After the 2007 recall, Congress demanded FDA update pet food regulations (which should have been completed by 2009). Last week, the FDA announced proposed revisions to regulations governing pet food and animal food. It cannot be emphasized enough, this is our golden opportunity to play a role in the future safety of pet food. Your action is needed.
At the end of October 2013, the FDA announced proposed revisions to the regulations that govern pet food and animal food – requiring pet food/animal food manufacturing to be held to similar ‘good manufacturing practices’ and ‘hazard analysis’ to that of human food manufacturing. The proposed pet food/animal food regulations lack a great deal. But…and this is a big but…it is an opportunity for change in pet food. We have a little more than 100 days to provide the FDA consumer input, and then our opportunity is gone.
To read the lengthy FDA proposed pet food/animal food regulations Click Here. Proposed regulations cover facilities that manufacture, process, pack, or hold animal food. Final rule will be determined after consideration of comments received during the required comment period.
But if you prefer to read my highlights, they are below. A warning – they are lengthy. These proposed revisions to pet food regulations were over 400 pages in length.
Again, this is VERY important. Certainly I am not the biggest fan of the FDA. But the FDA is the governing body over pet food and they are asking for input on these proposed regulations. I am certain Big Pet Food and their lobby organizations will fight these regulations. Thus we need a very strong consumer presence in the comments. No FDA bashing in the comments please! Your input on what proposed regulations you agree with and what proposed regulations you disagree with is what (we can hope) they will listen to. We don’t know if FDA will actually take into consideration the consumer comments, but we have to try. Please compile your input and post a comment on the Regulations.gov website.
Suggestion…After you read my highlights of the proposed regulations, pull out the areas of proposed regulation that is most important to you. In your own words, reference the section and provide FDA with your input. Please do not copy word for word what I write below – I suspect duplicate (word for word) comments will be discounted.
It is very easy to provide FDA with your comment. On the Regulations.gov page, right side you will see a button that states “Comment Now!”. Click on that button and complete your information.
Now…get comfortable, this is lengthy…my highlights of the proposed regulations…
1. From II. Background: “Other foods, like pet foods, are handled in homes and often in the kitchen. If the pet food is contaminated with a pathogen of human health concern, this could result in secondary contamination of human food-contact surfaces or human food. Humans could become ill from the pathogen through handling the pet food or through these secondary contaminations.”
2012 U.S. Pet Ownership Statistics state more than 80 million U.S. homes own a cat or dog.(1) In many cases, pet foods are sold right along side of human foods (grocery). Based on consumer statistics alone, pet foods should not be lumped into an ‘animal feed’ category (such as poultry feed) and should be held to the very same safety processing standards as human foods. To provide pet food manufacturing with less stringent regulations puts all consumers at risk.
2. FDA is asking for input to define a “very small business” which would be exempt from these record keeping, good manufacturing practices and hazard analysis requirements. The FDA offers three options to define a ‘very small business’. Very small business: Option 1: Total annual sales of <$500,000; Option 2: Total annual sales of <$1,000,000; Option 3: Total annual sales of <$2,500,000.
A ‘very small business’ should be no more than annual sales less than $500,000.00. With the growing number of small entities entering the pet food marketplace, all pet food and pet treat manufacturers selling product other than to friends and relatives, should register with FDA and be held to similar accountability as large manufacturers. By only holding larger manufacturers accountable, the health and safety of pets is at risk if those smaller manufacturers do not take the same safety precautions as larger manufacturers.
3. Another potential exemption from the proposed regulations mentions “Facilities solely engaged in the storage of packaged animal food that is not exposed to the environment.” I suggest that all pet food/animal food storage facilities be required to uphold Good Manufacturing Practices, hazard analysis and risk-based preventive controls. Example to why such protection to the foods warehoused is needed is the 2008 seizure of pet foods warehoused at a Petco facility in Joliet, IL in 2008. (2) This warehouse was infested with birds and rodents and products stored posed a significant risk to the consumer. To exempt warehouse facilities would provide an opening for potential contamination of pet foods – putting the pet and the consumer at risk.
4. Under Background – “A. Current Approaches to Animal Food Safety 2. Section 402 of the FD&C Act – 2.” (and in numerous locations throughout the proposed regulations), the FDA quotes Section 402 of the Food Drug and Cosmetic Act – with conspicuous exceptions. Parts of the law the FDA neglected to include in these proposed revisions of pet food/animal food regulations are…
(2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 346 of this title; or
(5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or
(6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
(7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title.
(b) Absence, substitution, or addition of constituents
(1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.
FDA provides animal food manufacturers (including pet food) with Compliance Policies allowing contaminated foods, adulterated foods, and rendered animals that have died other than by slaughter into pet foods. All of the Compliance Policies listed below are in violation of FD&C Act for any food.
CPG Sec. 675.100 Diversion of Contaminated Food for Animal Use
CPG Sec. 675.200 Diversion of Adulterated Food to Acceptable Animal Feed Use
CPG Sec. 675.300 Moisture Damaged Grain
CPG Sec. 675.400 Rendered Animal Feed Ingredients
CPG Sec. 690.300 Canned Pet Food
These FDA Compliance Policies remain a violation of federal law and FDA has no authority to pick and choose which laws it enforces. If FDA truly wishes to improve the safety of animal feed/pet food, the FD&C Act should be enforced as it is written.
Should FDA feel the enforcement of the full legal definition of an adulterated food (Section 402 FD&C Act) could result in a significant expense to many manufacturers that utilize waste ingredients and or companies that render waste ingredients into animal food/pet food ingredients, a simple solution that protects the consumers and the manufacturers is suggested – Warning Labels. A warning label should be required on all products that contain these ingredients. Warning labels similar to those found on cigarette packages. Example warning: Warning, this pet food /animal food contains ingredients that could be in violation of Section 402 FD&C Act.
5. Under Background – “A. Current Approaches to Animal Food Safety 4.” FDA discusses “Animal Proteins Prohibited from use in Animal Feeds”. In this section the FDA only addresses the risk of BSE (mad cow disease) contaminated animal foods, however there are more ‘animal proteins” that are legally prohibited from use in animal feeds not addressed. As mentioned previously, various FDA Compliance Policies allow animals that have died other than by slaughter (died in the field or euthanized) to become pet food ingredients. Federal law prohibits this and again, pet foods/animal foods should be required to abide by federal law. FDA should not pick and choose which food safety law it enforces.
6. Also under Background – “A. Current Approaches to Animal Food Safety 12.” FDA discusses Animal Food Safety Compliance Policy Guides. Any products made with FD&C Act illegal ingredients (such as rendered animals that died other than by slaughter or euthanized animals) should be required to provide a warning statement on the label for the consumer.
7. Under Background “Section C FDA Food Safety Modernization Act, Item 2 Requirements for Agency Rulemaking, subsection ‘e’ Exemption or modification of requirements for certain facilities.” – The FDA states: “Section 103 of FSMA applies to “food,” which is not limited to human food. Section 201(f) of the FD&C Act defines “food” to include “articles used for food or drink for man or other animals.” And then the FDA states they “tentatively concludes that the differences between human and animal food are best addressed through separate rulemakings.”
If the Food Safety Modernization Act applies “food” to include animal food and the FD&C Act defines “food” to include food for animals, how can FDA conclude there are any differences between human food and animal food? If FDA is truly guided by FSMA and FD&C Act (instead of acting independent of law), there should be no differences between rulemakings of animal food and human food.
8. Under Background “Section C FDA Food Safety Modernization Act, Item 2 Requirements for Agency Rulemaking, subsection e” – the FDA states: “Therefore, the Agency is proposing requirements to implement section 418 of the FD&C Act for animal food with only few modifications (e.g., no allergen controls.) The Agency requests comment on whether the requirements in section 418 of the FD&C Act should be modified further for facilities that are solely engaged in the production of food for animals other than man, based on scientific and public health principles.”
The FDA does not make clear what other ‘few modifications’ are included beside allergen controls. As well, pet food regulations should include consideration of allergens. Many pet food consumers pay high prices for specialty foods to address the allergy needs of a pet. Should one of these allergy foods contain an ingredient not listed on the label, the food should be deemed adulterated as in human foods.
9. Under Background “Section C FDA Food Safety Modernization Act, Item 2 Requirements for Agency Rulemaking, subsection f” – “The Agency requests comment on whether to include potential hazards that may be intentionally introduced for economic reasons. The Agency also requests comment on when an economically motivated adulterant can be considered reasonably likely to occur.”
There will always be economically motivated adulterants. I encourage FDA to include potential hazards that could be introduced into pet foods/pet food ingredients for economic reasons. The 2007 pet food recall might be history for FDA, but it remains a vivid reminder of what can happen to thousands of pet food consumers. Please do not ignore this very real threat.
10. “Section E. Animal Food Safety Incidents” of Background, “Examples and Monitoring”, the FDA discusses “2. Monitoring and Recalls”. For the future safety of pet food, here are several suggestions to be included into the ongoing monitoring of pet food adverse events.
One of the largest front lines of defense is practicing veterinarians and pet food retail outlets. I suggest the following to be included in the monitoring of pet food adverse events…
a) FDA establish a veterinarian only reporting portal, allowing veterinarians to report suspect pet food/pet treat adverse events.
b) Since veterinarians do not have the Centers for Disease Control to provide guidance to diagnose a food related illness (as human doctors are provided), we suggest FDA provide practicing veterinarians with on-going education to do such. A simple email notification system could be established to provide such education.
c) Often, when a pet food is believed to make a pet ill, the consumer returns the food to the place of purchase for a refund. We suggest to require all pet food retail outlets – when a food is returned due to a pet illness – to either report incident to FDA with customer details and hold the food should testing be required. Or to require all pet food retail outlets to provide the consumer with written information on how to report a pet food adverse event to FDA.
11. “VIII. Proposed Subpart A—General Provisions A. Proposed 507.1—Applicability and Status” FDA is proposing in 507.1(a) that the criteria in determining whether an animal food is adulterated to include only two sections of one very large law. I do not agree with FDA picking only a small segment of a very detailed law which defines an adulterated food. This is FDA choosing to ignore the FSMA and FD&C Act. FSMA and FD&C Act does not separate adulteration of human food and animal food – FDA should not either.
12. “Written Recall Plan.” The FDA proposes to require that the written recall plan be developed for animal food with hazards that are reasonably likely to occur. It would be preferred that all pet food/pet treat recall plans include plans for all potential hazards – not just those “reasonably likely to occur.”
We also request FDA to place requirements for a time frame for said recall plans. Consumers deserve to be notified of a risk pet food/treat in a very prompt manner.
There is no mention in the proposed FDA regulations of the ‘Silent Recalls’ many pet food/treat manufacturers utilize. Clarification needs to be developed for the consumer in relation to notification of product withdrawals – done either publicly or privately (silent recall).
13. Under “F. Proposed Subpart F—Requirements Applying to Records That Must Be Established and Maintained” FDA includes “Public disclosure” as a proposed requirement of “all records that would be required by the various proposed provisions”. However FDA does not explain what documents would be public and how/where these documents would be for public view. Further explanation is requested.
14. Under “A. Current Approaches to Animal Food Safety” the FDA discusses AFSS Working Group. AFSS identified the component “The levels of regulatory oversight are commensurate with risk to human and animal health.” FDA’s approach seems mainly focused in risk to humans. Example: “The use of risk concepts is not new for the Agency, as FDA routinely tries to estimate public health impact in deciding where to focus regulatory effort in general.“
The FDA should take significant consideration to ‘animal health’ such as foods that provide quality nutrition instead of ‘adequate nutrition’.
15. Under “Current Approaches to Animal Food Safety subsection 6 Animal Food Labeling”, FDA states: “In addition, the FDAAA required FDA to issue regulations to update the standards for pet food labeling. These implementing regulations are currently being developed by FDA.”
As these regulations are being developed by FDA, it is suggested that pet food labeling requirements be equal to human food labels. Pet food consumers should not be forced to learn the intricacies of pet food labeling laws in order to interpret their pet food labels. The very same nutritional statements on human foods should be required on pet foods.
16. Proposed 507.1(d) refers to “waste” from human food facilities. FDA states “For example, human food waste that is used for animal food would be treated as “food” for the purposes of its animal food use and as waste for the purposes of its role in human food production.”
There is a significant difference between “waste” from human food facilities such as rejected for use in human foods (adulterated in some manner) and “waste” from human food facilities due to foods not commonly consumed in the US (such as tripe, liver, heart, ect.). All animals deserve quality nutrition. Some “waste” which is currently allowed into pet foods is not nutrition, is illegal per FD&C Act and should never be allowed into pet foods or animal foods.
“Waste” that is USDA inspected and approved is welcome in pet foods; rejected for use in human food “waste” should not be allowed in pet food. Proposed 507.1 (d) should reflect allowed “waste” to be only USDA inspected and approved.
17. Under “Requirements of Section 418(l) of the FD&C Act”, the FDA references qualified facilities that would be exempt from the requirements provide notification on the label of the name and business address of the facility where the food was manufactured or processed. I assume this includes co-packer information on pet food and pet treat labels. All pet food and pet treat manufacturers should be required to include co-packer information on product labels – including co-packer name, address, and contact information (phone and or email) including the contact information of the private label company as well.
18. Under “B. Proposed 507.7 (A)(2) – Documentation Related to Food Safety Practices at a Facility” FDA states “the owner, operator, or agent in charge of a qualified facility certifying that facility” has implemented preventative controls, and the facility is in compliance. Much work needs to be done to make certain 3rd party certifications properly inspect and “certify” a facility. Example would be the recent Jensen Brothers cantaloupe Salmonella contamination. This company – just weeks prior to a massive recall – was provided a clean inspection report from a certified 3 party inspection service. Until FDA outlines strict guidance for 3rd party inspection services, the company itself should be accountable to implement preventative controls and that the facility is in compliance – not a 3rd party.
19. Under “Proposed 507.7(d)—Notification to Consumers”, it is agreed that consumers should be notified of the actual manufacturer or processor. However a contact phone number or email address be included. Often it is very difficult to make contact with a pet food/treat manufacturer with just a street address. Should a problem with the food or treat arise, the consumer needs a quick means to contact the company.
20. Under “Proposed Subpart B – Current Good Manufacturing Practice”, we find the following paragraph: “The proposed animal food CGMPs are not identical to the current and proposed human food CGMPs. The proposed animal food CGMPs do not address “cross-contact”, which for human foods is related to the inadvertent incorporation of allergens into foods. The Agency is not aware of evidence indicating that foodborne allergens pose a significant health risk to animals, or to humans through handling animal food. In addition, the proposed animal food CGMPs do not include a provision related to raw materials and ingredients, including rework susceptible to contamination with pests, undesirable microorganism, or extraneous materials complying with FDA regulations for natural or unavoidable defects if a manufacturer wishes to use such materials in manufacturing such food.”
I strongly feel pet foods CGMPs should be identical to human food CGMPs. FDA does not feel cross-contamination is an issue, however many pet food consumers would disagree. Many pets have severe allergies to certain foods and their owners go to great lengths and expense to assure their choice of pet food contains none of these allergens. By discounting cross-contamination in pet food FDA is discounting these pet food consumers.
As well, it is a concern that FDA has no regulations to prevent “natural or unavoidable defects” in an ingredient should a manufacturer wish to use such materials. ‘Natural or unavoidable defects’ would apply to many adulterants that could pose a health risk to the pet and the pet owner. As example, some would argue that Salmonella is a ‘unavoidable’ defect in poultry, or mycotoxins are a ‘natural’ defect in grains during drought. This section is very ‘grey’ and needs to be clearly defined what FDA considers as ‘natural or unavoidable defects’.
Each day, 80+ million US homes handle a pet food. Those consumers feel their pets are part of the family (and manufacturers market to this family connection), they deserve safe products held to the same standards as foods for other members of the family.
21. “Proposed 507.25(b)(1)(iv)” would recommend that containers and carriers of raw materials be inspected on receipt to ensure that their condition has not contributed to contamination or deterioration of animal food. Notice here FDA used the wording “recommend“. I suggest to FDA this be changed to “require“. Prevention is key.
22. “Proposed 507.25(c)(10)” “recommends” that animal food be protected from contaminants that may drip, drain, or be drawn into the food. This ‘recommendation’ needs to be a requirement. The perfect example to make this a ‘requirement’ is the massive recall of Peanut Corporation of America. This very large recall resulted in hundreds of illnesses and deaths – and was due to a hole in the roof. Contaminated water dripping onto the product. By only ‘recommending’ that no contaminant be allowed to drip or drain or be drawn into the food, FDA is enabling another massive recall to happen.
23. Proposed “507.14 (b)” references “recommendations” for pet food/animal food manufacturing personnel to be properly trained in proper food handling. Again, this “recommendation” should be a requirement. Proper training of employees is a must. As well, it is suggested that FDA establish a type of ‘hot line’ for employees to safely report (to authorities) any company mishandling of foods or ingredients that could cause a risk to pets or consumers. This ‘hot line’ should be required to be posted in all pet food/pet treat manufacturing facilities. Similar to a Crime Stoppers program.
FDA asks for comment in reference to proposed 507.14(b) – if proposed recommendations for personnel education should become a requirement. The answer is obvious. A hazard analysis and risk prevention program and a CGMP program can only be effective if personnel – all personnel – are properly trained to implement and uphold the programs. Untrained or improperly trained personnel makes for a weak link in the chain all pets and pet food consumers depend on.
All personnel should receive training upon hiring and at the same intervals that the company will be required to update their hazard analysis and risk prevention programs. Records should be required to establish that personnel has received this training.
24. “Proposed 507.36(e)” does not address ‘silent recalls’ – manufacturers pulling products from store shelves without consumer notification. These types of ‘recalls’ should be address and the requirement added to notify the consumer in a timely manner.
25. “Proposed 507.45(a)(1)(i)” does not address seasonal issues with manufacturing that could effect safely measures during production; excessive heat, cold, or moisture. It is suggested that monitoring be done throughout the year to take into consideration how extreme weather could effect manufacturing and the final product.
26. Under “Proposed 507.50—Requirements Applicable to a Qualified Individual”, FDA states “FDA will be working with an animal food alliance to develop a standardized curriculum for any final rule establishing requirements for hazard analysis and risk-based preventive controls.” It is a conflict of interest for FDA to work solely with a “animal food alliance” to develop requirements. If FDA feels the need to consult with outside parties to determine requirements, a broad group of experienced parties should be consulted including ‘animal food alliance’ groups, hazard analysis and risk-based preventive control experts, and health officials (veterinarians).
27. Under “K. Request for Comment on Additional Preventive Controls” it is agreed that preventive controls and verification measures discussed in this section should be part of a modern and safe animal food safety system. Many pet food consumers believe they are long overdue. FDA discusses the challenge of these controls due to “the diversity among animal food products” and “the wide variety of manufacturing and processing methods” involved in animal food. However a walk through any grocery, one will realize the human food manufacturing industry has similar diversity and similar variety of manufacturing. Listing challenges of product diversity and variety of manufacturing as a means to provide flexibility in animal food preventive controls should be no different than with human food.
28. “Under Environmental Monitoring”, pet foods – handled by millions of consumers each day – should be monitored with the most frequency. However Salmonella should not be the only environmental hazard monitored. Numerous other environmental hazards exist and should be given equal time when monitoring (example mycotoxins).
29. Under “Supplier Approval and Verification Program” the 2007 pet food recall proves to be the perfect example why verification of ingredient suppliers needs to be established and records maintained. Supplier approval and verification is of the utmost importance in preventing an food adverse event outbreak, plus could be the only means (proper record keeping of the supply chain) to promptly respond to a contamination of one ingredient used in numerous products.
Ingredient suppliers should be registered with FDA and should be held to these proposed provisions. Those that are not in compliance should not be approved (or in business). There should be no exemptions to compliance to food safety laws. It is certain that some suppliers are likely to be associated with more risk (due to their product), however all should be held accountable to uphold the same safety procedures.
Of significant concern is Chinese foreign suppliers. In the last seven years many thousand pets have died due to tainted/poisoned products imported from China. History has shown that FDA has held US companies to a different standard than Chinese companies (Example jerky treat inspection in China versus FDA inspection of Kasel jerky treat manufacturing in the US). It is important that US and foreign suppliers be held to the same regulations.
30. FDA asks for input regarding how a facility should review complaints and asks if complaint monitoring be required. A proper complaint monitoring system should be mandatory with pet food/animal food manufacturers. Further, as mentioned previously, it is vital that practicing veterinarians and pet food retail outlets become involved in the pet food complaint monitoring system to be established.
Veterinarians and pet food retail outlets should be provided with 1) documentation to provide to consumers on how to report a suspect food related animal illness, instructions to hold the food and even the animals body in cases of death; 2) a means to report the incident directly to authorities (either state or federal – brief information listing symptoms, product, and contact information); and 3) FDA should provide on-going education (similar to Centers for Disease Control) to veterinarians in how to diagnose a food related illness. A full spectrum of complaint monitoring and participation in filing complaints is key to preventing illnesses and deaths.
31. Under “Proposed Subpart F—Requirements Applying to Records That Must Be Established and Maintained”, FDA asks for records to be maintained for two years. It is suggested that records be kept in correlation to the shelf life of the product manufactured, plus six months.
32. Under “XV Legal Authority”, the FDA (again) is choosing selective enforcement of Section 402 of the FD&C Act. FDA admits within the proposed regulations “Section 402 of the FD&C Act applies to all animal food”, however continues in other parts of the proposed revisions to selectively choose only portions of Section 402. All parts of Section 402 should be applicable – as the legal definition of food requires – to animal foods and should be considered when establishing CGMPs.
33. Consumers should be provided access to all inspection reports of pet food manufacturing, warehousing, and ingredient suppliers. These report should be posted publicly on the FDA website and/or the State Department of Agriculture (if the state is who performed inspection) website. The pet food/animal food consumer deserves the opportunity to make informed, educated purchases for their pet and disclosure of manufacturing conditions should be known.
34. The proposed revisions did not address the disclosure of ingredient additives – introduced by the ingredient supplier – that are not required to be listed on a pet food label. Example being ethoxyquin added to fish meal ingredients. Consumers want to know what ‘additives’ are included in their pet food purchases; these additives should be a requirement in the ingredient panel.
35. The proposed revisions did not address the lack of regulatory established maximums for protein, fat, and many vitamins and minerals in pet foods. Without legal limits for various pet food nutrients, the proposed hazard analysis and preventative controls will have holes in regulations that could effect animal health.
36. And lastly, consumers deserve an assurance from the FDA the future of these proposed regulations will be upheld. There is a concern that more FDA Compliance Policies will be initiated after the proposed regulations are made into law – enabling manufacturers, ingredient suppliers, and warehousing facilities ‘opportunities’ to avoid the law. Existing FDA Compliance Policies that allow pet food loopholes to avoid federal law should be removed and none provided to replace them. The law is the law and we ask FDA to enforce it as it is written.
There ya have it. My notes on these proposed regulations. I won’t be posting my own comments on the FDA website just yet – I’m consulting with a few others that know more than me about actual manufacturing processes. But I will soon. Also, our consumer group – Association for Truth in Pet Food – will be posting a collective comment from myself, Mollie Morrissette and our members (so members…send me your thoughts). But please, please, please – take a few moments and post your comments on the Regulations.gov website. We have more than 100 days to comment. Quote or cite the proposed regulation you agree or disagree with, then provide them with your input. Make it as short or lengthy as you choose and feel free to add personal stories (such as your pet’s illness or death) as to why you feel so strongly.
These regulatory authorities need to hear from thousands of consumers. They need to hear our side. This is our chance. Please ask every pet food consumer you know to post comments as well. It could make a huge difference.
Wishing you and your pet(s) the best,
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