Beyond Cosmetics Testing: Other Animal Research Issues to be Concerned About
1. NEAVS
New England Anti-Vivisection Society
“Wait, remind me again who Kesha is?*”
*Or, other animal research issues to be
concerned about beyond cosmetics and
product testing
5. II. Overarching Threats: Government
Mandates and Funding
At a time when...
• Public opinion about animal research
indicates 44-50% of U.S. adults oppose the use
of animals in research. (Gallup) (Funk and Rainie, 2015)
• Between 50-89% of all preclinical research findings can not be reproduced.
(Freedman, Cockburn, and Simcoe, 2015)
• 95% failure rate of new drugs is largely a result of an approval process that
relies on animal experiments
• Yet, the government funds about 2/3 of all animal testing in the U.S at a cost
of $20bn
8. Points of contention with the FASEB et al. report
Reduction of burdensome bureaucracy is fine, but this cannot come at the
expense of animal welfare, lack of transparency, or weakened oversight.
• Moving to the lowest common denominator for species covered
• Moving from bi-annual to annual IACUC inspection
• Removing the requirement for annual USDA inspection
• Limiting IACUC oversight for “low risk, noninvasive, or minimally
invasive” research
• Limiting reporting to include only incidents that jeopardize the health
or wellbeing of animals
9. Open Comment Period
• Comments must be submitted
online by June 12th, 2018 by going
here
10. Transparency Issues
• APHIS redacting basic information,
including name of permitted
facilities and animal inventories
• FACT Act – Mandates reporting on
number of animals and types of
tests in tox research
11. IV. Our Strategies for Change
• Exposing abuse
• Changing policy
• Promoting human-relevant models
12. IV. Potential for a big win?
• At a minimum, I think we could all agree between 50-89% of tests—
those that are not replicable—should end. These tests are wasteful, cruel,
and serve no benefit to anyone other than the researchers earning salary
for their work and their affiliated institutions drawing overhead.
• This result might save over 50 million animals a year, worldwide.
First, I want to thank Ingrid and the AUWCL SALDF group for hosting this meeting, to everyone for attending, and to the ICVAAM representatives in the room who are making tremendous strides in replacing animal testing with non-animal methods.
The New England Anti Vivisection Society (I’m going to refer to us as NEAVS from here on out), as you can all tell from our name, exists to move society as quickly as possible toward ending the use of animals in research.
As you can see from this image from NEAVS’ first ever newsletter, published in 1915 for distribution to our membership, that NEAVS “opposes the contention of vivisectors, ‘implied or expressed,’… that it is no one’s business what happens to an animal, so long as the individual who is handling it can plead that to increase science is his aim.”
100-500k animals are used for cosmetics and personal care products annually, worldwide. This is a small portion of the more than 100 million animals used across research purposes.
Ensuring that animals aren’t used for cosmetics testing is important. We should all support the Humane Cosmetics Act and shop cruelty free by using the CCIC “Leaping Bunny” program, but it is also true that there is very little animal testing in the United States for cosmetics. This is true internationally as well, except for companies that are looking to sell their products in China where testing in government-run labs is still a requirement.
We understand that there’s tremendous regulatory burden associated with regulatory compliance.
Unfortunately, we are very concerned that the report’s recommendations put far too much focus on recommendations reducing administration at the expense of animal welfare.
Here are some of our key areas of concern:
The conclusion of the FASEB report highlights that, quote, providing exceptional welfare is paramount when conducting animal research, and regulatory requirements are vital to ensuring that research is executed safely, ethically, and humanely. End quote.
The push to amend regulations, policies, and even legislation as recommended in this report takes that commitment to welfare and oversight far too lightly. If relevant agencies and legislators decide to move on some of these recommendations, it’s likely that they will see strong and unified opposition from the animal protection community and the hundreds of millions of supporters across the United States we represent.
In February 2017, USDA’s AHPIS electronic reading room went dark.
In August 2017, the USDA announced that, with one exception, it had finished its
review of the information it used to affirmatively post on its website, and had made final
decisions about what materials it would continue to post in its Electronic Reading Room. The
one exception was the animal inventories that accompany USDA inspection reports. As to those
records, the agency informed the public that it “intend[ed] to make this information available in
the future.” https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/sa_awa/awa‐
inspection‐and‐annual‐reports.
50. The USDA has redacted from the records it used to routinely post in its Electronic
Reading Room information that would allow the public to identify by name, address, or license
number of the majority of regulated entities. Prior to February 3, 2017, such information had
previously not been redacted by the agency in its Electronic Reading Room.
51. The agency asserts that this same information that the agency had already publicly
disclosed is now exempt from disclosure “to protect privacy interests.”
52. The USDA has not re-posted the animal inventories that are part of each
inspection report, and it is now withholding from the public animal inventories that it had
previously posted in its Electronic Reading Room prior to February 3, 2017.
53. Although the USDA has reposted all previously posted research facility annual
reports for fiscal years 1999 through 2015, with respect to those annual reports, the USDA has
not disclosed all of the “Column E explanations”—i.e. information required from regulated
facilities explaining why they have not complied with minimum animal welfare standards and/or
Case 1:18-cv-00887 Document 1 Filed 04/16/18 Page 18 of 29
19
why certain animals used in procedures involving pain and distress were not provided
medication or other treatments to minimize their suffering—or the explanations for exceptions to
compliance with the standards and regulations, see 9 C.F.R. § 2.36(b)(3), (7). Likewise, although
the USDA has posted research facility annual reports for fiscal years 2016 and 2017, most—if
not all—of these reports have been posted without the requisite explanation pages.
54. APHIS is also continuing to withhold from the public all of the enforcement
records that it previously routinely disclosed to the public in its Electronic Reading Room,
including official warning letters; voluntary settlement agreements between APHIS and
regulated entities; and administrative complaints initiating formal administrative proceedings
before the USDA’s OALJ.
55. Many of the enforcement records that the USDA has failed to re-post were
already previously publicly available in the USDA’s Electronic Reading Room.
56. On January 18, 2018, Judge Cooper of this Court issued a memorandum opinion
dismissing Plaintiffs’ earlier case on the ground that, because the USDA had made final
decisions about what it would be re-posting in its Electronic Reading Room, Plaintiffs’ request
for declaratory and injunctive relief with respect to their claim that such information must be
affirmatively disclosed had become moot. However, with respect to such information, Judge
Cooper specifically noted that Plaintiffs “may raise challenges to the redactions that now
accompany these records.” Slip Op. at 7, n.3.
57. As to two categories of information that the agency had not reposted—i.e., certain
enforcement records and the animal inventories that accompany all USDA inspection reports—
Judge Cooper held that Plaintiffs had not adequately alleged that such records are subject to
Case 1:18-cv-00887 Document 1 Filed 04/16/18 Page 19 of 29
20
FOIA’ s affirmative disclosure requirement. Hence, as to those records, he dismissed Plaintiffs’
claims without prejudice. Id. at 12.
NOTE:
In August, the USDA unveiled a new limited database to search for inspection reports and research facility annual reports. However, the documents posted have significant information redacted, including the name of some of the permitted facilities, and does not provide previously included information such as animal inventories. To date, the USDA also continues to withhold important enforcement action records such as administrative complaints and official warning letters. – ALDF http://aldf.org/press-room/press-releases/animal-legal-defense-fund-appeals-dismissal-lawsuit-usda-blackout-animal-welfare-records/
In February 2017, USDA’s AHPIS electronic reading room went dark.
In August 2017, the USDA announced that, with one exception, it had finished its
review of the information it used to affirmatively post on its website, and had made final
decisions about what materials it would continue to post in its Electronic Reading Room. The
one exception was the animal inventories that accompany USDA inspection reports. As to those
records, the agency informed the public that it “intend[ed] to make this information available in
the future.” https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/sa_awa/awa‐
inspection‐and‐annual‐reports.
50. The USDA has redacted from the records it used to routinely post in its Electronic
Reading Room information that would allow the public to identify by name, address, or license
number of the majority of regulated entities. Prior to February 3, 2017, such information had
previously not been redacted by the agency in its Electronic Reading Room.
51. The agency asserts that this same information that the agency had already publicly
disclosed is now exempt from disclosure “to protect privacy interests.”
52. The USDA has not re-posted the animal inventories that are part of each
inspection report, and it is now withholding from the public animal inventories that it had
previously posted in its Electronic Reading Room prior to February 3, 2017.
53. Although the USDA has reposted all previously posted research facility annual
reports for fiscal years 1999 through 2015, with respect to those annual reports, the USDA has
not disclosed all of the “Column E explanations”—i.e. information required from regulated
facilities explaining why they have not complied with minimum animal welfare standards and/or
Case 1:18-cv-00887 Document 1 Filed 04/16/18 Page 18 of 29
19
why certain animals used in procedures involving pain and distress were not provided
medication or other treatments to minimize their suffering—or the explanations for exceptions to
compliance with the standards and regulations, see 9 C.F.R. § 2.36(b)(3), (7). Likewise, although
the USDA has posted research facility annual reports for fiscal years 2016 and 2017, most—if
not all—of these reports have been posted without the requisite explanation pages.
54. APHIS is also continuing to withhold from the public all of the enforcement
records that it previously routinely disclosed to the public in its Electronic Reading Room,
including official warning letters; voluntary settlement agreements between APHIS and
regulated entities; and administrative complaints initiating formal administrative proceedings
before the USDA’s OALJ.
55. Many of the enforcement records that the USDA has failed to re-post were
already previously publicly available in the USDA’s Electronic Reading Room.
56. On January 18, 2018, Judge Cooper of this Court issued a memorandum opinion
dismissing Plaintiffs’ earlier case on the ground that, because the USDA had made final
decisions about what it would be re-posting in its Electronic Reading Room, Plaintiffs’ request
for declaratory and injunctive relief with respect to their claim that such information must be
affirmatively disclosed had become moot. However, with respect to such information, Judge
Cooper specifically noted that Plaintiffs “may raise challenges to the redactions that now
accompany these records.” Slip Op. at 7, n.3.
57. As to two categories of information that the agency had not reposted—i.e., certain
enforcement records and the animal inventories that accompany all USDA inspection reports—
Judge Cooper held that Plaintiffs had not adequately alleged that such records are subject to
Case 1:18-cv-00887 Document 1 Filed 04/16/18 Page 19 of 29
20
FOIA’ s affirmative disclosure requirement. Hence, as to those records, he dismissed Plaintiffs’
claims without prejudice. Id. at 12.
NOTE:
In August, the USDA unveiled a new limited database to search for inspection reports and research facility annual reports. However, the documents posted have significant information redacted, including the name of some of the permitted facilities, and does not provide previously included information such as animal inventories. To date, the USDA also continues to withhold important enforcement action records such as administrative complaints and official warning letters. – ALDF http://aldf.org/press-room/press-releases/animal-legal-defense-fund-appeals-dismissal-lawsuit-usda-blackout-animal-welfare-records/
How?
Agency memoranda a la Chimpanzees requiring systematic review?
Legislation?
In the meantime, you can shop cruelty free using the Leaping Bunny program, support the Humane Cosmetics Act, make comments opposing deregulation that risks animal welfare, thank the EPA and ICCVAM for their leadership, support some of the state bills focusing on