Anatomy of a Recall

TOPICAL REVIEW

Anatomy of a Recall David A. Dzanis, DVM, PhD, DACVN Pet foods on the market that are contaminated or otherwise present a health risk to humans or animals may be subject to a recall under US Food and Drug Administration (FDA) regulations. Legally, all recalls are “voluntary,” but there is little incentive for companies to refuse a request by FDA to conduct a recall. While the firm does the bulk of the work, FDA oversees all aspects of a recall to help ensure that violative product is swiftly removed from the market. A recent new federal law will require FDA to improve its abilities to detect outbreaks of pet food-borne illness, respond to a contamination incident, and communicate with industry and the public on the matter of recalls. Veterinarians play a key role in detecting and reporting pet food-borne illness. © 2008 Elsevier Inc. All rights reserved. Keywords: pet food, dogs, cats, regulation, recalls

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istory shows us that commercial pet foods are relatively safe products. Compared with other sources of poisoning in dogs and cats, food ranks well below drugs, insecticides, plants, rodenticides, and cleaning products in terms of frequency of occurrence.1 In fact, only 1.7% of reported poisonings of dogs and cats could be attributed to food of any type. Despite these statistics, adverse signs in pets are very frequently blamed on the pet’s food. In any case of sudden illness in pets, it is prudent to diligently rule out other potential causes as a matter of course. Still, incidents of pet food contamination and illness do occur. Especially where exposure to the product may result in health risks to animals or humans, a product recall may be the most effective means of containing the risk in a swift manner. Most commonly, pet food recalls are limited in scope (eg, a single manufacturer) and involve a quickly identified and understood contaminant (eg, Salmonella, mycotoxins). Thus, the extensive recall of a large number of pet foods under many different brand and company names in 2007 was unprecedented. That recall was due to a deliberately adulterated ingredient, in which melamine and related compounds were added to “wheat gluten” and other vegetable protein ingredients to falsely increase their apparent protein content. While the actual number of products recalled was reportedly less than 1% of pet foods in the market at that time, the government, industry, and public were simply overwhelmed as the recall was unfolding. In response, the US Congress has recently passed legislation to help prevent similar incidents and to improve response to a recall scenario.

From Dzanis Consulting and Collaborations, Santa Clarita, CA. Address reprint requests to: David A. Dzanis, DVM, PhD, DACVN, Dzanis Consulting and Collaborations, 16256 Ravenglen Road, Santa Clarita, CA 91387-4014. E-mail: [email protected] © 2008 Elsevier Inc. All rights reserved. 1527-3369/06/0604-0171\.00/0 doi:10.1053/j.tcam.2008.04.005

The Recall Process Title 21 Part 7 of the Code of Federal Regulations details the process by which the US Food and Drug Administration (FDA) conducts a food recall (including pet foods).2 Recalls may be “firm-initiated,” wherein a company reports a problem and asks FDA for help in the recall, or “FDA-initiated,” wherein FDA discovers a potential health risk and asks the firm to conduct a recall. Either way, a little known fact is that by current law, all recalls are “voluntary,” ie, the company responsible for the contamination or other cause of health risk must agree to participate in the process. There is little incentive for a firm to refuse an FDA request for a recall, however. While recalls may be expensive to conduct, the potential repercussions of failure to honor the request in terms of legal liability and company/brand reputation may be much more costly in the long term. There was no indication that any of the firms involved in the 2007 melamine incident refused voluntary participation in the recall efforts. In the rare situation where a recall request is refused, FDA has other regulatory recourse. Actions could include seizure and detention of the contaminated product, court injunctions against the company, or in the most egregious cases, criminal charges.3 However, none of these methods are as swift and effective as a recall in retrieving product on the market that poses a health risk. The recall process starts with collection of data needed to assess the situation at hand. Firms submit information such as the product name and description of the type of food, its intended use, and its packaging. Details as to the site of production, the dates of production, the volume of distribution, names and locations of distributors, and applicable lot codes are also critical. Of course, information as to the reason for the recall and potential health risk the product poses is submitted as well. FDA uses this information to conduct a Health Hazard Evaluation, which forms the basis for classification of the recall (Table 1). Depending on its classification and other

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Table 1. Classification of Recalls Class

Health Risk

Typical Depth of Recalla

Class I

Reasonable probability of serious health consequences or death

Class II

Temporary or medically reversible adverse health consequences; probability of serious adverse health consequences is remote. Not likely to cause adverse health consequences

Consumer level—same as II and III, plus widespread public notification urging return or disposal of affected product Retail level—same as III, plus retrieval of product from retail shelves

Class III aDepth

Wholesale level—retrieval of product from distributors’ warehouses

of recall can vary with other factors, eg, extent of distribution, amount remaining in market, or ease of identification.

factors (eg, extent and pattern of distribution, the amount of product remaining unused in the marketplace, ease of identification), a depth of recall is prescribed. A problem for which the risk of health consequences is remote may require recall only to the wholesale level, or possibly retail level. Where risk of serious adverse health effects are likely, a much more extensive recall (down to the individual consumer level) is indicated. The bulk of the work involved in the recall is performed by the firm. However, FDA oversees all steps of the process, including contact with recipients of the violative product, physical retrieval of the recalled food, and recondition or, more typically, destruction of the product. Guidance is given on proper issuance of press releases and recall notifications. Means to evaluate the effectiveness of the recall and criteria by which a recall may be terminated are also directed by FDA. In addition to press releases and notifications performed by the firm, FDA will also issue its own public alerts on the matter. If state regulatory agencies are also involved, it coordinates efforts to make the most use of available resources. Throughout the recall, FDA may also conduct investigations, inspections, and analyses to determine the nature and cause of the contamination incident and what steps may be necessary to prevent its recurrence. Voluntary participation in a recall does not relieve the firm of other potential regulatory actions.

FDAAA Subsequent to US Congressional hearings during the 2007 recall of melamine-contaminated pet foods, a new law was passed by the legislature and signed by the President in September 2007. Titled “The Food and Drug Administration Amendments Act of 2007” (FDAAA), only a small portion of the Act pertains to pet foods per se. However, what it does say about pet foods will have a dramatic impact on both the government and the industry.4 Much of the new law puts the burden on FDA to improve all facets of the recall process. While FDA currently runs an adverse event reporting system for animal drugs, there is no similar system in place for pet foods. The agency has 1 year to

implement an early warning and detection program for pet food-borne disease patterned after or in coordination with existing programs within the US Department of Agriculture and the Centers for Disease Control. It must also improve its coordination efforts with the states. Improved communication with industry to collect needed information, and especially with dissemination of information to the public, is also mandated by FDAAA. In the future, all information about a recall must be posted on a single web site that is easily accessible, fully searchable, and readily understood by consumers. Another requirement under FDAAA is to establish a “reportable food registry.” With some exceptions, companies must report on any incident of contamination that potentially may pose serious risk to human or animal health within 24 hours of discovery. Further, the company must conduct an investigation of the cause and report its findings within the same timeframe. Reports must be kept on file and are potentially subject to public release under the Freedom of Information Act. While not directly related to the 2007 recall, Congressional inquiries also brought question to FDA ingredient, processing, and labeling standards for pet foods. Long before FDAAA, however, FDA has been investigating means of improving animal feed and pet food safety. Over the past 5 years, the FDA’s Animal Feed Safety System has sought ways to implement a comprehensive, risk-based approach to feed safety.5 Progress to date includes a means by which the relative risks of contaminants based on likelihood of exposure and potential health consequences can be ranked. FDA will evaluate this ranking data to help determine priorities and direct resources to where they can be of best use. FDA has also recently signed a Memorandum of Understanding with the Association of American Feed Control Officials (AAFCO) with respect to participation in the latter’s feed ingredient definition process.6 Under FDA law, all ingredients must be GRAS (generally recognized as safe) substances, approved food additives, or otherwise sanctioned for use in animal feeds. GRAS substances include those ingredients expressly codified in FDA regulations but may also include those that have demonstrated safety through long histories of use in animal feed. Some AAFCO feed ingredient

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Volume 23, Number 3, August 2008 definitions go back as far as the founding of the Association in 1909. New ingredients must go through a definition process by which information on its manufacturing, utility, and safety is evaluated. While heretofore an “informal” process compared with submission of a Food Additive Petition or GRAS Affirmation Petition to FDA, FDA has long been intimately involved in the AAFCO definition process, especially with regard to safety review. The new agreement between FDA and AAFCO gives FDA much more explicit control of the process, with final signoff on all new, amended, or deleted AAFCO feed ingredient definitions. This is seen as a means for FDA to formally recognize the AAFCO list of ingredients and to use that recognition as a basis for enforcement actions against noncompliant products. Under FDAAA, FDA has 2 years to promulgate new regulations pertaining to pet food nutritional labeling. Presently, FDA regulations cover basic labeling requirements (eg, net weight, ingredient list, manufacturer’s or distributor’s name and address) but does not address aspects such as nutrient content or nutritional adequacy.7 These aspects are covered under AAFCO model regulations.8 However, since AAFCO is a private body (but whose members are solely government employees), these models have no enforcement authority in and of themselves. Generally, states may adopt and enforce these models as part of their own regulations, where it only has effect within that state’s borders. Under FDAAA, FDA must seek input from stakeholders (including AAFCO) to help it determine what should be appropriate federal regulations for pet food labeling. FDAAA does not provide any change in recall authority. However, other proposed legislation currently within Congress may give FDA authority to conduct mandatory recalls in some cases in the future.

The Veterinarian’s Role Veterinary practitioners are on the “front line,” and in the best position to first detect a possible outbreak of pet foodborne illness. As mentioned above, there are many other more likely sources of toxicity in dogs and cats, but since every animal eats “something” before clinical signs of illness

are noted, it is easy to implicate the food as the cause. Still, the possibility of illness stemming from food contamination must remain on the differential diagnosis list until ruled out or until the definitive cause is determined. Veterinarians who suspect a case of pet food-borne illness should collect as much information on the food in question as feasible. In fact, a record of the dietary history of a sick animal is always prudent and may become important later if a pattern emerges or a notice of a recall is announced at a later date. Pertinent information may include the manufacturer’s or distributor’s name and address, the product and variety names, a description of the type of product, and any lot or date codes on the packaging. Effort should be made to determine the place and date where the food was obtained. Pet food companies report that even minor changes to color, odor, or texture of a pet food that have no bearing on safety are frequently reported to increase complaints to the companies’ consumer relations department. Except for overt moldiness, obvious rancidity, or visible inclusion of foreign materials, most incidents of pet food contamination are unlikely to be apparent on gross inspection, anyway. Thus, collection of samples for laboratory analysis may be indicated when the food is suspect. Proper handling of the sample as legal evidence may be critical if there is a possibility of a lawsuit at a later date.1 In submission of pet food samples suspected of contamination, effort should be made to improve the chances of detecting the possible contaminant. Vague references to “look for poison” on a sample submission form does not give much assistance. A tentative diagnosis, or at least a thorough description of clinical signs and laboratory findings, may give clues to the facility running the analysis on the suspected food as to which contaminants are likely and hence which analyses to conduct. Timely reporting of suspected pet food-borne illness may help curtail a larger outbreak (Table 2). Most pet food companies have an “800” phone number on the packaging by which to notify the company of concerns, and full advantage should be taken of them. In fact, the pet food company should be contacted promptly any time a food is suspected to be contami-

Table 2. Reporting Suspected or Confirmed Pet Food Contamination To Whom

How to Contact

Alternate Contact Method

Pet food company

“800” telephone number on label

Company web site

FDA

Find telephone number for FDA district office’s consumer complaint coordinator at: www.fda.gov/opacom/ backgrounders/complain.html

“Blue pages” in telephone directory for federal agencies

State feed control official (state agency varies, but most often in department of agriculture or chemist’s office)

Find telephone number in AAFCO membership directory at: www.aafco.org/Directory/Membership Directory/tabid/62/Default.aspx

“Blue pages” in telephone directory for state agencies

136 nated, as it may be in the best position to recognize an emerging pattern if multiple complaints regarding a product are received. FDA does not have an adverse event reporting system for pet foods in place at this time, but it may in the future with implementation of FDAAA. In the interim, the closest FDA field or district office may be contacted. Notification of the state feed control official (usually in the state’s department of agriculture or chemist’s office) is also prudent.

References 1. Miller EP, Cullor JS: Food safety, in Hand MS, Thatcher CD, Remillard RL, et al (eds): Small Animal Clinical Nutrition (ed 4). Topeka, KS, Mark Morris Institute, 2000, pp 183-198

Topics in Companion Animal Medicine 2. Title 21 Code of Federal Regulations Part 7. Washington, DC, Government Printing Office, 2007 3. Federal Food, Drug, and Cosmetic Act. Washington, DC, Government Printing Office, 1999 4. Dzanis DA: New US federal law to affect petfoods. Petfood Industry 49(12):36-37, 2007 5. Dzanis DA: FDA provides more details on AFSS. Petfood Industry 49(8):36-37, 2007 6. Dzanis DA: FDA, AAFCO sign feed ingredient agreement Petfood Industry 50(1):36-37, 2008 7. Title 21 Code of Federal Regulations Part 501, Washington, DC, Government Printing Office, 2007 8. AAFCO Official Publication. Oxford, IN, Association of American Feed Control Officials, 2008