Congressional Briefing Says Animal Testing Should be Replaced with Alternative Methods

Yesterday there was a briefing held on Capitol Hill to update lawmakers on the status of non-animal test methods for assessing the toxicity of chemicals.  Led by Dr. Paul Locke of the Johns Hopkins Center for Alternatives to Animal Testing (CAAT), the briefing discussed the "3Rs" in US chemical law and policy.  Speaking at the briefing was Representative James Moran, who is ranking member of the House Appropriation Committee's subcommittee on Interior, Environment and Related Agencies.

Moran is also co-chair of the Congressional Animal Protection Caucus (CAPC), a group staffed by both parties that seeks to raise awareness of animal welfare issues in Congress.  CAPC replaced the "Friends of Animals Caucus" that had existed in previous Congresses.  The briefing was in conjunction with CAPC.

Dr. Locke outlined the 3Rs, i.e., finding alternative testing methods that refine existing tests by minimizing animal distress, reduce animal usage, or replace whole animal tests.  Ultimately, CAAT and other organizations would like to see a shift to all non-animal testing such as those being developed as part of Tox21, the testing program that came out of the National Academy of Sciences report "Toxicity Testing for the 21st Century: A Vision and a Strategy."

Representative Moran concurred.  During the meeting he said that "virtually all animal tests are outdated in terms of efficiency and effectiveness."  He strongly suggested that the robotic tests being advanced by Tox21 could help rapidly screen the thousands of existing chemicals that so far have received no technical review, and do so more effectively than the standard animal tests.

More information on CAAT and the briefing can be found here.

Agencies Propose Using Fewer Animals to Identify Eye Hazards from Chemical Exposure

Two interagency projects have combined to propose a new alternative testing method that will reduce the number of animals used to determine if chemical exposures will lead to eye hazards.  The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), have issued a Federal Register notice requesting public comments on the proposal.

The Federal Register notice can be downloaded here.

Specifically, the interagency groups evaluated the classification criteria using results from testing only 3 animals instead of the usual 6 to 18 animals.  They determined that "using a classification criterion of at least 1 positive animal in a 3-animal test to determine eye hazards will provide the same or greater level of eye hazard classification as current FHSA requirements, while using 50% to 83% fewer animals."

Based on their analysis, ICCVAM has developed draft recommendations "to use this classification criterion for ocular safety testing procedures that use only a maximum of 3 animals per test substance."  The goal is to limit the use of animals in testing for the safety of chemicals.  Non-animal test methods are also being developed, and these reduced-animal tests are one step towards eliminating animal testing whenever possible. 

With the Federal Register notice these groups are requesting public comments.  Comments are due by September 26, 2011 and can be done online at the NICEATM-ICCVAM web site here.

ECHA Reports that REACH and CLP Chemical Regulations are "Working Well"

The European Chemicals Agency (ECHA) recently published two reports, both required by law, in which they conclude that despite many industry misgivings prior to enactment, the REACH and CLP regulations are "working well and that the various actors responsible for the work are responding as required." REACH is the chemical control law in Europe and the CLP is the Classification, Labeling and Packaging Regulation.  ECHA attributes the success largely to "the commitment and collaborative work between industry, stakeholders, the Member States, the European Comission and ECHA."

According to their press release, ECHA offers "three key lessons" from the experience:

•    The uncertainty over the number of registrations for the first deadline was a challenge to manage and more accurate estimates would be helpful in future.
•   Close working relationships with industry and stakeholders are vital to ensure success and the Agency can help by providing stable tools and guidance.
•    The interrelationship between the various elements of the two regulations is important and has become increasingly apparent.  For example, ambiguities in substance identification can lead to problems in forming Substance Information Exchange Fora (SIEF), evaluation and risk management activities. 

The report, which can be downloaded here as a PDF, offered recommendations for improving implementation of the laws in the future.

A second report on the implementation of efforts to reduce unnecessary animal testing can also be downloaded as a PDF here.

UK Intends to Stop Animal Testing on Household Products - Animal Rights Groups Rejoice

Recently the UK government signaled that it would end animal testing for household products.  And at least one animal welfare group has expressed its pleasure.  The British Union for the Abolition of Vivisection, more popularly known as BUAV, said that they welcomed "a statement made by Home Office Minister, Lynne Featherstone that the Government intends to ban the animal testing of both finished household products and their ingredients." 

BUAV notes that the "statement comes in response to a Parliamentary Question tabled by Adrian Sanders MP on March 28th 2011" and that the ban will include “all products that are primarily intended for use in the home, including detergents and other laundry products, household cleaners, air-fresheners, toilet blocks, polishes, paper products such as infant nappies [i.e., diapers], paints, glues (and removers), other furnishing and DIY products and household pesticides.”

Governments and animal welfare groups around the globe are working on ways to reduce or eliminate animal testing of chemicals.  I have discussed before how organizations are working to develop alternative testing methods.   Current protocols for testing chemicals and products involve doing in vivo, that is, in life, tests using various animals - mostly mice, rats and rabbits - as surrogates to assess toxicity.  So while some NGOs argue that more testing is necessary to characterize the hazards of chemicals, animal welfare groups argue that such animal testing is both cruel and unnecessary.

For more about BUAV you can check out their web sites: BUAV and Go Cruelty Free.

Korea Joins Effort to Reduce Animal Testing of Chemicals - Find Alternative Methods

Europe has one (ECVAM), the United States has one (ICCVAM), and now Korea has one (KoCVAM).  Last week the Republic of Korea (i.e., South Korea)'s Center for the Validation of Alternative Methods (KoCVAM) officially joined a collaborative effort to find alternative chemical test methods.  The international agreement, the International Cooperation on Alternative Test Methods (ICATM), "was officially created in April 2009, when an agreement was signed between validation bodies from Europe, USA, Canada and Japan." 

The goal of collaboration is to develop and validate chemical testing methods that reduce, or preferably eliminate, the need for live animals (i.e., in vivo methods).  The non-animal methods (in vitro) can include any number of tests ranging from excised tissues, artificially grown tissues or cells, and genetic methods, as well as computer generated structure activity relationship (SAR) modeling.  The formal addition of KoCVAM to the agreement, it's fifth member, occurred during the 50th annual meeting of the Society of Toxicology in Washington DC.

With REACH entering its next stage, which includes review of proposed testing plans from the first registration deadline, and new chemical control efforts in Korea, Turkey, Switzerland and (maybe) the United States, a great deal of effort is being made to find alternatives to traditional animal testing.  REACH specifically encourages the use of non-animal methods such as QSARs, in vitro, ex vivo, and read-across from data available for related chemicals. 

For more information.

New Safe Chemicals Act Mandates Reduced Animal Testing

The new Safe Chemicals Act of 2010 (SCA), introduced recently by Senator Frank Lautenberg with a companion bill in the House, includes several concepts that are not currently part of the Toxic Substances Chemical Act (TSCA) that it seeks to reform. One of those differences is the inclusion of a mandate to reduce animal testing.

Section 31 of the SCA states that EPA "shall take action to minimize the use of animals in testing of chemical substances and mixtures." This includes:

1) Encouraging and facilitating a) use of existing data of sufficient scientific quality, b) use of test methods that eliminate or reduce the use of animals but provide data of high scientific quality, c) grouping of two or more chemicals into scientifically appropriate categories where data on one substance will provide reliable and useful data on others, d) formation of industry consortia to jointly conduct testing to avoid unnecessary duplication, and e) parallel submission of testing from animal based studies and from emerging methods and models.

Those familiar with REACH might recognize a similar approach. The idea is to provide scientifically defensible data in the most efficient manner, so that modeling, read-across, alternative testing, and other methods can be used to meet the data requirements. The bottom line means less animal testing. The consortium idea also comes from the HPV Challenge days.

In addition, the section also authorizes:

2) the funding of research and validation of studies to reduce, refine, and replace (i.e., the "3 Rs") the use of animal tests.

The section also goes into some detail about an "Interagency Science Advisory Board on Alternative Testing Methods" that EPA shall establish within 90 days after enactment. The Board would consist of representatives from several key programs such as the NIEHS, CDC, NTP, NCI, NTSC and others. [Sorry for the acronyms, but I can define them if anyone doesn't already know what they mean.] The EPA, with input from the Board, would have one year to publish a list of testing methods that reduce the use of animals in testing. EPA and the Board would also promote the development of new testing methods that are not animal based. Finally, the section gives EPA some flexibility to waive testing requirements if there is sufficient weight-of-evidence from other sources.

So all in all there is an effort to reduce animal testing. That said, it is highly likely that animal testing will remain a key tool in the evaluation of hazard and risk. At least until sufficient non-animal methods have been developed and validated, a process that will likely take a long, long time.

UK Promotes Ways to Minimize Animal Testing Under REACH

The UK's Health and Safety Executive (HSE) has released guidance in the form of a leaflet to help REACH registrants minimize the use of animal testing as they prepare their final documents for submission this fall. Between 5,000 and 10,000 registrations expected by the November 30th, 2010 deadline. Each of those, without any attempt to minimize the number of animal tests, could require over 5000 animals according to HSE. The animal rights group, British Union of Anti-Vivisectionists (BUAV) predicts even more animals will be used, all told they say that over 75,000 chemicals may need new testing, which could mean 16-54 million animals over the next ten years. I think this number is highly unlikely, but nevertheless there will be significant animal testing proposed under REACH.

The guide recommends that wherever possible registrants should employ the basic principles of the "3Rs," that is, reduction, refinement and replacement, in order to reduce the number of animals used.

Besides some specific suggestions for particular endpoints, the guidance strongly suggests that registrants use the techniques listed in Annex XI of the REACH regulation, including:

- Use of all existing data: Search for previous studies done on the chemical

- Weight of evidence: Use information from multiple sources to avoid having to do new tests

- QSARs: Use computer modeling wherever validated and supportable for a particular chemical

- Grouping and Read Across: Maximize the value of data for similar chemicals that can be used to estimate the values for your chemical

- In Vitro: Use in vitro methods rather than methods that require animals; also use new Ex Vivo methods

- Waive Data Requirements if Not Technically Possible to Test: Some endpoints cannot be measured or are not appropriate to measure for certain substances

- Exposure-Based Waiving: Don't do animal testing in cases where there will be no exposure to humans or the environment

More specifics can be found in the UK guidance.

These considerations and the strong actions of the animal welfare organizations will most certainly need to be part of the "new TSCA" that is expected to be introduced shortly in the United States.