FDA announces new program for state animal feed regulators

The U.S. Food & Drug Administration (FDA) and the Association of American Feed Control Officials (AAFCO) have a new program for state animal feed regulators, titled the Animal Feed Regulatory Program Standards (feed standards). The feed standards are designed to integrate the regulatory activities of partner agencies into an efficient and effective process for improving feed safety in the U.S.
The FDA Food Safety Modernization Act (FSMA) called for enhanced partnerships of government agencies and provides a legal mandate for developing an integrated food safety system (IFSS). A key principal of an IFSS is the uniform application of model program standards so that regulatory agencies conduct inspections under the same set of standards.
Model regulatory program standards currently exist for human food programs (Manufactured Food Regulatory Program Standards and the Voluntary National Retail Food Regulatory Program Standards), but prior to the development of the feed standards, there were no recognized uniform standards for state feed regulatory programs. As the U.S. moves toward integrating food safety resources, uniform standards across feed regulatory programs are critical.
The feed standards are standards for animal feed regulatory programs, not for manufacturers of animal feed. The feed standards are comprised of 11 individual standards:

• Regulatory foundation
• Training
• Inspection program
• Auditing
• Feed-related illness or death and emergency response
• Enforcement program
• Outreach activities
• Budget and planning
• Laboratory services
• Sampling program
• Assessment and improvement of standard implementation
The standards, designed to strengthen the safety and integrity of the U.S. animal feed supply, are also the core elements of a state's regulatory program. The feed standards will provide a framework that every state can use to determine the strengths and needs of their program. The feed standards also provide the foundation for mutual reliance on inspections and other work conducted by federal and state agencies.

NCC responds to FDA final Guidance 213 and Veterinary Feed Directive proposal

The U.S. Food and Drug Administration (FDA) on December 11 published its final Guidance 213 and proposed Veterinary Feed Directive (VFD) rule. The same day, the National Chicken Council (NCC) issued a statement, saying it supports the FDA's process for Guidance 213 and the Veterinary Feed Directive.
FDA's Guidance 213 implements a plan to phase out over a three year period the subtherapeutic use of medically important antibiotics in food producing animals.  The proposed VFD will ensure that all antibiotics that are administered to food producing animals will be done so under the supervision of a veterinarian.
In response, NCC Vice President of Scientific and Regulatory Affairs Ashley Peterson, Ph.D., released the following statement:
"NCC appreciates the open and collaborative process FDA has undertaken to phase out the use of subtherapeutic, or growth-promoting uses, of antibiotics that are medically important in treating humans.
"We strongly support the responsible and judicious use of FDA-approved antibiotics and the involvement of veterinarians in raising healthy chickens.  In fact, in raising chickens today, chicken farmers already maintain close relationships with licensed veterinarians who interact on a routine basis, with the farmers and their chickens, to provide the best care possible for the flock.
"Antibiotics are not always used in raising chickens; rather, they are administered only when needed and on those occasions, they are used judiciously under the care of a veterinarian.  For those antibiotics that are FDA-approved for use in raising chickens, the majority of them are not used in human medicine and therefore do not represent any threat of creating resistance in humans.
"That being said, we realize that there are strong emotions and conflicting views on the issue of antibiotic resistance - an issue that is very complex, and not black and white.  For that reason, NCC has supported and will continue to support FDA's Guidance 213 and VFD process and we will continue to work with our members and the agency on implementing this policy."

FDA issues guidance on color additives in animal food

The U.S. Food and Drug Administration has issued a document intended to help small businesses comply with regulations on declaring color additives in food for animals.
The document, entitled Small Entity Compliance Guide - Declaring Color Additives in Animal Foods, provides background and questions and answers on the 2011 regulation requiring that all color additives subject to the FDA's certification process be listed on the product label for animal feed or pet food. Color additives exempt from certification generally include those derived from plants or minerals.
All animal feed and pet food manufacturers must comply with the rule by November 18.

FSMA and animal feed — Strengthening oversight of imported foods

The U.S. Food and Drug Administration has issued two proposed rules under the Food Safety Modernization Act (FSMA) aimed at strengthening assurances that imported food meets the same safety standards as food produced domestically.
On July 26, the FDA issued proposed regulations that it says would greatly strengthen the oversight of foods imported for U.S. consumers. Under the Foreign Supplier Verification Program (FSVP) regulations, importers would be required to perform certain risk-based activities to verify that food imported into the U.S. has been produced in a manner that provides the same level of public health protection as that required of domestic food producers. The FSVP regulations would implement section 301 of the FDA Food Safety Modernization Act.
The proposed regulations vary based on the type of food product (such as processed foods, produce and dietary supplements), the category of importer, the nature of the hazard in the food and who is to control the hazard. All importers must establish and follow an FSVP, unless otherwise exempted. An importer of food under the proposed FSVP regulations is the U.S. owner or consignee of the food at the time of entry, or, if there is no U.S. owner or consignee at the time of entry, the U.S. agent or representative of the foreign owner or consignee. Under the proposed FSVP regulations, an importer would be required to develop, maintain and follow an FSVP for each food it imports.
Also on July 26, the FDA published for public comment its proposed rule to establish a program for accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. The proposed rule would implement Section 307 of the Food Safety Modernization Act.
Importers will not generally be required to obtain certifications, but in certain circumstances the FDA may use certifications from accredited auditors in determining whether to admit certain imported food into the U.S. that the FDA has determined poses a food safety risk or in determining whether an importer is eligible to participate in a voluntary program now under development for expedited review and entry of food.
The proposal contains requirements for accreditation bodies seeking recognition by the FDA as well as requirements for third-party auditors seeking accreditation. The requirements will help ensure the competence and independence of the accreditation bodies and third-party auditors participating in the program. In addition, it contains FDA procedures for recognition and accreditation as well as requirements relating to monitoring and oversight of participating accreditation bodies and auditors. These include procedures that the FDA will follow when removing an auditor or an accreditation body from the program.

Release of regulations for Food Safety Modernization Act delayed

The Food and Drug Administration’s release of proposed regulations to implement the cornerstone of the Food Safety Modernization Act has been delayed by the White House Office of Management and Budget, which is still in the review stage.
The FDA had hoped to release four separate sets of proposed regulations on January 4, the one-year anniversary of the Food Safety Modernization Act's signing into law. Two of those sets of proposed rules will pertain to the requirement that food and feed facilities analyze hazards, implement appropriate preventive controls and develop written food/feed safety plans — each of which is intended to minimize or prevent the potential for products to be adulterated or misbranded. One of the sets is to address human food, and will consist of a 400-page preamble, 200 pages of economic analysis and the regulations themselves. The second set will be for animal feed, feed ingredient and pet food manufacturers, and consist of a 200-page preamble, 100-page economic analysis and the text of the proposed regulations. The other two sets of proposed regulations pertain to law’s requirements that food and feed facilities implement a foreign supplier verification program; and produce growers and handlers implement hazard analysis, preventive controls and product-tracing systems for such products as fruits, vegetables, spinach and lettuce. The final regulations must take effect by July 3.

AFIA urges FDA to maintain separate animal feed, food FSMA rules

In comments to the U.S. Food and Drug Administration on the Food Safety Modernization Act’s preventive controls requirements, the American Feed Industry Association urged FDA to maintain the spirit and specifics of the new law’s separations for human food and animal food regulations.
FSMA requires FDA to publish final preventive control rules by July 2012, which AFIA says represents the largest change in regulation of feed, pet food and ingredients in history.
AFIA formed five working groups with more than 50 member firms involved. The groups represent major sections of the new law, and each focuses on what the law says and means, what should AFIA do, and each group provides compliance tools and assists in drafting comments to FDA.
In comments to the AFIA 41st Liquid Feed Symposium in Kansas City, Mo., Dr. Dan McChesney, an FDA official, said proposed preventive rules are on track to publish in early November 2011 with a short comment period. Then, final rule publication should meet the FSMA deadline. McChesney also said that firms that are in programs like Safe Feed/Safe Food Certification Program should have no problem meeting the requirements of FSMA’s preventive controls rule.
AFIA’s comments to the agency also highlighted the association’s SF/SF certification program, a supplier selection draft guide and AFIA’s “Salmonella Control Guidelines.” The comments were a product of AFIA’s FSMA Working Group on Hazard Identification and Prevent Controls. 
“This is AFIA’s first major policy piece to FDA. We’re highlighting some of the pre-FSMA efforts we have already taken to promote safe feed. FDA is actively soliciting industry comments and assistance," said Richard Sellers, AFIA vice president.

US feed industry supports FDA regulation of veterinary medical food

The American Feed Industry Association has encouraged the Food and Drug Administration to continue regulating veterinary medical food as “foods,” in comments submitted to the FDA.
According to AFIA members, veterinary animal foods are formulated from recognized — either as a food additive or generally recognized as safe — animal feed ingredients to help manage a specific disease or condition under a veterinarian’s supervision. “These products have a long history of safe use and do not present any known animal health concerns,” said AFIA Vice President Richard Sellers. “For these reasons, AFIA believes that it is most appropriate for the FDA to continue to regulate veterinary medical foods as 'foods'."
AFIA has proposed a national meeting, co-hosted by the FDA and a university affiliated with the American College of Veterinary Nutrition, to review how to best regulate veterinary medical foods. It has also urged the FDA to issue guidance with regard to its general enforcement policy on unapproved products. Public announcements of the agency’s position, rather than individual enforcements actions, would lead to a more level playing field and ensure that all stakeholders understand the FDA’s thinking and intentions, according to the statement.

GMP+ Food Safety Assurance participation grows

Participation in the GMP+ Food Safety Assurance (FSA) plan is growing, program administrators reported. On July 1, the program had 11,285 participants in 67 countries throughout the world. Program administrators expect participation to grow further, due to stricter market requirements, changed in certification and positive outcome for certified firms.
The GMP+ FSA is a whole feed chain program covering feed safety management, risk analyses, use of good production practices (prerequisites), early warnings and traceability. GMP+ International plans to change certification requirements to better match what happens in practice with companies in the feed chain, and in September will launch a worldwide 'roadshow' to develop the program in direct consultation with participating companies and start the Feed Safety Database (FSD) portal.

Feed association applauds derivatives reform

American Feed Industry Association President and CEO Joel G. Newman applauded derivatives trading reforms that are part of the Senate’s financial regulation overhaul. The bill includes reforms on derivatives trading sough for two years by AFIA.
AFIA will now begin to work with the Commodity Futures Trading Commission and others to make sure the final law, “remain(s) true to our goals for a well-regulated futures market that protects bona fide hedgers against the impacts of the massive speculative limit exemptions.”

Maryland considers ban on arsenic in chicken feed additives

Maryland congressional committees are considering a proposed ban on arsenic in chicken feed, according to Capital News Service. Industry members oppose the move, saying it would sicken poultry and put growers on an unlevel playing field with producers in other states.
Maryland’s attorney general, Douglas Gansler, told a senate committee that a ban would be beneficial to the poultry industry and the environment.
But Bill Satterfield, executive director of Delmarva Poultry Industry Inc., said that the feed additive Roxarsone, which contains arsenic, prevents intestinal illness in birds and that a prohibition on its use would cause "a lot more sick birds, a lot more dead birds." Perdue Farms, which says it no longer uses arsenic in its feed, also opposes the ban, saying that it is not supported by science.

Bangladesh parliament moves to ban harmful ingredients in feed

Bangladesh's parliament passed new feed regulations on January 19, according to The Financial Express, a national newspaper. The bill, which has not yet been signed into law, empowers the government to set standards for animal and fish feed, including restrictions on the use of antibiotics, growth hormones, pesticides and steroids that may have negative effects on human health.
It also requires government licensing for all parties involved in producing, importing, marketing or selling feed, the newspaper reported.
The bill comes a year after the antibiotic nitrofuran was discovered in a shrimp shipment to the European Union. In June 2009, Bangladesh suspended shellfish shipments to Europe so the nation's government could deal with sources of contamination, according to the Bangladeshi newspaper The New Nation.

Feed association cautions FDA on limitations of product-tracing systems

The National Grain and Feed Association has cautioned the U.S. Food and Drug Administration about the limitations of product-tracing systems for industries that handle large volumes of commingled commodities.
At a joint public meeting held by the FDA and the U.S. Department of Agriculture’s Food Safety and Inspection Service, the NGFA submitted a statement warning that overemphasis on such systems could divert finite human and financial resources away from efforts focused on preventing food and feed safety hazards. The NGFA said that prevention of hazards posing a risk to human or animal health should be the “primary focus” of both government and industry.
The NGFA said that the grain, feed and grain processing industry is covered by the Bioterrorism Act of 2002 requirement that facilities maintain records sufficient to identify the immediate previous source and next subsequent recipient of products they receive and subsequently ship, as well as the identity of the transporter used to distribute such products.
But the NGFA said traceability systems, “while certainly a tool as part of a comprehensive food/feed safety program,” are “reactive, rather than preventive” and “should not be considered in a vacuum or as a ‘be-all and end-all.’”
The NGFA said it believed any new product-tracing requirements imposed by government should be based upon the safety risk posed by the underlying commodity or food/feed product, as determined by a comprehensive risk assessment that considers past foodborne illness incidents and their severity.
The association urged the FDA to consider the impact of the government’s new Reportable Food Registry before considering additional product-tracing requirements. The Reportable Food Registry, activated in September, aims to increase the speed and accuracy of product tracing and specifically targets products that facilities determine may pose a serious risk to human or animal health.

Kansas State studies effects of proposed climate legislation on agriculture

An analysis of six economic studies by a Kansas State University team has concluded that the effect of proposed U.S. climate legislation would be largely neutral to positive for the agricultural sector.
Team leader Bill Golden of KSU’s agricultural economics department said, "Overall, the research suggests U.S. agriculture has more to gain than lose with the passage of H.R. 2454," which is also known as the Clean Energy and Security Act of 2009, or the Waxman-Markey bill. "The bill specifically exempts production agriculture from emissions caps, provides provisions to ease the transition to higher fertilizer prices and fosters the development of carbon offset markets, which will likely enhance agricultural revenues."
The studies considered by the KSU team make different assumptions about key variables that can have significant impact on the results, and not all of them included the various offset categories as they exist in the House-passed legislation. By analyzing the studies in light of recent revisions to the legislation, the KSU team was able to make the following key findings:
*In the short-run, per-acre profitability for both crop and livestock producers may decline but, for the most part, the short-term declines will be modest, with changes in production costs ranging from 0.3% to 6.4% by 2025.
*If other countries adopt similar legislation, the market for agricultural commodities will adjust in the long run and return producers' profits to pre-H.R. 2454 levels.
*The economic impacts will vary regionally and by crop and livestock sub-sector. The impacts depend on cultural and management practices and the farm-specific ability to sequester carbon and receive offset income.
*H.R. 2454 establishes a renewable energy standard that mandates a portion of all U.S. electricity be produced from low-carbon renewable energy sources. As the market for these energy sources expands, the agricultural sector will benefit financially.
"At the present time, it is not completely clear how renewable energy legislation and climate offset markets will function together," said Golden. Potential offsets include dairy digesters, improvements in soil management and tillage practices, advancements in nutrient management and alternative manure-management systems. “What is clear is that these markets have the potential to provide significant financial benefits to agricultural producers.”
American Farmland Trust sponsored the research, which did not cover the testimony presented to the House Agriculture Committee in December. The organization expects to conduct another summary analysis that will include this new research.
A copy of the KSU Study is available on American Farmland Trust's Web site or through Kansas State University.

Feed bill unanimously approved in Senate committee

The Senate Health Education Labor and Pensions Committee unanimously approved bill bill S.510 to upgrade the Food and Safety Law and reform the FDA.
In a press release from the American Feed Industry Association (AFIA), the industry body expressed its support for this legislation with the proviso that there should be distinct and separate language applying to the feed industry and allowing specific exemptions in the rulemaking process.
The AFIA also will request reasonable controls and due process relating to any mandatory recall. The organization is desirous of FDA maintaining recognition for third-party inspections and elimination of inspection fees that are directed at preventing foodborne diseases.
For more information, e-mail Steve Kopperud at skopperud@poldir.com.