FDA’s Food Protection Plan Recently Unveiled; Safety Enhancements for All Imports Also Announced
“Rome-ing” with CVM’s Representative to Recent FAO Conference
Codex Committee on Veterinary Drug Residues Acts on Several Documents at 17th Session
FDA Publishes “Indexing” Final Rule
The Food and Drug Administration has published the final rule to implement the Legally Marketed Unapproved New Animal Drug Index (the Index) authorized by the Minor Use and Minor Species Animal Health Act (MUMS Act) of 2004.
This rule provides an alternative means for companies to market veterinary drugs for uses that are not amenable to the full FDA approval process, such as products for species too varied or inherently valuable to be used in the studies usually conducted to establish a product’s effectiveness and safety. In short, these will be products for use in animals like ornamental fish, pet birds, laboratory animals, pocket pets, endangered species, and zoo animals.
Indexing will only be an option for species that are not used to produce food, with the exception of certain early life stages such as some fish eggs.
The Indexing final rule was published in the December 6, 2007, Federal Register, and it becomes effective on February 19, 2008. FDA will not be able to accept submissions for Indexing drugs until the final rule becomes effective.
The Indexing process will include three major steps. First, upon a sponsor’s request, FDA will evaluate the eligibility of a new animal drug to be considered for the list. Second, the sponsor will ask FDA to concur with its expert panel selection. This panel of experts will review all of the drug’s available target animal safety and effectiveness data. Third, the panel’s findings will be presented as a report to FDA so the Agency can determine whether the drug should be included in the Index. Drugs successfully reviewed under the Indexing rule are placed in a public index of unapproved drugs that can be legally marketed.
The rule was first proposed in August 2006. It was open for comments a total of 120 days. FDA made some changes to the final rule based on those comments, including changes to the rules concerning scheduling conferences, reviewing the written report of such conferences, and selecting appropriate members for the review panel.
The rule implements Section 572 of the Federal Food, Drug, and Cosmetic Act, entitled “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” The regulations describe the administrative procedures and criteria for listing a drug in the Index.
The Indexing regulations were designed to be a means by which companies can legally market veterinary drugs for certain minor species without going through the long and expensive new animal drug approval process.
The MUMS Act, of which Indexing is a part, was developed to provide new ways to bring products to market for the treatment of rare diseases in major species (cows, pigs, chickens, turkeys, horses, cats, and dogs) and to treat all other animal species (minor species). The MUMS Act was created because sponsors were developing or seeking approval for few drugs for minor uses or minor species due to limited markets or, in some cases, the difficulty in finding means to generate data necessary for approval.
The MUMS Act has two other key provisions already in effect:
Additional staff member
CVM has also announced that Dr. Joan Gotthardt will join the Center’s Office of Minor Use and Minor Species in February 2008 to direct the implementation of the Indexing provisions of the MUMS Act.
Dr. Gotthardt has been with the Center since 1995. For the past 5 years, Dr. Gotthardt has served as Director of the Division of Therapeutic Drugs for Food Animals in CVM’s Office of New Animal Drug Evaluation.
She received her bachelor’s degree in Animal Science from the
Dr. Gotthardt joins Dr. Bernadette Dunham, who serves as Director of the Office, as well as Deputy Center Director; Dr. Meg Oeller, who handles drug designation and serves as the FDA liaison to the USDA’s minor species program, NRSP-7; and Dr. Andrew Beaulieu, immediate past Office Director, now assisting the Office as a special consultant.
Indexing Implementation Dates
Indexing final rule becomes effective February 19, 2008. CVM can accept requests for eligibility on that date and not before.
The Final Rule was published December 6, 2007.
Steps Taken To Avert Shortage of Injectable Drug for Pigs
by Walt D. Osborne, M.S., J.D., Assistant Editor
Because of the shortage of the drug, iron dextran, the Food and Drug Administration is working with sponsors to exercise discretion on a case-by-case basis over the importation into the
Injectable iron dextran is approved by FDA for the prevention and treatment of iron deficiency anemia in baby pigs. Because injectable iron dextran is considered a medically necessary drug for this indication, and a shortage could result in undue animal suffering and disruption in the swine industry, FDA is working with sponsors to make adequate supplies of the drug available to treat newborn pigs.
Iron is essential for baby pigs
Iron administration within 1 to 3 days after a pig’s birth is essential for preventing iron deficiency or anemia. Newborn pigs are very vulnerable to iron deficiency, more so than many animals, for the following reasons:
(1) Newborn pigs are born with only moderate stores of iron, mostly in the liver, but only enough to sustain their hemoglobin for 3 to 4 days.
(2) Newborn pigs grow at an extremely fast rate, quadrupling their body weight in 3 to 4 weeks. Therefore, muscle mass and blood volume increase rapidly, and the hemoglobin quickly becomes diluted in the blood.
(3) Milk is the only food consumed by baby pigs during the first few weeks after birth, and milk is not a good source of iron; a quart of milk contains only about 1 mg of iron. Pigs require 7 to 8 mg of iron every day.
(4) Pigs are raised in an environment where they cannot get iron from other sources (e.g., nuzzling in the soil) because the floors are concrete, steel, rubber, or plastic.
All of this stated, it is important to note that no more than 200 mg of iron should be given to pigs. Higher levels of iron encourage systemic bacterial growth and can lead to diarrhea and possible toxicity.
FDA’s imported drug restrictions
Section 301 of the Federal Food, Drug, and Cosmetic Act prohibits the interstate shipment (which includes importation) of unapproved new drugs. Thus, the importation of drugs, whether for personal use or otherwise, that lack FDA approval, violates the Act. Unapproved new animal drugs are any drugs, including foreign-marketed versions of U.S.-approved drugs, which have not been manufactured in accordance with, and pursuant to, an FDA approval.
Unapproved drugs are considered unsafe, and therefore adulterated, under the Act. Under the Act, FDA may refuse admission to any drug that “appears” to be adulterated. The burden is on the importer to prove that the drug sought to be imported is in fact approved by FDA. Absent evidence that the specific drugs sought to be imported from a foreign country have been manufactured pursuant to an approved new drug application in the manufacturing facility permitted under the application, such drugs would appear to be adulterated and could be refused admission to the United States.
CVM is committed to working with sponsors to ensure that an adequate supply of injectable iron dextran product is available. More information is available on CVM’s Web site: http://www.fda.gov/cvm/Irondexupdate.htm.
CVM, AAFCO Sign Agreement on Feed Ingredient Listing
by Jon F. Scheid, Editor
The Food and Drug Administration’s Center for Veterinary Medicine has signed a Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) that allows FDA to formally recognize AAFCO’s process to develop a list of feed ingredients and defines the role FDA can play in deciding on the suitability of feed ingredients offered for addition to AAFCO’s list.
FDA’s formal recognition of the AAFCO list is one of the specific recommendations made in a “Framework Document” drafted by FDA’s Animal Feed Safety System (AFSS) Team. FDA created the ad hoc AFSS Team 4 years ago to develop ways to modernize the feed safety system in the
AAFCO is a voluntary organization comprised largely of regulatory officials who have responsibility for enforcing their State’s laws and regulations concerning the safety of animal feeds. It is made up of members from each State in the
A basic goal of AAFCO is to provide the means for ensuring the development and implementation of equitable laws, regulations, standards, definitions, and enforcement policies for regulating animal feed. AAFCO is an advisory group and has no enforcement authority. The State regulatory agencies that make up the membership of AAFCO carry out enforcement in their State if necessary.
AAFCO publishes an annual Official Publication (OP) that includes a list of all ingredients AAFCO has reviewed and found suitable for use in animal feeds. The OP also contains cross-references to certain sections of the Code of Federal Regulations that list approved food additives and ingredients that are Generally Recognized as Safe for use in animal feed. The OP is considered to contain the most current and extensive list of common or usual ingredient names. FDA has informally cited the OP’s ingredient list and has acted as AAFCO’s scientific advisor in reviewing petitions for the addition of ingredients to the list or for changes in the ingredient definitions. However, although the OP ingredient list does have the force of law in those States that adopt it, it does not carry the force of law for FDA.
Under the MOU, CVM assigns scientists to work with AAFCO in reviewing petitions for new feed ingredients or for modifications to existing ingredient definitions. Also, before it adopts a new feed ingredient definition or amends an existing one, AAFCO will ask CVM for advice and a letter of concurrence. In addition, the MOU requires AAFCO to remove a definition from its OP if FDA provides convincing scientific evidence that the ingredient is no longer suitable for its intended purpose.
The MOU went into effect on August 30, 2007, and remains in effect until September 1, 2012.
Correction
The numbers for the Complaint Coordinators published in FDA Veterinarian, 2007, No. IV, for
AAFCO Ingredient Definitions: Setting the Standards
by Jon F. Scheid, Editor
The Association of American Feed Control Officials (AAFCO) first started defining feed ingredients in 1909, just as the commercial feed industry was beginning to take shape in the
AAFCO’s function is to ensure the development and implementation of laws, regulations, standards, definitions, and enforcement policies for regulating animal feed throughout the
FDA recently recognized AAFCO’s process for developing its ingredient list by signing a Memorandum of Understanding (MOU) with AAFCO. (See related story, “CVM, AAFCO Sign Agreement on Feed Ingredient Listing,” on page 3.) The MOU specifies how FDA can work with the Association in reviewing the ingredient petitions submitted for new ingredient listings or for modifications of existing listings.
Acceptable feed ingredients along with their definitions are listed in AAFCO’s Official Publication (OP), published annually. New ingredients are added or existing definitions changed by means of petitions submitted by industry representatives. The petitions are reviewed by an AAFCO investigator, who has the responsibility for the applicable category of ingredients. AAFCO has more than 30 feed ingredient investigators, each with a different ingredient specialty.
Most of the investigators belong to State feed control agencies, but six, including Shannon Jordre, who is chair of AAFCO’s Ingredient Definitions Committee and a Consumer Safety Officer with FDA’s Center for Veterinary Medicine, work for FDA. (Mr. Jordre’s ingredient specialty is miscellaneous and special purpose feed ingredient products.)
When a petition arrives, an AAFCO investigator or FDA scientist reviews it to make sure it contains the information required by The Guide to New and Modified Ingredient Definitions in the OP, such as information about the ingredient and its intended use (including limitations). The investigator also makes sure the petition includes copies of the scientific literature cited concerning the product’s safety, and presents any concerns about toxicity or carcinogenicity, Mr. Jordre said.
Mr. Jordre said that investigators submit nearly all petitions to FDA for a safety review. FDA may not need to review petitions requesting only simple changes, such as a change to an ingredient’s nomenclature, he added.
Any time an ingredient presents a safety concern to the animal that consumes it, or the use of the ingredient will create a food safety risk, FDA will recommend against AAFCO adopting a definition until the ingredient has been the subject of an approved food additive petition.
If FDA finds that a proposed new ingredient is suitable for use in animal feeds, the AAFCO investigator will then submit the request to AAFCO’s Ingredient Definitions Committee during one of the two public meetings AAFCO holds each year. If accepted by AAFCO, the definition will appear in the next edition of the OP. In the meantime, the sponsor may market a product after receiving a letter from FDA saying that the Agency will use regulatory discretion and not take action against the use of the ingredient, when labeled and used as directed.
The ingredient listings in the OP reflect the increasing complexity of the feed industry over time. Some of the earliest definitions, dating back more than 80 years, were relatively straight forward. For example, “Ground Ear Corn” and “Wheat Bran” were added to AAFCO’s official list prior to 1920. More recent additions, such as “Soybean Meal, Dehulled, Mechanical Extracted,” added in 2004, show how new technology used in ingredient manufacturing has changed the type of ingredient submitted for a definition and listing in the OP.
Copies of the OP are available from AAFCO through its Web site, at http://www.aafco.org/.
FDA’s Food Protection Plan Recently Unveiled; Safety Enhancements for All Imports Also Announced
by Walt D. Osborne, M.S., J.D., Assistant Editor
After 6 months of intensive work to develop a food safety strategy, the Food and Drug Administration released its comprehensive Food Protection Plan on November 6, 2007.
The concerted effort began in May 2007 with the appointment of Dr. David Acheson as Assistant Commissioner for Food Protection. In announcing the plan, Commissioner of Food and Drugs, Dr. Andrew C. von Eschenbach, called it a “forward-oriented concept that uses science and modern information technology to identify potential hazards ahead of time as a means to keeping the American food supply safe.” The plan identifies internal administrative actions designed to achieve a more proactive and strategic food safety and defense system, and it also recommends legislative changes to strengthen FDA’s ability to continue protecting Americans and their pets from foodborne illness.
A safe food supply includes both human and animal food and feed. To that end, Dr. Stephen Sundlof, Director of FDA’s Center for Veterinary Medicine, has been a key player in the development of the Agency’s new initiative. The Food Protection Plan is the end-product of months of study, analysis of consumer demographics and buying trends, an awareness of the vast growth of foreign imports, close consultation with many Federal agencies, and an in-depth review of the Agency’s existing food safety mechanisms.
The year 2007 was marked by nationwide recalls of contaminated peanut butter that resulted in 300 illnesses and 50 hospitalizations. Contaminated spinach was implicated in more than 200 illnesses, 3 deaths, and more than 100 hospitalizations. And reports of kidney failure and deaths in cats and dogs led to a recall of nearly 200 brands of pet food.
Over the past few years, FDA has worked diligently to address microbial and other food safety hazards associated with both domestic and imported food products. As Dr. Sundlof has pointed out, the Agency’s continuing challenge has been the dramatic increase in the volume of imported human and animal food. Specifically, the volume of FDA-regulated products has doubled in the past 5 years, and 60 percent of these product shipments are food products, valued at $49 billion; roughly 15 percent of our food supply now comes from outside the
Three elements of protection
The plan addresses both food safety and food defense for domestic and imported products, and it is integrated with the Administration’s Import Safety Action Plan that was announced the same day. That plan is discussed in further detail below. The Food Protection Plan consists of a three-pronged approach: prevention, intervention, and response. All three of these have both internal aspects that the Agency can carry out on its own, as well as legislative authority aspects that would necessitate statutory changes by Congress.
Internally, FDA’s plan will involve preventing foodborne contamination by promoting increased corporate responsibility for the prevention of foodborne illnesses at the onset. This aspect of the plan also includes identifying food vulnerabilities and assessing risks, as well as expanding the understanding and use of effective mitigation measures.
The plan will also need intervention at critical points in the food supply chain, with a focus on inspections and product sampling based on risk, as well as enhanced risk-based surveillance. FDA also plans to improve the detection of food system signals that indicate contamination.
Lastly, the Agency acknowledges that in order to minimize harm to humans and animals from a foodborne illness, a rapid response is crucial. Even though FDA has made improvements in this area, the Agency realizes more can be done to further improve its immediate response mechanisms. Going hand-in-hand with this element of the plan is the need for improved risk communication to the public, industry, and other stakeholders.
Cross-cutting principles
FDA envisions four important cross-cutting principles that will allow a comprehensive food protection approach along the entire production chain:
(1) Focus on risks from production to contamination over a product’s life cycle. This focus includes consideration of the areas that might fall victim to both intentional and unintentional contamination, such as the point at which the food is grown or produced, and the points of processing, distribution, and storage as well. It also includes handling and storage of the food once it is in consumers’ homes.
(2) Target resources to achieve maximum risk reduction. Many variables define a risk, and all of these must be considered, including whether consumption of a food will result in illness from contamination, how that contamination occurred, and the severity of the illness if it does occur.
(3) Address both unintentional and deliberate contamination. FDA has devoted significant efforts over the past 6 years to address defense of the food supply against deliberate attack—something that food safety efforts have not traditionally included.
(4) Use science and modern technology systems. To fully support the implementation of the plan, FDA plans to enhance its information technology capabilities and further integrate its information systems. FDA’s plan emphasizes the need to know the underlying science that is pivotal to understanding how and where a particular food becomes contaminated and what risks are associated. From there, the priority becomes the need to minimize the likelihood of any harm.
Possible enhanced authority
Legislative changes in the three basic areas of FDA’s Food Protection Plan would involve partnering with Congress to seek FDA authority to do such things as: prevent intentional adulteration by terrorists or criminals; accredit highly qualified third parties for voluntary food inspections; require electronic import certificates for food shipments of designated high-risk products; have enhanced access to food records during emergencies; and issue a mandatory recall of food products when voluntary recalls are not effective. This latter enforcement tool has been explored and discussed in the past. Although FDA currently has the statutory authority to seize adulterated or misbranded food, this tool is not always practical when contaminated products have already been widely distributed. Most recalls of FDA-regulated products are handled voluntarily by product manufacturers or distributors. However, there are occasional situations where a firm is unwilling to carry out a recall. In these situations, it would be extremely useful for FDA to require a product recall in order to ensure a quick and complete removal of an adulterated and potentially dangerous product from the distribution channels.
Import Safety Action Plan
As mentioned above, FDA’s Food Protection Plan is integrated with the Administration’s Import Safety Action Plan, which was released the same day by the Interagency Working Group. President Bush created the Working Group on Import Safety in July 2007. The Group was charged with carrying out an extensive review of the
The Import Safety Action Plan is a comprehensive approach that provides 14 specific short- and long-term recommendations and 50 action steps to better protect consumers and enhance the safety of the increasing volume of imports entering the
In closing
Simply stated, implementation of FDA’s Food Protection Plan and the Administration’s Import Safety Action Plan will lead to less illness and fewer injuries to the public and a reduced likelihood of a successful terrorist attack on our food and consumer product supply. Our public health mandate requires nothing less than that.
To download a copy of the full Food Protection Plan, go to: http://www.fda.gov/oc/initiatives/advance/food/plan.html or for a pdf version go to http://www.fda.gov/oc/initiatives/advance/food/plan.pdf. Copies of the Import Safety Action Plan may be obtained by going to: http://www.importsafety.gov/
New Hires
Office of New Animal Drug Evaluation
Office of Surveillance and Compliance
Departures
Office of Management
Office of New Animal Drug Evaluation
“Rome-ing” with CVM’s Representative to Recent FAO Conference
by Walt D. Osborne, M.S., J.D., Assistant Editor
I am sure that most readers are familiar with the expression, “When in
I recently had an opportunity to spend a few moments with Dr. McChesney to learn more about the conference and to see what it is like to attend such meetings.
“It’s just another day at the office, only you get on a plane,” Dr. McChesney commented. The grandeur that was (and is) Rome was only a fanciful notion for Dr. McChesney, who barely had a chance to see the top of St. Peter’s Basilica and a few other sights in the distance from the eighth floor balcony of the FAO headquarters building.
The purpose of the conference was to review the current knowledge on animal feed and its impact on food safety to assist efforts by the Codex Alimentarius Commission (part of FAO) to develop further risk management guidance on the issue at the international level. As set forth in the “Charge” letter from FAO/WHO, a concomitant objective of the meeting was to formulate advice on the issue to share with Member Countries and international organizations. This year’s conference brought together representatives from the World Organisation for Animal Health (OIE), the European Commission (EC), and 13 other countries:
The assembled representatives met as a large group to discuss related topics that covered three general areas: the European Union (EU) and United States views of feed safety as it relates to food safety; toxicology (i.e., microbials, chemicals, and mycotoxins) and its role in feed and food safety; and contaminants (naturally occurring ones, those legally introduced into feed ingredients during their manufacture, and those possibly added as deliberate acts of terrorism). In addition, risk management as it pertains to additives in animal feed was discussed.
Report of the proceedings
Sometime in January 2008, a report on the proceedings from the FAO/WHO Conference will be made available in English, Spanish, and French on the FAO/WHO Web site. Preparation of this report is a fairly detailed and complex process, involving several iterations of the draft document before release of the final product.
Dr. McChesney noted that the
Other somewhat thorny issues involve the various countries’ different nuances of meanings for certain terms. For example, certain products that the
In
All roads lead to
This famous catchphrase, attributed to Julius Caesar, has stayed in our common parlance for more than 2,000 years. For those attending an FAO conference, their taxi will take them to Viale delle Terme di Caracalla, where the flags of many nations flutter in the Roman air to greet anyone entering FAO headquarters. But as Dr. McChesney learned on his first trip to the
When asked about the value of this and similar FAO/WHO conferences, Dr. McChesney answered, “Just being able to hear international animal feed experts share their knowledge on this globally important topic was well worth it. Meanwhile, my wife’s vivid description of her view of the Sistine Chapel will have to suffice.” Eccellente!
Codex Committee on Veterinary Drug Residues Acts on Several Documents at 17th Session
by Brandi Robinson, Executive Secretary to the
At its meeting earlier this year, a Codex Alimentarius Commission’s (CAC) committee on animal drug residues, which is hosted by the United States and chaired by Dr. Stephen Sundlof, the Food and Drug Administration’s Director of the Center for Veterinary Medicine, made decisions about several pending documents covering the safety of drug residues in food and formed many ad hoc electronic Working Groups (EWGs) to deal with some arising issues.
The committee, titled the “Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF),” held its 17th Session September 3-7, 2007, in
The CAC was established jointly by the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations in the early 1960s and was designed to be an international reference point to aid countries in development of standards for food safety and consumer protection to protect consumers and alleviate trade concerns. The CAC’s purpose is to compile the “Codex Alimentarius,” a collection of standards, guidelines, codes of practice, principles, and other recommendations.1
While the CAC compiles and adopts the food standards to be included in the Codex Alimentarius, there are many committees and task forces that develop the new standards and texts for adoption by the CAC, including the CCRVDF.
The CCRVDF has four major goals as described in its terms of reference, which define the purpose of this Committee:
1) to determine priorities for the consideration of residues of veterinary drugs in foods;
2) to recommend maximum levels of such substances;
3) to develop codes of practice as may be required; and
4) to consider methods of sampling and analysis for the determination of veterinary drug residues in foods.2
In accordance with the terms of reference established by the CAC, the CCRVDF prioritizes a list of veterinary drugs used in food-animals that should be evaluated or re-evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The JECFA evaluates veterinary drugs to see if an Acceptable Daily Intake (ADI) and Maximum Residue Limits (MRLs) can be recommended for each. An ADI indicates the maximum amount of a veterinary drug that humans can consume daily without the drug causing health problems.
The MRL is generally calculated from the ADI, but sometimes this calculation takes into account other factors. The MRL is the maximum amount of a residue of a veterinary drug that can be in a specific animal tissue (muscle, fat, liver, etc.), as indicated by the ADI. A single veterinary drug will have only one ADI suggested, but may have different MRLs for different animals and tissues combinations. Although the MRLs may be different, they are calculated to prevent consumers from exceeding the established ADI for the drug.
When experts on the JECFA have completed their evaluation, they recommend an ADI and MRLs to the CCRVDF or, in the event they cannot make those recommendations for a particular drug, they explain the reason no recommendation can be made.
The CCRVDF deliberates over the recommended MRLs from JECFA and, using the Codex Step procedure (see sidebar, “The CAC Step Procedure for Reviewing Documents”), recommends them to the CAC for adoption as Codex Standards and inclusion in the Codex Alimentarius.
The CCRVDF also develops any other guidances as needed. Each of these guidances follows the Codex Step Procedure in order to become a Codex standard. These texts are developed by the CCRVDF, through Physical or Electronic Working Groups. Electronic Working Groups work over the Internet and with e-mail, while Physical Working Groups work through face-to-face meetings. Both types of work groups are made up of Member Countries and Member non-government organization delegations. One example of a text that recently completed the Step procedure and became a Codex Standard is the “Code of Practice to Minimize and Contain Antimicrobial Resistance” (CAC/RCP 61-2005).
CCRVDF decisions from 17th Session
Flumequine: At its 16th session, held May 2006 in
MGA: The CCRVDF could not reach consensus on the advancement of the MRLs for melengestrol acetate (MGA). The CCRVDF agreed to retain the draft MRLs for MGA in cattle tissue at Step 7 with the understanding that the European Community (EC) will provide new data for a reevaluation of MGA by JECFA. If no new information is forthcoming, or if JECFA reaffirms its decision, the CCRVDF agreed that it would advance the MRLs for MGA to Step 8 at its 18th Session.
Colistin: The CCRVDF agreed to advance the draft MRLs for colistin in cattle, sheep, goat, pig, chicken, turkey, and rabbit tissues, in cattle and sheep milk, and in chicken eggs to Step 8.
Ractopamine: The CCRVDF agreed to advance the draft MRLs for ractopamine in cattle and pig tissues to Step 8, while acknowledging the strong reservation of the delegations of the EC,
Erythromycin: The CCRVDF agreed to advance the proposed draft MRLs for erythromycin in chicken and turkey tissues to Step 5/8.
Triclabendazole: The CCRVDF agreed to place triclabendazole on the “Priority List for Reevaluation” by JECFA and, in doing so, to return the proposed draft MRLs for triclabendazole in cattle, sheep, and goat tissues to Step 2. The CCRVDF agreed to consider at its next meeting, its 18th Session, the MRLs recommended by the JECFA.
Other actions
The CCRVDF agreed to use the comments submitted by the delegations of the United States and the EC as a starting point for an in-session working group to revise the draft “Guidelines for the Design and Implementation of National Regulatory Food Safety Assurance Programmes Associated with the Use of Veterinary Drugs in Food Producing Animals” for consideration by the plenary. The in-session working group was successful in revising the draft guidelines. After consideration of the revised draft guidelines, the CCRVDF agreed to circulate the document at Step 6 with a view to further consider the document at its 18th Session and forward it to the Commission for final adoption. The CCRVDF agreed that this process will provide countries with an opportunity to consider the revision in detail, analyze the specific provisions, and evaluate the implications for their implementation.
The CCRVDF agreed to establish an ad hoc EWG to prepare a discussion paper to address the future of the Compendium of Methods that had been maintained by the Physical Working Group on Methods of Analysis for Residues of Veterinary Drugs in Foods, the link between analytical methods of advancing the Codex MRLs to Step 8, and the criteria necessary for analytical methods to be assessed and considered acceptable. The members of the CCRVDF agreed that they would not re-establish the Physical Working Group before its 18th Session.
The CCRVDF agreed to forward the “Priority List of Veterinary Drugs for Evaluation or Reevaluation” by JECFA to the 31st Session of the Commission. This list included: dexamethasone (proposed by
Malachite green was included on the “Priority List” requesting JECFA to consider a literature review and advise the CCRVDF whether this substance can be supported for use in food-producing animals, as the available data were probably not sufficient to derive an ADI and MRLs.
The CCRVDF also agreed to establish an EWG to prepare a Priority List of Veterinary Drugs for Evaluation or Reevaluation by JECFA and a working document listing veterinary drugs of potential interest, based on Annex 1 to the “Report of the Physical Working Group on Residues of Veterinary Drugs without ADI/MRL” (document CX/RVDF 07/17/12).
The CCRVDF considered the six recommendations that were provided by the report of the Working Group on Residues of Veterinary Drugs without ADI/MRL (CX/RVDF 07/17/12). The Committee agreed to postpone discussion on “Recommendation A: Complete List of Evaluations/Decisions Made Publicly Available” until its next session. On “Recommendation B: Specific Veterinary Drugs,” the CCRVDF agreed to establish an ad hoc EWG to develop risk management recommendations for veterinary drugs with no ADI and/or MRLs due to specific health concerns, pending formal approval by the Commission. The CCRVDF noted that the delegations of
The CCRVDF agreed with and endorsed “Recommendation C: Scientific Evaluation,” “Recommendation D: Prioritisation,” “Recommendation E: Closing Data Gaps,” and “Recommendation F: Evaluation of Consignments” with some amendments and noted that the JECFA secretariat stated that the expert group from Recommendation C would not be possible with JECFA’s current resource constraints.
The CCRVDF agreed to establish an ad hoc EWG on “Risk Management Options and Topics” to prepare a discussion paper that would make appropriate risk management recommendations on various issues to the CCRVDF for further consideration and action. The EWG would also collate new proposals with relevant background information and appropriate recommendations to the CCRVDF.
The 18th Session is tentatively scheduled to be held in 2009. The location has not yet been determined.
1 WHO and FAO. (2006). Understanding the Codex Alimentarius (3rd ed.).
2 WHO and FAO. (2006). Codex Alimentarius Commission Procedural Manual (16th ed.).
U.S. Delegation to CCRVDF
The U.S. Delegation to the Codex Committee on Residues of Veterinary Drugs in Food (CCRVDF) is composed of individuals from various Federal agencies, private industry, and organizations. The Delegation holds several meetings and communicates through e-mail to prepare for each CCRVDF session. The draft
The
If you are interested in participating in the U.S. Delegation activities, contact the U. S. Codex Office (uscodex@fsis.usda.gov).
Codex Alimentarius Step Procedure for Reviewing Documents
The Codex Alimentarius Commission (CAC) and all of the associated committees utilize an eight-step procedure in developing and adopting standards for the Codex Alimentarius. The text for each standard must go through this procedure before adoption as a Codex standard.
Before any project is undertaken, a project proposal is created and discussed at the committee level. The CAC has created several standing committees and ad hoc task forces, each with a defined area of responsibility. If the committee agrees on the proposal for new work, the step procedure starts for that project.
Warning Letters
The Food and Drug Administration issued a WARNING LETTER to Jim Wilson, John Wilson, partners, and to Wesley S. Killion, Feedlot Manager of Beef Northwest Feeders LLC of Boardman, OR, for violations of the adulteration provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). Specifically, the firm sold a steer for slaughter as food that was found to have residues of the drug sulfadimethoxine at 2.13 parts per million (ppm) in the liver tissue and 1.20 ppm in the muscle tissue. A second steer that was sold by the firm was found to have residues of the same drug at 1.36 ppm in the liver tissue and 1.17 ppm in the muscle tissue. A tolerance of 0.1 ppm has been established by FDA for residues of sulfadimethoxine in the uncooked edible tissues (21 Code of Federal Regulations [CFR] 556.640(b)). Having exceeded the established tolerance, both animals were adulterated under section 402(a) of the FFDCA. The firm was also found to have administered Albon® S.R. (sulfadimethoxine) sustained release bolus without following the pre-slaughter withdrawal time set forth in the approved labeling, and it did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, the extralabel use resulted in an illegal drug residue. Because the extralabel use of this drug was not in compliance with 21 CFR 530, the drug was also unsafe under section 512(a) of the FFDCA.
Christopher J. Elbe, owner of the Chris and Tracey Elbe Dairy Farm of West Bend, WI, received a WARNING LETTER from FDA for offering an animal for sale that was adulterated under section 402(a) of the FFDCA. Specifically, the firm shipped a dairy cow for slaughter as food that was found to have residues of penicillin at 0.49 ppm in the kidney tissue. A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle as codified in 21 CFR 556.510. The presence of this drug in kidney tissue from this animal in this amount caused the food to be adulterated within the meaning of section 402(a) of the FFDCA. The firm also failed to maintain animal treatment records and it lacked an adequate inventory system for determining the quantities of drugs used to medicate its livestock.
Similar violations of the adulteration provisions of the FFDCA were cited in a WARNING LETTER from FDA to Edward J. Eury, Jr., of
FDA issued a WARNING LETTER to James M. Lopez, President and Chief Executive Officer of Tembec, Inc., of
Duane K. Oxendale, owner of Duane Oxendale finishing operation, received a WARNING LETTER from FDA for violation of the adulteration provision in section 402(a) of the FFDCA. Specifically, Mr. Oxendale sold a heifer that was slaughtered for human food that was found to contain 40.96 ppm sulfamethazine in the liver and 23.91 ppm of the drug in the muscle. A tolerance of 0.1 ppm has been established by FDA for residues of sulfamethazine in the uncooked edible tissues of cattle (21 CFR 556.670). These higher levels rendered the animal adulterated. Mr. Oxendale was also warned of providing a false guaranty, a prohibited act under section 301(h) of the FFDCA. He was also cited for failure to maintain treatment records.
FDA issued a WARNING LETTER to Matthew Toms, owner of Matthew Toms dairy operation, Walkersville, MD, for violations of the adulteration provisions of sections 402(a) and 501(a) and of the safety provision in section 512(a) of the FFDCA. Specifically, Mr. Toms consigned a culled adult dairy cow for slaughter as food through a hauler. Tissue samples taken by USDA inspectors revealed the presence of the drug penicillin at 0.17 ppm in the kidney tissue. A tolerance of 0.05 ppm has been established for this drug in the uncooked edible tissues of cattle (21 CFR 556. 510). The higher level rendered the meat adulterated under section 402(a). In addition, Mr. Toms was cited for failure to use penicillin in conformance with its approved labeling in violation of section 501(a) of the FFDCA. The drug was also used extralabel in violation of section 512(a) of the FFDCA, because such use was not done under the supervision of a licensed veterinarian.
Bryan Vander Dussen, Partner in Golden View LP,
Violations of section 501(a) and 512(a) of the FFDCA are the bases for the issuance of a WARNING LETTER to Ben J. Weaver of
FDA has issued a WARNING LETTER to Michael Brent Masterson of the Tri Mast Dairy,
Mrs. Maria Borges, owner of the J&M Dairy,
A WARNING LETTER was issued by FDA to Ray and Eric Veldhuis, owner and general manager, respectively, of the Veldhuis North Dairy,
Anthony Richard Van Ryn, partner in the Moreno Valley Dairy,
Recalls
A firm-initiated Class I recall is ongoing by United Pet Group, Inc., of
ChemNutra, Inc., of
A Class I firm-initiated recall is ongoing by Del Monte Food,
Cereal By Products of Mount Prospect, IL, is carrying out a firm-initiated Class I recall of 405,482 lbs. of rice protein powder that was made in
A Class I firm-initiated recall is ongoing by Hills Pet Nutrition, Inc., Topeka, KS, for 11,681 units of Prescription Diet Feline. The product was found to be made with raw material wheat gluten that was contaminated with melamine. The product was distributed nationwide and internationally.
Nestle Purina Petcare Co.,
A total of 63,049 cases of Ol’ Roy and Happy Tails dog food products are involved in an ongoing firm-initiated Class I recall by Del Monte Foods,
Sunshine Mills, Inc.,
A Class I firm-initiated recall is ongoing by Menu Foods Midwest Corp., Emporia, KS, for approximately 127,700 cases of various cat food products that were distributed nationwide and in Canada. Prompted by reports from FDA of the presence of melamine in cans of cuts and gravy pet food produced in Menu Foods’ Canadian facility, the firm identified a single interplant transfer of the ChemNutra-supplied wheat gluten, shipped from its plant in
Menu Foods Midwest Corp.,
American Nutrition, Inc., of
A total of 155 metric tons of rice protein concentrate is the subject of an ongoing, firm-initiated Class I recall by Wilbur Ellis Company,
J Foods, Inc., of
A Class I, firm-initiated recall is ongoing by Natural Balance Pet Food, Inc., of
Lortscher Agri Service, Inc., of
The Scoular Co. of Minneapolis, MN, is conducting a Class I recall of seven lots of a batch of wheat gluten (308, 644 lbs.) made by Xuzhou Anying Biologic Technology Development Co., LTD., of Peixian, China (Mainland). The reason for the recall is that FDA detected the presence of melamine in certain lots of the wheat gluten. Distribution of the product was limited to
Mars Pet Care Co. of Everson, PA, has completed a firm-initiated Class I recall of 1,623 bags of dog food that were distributed in New York, Massachusetts, New Jersey, Connecticut, and Pennsylvania. The recall was undertaken because of a possible contamination with Salmonella.
A Class I firm-initiated recall is ongoing by Castleberry’s Food Company, August, GA, for 114,779 cases of dog food under the Dick Van Patten’s Natural Balance label. The products, which were distributed nationwide, and in
A total of 18,000 lbs. of frozen chicken and turkey dog and cat food products are involved in an ongoing firm-initiated Class I recall by BRAVO!! LLC,
Nutra Blend LLC,
A Class III recall has been completed by Kent Feeds, Inc., of Muscatine, IA, for 4,315 50-lb. bags and 39.46 bulk tons of the following items: (1) Bulk Kent HP Calf Creep LTD 30R Medicated, containing 30 g/ton Monensin (as Monensin Sodium; (2) Kent First Rate Show Goat 20R Medicated, packaged in 50-lb. bags, containing 20 g/ton Monensin; and (3) Kent 16% Goat 20R Medicated, packaged in 50-lb. bags, containing 20 g/ton Monensin. The recall was conducted because labeling on the products lacks expiration dates. Distribution of the products was limited to
A Class III firm-initiated recall is ongoing by Virbac AH, Inc., of Fort Worth, TX, for 22,752 units ResiPROX Leave-on Conditioner, 8oz.; active ingredient: Pramoxine HCl 1.5%. The product, a topical conditioner for dogs and cats, is contaminated with bacteria. Distribution of the product was nationwide.
A firm-initiated Class III recall is ongoing by Valley Proteins, Inc., of Winchester, PA, Inc., for more than 13 million pounds of 58% Protein Poultry Meal Blend that were suspected of containing melamine. Distribution was limited to
Menu Foods Midwest Corp. of
A Class III firm-initiated recall is ongoing by Brown’s F M Sons, Inc., of
Ginger Inc. of
A Class III firm-initiated recall has been completed by SouthFresh Feeds of Demopolis, AL, for 233.9 tons of shrimp feed distributed in Alabama and in the country of Belize. The reason for the recall was that the products were manufactured using an aquatic binder that contained melamine, which is unapproved for use in animal and fish feeds.
A Class III firm-initiated recall is ongoing by Uniscope, Inc., of
HBH Enterprises of Springville, UT, is carrying out a Class III recall of 165,740 lbs. of its shrimp pellets that were made from a melamine-containing aquaculture product that were used in a variety of ornamental fish foods. Distribution of the affected products took place nationwide and internationally.
A Class III firm-initiated recall has been completed by ADM Nutrition Alliance, Inc., of
Rangen, Inc., of Buhl, ID is carrying out a Class III recall of 10.8 million pounds of various fish feeds that were distributed nationwide. The reason for the recall is that the firm received binder (Aqua Tec II) that was contaminated with melamine from another manufacturer that subsequently used the binder in the manufacture of its finished products. The same company is conducting a Class III recall of Rangen, Inc., fish feed products that were manufactured using an ingredient contaminated with melamine and its analogs. Distribution of the 10.7 million pounds of feed took place in
More than 1.08 million pounds of shrimp and prawn feed products are involved in a firm-initiated Class III recall by Zeigler Brothers, Inc., of
A Class III firm-initiated recall is ongoing by Skretting Company of Canada, Inc.,
Royal Canin USA, Inc., St. Charles, MO, is carrying out a firm-initiated Class III recall of approximately 322, 600 bags of various dog and cat foods that were distributed nationwide. The pet foods contain rice protein concentrate of Chinese origin found to be contaminated with cyanuric acid, an unapproved food additive. The same firm is recalling 48,486 bags of pet foods under the KASCO label for the same reason, along with approximately 262,000 bags of various sizes of dog and cat foods under the Royal Canin and Sensible Choice labels that were also distributed nationwide.
Tembec BTLSR, Inc.,
Contamination with melamine has also led to a firm-initiated Class III recall by LCP Products,
Rangen, Inc., of Buhl, ID, has completed a firm-initiated Class III recall of 10.8 million pounds of aquaculture and fish feeds that were distributed nationwide. The firm had received a binder product, Aqua Tec 110, that was contaminated with melamine from another manufacturer and subsequently used in the manufacture of their finished products.
Approvals for September and October 2007
CVM has published in the Federal Register notice of the approval of these New Animal Drug Applications (NADAs)
CVM has published in the Federal Register notice of the approval of these Supplemental New Animal Drug Applications (NADAs)
CVM has published in the Federal Register notice of the approval of this Conditional Approval (CA)
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