  dog  and  cat  deaths,  believed  to  be  the  result of  melamine contamination  in  imported  Chinese  gluten  used  to  make  pet  food.
Sixty million packages  of pet food were  recalled  in  the  United  States.
The  potential  health  impacts  were  not necessarily  limited  to  pet  food,  however,  because  some  of  the  melamine-­contaminated  pet  food  was  redirected  to  hog  farms. Thousands  of  hogs  that  ate  the  contaminated  food  were  put  to  death  in  an  effort  to  keep  melamine-­contaminated  meat  from  entering  the  food  supply.
But the  FDA  and  USDA  still  allowed  56,000  hogs that  ate  melamine­tainted pet food  to  be  processed  into  pork,  which  was  then  sold  at  supermarkets.
By  2008,  the  FDA  had  identified  melamine  in  imported  wheat  gluten  and rice protein  from  China  (used  in  pet  food),  prompting  rejections  of  44  percent  and 32 percent  of these  products, respectively.
While the FDA stopped these shipments, pet food imports from  China  to  rise  and reached  79  million  pounds  in  2010.
Pet food turned out to be only the tip of the melamine iceberg.  Because melamine  was widely used  in  China  to  adulterate  dairy  products  such  as milk  powder,  processed food products  including  candy,  hot  cocoa,  flavored  drinks  and,  most  tragically, infant  formula contained  the  chemical.
An infant  formula  scandal  erupted  just  before  the  2008 Beijing Olympics and ultimately  an  estimated  300,000  infants  and  children  in  China  were sickened by melamine;  more  than  12,000  were  hospitalized.
At least  six  children  died.
While the melamine may be the most widely covered Chinese food safety scandal, unfortunately  it  was  not  an  isolated  incident. International media  sources  routinely cover food  safety  problems  originating  in  China,  ranging  from  widespread smuggling  of  products like  honey  to  avoid  tariffs  and  food  safety  restrictions, mislabeled  products  “transshipped”  through  another  country  but  produced  in China, and  importing  countries discovering  violations  of  pesticide  or  other  food safety regulations.  A  2013  report  by  a  food  industry  analyst  found  that among  reported food  violations  in Chinese  products,  the  most  frequent cause  was  pesticides, followed  by  pathogen contamination. The report cited 32  pesticides  found  in laboratory  testing  of  Chinese  foods,  mostly  in  produce,  fruit  and  spices  and  noted that  “economically  motivated  adulteration”  is  a  persistent  issue  in  food  production in  China.

U.S.  Food  Imports  From  China:  After joining the World Trade Organization 2001, China’s food exports to the United States tripled to 4.1 billion pounds of food in 2012.
In  addition  to  Chinese  firms  exporting  to  the  United  States,  U.S.  food  and agribusiness  companies  have  capitalized  on  China’s cheap  labor  costs  and weak regulations,  hoping  to  sell  to  a  growing  class  of  Chinese  consumers and  export  to the  United  States.
The  millions  of  pounds  of imports  from  China  represent  a  considerable  portion  of the  food  eaten  by  U.S.  consumers.  For  example,  in  2011  eighty percent of the tilapia Americans ate came from the 382.2 million pounds of imports  from China.  The United States imported 367 million gallons of apple juice from China amounting to almost half (49.6 percent) of U.S. consumption.  The 70.7 million pounds of cod imported from China amounted to just more than half (51 percent) of U.S. consumption.  The 217.5 million pounds of imported garlic was 31.3 percent of U.S. consumption.
  
The 39.3 million pounds of frozen spinach represented 11 percent of U.S. consumption.  Other Chinese exports include processed foods and food ingredients, products which most consumers purchase without considering where they came from.  China is a leading supplier to the United States of ingredients like xylitol, used as a sweetener in candy, and sorbic acid, a preservative.  China supplies around 85 percent of U.S. imports of artificial vanilla, as well as many vitamins that are frequently added to food products, like folic acid and thiamine.  By 2007, 90 percent of America’s vitamin C supplements came from China, and by 2010, China supplied the United States with 88 million pounds of candy.  The United States also imported

102 million pounds of sauces, including soy sauce; 81 million pounds of spices; 79 million pounds of dog and cat food; and 41 million pounds of  pasta and baked goods from China in 2010.

China’s food safety system:  Chinese officials have readily acknowledged the country’s food system as “grim.”  The country’s decentralized and overlapping regulatory system has not been able to address China’s sprawling food-processing industry.  Repeated government efforts to reform food safety rules have so far failed to stem the tide of adulterated food.  After a major food safety law from 2009 went into effect, a professor at the Chinese Academy of Governance stated that poor coordination between agencies, lackluster enforcement and inadequate government oversight hindered the enforcement of food safety laws.  It remains to be seen if an overhaul of the food safety system, announced in 2012, will manage to coordinate efforts government-wide and tighten food safety standards.

Reports on food safety problems since 2009 yield a long list of problems in both the domestic food supply and exported products.  One persistent trend is “economically motivated adulteration” or what has been described as a culture of adulteration in China’s agricultural sector.  Melamine contamination in Chinese food continues to be a problem, with a crackdown on melamine in milk powder in 2010 resulting in 96 arrests and 26 public officials being fired and U.S. regulators finding high levels of
Melamine in a dog food shipment in January 2011.

After increased attention to the problem of melamine, some Chinese dairy producers appear to have switched to a new protein adulterant that is even more difficult to detect – hydrolyzed leather protein made from scraps of animal skins.
           
Even veterinary drugs banned in China –such as clembuterol, administered to animals to give them             leaner meat and pinker skin –remain widely used in China despite years of documented consumer illnesses from residues in meat and organs, and controversies over athletes avoiding meat for fear of testing positive for the performance enhancing drug.
           
 Since 2009, the Chinese government has made a point of making public displays of enforcing food safety rules, inspecting food facilities and punishing people connected with tainted food.
  
News reports frequently reference millions of inspections of facilities and frequent
“crackdowns” on particular products.  A search of news reports reveals a variety of enforcement efforts.

The scandal over melamine – contaminated infant formula led to the            
 execution of two people and prison terms for dairy company executives.
    
In 2011, industry and commerce authorities reported 62,000 cases of substandard food, leading to 43,000 unlicensed operations being shut down and 251 cases being sent to the judicial system.
             
A 2011 crackdown on food safety violations resulted in 2,000 arrests and 4,900 businesses being closed.           
  
The  Chinese news  agency  Xinhua reported  in  June  2012  that  authorities shut down   5,700  unlicensed  food  businesses  and discovered  15,000  cases of “substandard  food”  so  far  that  year.In  early  May  2013,  news  reports  described a  Chinese government  campaign  to  break  up  a  fake  meat  operation, leading  to arrests  of  more  than  900  people  accused   of  passing  more  than  $1 million  of  rat meat  as  mutton.  Ironically,  the  discovery  of  thousands of dead pigs in the Huangpu River was actually described in some media reports as “an encouraging step forward in Chinese public  health,” because             it indicated that rather than sell diseased animals into the food supply,  producers dumped them into the  river      But  despite  the  concerted  effort to  show  that the  government  is tough  on             food  safety violators,  problems  persist.  

A small sample of food  safety  problems:  In 2010,  a scandal  erupted  over  the  use of food  coloring  and  bleach  to plump  up old  peas so  they  would  appear  fresh.  Authorities detected plasticizers, chemicals linked  to  immune  reproductive  system damage,  in  samples  of  a  leading  brand  of  distilled  white  liquor

Testing  by  Greenpeace  of 18  varieties  of  tea  found  that  every ample contained            at   least  three  different  kinds  of  pesticides.  12  of  the  samples  showed  traces of banned pesticides.  

In September  2012,  FDA  refused  10  shipments  of  canned  mushrooms  from  China  due  to  pesticide  contamination,  resulting  in  the  Chinese  government  halting  exports              of  canned  mushrooms  to  the  United States.  China Central  Television reported in 2012  that  testing  of  preserved  fruit  from  16 different  companies  found excessive pigments,  bleaching  agents  and  preservatives,  well  as  incorrect expiration dates.  The Xinhua News Agency reported in  2012  wholesale vegetable dealers  in  Handong -province were  found spraying with formaldehyde, presumably  to  preserve  them  during transport without refrigeration.  A 2012 report noted  that  fish  vendors  in Beijing  were using  a  chemical used  for   temporary  dental  fillings to tranquilize fish during transport.  In May 2013, officials in  Guangdong Province, announced excessive  levels of  cadmium  in  over  100  batches  of  rice.   In December  2013, a Chinese government official  announced  that  eight million  acres of  farmland  in China was so polluted  that it  should not  be  used  for  growing  crops. Five strains of influenza have emerged in China  in  the  last 17  years. In   2013, China had 115 human highly pathogenic avian flu cases  in  humans,  including   25  deaths.  Chinese consumers are not confident about their domestic food supply A found food safety is  a  major concern for  almost  70  percent  of Chinese consumers, and there  are regular  reports of Chinese tourists emptying store  shelves  in  other  countries in search of infant formula  not produced in China. Another recurring theme is the lack of transparency. In China’s food safety enforcement system   It lacks  the  transparency necessary to warn  the  public about  dangerous products or deter  dangerous  food-processing             practices. The USDA  reports  that  the  Chinese  government   zealously guards  the             food  safety  data  it  collects,  making             it  difficult  to  impartially  evaluate China’s  food safety  performance.  In 2010,  some  officials  criticized  regional authorities that  publicized  a  widespread  case  of  pesticide adulteration  rather  than obeying the “unspoken  rule”  of  keeping  food safety problems  hidden  from  the public.  The father of   one  child  sickened by  melamine-­tainted  milk  powder was jailed,  and  eventually paroled,   for  his  activism  on  the  issue.  

U.S.  Regulation of  Chinese Food Imports:  U.S. oversight of  Chinese food processors  has  not remotely kept pace  with  the  growth  in   imports.  Though the- Food and Drug Administration prevented 9,000 unsafe  Chinese   products  from  entering  the  country  between 2006 and  2010, it is  not  because  of  vigilant inspection  at  U.S-  borders  and  ports.  The agency’s low  inspection  rate  less  than 2 percent  of  imported  produce,  processed food  and  seafood almost  guarantees  that unsafe   Chinese products are-making their way  into  American  grocery  stores.   Other importers of  food from China have instituted more  intensive  testing  regimes  for  Chinese  imports.  From 2004  to 2009,  Japan tested between 15 and 18 percent  of  food  products from China, and up  to 38  percent  of  frozen vegetables.    In  2007,  the  FDA’s director  of the Center  for  Food  Safety and Applied  Nutrition  stated  that   the  growing Chinese  food exports  have  “outstretched  and  outgrown  the  regulatory  system  for  imports  in  the U.S.”  During  the  melamine-­tainted pet  food  crisis, it  took  the  FDA  one  month  even identify  their  FDA inspectors  to  be  stationed in  China, and  the  FDA  opened  its first office  in  2008.  However, the few FDA  inspectors  in  China  were  overwhelmed by  the  sheer  size  of  the  nation’s  food  production,  including  an  estimated 1  million  food-­processing companies.  

Between  2001  and  2008, the  FDA  inspected  46  food  firms  in  China  —  less than  six a year.  After  the spate of  import  scandals,  the  FDA   increased  inspections,  but  still only conducted 13  food inspections in  China  from  June  2009   to June  2010.  In  fiscal  year  2012,  FDA  conducted 10  inspections of             food  facilities  in   China 

Meat             and poultry  imports  are  the  responsibility of  the U.S.  Department of griculture.  Until  2009,  FSIS  conducted  indepth annual on­site  audits of countries eligible to export  meat, poultry and egg products to the United States.   The department recently announced that in 2009 it made a  major  change  to this  system  by ending  annual  visits  to  exporting countries,   and  instead  starting  to  rely  on  a  “Self-­Reporting  Tool”  for  countries  as  a  substitute  to   annual  audit  visits.  With  this  change,  USDA  began  conducting  audit  visits  every  three  years   instead  of annually  and  the agency  stopped  the  practice  of  publishing  the  audit  results  of   individual  foreign  meat,  poultry,  egg  plants  that  exported  products to  the  United States. 

Poultry:   The  USDA’s  approach             to  China’s  interest  in  exporting  poultry  products  to  the  United  States   offers  a  telling  example  of  how  the  pressure  to increase  trade  can  leave  food  safety   concerns  as  a             lower  priority.  Currently,  States  does  not  import  poultry  for   human  consumption from  China.  U.S.  agribusinesses  have invested  heavily  in  Chinese chicken production and  processing  both  to  feed  Chinese  consumers  and  as  a  future   export  platform  to  U.S.  consumers and  they  have  been  working  to  get  USDA  approval   Chinese  poultry  exports  to  the  United  States.    In  2006 the USDA  finalized China’s request  to  begin  exporting  processed  chicken  to  United  States  the  very  same day  as  a  visit  from  China’s  president.  This action   apparently prompted  China  to  resume  negotiations  over  lifting  its  ban on  American  beef,   instituted  in  2003  after  the  discovery  of  mad  cow  disease  in  the  state  of  Washington.  Despite  the Bush  Administration’s  public  blessing  of Chinese chicken,  the  USDA’s  internal   inspection  reports  of  Chinese  poultry facilities  showed  egregious  food  safety problems,   including  mishandling  raw chicken  throughout  the  processing  areas,  failing  to  perform  E.   coli  and Salmonella testing,  and  routinely  using  dirty  tools  and  equipment.  As  these   internal  reports emerged,  Congress  refused  to  implement  the  Bush  Administration   proposal, effectively  maintaining  a ban  on  Chinese  poultry  imports.   China contended the U.S. prohibition-against its chicken, produced  in unsafe  plants  with   insufficient-  inspection,  was  an  illegal  trade  barrier.  The World  Trade  Organization  agreed in  September 2010  The same month, China announced it would impose high tariffs  on American chicken products for allegedly  being priced cheaply In January 2011, Chinese President Hu Jintao  again visited the United States, cementing  tens of  billion of dollars-in trade deals with the Obama  Administration. Shortly after this visit, the USDA announced new steps it  had taken to honor China’s request  to  export chicken to the United  States. Currently, the USDA’s Food Safety and Inspection  Service is working through  the steps  to approve  China as an exporter of  poultry-products to the United  States.  In August 2013, USDA  declared that the Chinese government’s inspection system -for poultry-processing plants was equivalent to USDA inspection, thereby clearing  the way for certain chicken-processing facilities in China to be  able to  export poultry  products  to the United States.  The  Chinese government must  certify plants that are eligible to  export to the United States  before shipments can begin.  In December 2013, USDA stated that China’s inspection system  for poultry slaughter  is not equivalent to USDA inspection.   But it is widely  believed that the ultimate goal of the poultry industry is to  have this equivalence  determination made so that products-from  Chinese-­origin birds  can- be exported to the United States. The processed  -poultry that  could  eventually arrive  in  the  United States  are supposed  to  be  made in Chinese  plants  from birds  that have  been  sent  from  “approved”   sources, including  the States  or Canada, but not  China. But without stationing USDA inspectors in Chinese processing plants, it will be virtually impossible to verify that these   products are made from birds from approved sources rather than Chinese producers. There are also concerns about the potential for processed poultry products  from China to end up in school  cafeterias. While the USDA’s  National School Lunch Program does source domestic product, most schools also procure food from private vendors. These purchases are supposed to source domestic product to the maximum extent possible.”  In addition to cost pressure that could drive school systems to source Chinese processed poultry, the definition used to define U.S. product for school lunches also presents a pathway for Chinese processed poultry to end up in schools.  Because the school lunch-standard for  a            U.S. product is that at  least 51 percent of the product must be domestic, a processed food item that contains chicken as well as other ingredients could contain Chinese processed poultry and still meet the definition of a U.S. product.  The FY 2015 agriculture appropriations bill being considered by  the -House of Representatives currently includes  a  prohibition on purchase  of Chinese­processed  poultry products  for  any  of  the  USDA’s  nutrition  programs.  This  follows  widespread  public  opposition to  the  idea  of  importing  poultry  products from  China,  including  petition  signed-   by  over  300,000 people  urging  Congress  to-  prevent  China chicken  products   from reaching U.S. supermarket  shelves or  school  cafeterias.

Pet  Treats:  The  FDA  reports  from  2003,  when  China  first  approached  the USDA  about  poultry  exports,   to  2011,  the  volume  of  pet food  exports  (regulated  by  the  FDA)  to  the United  States  from  China  has  grown  85-fold.”   Since 2007, thousands of American dogs have fallen ill or  died  after  eating chicken  jerky  treats made in China.  In August 2012, four months after visiting Chinese  processing  plants   that export pet treats  to the United  States,  the  FDA  published inspection  reports  that  revealed  that  the  factories  refused  to  allow  U.S.-  inspectors  to collect  samples  for   independent analysis.  Ultimately, testing done  by  the  New  York  Department  of   Agriculture  and  Markets found  contamination  of  some  of the  treats  with residues of an  undisclosed  antibiotic,  triggering  voluntary  recalls  of  the  products by  the manufacturers.  Just last month, the FDA released an  update on  this  continuing  health threat to  U.S. pets.  As   of May16, 2014, the agency had received 4800 reports of illnesses, involving 5600 dogs, 24 cats, and three people,  and  over 1000 canine deaths  linked to  consumption of  jerky pet  treats  from  China. The most common problems reported were gastrointestinal illness  and kidney problems.  Despite the long-running- investigation and growing public awareness of this problem, the has not identified a cause for the illnesses and- deaths. Recently, some observers of global food industry have urged the FDA to look not only at finished products, but also   further up the supply chain of ingredients.  In particular, they cited  the  possibility  that   leather-­processing  byproducts,  tainted with chromium, were  being  used  to  extract   proteins  that  are  added  to poultry  feed.  While two major producers of  chicken  jerky treats  did announce  a  voluntary  recall of their   products  in  early  2013,  both  have resumed  sales  of these  products.  One of the companies has switched to American poultry for its product, while the  other continues to produce   jerky  treats in  China  but  has  committed,  through the settlement  of a class action  lawsuit  by  pet owners,  to perform  more  testing  of the ingredients  and finished product  it  uses  and  to   source  poultry  from  just  one supplier and one factory.   Victims of tainted pet treats have been working to draw attention to this problem and demand action to prevent any more pets from  falling- ill. They organized several petitions urging major pet  food  manufacturers  to recall their products  and  are  currently targeting retailers to  urge them  to  stop  selling pet  treats  imported  from  China.  Recently  Petco  and  Petsmart  announced  their intention  stop  selling  pet  treats  from  China  over  the  course of  the  next  year,  and the Canadian pet food  store  chain,  Global  Pet  Foods   announced  its  intention  to stop carrying  pet  treats  made  in  China. 

Inadequate Labeling Requirements:  One tool that U.S. consumers is labeling, but  in the  case  of  both  processed  poultry products- and pet treats, inadequate labeling rules  leave  consumers  without  all  the  information  they  need  if  they  wish to avoid  products  from  China.  Thanks to federal labeling requirements, country of origin labeling is required for beef, pork, lamb, chicken, goat meat, wild and farm-­raised  fish  and  shellfish,  perishable agricultural  (fruit and  vegetables),  peanuts, pecans,  ginseng,  and  macadamia   nuts.  But these labeling rules do not apply to processed forms of these foods, and the SDA’s definition-of processing  is far too broad,  which  excludes  many  foods  from the  labeling  requirement.  This exemption includes processed forms of poultry that could soon becoming from Chinese plants.  Pet food and  treats  are  not  covered  by  country of origin labeling requirements that apply to  human  food. This makes it very difficult for consumers to know-if these products were produced in or contain ingredients from China.  

The Customs Department oversees country of origin claims on products and relies on-a standard that the country where  a  “substantial   transformation”  of raw materials into  a finished-  product  takes  place  is  the  country of   origin. In the case  of-pet treats,  the substantial transformation could indeed be the United States,- resulting in a U.S.origin label even if the product contains ingredients from China. There is no requirement for manufacturers to list the country of origin for ingredients in their products1  The  Federal Trade  Commission does regulate use  of  “Made  in  USA”  labeling  claims  and   relies  on  a  standard  that  “major components” product  must  be  of  U.S. origin  for  a   product  to  bear  a  “Made  in  USA” label.  But as the melamine-contamination of pet food   illustrates, even minor ingredients that are adulterated can  pose  a health  threat and, increasingly,  these  kinds  ingredients come from outside  the United  States.

U.S. Policies to address unsafe imports: The World Trade Organization’s Agreement on Agriculture has been  a failure  in the  United  States  and  has encouraged  the  growth  of  export  platforms-in  places  like  China  that  benefit  from low wages  and  weak  regulatory  standards,-putting  consumers  around  the   world  at risk.  Congress and the Obama administration must revisit the current trade agenda to make public health, environmental standards and consumer safety the highest priorities when making decisions about policy.  Specifically: The USDA should restart the process of determining if China’s poultry inspection system is equivalent to the U.S. system and conduct an entirely  new  investigation  before allowing Chinese poultry products  to be  exported  to  the  United  States.

The USDA needs  the  resources  to  increase  current levels  of  inspection  of  imported meat  and  poultry.  If China             is  ever  able  to  export  processed  poultry products  from approved sources, USDA inspectors  should  be stationed in  Chinese  plants  to  ensure   that  Chinese-­origin  birds  are  not  being processed into  products  destined  for  the   United  States. The FDA needs the resources to effectively inspect the growing volume of  food   imports  from  China  and  other  countries.  Congress and the Obama Administration   must instruct and provide adequate funding for the  FDA  to increase import  inspections  and  to  increase  the rigor  of  those  inspections  to  include testing for  pathogens and chemical,  pesticide and drug  residues,  and  to increase inspection  of   processed  food  ingredients.  The FDA needs the resources  to conduct  inspections in food facilities in  China,  rather than relying  on third--party certifications of  the safety  practices used by exporting  firms. The use of third-party certifications in China has already been shown to be questionable in the certifications used for organic products and in pilot projects on aquaculture conducted by the FDA.  This type of system should not be used as a substitute for safety inspection by U.S. government inspectors.   FDA should block the import of jerky pet treats from China until a cause of illnesses and deaths has been identified.  FDA should require that any results that show contamination or adulteration of pet treats or ingredients from testing conducted by manufacturers be reported to the agency’s Reportable-Food Registry, required by the FDA Food Safety Modernization Act.  The USDA should close  the loopholes  in  the current  country  of  origin labeling  rules  and expand  to processed  meats,  fruits  and  vegetables.  

This labeling could be modeled on existing regulations for ground beef, which allow a “shotgun” label for products that may contain covered commodities from multiple sources Congress should require mandatory country of origin labeling for foods currently covered existing law, to require basic manufacturing  information about where,  and  by  what  company, processed foods were produced.  

For pet food and treats, FDA should work with the Customs Department and the  Federal Trade  Commission  to  develop  labeling  requirements  that  not  only  require   disclosure of the  country where the product  was  made, but also the  origin  of  major similar  to  how  juice-labeling provides  the  source  of juice  concentrate even if the product  is reconstituted  in  the United  States  June 17, 2014



Testimony of Christopher J. D’Urso
Student and Consumer Advocate

Introduction:  According to President John F. Kennedy in his “Special Message to the Congress on Protecting the Consumer Interest”, “If the consumer is unable to choose on an informed basis, then his dollar is wasted, his health and safety may be threatened, and the national interest suffers” (Kennedy). Unfortunately, this key tenet of consumer rights has been undermined by weak country of origin labeling (COOL) laws.

Under the Tariff Act of 1930 and the Farm Bills of 2002 and 2008, imported products must be clearly labeled with country of origin. However, these laws contain a disturbing exemption which has been exploited and misconstrued by businesses: any imported product that is processed in the U.S. is not required to have COOL.

Consequently, the majority of products remain unlabeled (Jurenas). As imports continue to increase, these inadequate laws not only compromise the consumer’s right to know but also pose a threat to the public health and economy of the U.S. Thus, COOL must be required for all food products (defined as both human and pet), pharmaceuticals, and dietary supplements.

Issues with Current COOL Laws:  The aforementioned COOL laws do not define what constitutes processing. Thus, U.S. Customs and Border Patrol, which enforces the Tariff Act for pharmaceuticals and dietary supplements, has broadly defined processing to be any method which results in the substantial transformation of a product whereby the product experiences a change in name, character, or use (Country of Origin Marking). On the other hand, the Agricultural Marketing Service (AMS), which enforces the Farm Bills for food products, has defined processing to be any type of cooking, curing, mixing, smoking, or restructuring (e.g. emulsifying and extruding). The interpretations of these agencies are highly subjective, loosely defined, and possibly contradictory. For instance, AMS has broadly construed their interpretation of processing to include mixing peas with carrots, roasting peanuts or pecans, and breading meat (Jurenas).

Equally disturbing, chicken that is slaughtered in the U.S. can be exported to China for
processing and subsequently re-exported to the U.S. as a nugget or soup without COOL (Strom).

As a result of such loose standards, only 11% of pork, 30% of beef, 39% of chicken, and 40% of fruits and vegetables may be required to have COOL (Jurenas). The balances are either produced in the U.S. or imported and processed in the U.S. However, consumers will not know which is the reason. Therefore, Secretary of Agriculture Tom Vilsack has acknowledged that COOL exemptions “may be too broadly drafted” (quoted. in Jurenas).

Imports to the US:  Compounding the issue of weak COOL laws, imports in pharmaceuticals, dietary supplements, and foods have reached all-time highs and are rapidly increasing. In the U.S. pharmaceutical industry, growth in the prescription drug market has flattened and the rate of return on pharmaceutical investments has dropped to just above the cost of capital. Coupled with demand for lower-cost products, these trends have caused a relocation of production to less developed nations such as China and India where the cost of formulation of an active pharmaceutical ingredient (API) can be 15-40% cheaper.

Consequently, imports of pharmaceuticals increased by 13% annually from
2004 to 2011. Especially distressing, 10-15% of all food, including 60% of fruits and vegetables and 80% of seafood are imported (Pathway).