By-products in animal food will be regulated under FSMA

By-products from human food, alcohol and produce are all under discussion as part of the Food Safety Modernization Act (FSMA) regulations covering human and animal foods.

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The regulations modify and/or create current Good Manufacturing Practices (cGMPs), and provide for a completely new process of analyzing food adulteration hazards and creating a written safety plan that includes risk-based preventative controls designed to eliminate or minimize those adulteration risks. But questions have come up about what requirements would be imposed on suppliers of various by-products that ultimately end up as ingredients in animal foods. 
As far as human food by-products goes, facilities that are covered by the FSMA human food regulation must follow human food cGMPs and create a safety plan for the manufacturing of their human food. According to reports, it is likely that when the revised proposed regulations are issued, human food manufacturers will need to make their safety plan broad enough to consider any risks associated with the by-products used as ingredients in animal food or feed.
Regarding by-products from alcohol, the FDA has said that the potential hazards associated with the use of spent grains in animal food were minimal. FDA also said that they wanted brewers and distillers to take common sense and reasonable measures to ensure that the spent grains were safe from chemical and physical hazards.
By-products from produce have not been discussed as extensively, and whether produce growers could fall within the requirements of animal food manufacturers by reason of their by-products going into animal food or feed has yet to be addressed.

AFIA supports AMS/FDA animal feed export certification program

The American Feed Industry Association (AFIA) has said that it is pleased with the U.S. Department of Agriculture (USDA) and U.S. Food and Drug Administration (FDA)'s new agreement that designates USDA's Agricultural Marketing Service (AMS) as the authority to certify animal feed and petfood products for export to foreign countries. 

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"The agreement is a result of AFIA's efforts to inform USDA's Foreign Agricultural Service about several issues that industry has had exporting to various markets, such as Brazil's requirement for Good Manufacturing Practice certifications and products under the implementation of China's AQSIQ Decree 118," said Gina Tumbarello, AFIA manager of international trade. "The need to find a feed export certification solution for the increasingly popular requirements being put out by several countries ultimately led to these government agencies coming together to develop an agreement that would allow AMS to serve as the competent authority for feeds and register, audit and certify feed facilities as needed based on foreign requirements."
AMS was selected to lead the program due to its experience in working with stakeholders to develop export certification programs that meet the specific requirements of foreign countries. The agreement was modeled after a previous USDA/FDA agreement on processed egg programs. "This agreement is a big step toward helping U.S. feed exporters take advantage of the growing global demand for these products," said AMS Administrator Anne Alonzo.
The agency now has the ability to certify a wide range of animal feed products, including petfood and treats, dried distillers' grains with solubles, mixed-ingredient feeds and feed additives.
The program will not be implemented across the board for all feed and feed ingredient products to all markets. Instead, it will be addressed on a country-by-country basis. AFIA will help identify markets where the feed, feed ingredient and petfood industries are currently experiencing export difficulties related to certifications on foreign requirements. AMS will then work with the foreign government to determine if there is an opportunity for AMS to fulfill the requirements. The hope is for AMS to develop a program and certificate that could be used across several export market requirements, rather than creating a separate certificate for each market.

AFIA seeks comment from member companies on ingredient approvals

The Association of American Feed Control Officials (AAFCO) ingredient approval process, used by 49 states, has an unclear future with the U.S. Food and Drug Administration. Despite a 35-year cooperative relationship, the American Feed Industry Association (AFIA) has learned that FDA feels specifically "the AAFCO process ultimately falls short" and "the majority of ingredients that are included in the AAFCO 'official publication' are neither approved food additives nor are they generally recognized as safe (GRAS)."

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The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires FDA to establish petfood processing and ingredient "standards." Initially, this caused FDA confusion over the legal differences in interpreting "definition"-the term used in the AAFCO OP-and FDAAA's use of the word "standard," a term of legal art found nowhere in the federal Food, Drug and Cosmetic Act (fFDCA). It now appears FDA is trying to harmonize the AAFCO process with the requirements in the fFDCA. FDA is working to complete a GRAS analysis for ingredients listed in the OP and are exploring the options to address the other ingredients in the OP that are not GRAS nor approved food additives.
After several situations where FDA agreed to either a legislative fix or an administrative remedy-only to back out at the 11th hour-AFIA turned to Congress for help. AFIA has recently met with congressional offices to put pressure on FDA to stop complicating the issues surrounding ingredient approvals. Instead, AFIA is pushing FDA to administratively remedy a situation that is discouraging ingredient development.
Last fall, with strong AFIA membership support, 38 members of Congress wrote letters to FDA asking for a solution and clarifying that it was never the intent of Congress to interfere with the AAFCO ingredient approval process.
AFIA met with Rep. Collin Peterson (D-Minn.) and his staff again recently. They have not decided how they will respond to FDA but remain willing to help. The staffs in other offices continue to demonstrate their willingness to assist AFIA.
AFIA equipped several dozen state grain-feed/agribusiness leaders who flew to Washington, D.C., recently with a one-pager and briefed them on the issue. What AFIA is looking for now is the industry's help. The organization would like to hear from member companies about their experiences with ingredient approvals so AFIA can share them with congressional offices and with FDA.
Please think about recent ingredient approval processes your company has experienced-FDA has told Capitol Hill this agency confusion has not held up pending approvals-and let AFIA know what an ideal process would be moving forward. Also please think about how regulatory uncertainly has affected your business, especially in terms of investment/innovation, revenue and jobs. AFIA will soon send out a form to collect such information.

PIJAC urges California to vote down pet food labeling proposal

In the elections on November 6, residents in California, USA, will have the chance to vote on a proposal that could impact pet food labeling requirements in that state.
Proposition 37 is a labeling initiative aimed at providing consumers with information about "genetically engineered food," including petfood. The proposal would no longer allow any processed foods to be labeled as "natural," and retailers would be responsible for ensuring all processed foods containing any covered any covered material are identified as “Partially Produced with Genetic Engineering” or “May be Partially Produced with Genetic Engineering.” For any product not so labeled, the proposal would require “a retailer generally must be able to document why that product is exempt from labeling.”
According to the Pet Industry Joint Advisory Council: "Not only does the proposal mandate far-reaching labeling requirements, it allows lawsuits by private parties to enforce the provisions, authorizing courts to award all costs incurred in investigating and prosecuting the action. Additionally, consumers could sue for violations under the state Consumer Legal Remedies Act, meaning consumers need not even demonstrate any injury to recover damages."
The Pet Industry Joint Advisory Council also says that processed foods, such as foods that have been canned, smoked, pressed, cooked, frozen, dehydrated, fermented or milled could no longer be labeled as natural. The group says the California Attorney General’s official summary states that “these restrictions [could] be interpreted by the courts to apply to [such processed foods] regardless of whether they are genetically engineered.”
If adopted, the Pet Industry Joint Advisory Council says Proposition 37 would impose significant costs on California consumers, including pet owners, and would not be able to be changed if it is adopted because it is a ballot initiative. The group urges California pet owners and consumers to vote down Proposition 37. Those with questions about the proposal may contact Michael Maddox, of the Pet Industry Joint Advisory Council, by calling +1.202.452.1525, ext. 106, or emailing Michael@pijac.org.

Groups commend FDA, AAFCO for ingredient definition process extension

Five major US grain, animal feed, feed ingredient and petfood organizations commended the US Food and Drug Administration and the Association of American Feed Control Officials for extending the current Memorandum of Understanding between the two parties, entitled Memorandum of Understanding Between the US Food and Drug Administration and the Association of American Feed Control Officials.
"This 12-month extension is vital to the continued success of the AAFCO ingredient review process. The US animal feed and petfood industries need workable paths for getting new feed ingredients approved and into the marketplace. The extension of the current [Memorandum of Understanding] will ensure there is no gap in available review mechanisms for the industry in short order.
"The ingredient review process has worked for many decades and we look forward to another very successful year and hopefully many more to come,” according to the five associations. 

US Senate rejects proposal to turn deer processing waste into petfood

A US Senate subcommittee has rejected a South Carolina bid to turn waste products from deer processing into petfood, turning away a bill that would have allowed deer processors to grind up and sell as petfood the parts of the animals they now throw out—organs, bones and other viscera.
The state Department of Natural Resources told the committee that the change could hasten the arrival of wildlife diseases, including chronic wasting disease, from other states. Deer processor Michael Cordray of Cordray's Venison Processing, who initially suggested the bill, said he sees it as a chance to reduce waste and create jobs. According to Cordray, hunters kill more than 200,000 deer a year in South Carolina, and many of those hunters rely on professional processers to remove the meat from the carcasses. Processors could get five to 25 pounds of guts, organs and bones from each deer. 
Currently, no other state in the Southeast allows the use of deer processing leftovers for petfood.

FDA schedules March 29 hearing on Food Safety Modernization Act implementation

The US Food and Drug Administration will hold a meeting on March 29, allowing petfood companies to provide input on how the agency implements the Food Safety Modernization Act's import safety provisions.
FDA's notice said the agency seeks information on importer verification, the Voluntary Qualified Importer Program, import certifications for food, and third-party accreditation.
The meeting will take place from 9 a.m. to 5 p.m. EDT in Silver Spring, Maryland, USA, and will be available on that day as a live webcast. FDA also scheduled a public hearing on March 30 and 31 in College Park, Maryland, USA, to discuss its use of international comparability assessments to enhance the safety of imported foods and animal feed.

New food safety law impact on imports discussed at Global Food Safety Conference

US Food and Drug Administration Deputy Commissioner for Foods Michael Taylor focused on the new food safety law's impact on imports at the Global Food Safety Conference in London.
"All of you in this room acutely understand the major disruptions to our economies and to international trade that occur in the wake of major foodborne illness outbreaks and product recalls," said Taylor at the Global Food Safety Initiative-produced event. "You understand how these crises can undermine consumer confidence for months and years to come ...we know we can do better, and we must do better."
According to Taylor, import safety was a driving force behind the new law, which increases inspection frequencies, authority to access records and third-party verification abroad. "Importers will, for the first time, have a clearly defined responsibility and accountability for the safety of the food they bring into our country," said Taylor. "The new importer accountability provisions require importers to implement a foreign supplier verification program."
The expectations under the new law will be difficult to meet, said Taylor, but they are necessary. "Consumers around the world, not just in the United States, expect and demand safe food, no matter its source," he said. "We need to live up to those expectations."

Food Safety and Modernization Act affects petfood industry

The Food Safety and Modernization Act, signed into law by President Barack Obama on January 4, 2011, will affect petfood as well as human food as companies work to become compliant with the new rules set forth by the act.
Five areas of the act should be of particular focus to petfood manufacturers and processors:

• Preventive controls: Petfood manufacturers and processors must implement preventive measures and controls versus fixes to quality issues after product has been shipped out.
• Inspection and Compliance: The law now states how often the Food and Drug Administration should inspect petfood manufacturers. In addition, funding to safety and enforcement will increase, as will the field staff that performs inspections.
• Importation: Petfood companies will now be required to verify and document that their foreign suppliers have adequate controls to ensure the safety of their products. Qualified third parties will certify that foreign petfood facilities comply with current US food safety standards and practices.
• Recall Authority: The FDA will have mandatory recall authority for all petfood products.
• Partnerships: The new law discusses the strengthening of existing relationships and the establishment of new partnerships to help achieve public health goals. 

Petfood in Taiwan passes all safety tests in 2010

Random checks on 402 different petfoods in Taiwan in 2010 turned up no safety violations, according to Taiwan's Council of Agriculture.
Tests for aflatoxin, Salmonella, T-2 toxins, melamine and heavy metals all came back with results meeting international standards. The results for aflatoxin are particularly significant because in 2009 it came to light that more than 300 dogs had died in Taipei after eating aflatoxin-contaminated dog food.

Eurofins responds to changes in US food safety legislation

Eurofins commented on the recently passed, US Food Safety Modernization Act, with praise of the bill's increased regulation as well as an offering of the company's services to help food processors and petfood manufacturers comply with the changes.
The main highlights and implications of the bill in the petfood industry include mandatory risk prevention plans for all handlers and processors of food; required updates to the Foodborne Contaminant list every two years; mandatory measures for traceability, sanitation and testing performed by accredited laboratories; more animal feed products required to meet food safety standards; and foreign supplier verification programs required for US food importers.
Eurofins offered its services to companies affected by the legislation changes to ensure maximum compliance, some of which include microbiological testing capabilities including assays for process control, spoilage and pathogens; contaminant testing for chemical residues, antibiotics and mycotoxins; sanitation standard operating procedures development, auditing and reassessment; hazard analysis and critical control points plan development, auditing, training and recall management; and good manufacturing practices development.

FDA seeks comment on establishment of network for tracking petfood diseases

The US Food and Drug Administration is seeking comment on issues related to a proposed Pet Event Tracking Network (PETNet) for detection of petfood-related illnesses.
FDA is seeking public comments on the paperwork and regulatory burdens associated with the proposed establishment of PETNet, which would be "a system for sharing information between FDA, other Federal agencies, and the States about food-borne illness outbreaks in companion animals," according to FDA.
PETNet would provide timely information about petfood-related incidents to FDA, as well as to federal government agencies and officials in all 50 US states that choose to participate. Members of the network would be able to both receive and create alerts about petfood incidents. The deadline for comment is Jan. 24, 2011. More information on PETNet and how to submit comments can be found here.

Prepare for new food safety regulations: learn from experts at Petfood Workshop: Safety First

Though S. 510, the new US Food Safety Modernization Act, is not yet law because of a procedural snafu in the Senate version passed last week, it's likely that the US Congress will work out the problems soon and pass it for President Obama's signature. That means most food producers, including petfood manufacturers, will need to register with the Food and Drug Administration (FDA) and prove they are using written, risk-based hazard control programs such as HACCP or cGMPs.If you're concerned your company might not be ready, or you just want a better idea of what to expect with the new regulations, you might want to consider attending Petfood Workshop: Safety First April 13-14 at the Renaissance Schaumburg near Chicago's O'Hare airport. (It happens just after Petfood Forum 2011 at the same venue.)Petfood Workshop: Safety First will bring you face-to-face with experts on:

* The Global Food Safety Initiative, a consortium of companies and organizations from around the world, led by retailers such as Walmart, that strives to continuously improve food safety management systems to ensure confidence in the delivery of food to consumers;

* The quickly changing regulatory landscape, especially in the US (speaker is Judi Lazaro, director of customer relations for AIB International);

* How to prepare for -- and survive -- an FDA inspection (presented by Bob McDonald of Food Safety Validation); 

* Creating and improving a HACCP program (by David Rosenblatt, DVM, of Sher Consulting and Training);

* Testing and controlling for toxins and other contaminants.Be sure to register for Petfood Workshop by February 15, 2011, to save up to 15%. If you also register for Petfood Forum, you'll save even more on your Petfood Workshop registration!

Food safety legislation: what's next

Food safety in the US seems to have taken a big step yesterday with US Senate passage of S. 510, also called the Food Safety Modernization Act of 2010. (Whether that step is forward or backward depends on your point of view regarding the bill and, possibly, legislation in general.)
But it's not law yet. Just this morning brought news of a snafu holding up approval by the US House of Representatives. (It passed its own version of the bill, way back in July 2009, but because the Senate made changes, the House now has to vote again.) Apparently the Senate version includes a section that "violates a constitutional provision requiring that tax provisions originate in the House," according to John Stanton of Roll Call.
That's a big oops, and considering this is a lame duck Congress trying to tackle many other pressing issues before the end of the year and end of this Congressional session, working out the problem in a timely manner is not guaranteed. (Even with what constitutes "timely" by US Congressional standards.)
The legislation is likely to pass eventually, and that fact is generating quite a bit of praise and criticism. Even proponents are expressing concern about what the nitty-gritty details will look like once regulators start working with it.
This is possibly cause for concern for petfood manufacturers, too. But the good news for our industry is that most players -- manufacturers, suppliers and regulators -- have been anticipating, discussing and preparing for the impending new regulations for well over a year. Dan McChesney, PhD, director of the Office of Surveillance and Compliance for the US Food and Drug Administration's (FDA) Center for Veterinary Medicine, and others have been giving industry talks predicting what is likely to happen.So what is that? For one, the bill will require that companies currently registered as food producers under the Bioterrorism Act -- and that includes petfood producers -- register with FDA and create written, risk-based hazard control programs. If you already have, use and thoroughly document within a HACCP program or current GMPs (good manufacturing practices), you're probably in good shape.If not, you would do well to start creating such a program soon. The folks at Extru-Tech Inc. have some good tips and suggestions in the latest issue of their e-newsletter.

Performance Pet Products petfood facility certified by USDA inspection service

Performance Pet Products announced that its canned petfood facility was approved by the US Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) for shipments to the European Union (EU).
In compliance with APHIS regulations, every ingredient used in these products must be sourced from EU-certified suppliers. FDA is currently in the process of establishing more rigorous guidelines for petfood processing plant compliance and inspections of petfood facilities.

Government regulation in the petfood industry

Currently, natural petfoods and supplements are regulated at a federal level by the Food and Drug Administration (FDA)'s Center for Veterinary Medicine, but many pet parents and manufacturers feel a need for tighter oversight of the petfood industry, according to an article from Natural Products Marketplace.
For greater regulation than the government provides, the National Animal Supplement Council (NASC) puts its seal on approved products. NASC is comprised of companies in the industry that have passed an on-site audit conducted every two years at random by NASC officials. Additionally, NASC performs independent product tests and reviews product claims for misleading statements, while maintaining an independent adverse event reporting (AER) system.
All NASC members are required to follow a written quality manual that meets good manufacturing practices (GMP) standards. This goes one step further than FDA, which requires natural human products to follow GMPs but not pet health products. Petfood GMPs are being developed by FDA's Animal Feed Safety System (AFSS) and the Association of American Feed Control Officials (AAFCO).

Proposed legislation to prevent petfood contamination

After the case of the melamine-laced petfood that killed thousands of pets three years ago, US Congress is stepping in to propose legislation that will help prevent petfood contamination from happening again.
The Food Safety Modernization Act is intended to amend the Federal Food, Drug and Cosmetic Act but is still awaiting debate in the Senate.
In the House, the Food Safety Enhancement Act of 2009 was passed July 2009 and would give the Food and Drug Administration more power to prevent contaminations.
Michael Markarian, chief operating officer at the Humane Society of the United States, told the Scripps Howard News Service that the bills will give the FDA additional authority to control recalls and to make sure poisonous materials don't come in from abroad.

China to regulate petfood

The Executive Yuan of China has passed the eighth draft amendment to its Animal Protection Law to regulate petfood products and suppliers, according to The China Post.
The draft states that petfood manufacturers, processors and importers will be under the regulation of the government, have to register their products and provide proof of their products' safety.

Petfood Insights: FDA proposes new color additive regulations

Both certified and non-certified food colors must be approved by the FDA before use in food or feed. ...Read the full column in Petfood Industry.

FDA seeks feedback on petfood recall questionnaire

The US Food and Drug Administration (FDA) is asking for public comment on its recently released Pet Food Early Warning Recall Rational Questionnaire.
With respect to the administration’s collection of information, FDA invites comments on these petfood topics:
(1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
(2) the accuracy of FDA’s estimate of the burden of the proposed collection of information;
(3) ways to enhance the quality, utility and clarity of the information to be collected; and
(4) ways to minimize the burden of the collection of information on respondents.
Submit electronic comments on the collection of information to www.regulations.gov and written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
All comments should include the docket number (FDA-2008-N-0546) and must be submitted by January 29.