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Use of FOIA by animal rights activists.

institutions. Animal rights organizations most frequently requested information related to specific grant applications and often included requests for summary statements, progress reports and correspondence pertaining to grants. Requests for all correspondence between specific research institutions and the Office of Laboratory Animal Welfare (OLAW) increased during 2014 as well. OLAW received a total of 27 requests for information on 217 institutions compared to 12 requests involving 28 institutions in 2013. FOIA was originally enacted to ensure government accountability and transparency, but it can also be abused by organizations and individuals and add significant costs to the biomedical research process. Animal rights organizations continue to use FOIA to obtain information from APHIS and the NIH about research institutions, adding to the cost of more than

Updates on the legal front.

5 million in taxpayer money in fiscal year 2014 that is needed to respond to FOIA requests. Because of the broad nature of the requests from animal rights activists, it is likely that these requests cost agencies more than average FOIA requests. Based on an early analysis of fiscal year 2015 data, activists continue to exploit FOIA by submitting broad requests for large amounts of data about research facilities. Research facilities should carefully review any information submitted to a federal agency to ensure that it accurately reflects the institution’s animal care and use program and does not contain proprietary or personal information. Institutions should always be cognizant that information submitted to the federal government can be released at any time.

Understanding USDA's enforcement process.

within the statute.” The National Association for Biomedical Research, joined by eleven other organizations, filed an amicus brief in the original suit. Individual researchers who had been targeted by animal rights extremists also filed an amicus brief. The amicus brief supported the government’s motion to dismiss the case and urged the court to find the AETA constitutional. In February 2014, a three-judge panel consisting of Chief Judge Sandra L. Lynch, Judge O. Rogeriee Thompson and Judge William J. Kayatta Jr. conducted a 30minute hearing on the appeal. Given their early and continued questioning, the judges clearly had read and considered the written arguments made by both sides. Chief Judge Lynch’s questions primarily focused on the activists’ standing to challenge the AETA after the recent Supreme Court decision in Clapper v. Amnesty, which ruled that a plaintiff must show certainly impending harm in order to have standing4. Attorneys for the activists focused on the merits of the law in their arguments. The judges did not indicate when a final decision would be reached.

A review of USDA enforcement actions in 2014.

Office of General Counsel. A Complaint from this Office gives notice to a facility of a formal allegation of possible violations of the AWA. The Complaint does not mean that the facility is guilty of these violations but serves as a notice that the facility must respond and either agree to the allegations in the Complaint or seek a hearing date before a USDA administrative law judge. The judge issues a Decision and Order, which is based on the evidence presented by APHIS and the facility. The facility has the right to appeal this decision. A copy of the final Decision and Order is posted on the USDA website. This process is initiated after an IES investigation in response to a serious NCI, a Repeat Direct NCI or multiple Direct NCIs, with no progress toward compliance, where animal health and welfare have been compromised, and when the facility typically has had previous enforcement actions. Research facilities should have in place a proactive, progressive animal care and use program and remain in compliance with the AWA regulations and standards. If issues do arise, responsible individuals must ensure that they have a working knowledge of the inspection process and an understanding of the enforcement process.

Rulemaking by petition

a result of actions taken by an administrative law judge, an agency judicial officer or a federal court. Since NABR has been monitoring the enforcement process, no research facilities have been subject to paying civil penalties, and those research facilities that were subject to enforcement have settled at the level of stipulations or consent decrees. Our following review, which concerns the results of the enforcement process, uses data from the monthly enforcement reports, which has been consolidated into a spreadsheet format. For those actions that affected research facilities, the pertinent documents have been reviewed and an analysis of each was prepared. Our spreadsheets for 2014 describe 175 letters of warning issued to organizations covered by the AWA. Of those, 21 were issued to registered research facilities. There were 11 complaints filed, two of which involved research facilities, and one of those was settled with a consent decision and order that resulted in a stipulated penalty of

FOIA in your state.

127,100. The complaint document requires the recipient to file an answer in accordance with the AWA Rules of Practice5. If the recipient does not admit to the allegations in their answer or does not file an answer, the process then moves ahead to an oral hearing stage. Under the category of ‘Decisions and Orders’ there were 14 cases, of which one was listed as a default decision and order because the recipient of the complaint did not respond. An administrative law judge issued an order which included both a monetary and non-monetary judgement. There were seven pre-settlement agreements and none involved research facilities. There were 54 stipulations of which only seven involved research facilities. These seven stipulation agreements included a total of 36 items of noncompliance, which were not evenly distributed across institutions. One institution had almost half of the non-compliance items included in their enforcement records, one of which provides monthly updated information on enforcement actions for the Horse Protection Act and the AWA for each fiscal year going back to May 2010. This same link appears on the website of the USDA Animal Care program, and the National Association for Biomedical Research (NABR) has been monitoring this summary since May 2010 as it includes actions taken against research facilities. The data posted by the IES for the 2014 fiscal year includes a summary of all enforcement actions that details the initiation of 2,743 new cases. Of those cases, 252 involved potential violations of the AWA. The summary data for cases that involved the AWA include 170 warnings and 64 settlement agreements reached. These agreements frequently involve monetary penalties which totaled

Revisions to the animal welfare inspection guide.

300,938. They also reported 9 non-monetary stipulations, which appear to take place when a dealer voluntarily relinquishes its license as part of either a stipulation agreement or a consent decision and order, following the filing of a complaint by the Office of General Council. The complaints are filed after the IES refers a case and its supporting evidence to the Office of General Council. These terms, titles and processes can be confusing and disorienting for unfamiliar readers, but the APHIS Overall Summary4 links specific terms to a page titled ‘Enforcement Glossary’ that helps to explain these terms. NABR monitors monthly postings on the IES website, which reports enforcement actions in five categories: letters of warning, complaints, decisions and orders, presettlement agreements, and stipulations. In addition to information on cases that have been initiated, the summary data that appears on the IES website also includes warnings, settlement agreements, stipulated penalties assessed, non-monetary stipulations, referrals to Office of General Council, administrative complaints, administrative decisions, and civil penalties In a previous Policy Watch column entitled “Understanding USDA’s enforcement process”1, we reviewed the four possible enforcement options that were described in the United States Department of Agriculture (USDA) Inspection Requirements Handbook, and we encouraged facilities to have in place proactive, progressive animal care and use programs to help assure compliance with the regulations and standards of the Animal Welfare Act (AWA) in an effort to avoid experiencing any of the four options. Since that column was published, revisions have been made to the Animal Welfare Inspection Guide2, including an introduction written about the teachable moment that takes place during the inspection process. Additionally, the Freedom of Information Act has been increasingly used to call for more enforcement of the regulations and standards of the AWA. All of these recent changes can potentially affect the process of USDA enforcement. In this column we review the outcomes of the enforcement process for research facilities, using information that has been posted on the website of the Animal and Plant Health Inspection Service (APHIS). On May 14, 2015, an announcement from APHIS to its stakeholders entitled “Availability of Agency Investigative and Enforcement Data” announced the publication of frequently requested information on the website of the Investigative and Enforcement Services (IES)3. Initially, summaries and data outlining enforcement actions were posted for the 2014 fiscal year, with a commitment to update the information at the end of the 2015 fiscal year and biannually thereafter. The announcement contains a link to the IES website, which itself includes links to the laws that APHIS enforces, as well as links to bulleted descriptions of the investigative and enforcement processes. There are also links to various summaries of A review of USDA enforcement actions in 2014

USDA Animal Welfare Inspection Guide

of proposed rulemaking be published in the Federal Register (§553(b)) and states that we shall be given “...an opportunity to participate in the rule making through submission of written data, views, or arguments...” (§553(c)). In addition, Title 7, Subtitle A, Part 1, Subpart B of the Code of Federal Regulations2 requires the Secretary of Agriculture to give prompt consideration to the petitions and to notify the petitioner of the disposition of their petitions (§1.28). The original petitions and public comments on these petitions can be viewed at the US government’s website for information on the development of federal regulations (http://www.regulations.gov) by entering the docket number in the search box and then opening the docket folder. As an example, the petition from the Physicians Committee for Responsible Medicine (APHIS-2014-0050) received 250 comments (many of which were submitted by the laboratory animal science community), with most of them opposing the petition. Once the comments are received, staff within the Collaboratory unit of the newly aligned United States Department of Agriculture Animal Care program will review them and determine whether APHIS will issue a proposed rule. If APHIS decides to issue the proposed rule, it would then be published in the Federal Register and be open for comments as described above. APHIS then analyzes the comments and any other information received to determine whether or not to issue a final rule. The right to file a petition is guaranteed in the Constitution and is codified in the Administrative Procedure Act. Filing a petition is the first step in the process of amending a current regulation, but whether or not a petition ultimately results in amended regulations depends upon the comments received regarding the issues raised in the petition and whether the agency determines that those comments warrant moving forward with a proposed rule. bad actors and by alleging that nonhuman primates at research facilities are routinely and callously neglected. The petition also relies heavily on outdated, inaccurate and incomplete data to reach its conclusion that the current regulations require changes. The third petition, entitled “To amend regulations on reporting requirements from USDA licensees regarding animals used for research, breeding and exhibition and to improve the accuracy and ease of obtaining more informative data by the public” (docket no. APHIS-2015-0033), was submitted on December 15, 2014 by the National Anti-Vivisection Society. As with the other two petitions, this one also has serious issues. The petition specifically requests rulemaking that is beyond the statutory authority of the United States Department of Agriculture under the Animal Welfare Act. It requests that APHIS collect additional information that is not necessary for the agency to fulfill its mission and could facilitate increased targeting of research by animal rights organizations. Additionally, obtaining the requested information would require both a costly investment in the recently updated animal care information system database and ongoing costs to both APHIS and the research community, with little to no benefit to either the agency or the public. The basis of the petition process can be traced back to the United States Constitution. The First Amendment of the Constitution prohibits Congress from making laws that prohibit the citizenry from petitioning the government for a redress of grievances. So the right to petition, like the right to free speech, is granted to every person. To implement this requirement, Part I, Chapter 5, Subchapter II of the Administrative Procedure Act1 states that “[e]ach agency shall give an interested person the right to petition for the issuance, amendment, or repeal of a rule” (§553(e)). It also ensures that we can participate in the Between March 30th and May 22nd, the Animal and Plant Health Inspection Service (APHIS) posted a Notice of Petition for three different petitions submitted by animal rights groups requesting amendments to several Animal Welfare Act regulations. The issuance of Federal Register notices for three petitions in just over a two-month period has raised many questions in the research community about how the petition process works. In each of the three petitions described below, APHIS is requesting comments on any issues raised by the petitions as well as responses to specific questions posed by the agency. In this article we will provide a brief analysis of the petitions and an explanation of the petition process. The first of those petitions, entitled “Petition to define alternatives to procedures that may cause pain or distress and to establish standards regarding consideration of these alternatives” (docket no. APHIS-2014-0050), was submitted on October 30, 2013 by the Physicians Committee for Responsible Medicine. This petition relies on false premises to reach its conclusion that regulatory changes are needed, and the proposed changes are well beyond the scope of any potential concerns raised in the petition. The second petition, entitled “To establish criteria to promote the psychological well-being of primates as required by the Animal Welfare Act (7 U.S.C. § 2143(a) (2)(B)), including adopting the ‘ethologically appropriate environments’ accepted by the National Institutes of Health with respect to all primates used in research” (docket no. APHIS-2014-0098), was submitted on May 7, 2014 by the New England Anti-Vivisection Society and three other organizations. This petition misrepresents reality by arguing that research facilities are Rulemaking by petition?

Current regulations and requirements for managing an animal care and use program.

meaning they are factual, are devoid of extraneous information and accurately reflect an institution’s animal care and use program. In addition to ensuring that institutional documents are FOIA-ready, a public university should have in place a records retention policy that meets the requirements of the state’s open records law while ensuring that documents are not retained longer than required or necessary. T h e N a t i o n a l A s s o c i a t i o n f o r Biomedical Research has completed an analysis of state open records laws for its members, which summarizes and analyzes the open records laws of every state and the District of Columbia as they relate to biomedical research records3. The analysis addressed three criteria: (i) whether the statute exempts research data itself; (ii) whether the statute protects personal information, such as a researcher’s name, home address and telephone number; and (iii) whether the law permits a research institution to recover the costs associated with providing the information. On the basis of that analysis, suggestions for improving the open records laws of each state as they relate to biomedical research records were developed. Managers of animal care and use programs at research inst itut ions may wish to use these suggestions to seek revisions to the open records law in their states.

The top USDA citations of 2012.

contains a Notice with a definition of “A quorum”, which has been revised to accurately reflect the definition in the AWA. Page 11 contains a statement emphasizing the fact that the AWA does not authorize the IACUC to dictate to researchers how to conduct their research. Following a list of IACUC functions on page 17 is a new Notice, which reads, “There is no requirement for every SOP to be reviewed every six months. The IACUC may determine a reasonable schedule for review of SOPs.” On page 20, six bulleted items have been included as examples of the type of rationale the USDA is looking for in the protocol section on determining the number of animals to be used. On page 24, there is expanded guidance under the subsection on ‘Major Operative Procedures’, and on page 25, there is a new Notice on laparoscopic surgery. On page 41, the subsection on ‘Continuing Review’ has been expanded to include more definitive information on the timing of the review, how the review should be conducted and what should be considered in the review. There is a new section on ‘Contracted Research or Projects that Involve Multiple Registrants’ on page 43, which describes the requirements for assigning responsibilities for such arrangements. The revisions to Chapter 7 of the AWIG have also addressed some of the inconsistencies in the previous version, which should make it more user-friendly for those responsible for managing the inspection process.