A Survey of Regulatory Practices Regarding Non-Amendable Species: Slaughter, Processing and Sale for Human Consumption

Mr. Erik Bungo

Food Safety Field Supervisor

Virginia Department of Agriculture & Consumer Services (VDACS)

International Food Protection Training Institute (IFPTI)

2012 Fellow in Applied Science, Law, and Policy: Fellowship in Food Protection

Abstract

This study explores protocols that state government agencies with animal health jurisdiction in the United States are implementing in response to the growth of the game animal industry and the slaughter and processing of non-amenable species of animals (Klein, 2004).  The Federal Meat Inspection Act (FMIA) defines the species of animals that must be slaughtered and processed under United States Department of Agriculture Food Safety and Inspection Service (USDA/FSIS) oversight.  Animals mentioned under the FMIA are amenable; animals not mentioned are non-amenable (not covered) under the FMIA and these animals are exempt from USDA/FSIS requirements.  Non-amenable species may be a vector for agents of public health concern because deficient slaughter and preparation could cause human disease.  Demand for food products from non-amenable species has increased pressure on policymakers and regulators to evaluate a range of regulatory options that may not be uniform or that may not effectively address public health concerns.  Online survey results suggest that demand for non-amenable species products is a growing concern and more uniform regulatory action is needed to protect public health.  A review of literature and analysis of current government policies indicate that inadequate regulatory oversight may be provided for these products intended for human consumption due to inconsistent application of varying regulations amongst the states.  Recommendations based on current best practices are presented to provide insight to policymakers in other states.

Background

The United States Department of Agriculture Food Safety and Inspection Service (USDA/FSIS) regulates meat and poultry products in interstate commerce and foreign export under the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA).  The United States Food and Drug Administration (FDA) regulates food in interstate commerce and has agreements with the states for regulation of food in intrastate commerce.  Interstate movement of state-inspected or voluntary FSIS-inspected non-amenable species and products is dictated by FDA and state laws and regulations.  The FMIA permits the states to enter into cooperative agreements with the USDA/FSIS, whereby states may impose and enforce mandatory inspection programs equal to that of federal standards; this arrangement limits state-inspected amenable species to intrastate commerce only.  There are currently 27 states with State-Federal FMIA cooperative agreements according to the FSIS (Figure 1).

In Virginia, the Office of Meat and Poultry Services (OMPS) within the Virginia Department of Agriculture & Consumer Services (VDACS) ensures the production of safe, wholesome, and truthfully-labeled meat and poultry products as well as the humane treatment of livestock.  OMPS also provides inspection services to individuals and companies that slaughter and/or process meat and poultry products.  The USDA/FSIS and OMPS both exempt non-amenable species from the inspection process and offer voluntary inspection for farm-raised game animals.  The Agricultural Marketing Act (AMA) of 1946 allows FSIS to inspect non-amenable species under a voluntary inspection program that does not require Hazard Analysis & Critical Control Points (HACCP) or Standard Sanitary Operating Procedures (SSOPs).

The producer must pay for the voluntary inspection, which includes an hourly fee and travel cost associated with this service.  Mandatory inspection, however, is funded by tax dollars.  When a processor does not produce meat products under FSIS/OMPS voluntary inspection, the processor is subject to FDA inspection under the Food, Drug & Cosmetic Act (FD&C Act). General sanitation inspections of the facilities utilizing 21 CFR 110 (Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food) and the FD&C Act could unintentionally allow an unsafe food product to enter into commerce since animal health considerations are not prescribed in these rules to the extent they are in the FMIA.

The primary concern regarding game animals according to Annex 3 of the FDA Food Code relates to animals not commercially raised but obtained in the wild.  Specifically, wild game animals may be available as a source of food only if a regulatory inspection program is in place to ensure that these animal products are safe for human consumption.  This inspection is important because wild animals may be carriers of organisms or parasites that cause human illness.  Non-amenable species appear to present health risks similar to those associated with poultry and meat products already subject to mandatory inspection (NACMPI, 1999).  In addition to the risk posed to consumers, there is a risk to the people who harvest, process and prepare wild game.  Wild game species that can be legally hunted under Federal or State regulatory authority can be harvested for personal consumption; however, they cannot be sold for food in Virginia according to the Virginia Department of Game and Inland Fisheries (VDGIF) even though there is an exception in the VA Retail Food Establishment Regulations administered by VDACS.

Farm-raised game animals must be cleared through VDGIF and if approved, the producer must obtain a permit.  However, the species that are farm-raised cannot be native to Virginia.  A game animal may not be received for sale or service if the species is listed in 50 CFR Part 17, Endangered and Threatened Wildlife.  The PPIA was expanded in 2001 to include rhea, ostrich, and emu because the USDA determined that the food safety hazards are essentially the same as those posed by species already included within the Act.

The 2010 Retail Food Establishment Regulations for the Enforcement of the Virginia Food Laws state that game animals received for sale or service at a retail establishment must either be inspected by VDACS OMPS under their voluntary inspection program or inspected by the Food Safety and Security Program utilizing OMPS laws and/or regulations.  Although Food Safety Specialists (FSS) in VDACS have expertise in a wide variety of food processing operations, they do not have expertise in the slaughter of animals. 

Addressing the slaughter of animals requires specialized knowledge including the ability to identify zoonotic diseases and concerns relative to both ante-and post-mortem examinations.  FSIS regulations require ante-mortem and post-mortem inspections of each animal and daily inspection of the processing facility.  FSIS/OMPS inspectors examine each animal before and after slaughter for visible defects that can affect the safety and quality of meat and poultry products.  This examination is not the case with FDA regulations, as only the source and sanitary process, not the ante-and post-mortem inspection of the animal itself, must be evaluated.   

Anecdotally, there is increasing inquiry in Virginia about the slaughter and processing of non-amenable species of animals for sale to the public.  The growing demand for non-amenable species food products has created some concern within VDACS as there are significant issues in providing sufficient regulatory oversight.  Exploring how other regulatory agencies throughout the United States regulate non-amenable species processors could provide policymakers in Virginia and in other states with additional options in regards to modifying regulatory oversight of these types of businesses.

Problem Statement

VDACS is unaware of how other states regulate the slaughter and processing of non-amenable species.  This information could be useful to VDACS and other states to help make good regulatory policy decisions about how to ensure public health.

Research Question

How are state programs ensuring food safety and public health with regard to food products derived from non-amenable species?

Methodology

This study examined how state agencies with animal health jurisdiction and routine inspection programs are enforcing section 3-201.17 of the FDA Food Code related to the processing and sale of wild game animals and non-amenable species at the retail level and what challenges they are encountering.  Program Managers and Directors from regulatory agencies with animal health jurisdiction in all 50 states were identified utilizing the AFDO Directory of State and Local Officials.  One key individual from each state, identified as the person most responsible for regulations governing non-amenable species, was contacted via email and invited to participate in an online survey developed through SurveyMonkey®.  The 14-question multiple-choice survey was written to identify procedures and strategies used by other states to help determine the best course of action for VDACS.  The email briefly explained the IFPTI Fellowship Program, the research project and included a link to the online survey.  The survey was administered with response anonymity and the states could not be identified by the submissions.  Data from the survey was exported from SurveyMonkey® and entered into an Excel spreadsheet.  A tabulation of survey results and trends was used to capture the comparative overall application of federal/state oversight relative to the slaughter and processing of non-amenable species.  An analysis comparing differences in regulatory approaches was conducted to determine several recommendations.   

Results

This analysis is based on 17 responses from 50 state programs surveyed for a 34% response rate.  Thirty-three percent (33%) of respondents indicated inspection of non-amenable species processors was accomplished using USDA/FSIS voluntary inspection and 9% indicated voluntary inspection was performed by the state agency with animal health jurisdiction.  Fifty-three percent (53%) of respondents indicated that only routine, sanitary inspection by the state agency with/without animal health jurisdiction is conducted and the remaining 5% indicated this was not applicable to their state program (Figure 2). 

However, 29% of respondents indicated that they attempt to arrange for voluntary inspection of prospective processors through their state’s respective meat inspection program while 53% do not.  Eighteen percent (18%) indicated that voluntary inspection does not apply to their state program.  Another 41% indicated that the state food safety program is attempting to arrange for inspection of these prospective processors.  Fifty-three percent (53%) of respondents indicated that state inspectors do not perform ante-and post-mortem examinations of the animals and only 6% indicated that a trained veterinarian is present with the inspector during the inspection.  Twenty-nine percent (29%) of respondents indicated that a guidance document for the inspector/processor has been developed by the state program with regulatory authority while 53% indicated that a guidance document does not exist.  Seventy-one percent (71%) of respondents indicated that there are currently 25 or fewer establishments processing non-amenable species on file in their jurisdiction.  Deer, rabbit, elk, bison, buffalo, pheasant and quail were reported as the most commonly slaughtered and processed non-amenable species and some comments from the survey indicated minor interest in processing other types of animals. 

Conclusions

The processing and sale of non-amenable species may present unique challenges to state regulatory agencies as survey results indicated varying approaches used by the states represented by the respondents.

The high number of states that rely only on sanitary inspection as their regulatory policy, in addition to the low number of respondents indicating use of veterinarians on inspections, calls for further study of the reasons as to why the USDA/FSIS approach (voluntary inspection) is not used consistently.  The low number of estimated establishments processing non-amenable species (<25 in 71% of responses) could indicate a low potential for exposure for the general U.S. population.  However, there is elevated food safety risk for consumers of non-amenable species food products due to the inconsistency of approaches to regulatory oversight.  A uniform approach is needed and agencies must collaborate and communicate to ensure public health. 

Results indicated that cost has been prohibitive for start-up processors.  Construction of new facilities must meet certain minimum requirements and hourly voluntary inspection fees range from $29 for state inspection to $60 for USDA/FSIS inspection.  Limited government resources within state programs place the burden on the processor to come under voluntary USDA/FSIS inspection as state regulatory options may not be available.

Recommendations

State agencies need more guidance and studies should be done to determine the most cost-effective approach to this emerging issue of regulatory oversight of non-amenable species.  Several recommendations based on the study data are outlined below:

·       A risk assessment should be conducted on the consumption of commercially processed non-amenable species.

·       Further study should be conducted to identify uniform regulatory approaches and associated costs.

·       State agencies should collaborate in a more comprehensive survey of nationwide practices, findings and approaches.

·       Processors should be encouraged to participate in a voluntary state inspection program through incentives such as certification and consideration as an approved source that can sell anywhere intrastate (farmer’s markets, retailers, restaurants).

·       Firms not under voluntary inspection by FSIS or a State-Federal cooperative program should be required to meet more stringent requirements such as keeping written, up-to-date Good Manufacturing Practices (GMPs), SSOPs, and HACCP plans including hazard analyses.

·       To aid in outbreak investigations, non-amenable species slaughter logs detailing dates and numbers should be required.  Processors should also provide, and keep a copy of, an invoice that includes the business name, address, date, identity and quantity of product sold to every customer.

·       Processors not under voluntary inspection by OMPS should label their products with a statement indicating that slaughter and processing took place without the benefit of state/federal ante-and post-mortem inspection. 

·       FSS in VDACS could inspect slaughtering operations using OMPS laws and regulations.  This concept could be applied to other states where one state agency is either trained in another agency’s expertise or is given shared regulatory authority between agencies.

·       FSS in VDACS could be allowed to inspect the post-slaughter portion of non-amenable species processing under current food safety laws and regulations where OMPS provides inspectional assistance relative to the slaughter portion of the operation.

·       As an alternative, FSS in VDACS could inspect slaughter and processing operations under current food safety laws and regulations utilizing a comprehensive guidance document developed by OMPS.

·       The Association of Food and Drug Officials (AFDO) could assist in promoting guidance for State agencies.

·       The guidance document titled “Guidelines for Exempt Slaughter and Processing Operations” developed by AFDO is available for reference to help meet the regulatory needs of various states.  These guidelines are intended to provide a national standard for the regulation of slaughter and processing operations not subject to mandatory inspection under federal laws (AFDO, 2011).

Other considerations may include establishing priorities with respect to levels of coverage to determine the most effective use of resources when there are already additional food safety responsibilities that demand attention.  Other states are currently considering options similar to those suggested based on public health rationale and relative food safety risks presented by different animal foods.

Acknowledgments

I would like to thank the International Food Protection Training Institute (IFPTI) for giving me the opportunity to participate in Cohort 3 of the Fellowship in Food Protection Program.  I would like to thank Mrs. Pamela Miles, Program Supervisor, and Mr. Ryan Davis, Program Manager, for supporting my participation in the IFPTI Fellowship.  I would like to thank my mentor, Dr. Joanne Brown, for continually providing me with help and guidance throughout the year.  I would like to thank Mr. Heath Gerber, Regional Manager, for providing me related subject matter information and background data on this topic.  Special thanks to Mr. Rick Barham and Mrs. Courtney Mickiewicz, Regional Managers, for providing feedback and reviewing my project throughout the process.  Finally, I would like to thank my wife Kathryn for supporting me with this project and the Fellowship program travel requirements.

References

2 VAC5 Chapter 585. (2010). Retail Food Establishment Regulations for the Enforcement of the Virginia Food Laws. Retrieved from: http://www.vdacs.virginia.gov/fdsafety/pdf/retailfoodregs.pdf

9 CFR Part 301. (1970, October 3).  Subchapter A – Mandatory Meat Inspection.  Part 301 Definitions.  Retrieved from: http://www.gpo.gov/fdsys/pkg/CFR-1998-title9-vol2/pdf/CFR-1998-title9-vol2-part301.pdf

9 CFR Part 321. (1970, October 3).  Part 321 Cooperation with States and Territories.  Retrieved from: http://www.gpo.gov/fdsys/pkg/CFR-2006-title9-vol2/pdf/CFR-2006-title9-vol2-part321.pdf

9 CFR Part 352.  (1985, October 16). Part 352 Exotic Animals and Horses; Voluntary Inspection.  Retrieved from: http://www.gpo.gov/fdsys/pkg/CFR-2011-title9-vol2/pdf/CFR-2011-title9-vol2-part352.pdf

Association of Food and Drug Officials.  (2011, June).  Guidelines for Exempt Slaughter and Processing Operations.  Retrieved from: http://www.afdo.org/Default.aspx?pageId=1279485

Federal Meat Inspection Act.  (2011, April 28).  Retrieved from: http://www.fsis.usda.gov/regulations/federal_meat_inspection_act/index.asp

FIGURE 1: States with USDA/FSIS Cooperative Programs. (2012). Retrieved from:

http://alpacameatcouncil.com/resources/

FSIS Directive 5720.2 Revision 3.  (2004, November 16).  Retrieved from: http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/5720-2Rev3.pdf

Klein, Patrice N. (2004, December). Game Meat: A Complex Food Safety and Animal Health Issue.  Food Safety Magazine. Retrieved from: http://www.foodsafetymagazine.com/magazine-archive1/december-2004january-2005/game-meat-a-complex-food-safety-and-animal-health-issue/

National Advisory Committee on Meat and Poultry Inspection (NACMPI).  (2000, May). Mandatory Inspection of Non-Amenable (Exotic) Species.  Retrieved from: http://www.fsis.usda.gov/OPPDE/NACMPI/May2000/Amenability.html

National Advisory Committee on Meat and Poultry Inspection (NACMPI).  (1999, October). Concept Paper on Extending USDA’s Inspection Program to Additional Species.  Retrieved from: http://www.fsis.usda.gov/OPPDE/NACMPI/May2000/Concept_Paper_Attch1.html

Poultry Products Inspection Act (PPIA).  (2011, May 2).  Retrieved from: http://www.fsis.usda.gov/regulations/Poultry_Products_Inspection_Act/index.asp

U.S. Public Health Service.  (2009) FDA Food Code 2009: Annex 3, Pages 377, 378.  Retrieved from: http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodCode/FoodCode2009/ucm189211.htm