Research involving animals at Procter & Gamble

Background
Over recent decades, there has been growing interest and questions concerning the use of animals for scientific purposes. Some animal protection organisations have called for the elimination of such uses or substantial changes in animal welfare practices. Their central argument is that the use of animals in scientific research is morally wrong and that there are readily available alternatives.

In the absence of proven alternatives methods, companies such as P&G have historically used animals to demonstrate safety and efficacy in: (i) pharmaceutical research, (ii) pet nutrition studies and (iii) for consumer products. These activities have attracted attention from stakeholders - especially animal protection organisations and concerned consumers. We are consequently often asked for information on our policy concerning research involving animals, and whether our products or their constituent ingredients have been tested using animals.
Our Policy
P&G will only conduct research involving animals in the development and evaluation of our products as a last resort, when all reasonable alternatives have been exhausted. In those situations where such research is necessary (e.g., when required by law), we will ensure the humane treatment of all animals and will meet or exceed all legal requirements regarding animal welfare. The following sections describe how this policy is put into practice across our businesses.
Healthcare
Research involving animal use has led to considerable progress in understanding human and animal diseases and the ability to cure them. The products of such research include numerous lifesaving vaccines, surgical procedures and pharmaceuticals. The collective benefits for human and animal health are clear. Some interest groups however, now question whether medical research using animals should continue. They question the ability of scientists to relate animal models to human health, and suggest that they have been superseded by breakthroughs in areas such as genetics and in vitro cell culture methods. They contend that animal testing has outlived its usefulness and argue that it is morally wrong for it to continue. Some even argue that animal research diverts money and scientific knowledge away from direct work on the human patients who need it most.

It is indeed true that science and technology have made great progress toward the reduction of animal use in medical research development. However, we believe that some animal use in pharmaceutical research remains both ethically and scientifically necessary to advance medical science and protect human health. This position continues to be supported by the broader public health community (1) and in regulatory standards that require animal use in the research process of developing new pharmaceuticals e.g., EU Directive 2001/83/EC relating to Medicinal Products for Human Use (2) or Federal Food, Drug and Cosmetic Act (3). Much work remains in order to ensure that alternative methods are truly predictive and protective of human health. Many of the new techniques highlighted in these discussions (e.g., in vitro cell cultures, gene assays, mathematical models) are often complementary rather than stand-alone methods (1). Indeed, there are cases of where the breakthroughs in technology highlighted by those who argue against the use of animals in biomedical research, actually confirm the consistency in biology across species that supports the use of animal models. For example, humans share 97.5% of their "working" DNA with mice (4). The broad applicability of rodent studies to humans for endpoints such as teratogenicity (5) is consistent with this. Other work confirms the value of in vivo animal studies for predicting significant human toxicity of pharmaceuticals in particular (6). The need for animal studies prior to any human exposure is explicit in the World Medical Association's Ethical Principles for Medical Research Involving Human Subjects and likewise recognized elsewhere (7). To do otherwise would be unethical.

P&G is developing innovative medicines targeted against osteoporosis, cardiovascular disease, diabetes, osteoarthritis, colds and pain relief. In line with current public health and regulatory standards, we are required to continue a limited amount of research involving animals, both to safeguard humans and to direct the basic research process prior to testing in people.

We ensure very high care standards for all animals. Our research is carefully monitored under the appropriate animal welfare and legislative frameworks and is subject to internal and external regulatory review and approval. All procedures are pre-reviewed to avoid any use of animals whenever a reasonable alternative is available. We carefully consider whether alternatives are available and require formal justification of why the research cannot be addressed via another route. We are also working toward the goals of refinement, reduction and replacement of animal use on an ongoing basis. In particular, we are evaluating screening techniques which can take the place of animal tests in the earliest phase of drug discovery.
Pet Nutrition Products
P&G is committed to helping dogs and cats live, longer, healthier lives through innovative nutrition and pet care products. Dogs and cats are our "consumers". We need them to try our new products during development to ensure they will deliver expected health benefits. However, such feeding studies will only be conducted if alternative non-animal methods or existing research cannot provide the information.

We will not fund or participate in any study requiring or resulting in the euthanasia (intentional death) of dogs or cats. We will only conduct studies that are the veterinary equivalent of nutritional or medical studies done with human volunteers. This includes the collection and analysis of urine, faeces and blood, allergy tests and skin and muscle biopsies. As in human studies, adequate anaesthesia and analgesics are provided whenever necessary to ensure safety and minimize pain and discomfort. As appropriate, we will test our foods on dogs or cats within the general population who already suffer from target diseases or conditions - but we will not support any study involving surgeries or other actions that create or mimic diseases. At the same time, we are working hard on alternatives to find even better ways of getting needed information and eliminating the need for research with other animals.

P&G will ensure the humane treatment of all dogs and cats in our studies, and provide for animal well-being, socialisation and husbandry. We meet or exceed standards established by the Animal Welfare Act of the US and Directive 86/609/EEC of the European Union. Following participation in our studies, when their help is no longer needed, dogs and cats are adopted into loving homes or placed in our retirement facility. This facility has been specifically designed to provide a comfortable and stimulating life for its residents.

The results of all research involving our products help veterinarians and pet owners worldwide enhance the well-being of dogs and cats and manage important pet health conditions. Findings are communicated (e.g., through scientific publications) in order to benefit others who are seeking to improve the health and well-being of dogs and cats, and to help prevent unnecessary repetition of animal tests. At the same time, we continue to work on alternative methods to find even better ways of getting this information and ultimately eliminate the need for animal testing.

For more information on our policy on animal use in pet nutritional studies please visit the dedicated website: http://www.iamstruth.com.
Consumer Products
P&G's products are used in homes two billion times a day around the world. We are committed to improving consumers lives with innovative high quality products that clean homes, enhance personal wellbeing and contribute to family hygiene and health. It is our longstanding policy to ensure that such products are safe for both our consumers and the environment. This legal and ethical obligation to ensure safe products is a requirement for conducting responsible business and an essential element of building and maintaining public trust. Regulations governing the use of household consumer products that have been put in place by national governments reinforce this ethical commitment by imposing a legal obligation upon manufacturers to ensure that such products are safe, e.g., the European Cosmetics Directive 1976/767/EEC (8) or the US Toxic Substances Control Act (TSCA) of 1976 (9). Whilst we all want progress in alternatives to animal testing, the current scientific and legal paradigm is such that safety assurance is explicitly linked to the use of animal-based toxicological tests to characterise the hazards and risks of chemicals used in products. For example, guidance is provided by the European Commission's Scientific Committee on Cosmetics and Non-Food products (SCCNFP) on the use of animal-based toxicological tests to ensure the safety of cosmetic ingredients (10). The use of animal toxicology data is similarly mandated for other household products e.g., Dangerous Preparations Directive 1999/45/EC (11). These requirements sometimes necessitate research involving animals. This is especially the case when employing new ingredients in innovative products. In all of such research we meet or exceed the animal welfare requirements of relevant legislation.

For existing substances, it is our practice to use existing scientific data (often hazard assessment data generated on chemicals), whenever possible. The availability of such data help to ensure the long-term safety of products that are used on a daily basis throughout people's lives. The data from research involving animals are also made available to poison control centres for emergency-room treatment of acute accidental poisoning with household products.

Where it's legally, ethically and morally appropriate, direct human testing is an important part of our safety research. Common examples of human clinical studies include skin patch tests or product use studies to check for skin irritation or allergies. However, these studies are largely designed to be confirmatory - human volunteers may be exposed to new ingredients or products only after there is sufficient evidence from historical data - sometimes including animal safety studies - to predict that they will not be harmed.

We consistently make available animal testing data and details of the development of alternatives via publication in the scientific literature (12). Responsible companies do this in order to help avoid duplicate testing. Some companies which make "not tested on animal" product claims, often rely on historical data made available from such sources.

Safety tests involving animals are typically conducted according to protocols established by the OECD, US FDA, US EPA or other national agencies. These test methods are designed to optimise the information obtained while limiting animal use and the potential for suffering or distress. Furthermore, the use of standardised protocols (especially those from the OECD) ensures the global acceptance of data, thereby precluding the need to repeat tests for submission in different countries under their respective national legislations. Consequently, P&G strongly supports the concept of global standardization and has contributed to the development and validation of OECD test methods (e.g., OECD TG 429 Skin Sensitisation Local Nymph Node Assay - LLNA) (13).

There are different levels of understanding amongst stakeholders vis-�-vis research involving animals, regulatory requirements, the nature of animal tests and the status/availability of alternatives. One particular misperception is that large numbers of animals are used to test for such products. In reality, relatively few animals are used for household or cosmetic products testing (0.065% in the EU) compared to total animal use (14)1. Comparable statistics are not available for the United States as the Animal Welfare Act does not regulate use of rats, mice or birds and they are consequently not considered in the annual Animal Welfare Report of the USDA (15)2.
Our Activities in the Search for Alternatives
Animal test methods are subject to continued revision as scientific progress allows for the development of alternative methods based on refinement, reduction or replacement techniques (16). This globally accepted approach, collectively known as the "Three Rs", provides a rationale and stepwise approach to minimizing animal use while maintaining the quality of scientific work that protect or improves public health. Such techniques respectively allow for improvements in animal welfare, reduced animal use or even substitution of animals with cell cultures or computer models.

Within P&G we are committed to the 3Rs and are actively working to eliminate research involving animals. Since 1985 we have invested over $190 million dollars in the development of alternatives. We are recognised as a leader in alternatives development and validation, with more than 300 scientific publications (12). Of particular note is our participation in the successful development and validation of test methods that have subsequently been adopted into legislation (e.g., the Local Lymph Node Assay - LLNA). Contributions are reflected in various awards such as the HSUS Russel and Burch Award (1999), the SmithKline Beecham Laboratory Animal Welfare Prize (2000) and the HSUS Humane Award (2001). Our in-house safety evaluation strategy adopts a tiered approach with alternative methods as the starting point for all testing, when available. Whenever possible, we use computer models, non-animal tests, and published scientific studies prior to considering the need for any animal-based research. Our commitment to alternatives is serious, ongoing and will continue.

Despite our good intentions and those of others, some stakeholders remain frustrated at the lack of apparent progress in the development and use of alternative methods. We also want more progress. A major challenge is the necessity for alternative methods to offer a level of protection to consumers equivalent to that now offered by toxicological studies performed on animals, and for this to be demonstrated via scientific validation. Experiences with the European Centre for the Validation of Alternative Methods (ECVAM) indicate that validation typically takes more than 5 years due to the rigour expected by the scientific and regulatory community. Only after this process has been successfully completed can a method be considered as an acceptable alternative. Despite this reality, some progress has been made and four alternative methods have now been validated for use in safety assessment in the European Union and consequently incorporated into Annex V of Directive 67/548 on the Classification, Packaging and Labelling of Dangerous Substances (DSD). P&G makes full use of validated alternative methods. The Local Nymph Node Assay for skin sensitisation is one of those four methods. It was accepted by the OECD in 2002 and incorporated into Annex V of the DSD in 2004. P&G participation was central to the development of the LNNA (13).

Despite suggestions to the contrary (17), it is important to realise that some level of reliance on animal testing for chemical safety will continue to be considered necessary by scientific experts and government regulators, for the foreseeable future. This has recently been reaffirmed by two of the European Commission's own Scientific Committees (18, 19). It is also likewise highlighted in a report from the Commission's Institute for Health and Consumer Protection (IHCP) on likely animal testing needs under the revised European Chemical Policy (20). As such, the scientific and legal paradigm for determining consumer safety based in part on animal data will likely remain for the immediate foreseeable future. This fact confirms to us that the task of developing further alternatives will require a substantial commitment over a long-term period. Nevertheless, P&G stands ready to contribute to this process.

In continuing to support the search for alternatives to animal testing, we listen and respond to the concerns of consumers and stakeholders about research involving animals at P&G. In recognition of their concerns, we will continue to:

  • Work with regulatory authorities to challenge any technically unjustified regulatory requirements relating to animal testing (such as those requiring finished product testing);
  • Work to expedite the development and validation of alternative methods;
  • Work with stakeholders to identify opportunities to promote the regulatory acceptance of such alternatives


The prime consideration as we progress these actions, however, will always be ensuring that all our progress in alternatives allows us to ensure the safety of our consumers. Details of our commitment to animal alternatives research and our animal research policy can be found on the P&G internet site at http://www.pg.com/science/animal_alt.jhtml

For more information download the Research involving animals brochure.

1 In the EU in 1999 a total of 9.8 million animals were used for experimental or scientific purposes throughout the fifteen member states. Three of the EU's five categories of experiments accounted for the bulk of animal use; (i) the discovery, development or quality control of products or appliances for human and veterinary medicine (52%), (ii) biological studies of a fundamental nature (30%) and (iii) toxicological or other safety evaluations (10%). Within the 10% employed in toxicological evaluations, 54% were used for medicine, 11% for industrial products, 8% for agricultural products, 3% for human food additives, 0.4% for cosmetics, 0.4% for animal food additives, 0.25% for household products, 7% for environmental contaminants not otherwise classified and 16% for other evaluations. Source: http://europa.eu.int/eur-lex/en/com/rpt/2003/com2003_0019en01.pdf

2 The total number of animals reported used in research in the US in 2001 was 1.24 million (excluding rats, mice and birds). Source: http://www.aphis.usda.gov
References and Further Readings