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AWA Compliance: Understanding the Basic Framework

Animal Law

The Animal Welfare Act (AWA)1 is the 50-year-old federal law that provides the standards for the humane care and treatment of certain species of animals, primarily mammals, in specific settings. This article provides an overview of the AWA and its two main enforcement mechanisms: inspections and investigations.2 When the AWA is considered along with the Excellence Beyond Compliance (EBC)3 model of animal care that encourages a proactive approach to enhancing animal welfare beyond minimum compliance standards, those entrusted with the care of animals have clear guidance continuously improving their efforts on behalf of animals under the AWA.

A Brief Overview of the AWA Structure
The AWA provides “minimum requirements”4 for the humane handling, care, treatment, and transportation of regulated animal species involved in certain activities, including public exhibition at licensed entities, such as zoological organizations, research labs, and those who breed and sell animals. The AWA does not cover farm animals used in agricultural production, nor does it cover rats, mice, and birds bred for research, and those species constitute the greatest numbers of animals in research facilities.5 The AWA is implemented, administered, and enforced by the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) Animal Care program. APHIS’s policy is to promote “continuous compliance” with the AWA through use of unannounced inspections, ongoing education of regulated entities, and, as needed, enforcement actions.

The AWA regulations include requirements relating to licensing, inspections, and recordkeeping. In addition to these administrative requirements, the regulations also include substantive provisions setting forth generally applicable standards for veterinary care and animal handling, and specific standards for each of several classes of covered species, including dogs and cats, guinea pigs and hamsters, rabbits, nonhuman primates, marine mammals, and other warmblooded animals (including many zoo animals). Within each category of species and the overall catchall (other warmblooded animals), the regulations refer to indoor and outdoor facilities, space, feeding, sanitation, staffing, transport, and a few species-specific elements (e.g., “environmental enhancement to promote psychological wellbeing” of nonhuman primates).6

The substantive requirements include a mix of engineering and performance-basedstandards. Engineering standards quantify or specify a requirement — for example, the dimensional measurements for an enclosure — and typically are expressed as “minimum” standards due to their specificity. The performance-based standards — for example, an animal must be handled safely so as to avoid a certain condition — allow for some discretion in interpretation because these are outcome-oriented requirements. Because the broader performance-based standards permit creativity and flexibility, they foster animal welfare-enhancing innovation. The APHIS Animal Care program uses two primary tools for ensuring AWA compliance: inspections, which are conducted by an animal care inspector or veterinary medical officer (inspector), and investigations that are generally conducted with or by APHIS Investigative and Enforcement Services (IES).

Inspections
Inspections of covered entities are conducted periodically and may be unannounced. After an inspector completes an inspection, any noncompliance and associated corrected dates are recorded in an inspection report presented to the regulated entity. Following a “clean” inspection, APHIS issues a report stating: “No noncompliant items identified during this inspection.”7 Regulated entities achieve “continuous compliance” by earning multiple, consecutive, fully compliant inspection reports.

Inspection Report Appeals
If an inspection report yields less than a fully compliant determination, and differences exist as to its contents, a regulated entity may decide to appeal. The inspection report appeal allows for review and reexamination of inspection reports or selected items and for resolution of other issues, e.g., interpretation of regulations. The appeal begins with discussing the inspection report with the inspector; then, if necessary, regulated entity officials consult agency guidelines on timely submission of an appeal to the APHIS regional office.8 It is advisable to immediately contact the regional office to inform them of an interest in appealing and to learn about any updates to the process for the appeal, detailed in the Animal Welfare Inspection Guide (2016) and in recent agency guidance.9 Timing at this stage is critical because once the appeal window has closed, the inspection report becomes a part of the regulated entity’s permanent record.

Inspection Appeal Tips
Act Fast — Inspection report appeals must be filed within 21 days of the facility receiving the final inspection report. Also, because there is a 21-day delay before inspection reports are posted online, a timely appeal should be accompanied by a request that the inspection report not be posted pending the appeal. This is consistent with current agency policy and practice and can be helpful, for example, by allowing a well-intentioned organization to improve itself during the appeals process before the final report is posted. The appeals process is discussed below, and filing requirements are detailed more fully in agency guidance.10

Stay Constructive During the Appeal — While it may be desirable to “prevail” on appeal, the process as viewed through the EBC model is most effective when approached collaboratively, allowing the regulated entity and APHIS to develop enhanced understanding of the AWA and related animal-welfare implications, which then leads to more effective inspections and compliance efforts in the future. In other words, an appeal can and should be used to build better working relationships in addition to clarifying and resolving any disputed items.

Make the Appeal Credible and Substantial — A respectfully submitted appeal (or discussions on the topic) should be focused, credible, and include all relevant expertise, documentation, professional, and scientific literature, agency regulatory history, and other guidance. An appeal may also include, when appropriate, acknowledgment of where the entity could have done a better job in explaining a situation or providing all relevant documentation during the recent inspection process.

Potential Bases for Appeal — An inspection report appeal can seek review of whether a noncompliant item was actually compliant, whether it was a direct or repeat noncompliance, and whether it was corrected at the time of inspection. It can also question or seek to clarify or revise the wording of the inspection report, the proposed correction dates, and whether a noncompliant item was cited under the proper regulatory provision. All of these elements must be examined carefully as they have different consequences for the entity, as well as for animals, and the report will become a permanent part of the entity’s compliance history.11

Outside Consultation or Review — This can prove invaluable during the appeals process. The support of a relevant population management and conservation group (Taxon Advisory Group), other experts, and experienced counsel providing independent review and examination may prompt new and different perspectives essential to furthering awareness of and commitment to animal welfare, as well as providing information that is useful on appeal.

Inspection Report Appeals and the Freedom of Information Act12 — In 2012, APHIS’s Animal Care program changed its policy and practice with respect to inspection reports, inspection report appeals, and FOIA. While inspection reports under appeal are still withheld from disclosure online, hard copies are available pursuant to an FOIA request. In the event an inspection report under appeal is disclosed pursuant to an FOIA request, be prepared to use the following agency statements and, if necessary, request confirmation of these agency positions from the appropriate regional office to make clear that the subject inspection report is nonfinal. “An inspection report may be amended to correct an error or in response to an appeal submitted by a USDA licensee/registrant….Once amended, the original, unmodified report is no longer valid, and the revised report becomes the final determination of compliance by APHIS.”13

Investigations and Enforcement
APHIS’s Animal Care program works with APHIS Investigative and Enforcement Services (IES) and the U.S. Department of Agriculture Office of General Counsel (OGC) as necessary to enforce the AWA. In cases of serious and/or repeated noncompliance, Animal Care refers a case to IES for investigation and resolution.14 Even respected regulated entities may find themselves in the enforcement process as a result of an unfortunate high-profile incident or tragedy, an inspection report or reports with serious noncompliant items, evidence of a pattern of noncompliance with the AWA, or a complaint.15 An entity that knows or has reason to believe it is the subject of an investigation must make constructive use of the situation while properly protecting itself from liability.

Investigation Tips
Seeking Counsel — Regulated entities dealing with serious incidents and potential or actual investigations should immediately seek counsel. This counsel can come from knowledgeable accrediting and other professional associations in which the entity participates, and should also include legal and public relations counsel to make certain that while being proactive and pursuing the truth, the entity’s legal rights and reputational interests are protected. In addition to appropriate expertise, counsel should always demonstrate sensitivity to the animal-related considerations inherent in the alleged noncompliance.

Preparedness for an Investigation — Ill prepared entities compound any underlying problems, leave themselves unprotected, and may appear to fail to appropriately demonstrate concern for animals, staff, and the public. Well-prepared entities seek to develop an understanding of all the facts so as to assess what, if anything, went wrong, why, and how it should be addressed. To the best of their ability, well prepared entities under the EBC model accept accountability as appropriate and immediately work to resolve challenges. Simply put, they are willing to do more to make things better instead of waiting for agency action, though such organizations are mindful of agency processes and its implications, and adjust their approach as needed.

Understand the Investigative/Enforcement Process — Understanding how the agency, especially IES, handles the investigation and enforcement process is essential. The APHIS IES website and related publications provide detailed explanations.16 In summary, when APHIS personnel discover a potential violation of APHIS regulations, they may request a formal investigation by IES that is fact finding in nature, and which culminates in the Report of Investigation (ROI), which summarizes the investigative findings. Once the ROI and evidence is sent to IES’s enforcement staff for review, a specialist reviews and analyzes the information to determine if the purported violation is substantiated by the evidence provided. If the evidence shows a violation occurred, the enforcement staff determines whether an enforcement action is appropriate. What enforcement action is taken, if any, depends on the seriousness of the issue and the number of alleged violations, among other things.

Before carrying out any enforcement action under the AWA, IES consults with the referring program, i.e., APHIS’s Animal Care program. Enforcement actions may include an official warning, which then closes the investigative file as to that violation; a voluntary settlement agreement; a referral to the OGC for administrative action; or, in cases involving the most serious violations, a referral to the U.S. Department of Justice for civil or criminal enforcement actions. The rules of practice17 applicable to proceedings pending before the Secretary of Agriculture govern all proceedings filed by OGC.18

“High-Priority” Designation Cases — APHIS Animal Care, in conjunction with IES, may give certain cases a high-priority designation, which means that they will be expedited through the investigative and enforcement process and the entity must plan accordingly. The agency uses the high-priority designation based on the following criteria: severity of animal suffering (death or severe injury); past compliance history of facility; potential public or animal safety or health concerns; abusive or potentially violent nature of licensee or registrant; type of facility and species of animal involved; and severity of the issue resulting in extensive public interest.19

• Potential Ground Rules for Dealing with Investigations — Regulated entities dealing with serious incidents and potential or actual investigations should, in consultation with counsel, establish reasonable ground rules for dealing with any such investigations. For example, while the organization’s leadership and staff are required to cooperate with the agency (even while exercising the right to counsel), staff availability should be managed without compromising staff responsibilities to fulfill essential animal welfare functions. If counsel is unable to attend interviews, a management-level staff person should be allowed to sit in on all interviews with counsel available via telephone if needed, and any draft sworn statements prepared by the agency after staff interviews should be reviewed by counsel prior to signature by staff. Finally, copies of all documentary or other evidence and records taken by the investigator should be identified and marked for ease of internal review and preservation.

Upon the Conclusion of an Investigation — Once IES has finished its investigation and consulted with Animal Care, a case is usually either closed or a proposed settlement or complaint is issued. There is no formal mechanism for requiring that a regulated entity be informed that a case has been closed, but inquiries can and should be made to ascertain whether a matter is closed or pending, and to otherwise remain updated on the status of a case and to ensure compliance and/or appropriate follow-up action is completed.

Settlement Considerations
In appropriate instances, IES may offer pre-litigation settlement agreements to alleged violators or may refer a violation directly to OGC for administrative action, without first offering a settlement agreement. Settlement agreements may include a monetary penalty or other sanction and generally are more favorable to the alleged violator than what APHIS would seek through administrative, civil, or criminal enforcement. IES determines monetary penalties using guidelines that APHIS developed based on penalty provisions in the various laws that APHIS administers. Settlement agreements also advise the alleged violator that he or she has an opportunity for a hearing, and that he or she may waive the hearing by accepting the settlement agreement and paying the penalty, or accepting the terms of settlement, within a specified time. If the alleged violator accepts the settlement agreement, IES closes its investigative file; if the settlement is rejected, IES refers the violation to OGC for administrative action, generally seeking a larger penalty or more serious sanction.

Practitioners should be aware of the implications of settlement. Settlement by stipulation (prior to a hearing) or consent decree (after a hearing, as discussed below) can be an effective step in moving forward, and a reasonable settlement can conserve resources. Appropriate settlement can also preclude adverse adjudication or findings on the merits (perhaps establishing culpability), preserve reputational integrity (if approached constructively and proactively), and serve to establish a fresh starting point for AWA compliance (and avoid an admission of noncompliance). Note, however, that in this author’s view, settlement is merely a starting point for regulated entities committed to the EBC model. Settlements of alleged noncompliance or alleged or apparent violations should be and often are accompanied by additional constructive and proactive measures. Regulated entities are encouraged as part of any settlement to consider and implement all reasonable measures to prevent reoccurrence of any alleged noncompliant items as well as to implement additional measures to enhance animal welfare (even some not necessarily related to the alleged noncompliant items); for example, an animal welfare enhancement plan or another improvement plan developed in consultation with the agency. In addition, to the extent possible, invite agency review or inspection to validate and verify the entity’s implementation of reported improvements — this effort puts the entity in a much better position by the time a settlement is finalized and made public and also makes the settlement agreement a springboard for constructive action to enhance animal welfare, thereby accomplishing an important goal of the EBC model.

Defending the Prosecution of Alleged Noncompliant Items
As noted above, a regulated entity may choose to reject a pre-litigation offer of settlement from the agency and instead invoke its right to a hearing, or if IES declined to offer a pre-litigation settlement and instead referred the matter to OGC, the entity may be served with a formal complaint. In such cases, although settlement by consent decree may still be a possibility in the future, the following should be taken into account in deciding to litigate.

First, if an organization has not yet been served a formal complaint and has a choice as to whether to reject a pre-litigation settlement, it should think carefully about invoking the right to a hearing and have a firm understanding as to the merits of any defense. In some cases, a vigorous defense may be necessary and likely to succeed. In many cases, whatever the outcome, the cost in financial terms (i.e., counsel fees and staff time) and reputational damage from the publicity attendant upon adversarial proceedings is often greater than the benefits of proceeding even if the entity ultimately prevails. Of course, the terms of any potential resolution or settlement must also be weighed in the decision-making process regarding invoking the right to a hearing. Next, if the entity decides to proceed to a hearing, the use of a credible and outstanding expert witness can make a significant difference.20 Involving an expert witness may provide the additional benefit of helpful insight into existing conditions that can then be used to better inform enhancements in animal welfare.

Whatever the outcome of a hearing — even if the entity prevails, and especially if it does not — it is in the best interests of the entity and the animals in its care to further strengthen its focus on efforts to foster AWA compliance and enhance animal welfare, consistent with the principles of the EBC model. In sum, the best protection for a regulated entity and the animals they exist to serve is to comply with the AWA at a minimum, and also strive to achieve excellence in animal welfare for the benefit of the animals entrusted to their care.

Conclusion
The EBC model encourages entities subject to the AWA to meet and exceed the federal law, thereby actively promoting a continuous cycle of improvement that is in the best interest of the animals at the heart of this federal regulatory system.

1 7 U.S.C. §2131, et seq. For an interesting chronology of the history of AWA amendments, see USDA, Animal Welfare Information Center, Legislative History of the Animal Welfare Act: Table of Contents, http://awic.nal.usda.gov/legislative-history-animal-welfare-act-table-contents; USDA APHIS, The Animal Welfare Act: A Legislative and Regulatory History, available at https://www.aphis.usda.gov/animal_welfare/downloads/awa_leg_history.pdf.

2 9 C.F.R. §1.1, et seq.

3 For a more detailed explanation of the EBC, see James F. Gesualdi, Excellence Beyond Compliance: Enhancing Animal Welfare Through the Constructive Use of the Animal Welfare Act, available at http://excellencebeyondcompliance.com/.

4 7 U.S.C. §2143(a)(2)(1).

5 As is apparent, the AWA is limited in scope. For additional insight, see 9 C.F.R. §1.1, et seq.

6 9 C.F.R. §3.81.

7 See Gesualdi, Excellence Beyond Compliance, Appendix B: Inspection Report Notice, available at http://www.aphis.usda.gov/animal_welfare/downloads/IR_Explanation.pdf (for a concise explanation of inspection reports).

8 See Gesualdi, Excellence Beyond Compliance, Appendix C: Inspection Report Appeals: Animal Welfare Inspection Guide, General Inspection Procedures, available at https://www.aphis.usda.gov/animal_welfare/downloads/Animal%20Care%20Inspection%20Guide.pdf; APHIS, Animal Care, Factsheet (July 2014), available at https://www.aphis.usda.gov/publications/animal_welfare/2014/appeals_process.pdf.

9 See Gesualdi, Excellence Beyond Compliance, Appendix C: Inspection Report Appeals.

10 See id.

11 See also Gesualdi, Excellence Beyond Compliance, Ch. V: The Inspection Exit Briefing, Item6 (relevance of specific wording in inspection reports).

12 U.S. Department of Justice, The Freedom of Information Act, 5 U.S.C. §552, available at http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm.

13 Animal Care Letter to Stakeholders, Update from Chester Gipson, Animal Care Deputy Administrator Regarding the Posting of Amended Versus Original Inspection Reports on APHIS’ Website (2012). See Gesualdi, Excellence Beyond Compliance, Appendix C: Inspection Report Appeals.

14 See Gesualdi, Excellence Beyond Compliance, Ch. VII: Investigations and Enforcement and Appendix F: Enforcement Information. Note that noncompliance can be resolved with no further action, letter of warning, proposed stipulation of settlement, formal prosecution, consent decree, or full administrative adjudication culminating in sanctions, including fines, license suspension, or revocation.

15 Animal Care created both online and hard-copy complaint forms for the public to submit concerns about animals covered under the AWA. For the hard copy form, see USDA, APHIS, Animal Care, Animal Welfare Inspection Guide at A-27 (2016), available at https://www.aphis.usda.gov/animal_welfare/downloads/Animal%20Care%20Inspection%20Guide.pdf. For the online form, see USDA, APHIS, Animal Care Animal Welfare Complaint, available at https://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare/complaint-form.

16 See Gesualdi, Excellence Beyond Compliance, Appendix F; U.S. Dept. of Agriculture, IES Frequently Asked Questions, https://www.aphis.usda.gov/aphis/ourfocus/business-services/ies/ies_faq; Open Letter to Stakeholders on Investigation and Enforcement Process Streamlining (Jan. 2012), available at http://www.aphis.usda.gov/ies/pdf/ies_stakeholders_letter.pdf; APHIS, Investigative and Enforcement Services, Factsheet, Questions and Answers: APHIS Enforcement Process Streamlining (Jan. 2012), available at http://www.aphis.usda.gov/publications/aphis_general/2012/IES_process.pdf.

17 See USDA Rules of Practice Governing Formal Adjudicatory Proceedings Instituted by the Secretary and Supplemental Rule of Practice and Procedure (Apr. 20, 2005), available at http://www.oaljdecisions.dm.usda.gov/rules-practice-and-procedure.

18 See APHIS, Animal Welfare Act Enforcement, https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/sa_awa/ct_awa_enforcements (defining and providing links for types of enforcement actions); U.S. Dept. of Agriculture, Investigative and Enforcement Services (detailing investigative process and enforcement process, and providing additional information), https://www.aphis.usda.gov/aphis/ourfocus/business-services/ies.

19 See Animal Welfare Act Enforcement, https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/sa_awa/ct_awa_enforcements (the high-priority designation).

20 See, e.g., Hodgins v. U.S. Department of Agriculture, 2000 WL 1785733 (6th Cir. Nov. 29, 2000), aff’d, 33 F. Appx. 784, 2002 WL 649102 (6th Cir. Apr. 17, 2002). See also In Re Michael A. Huchital, Ph.D., 58 Agric. Dec. 763, 788 (Nov. 4, 1999) (testimony of expert with substantial animal handling experience accorded greater weight than experienced veterinarians not necessarily familiar with species or handling technique at issue).

James F. Gesualdi is an attorney in Islip, New York, and author of Excellence Beyond Compliance: Enhancing Animal Welfare Through the Constructive Use of the Animal Welfare Act. He is a special professor of law at Hofstra University School of Law where he teaches animal law. He earned his B.A. from St. Lawrence University, magna cum laude; M.A. in political science from the State University of New York at Stony Brook; and J.D. with distinction from the Hofstra University School of Law. He also served as a notes and comments editor for the Hofstra Law Review.

This column is submitted on behalf of the Animal Law Section, a new section of The Florida Bar as of July 1, Ralph DeMeo, chair, and Gregg Morton and Ralph DeMeo, editors.

Animal Law