**3. Situation in other countries**

Whereas the EU has banned the use of all hormones, other countries do allow the use of steroid hormones and hormone-like substances in various combinations with the aim to improve weight gain and feed efficiency in livestock farming. Recommended application occurs in the form of small implants or devices, containing the active hormones, into the subcutaneous tissue of the ears. Both ears are completely discharged at slaughter27 (Galbraith, 2002). Pharmaceutically, these implants represent slow-release devices, containing relatively large quantities of hormones, which are fractionally released over a period of several months.

In the United States28, Canada, Australia, New Zealand and in some countries in South America, Asia and Africa the natural hormones - testosterone, 17ß-oestradiol and progesterone - and the (semi-) synthetic hormones trenbolone, zeranol and melengestrol acetate can be used to promote growth.

In particular, in the USA29 five hormones are authorized as the active component of solid ear implants (17-estradiol - as such or as benzoate, testosterone - as such or as propionate,

Enforcement/GuidanceforIndustry/ucm123821.htm Accessed August 26, 2011.

29 The United States continues to maintain that U.S. beef from cattle treated with certain approved growth hormones pose no public health risk. Overall, the official U.S. position is that "there is a clear world-wide scientific consensus supporting the safety of these approved and licensed hormones when used according to good veterinary practice".

The United States claims that this position is supported by "scientific reviews of the six hormones, international standards pertaining to their use, and a longstanding history of administering the six hormones to cattle for growth promotion purposes". Accordingly, the United States claims that the use of these hormones as growth promoters in beef production is safe, when applied in accordance with good veterinary practices.

The United States has criticized the EU's scientific opinions for focusing on only one growth promotant, estradiol-17β, and on its potential genotoxicity, while directing relatively little attention toward the other natural and synthetic hormones. The United States also claims that the "EU failed to use solid evaluative methods in their studies and completely disregarded the large body of evidence from epidemiological studies that indicate that estradiol does not contribute to any increased cancer risk and that meat from animals tested with estradiol is safe for consumers".

Regarding the EU's more recent reviews, the United States claims they fail to provide any new evidence that would call into question the findings and conclusions of other authoritative reviews.

More broadly, the United States also disputes whether the EU's scientific reviews serve as a risk assessment. The United States claims: "There has been no new risk assessment based on scientific information and reasoning presented by the EU," further claiming that the "17 studies" funded by the Commission beginning in 1998 were "not intended as a to serve as a risk assessment, but instead were

mummification in cattle, and for the treatment of pyometra. Commission of the European Communities – SEC(2005) 1303 of 11.10.2005.

<sup>27</sup> See European Commission, 1999. Scientific Committee on Veterinary Measures relating to Public Health (SCVPH). Assessment of potential risks to human health from hormone residues in bovine meat and meat products. Available at http://europa.eu/comm/food/fs/sc/scv/out21\_en.html Accessed August 23, 2011.

<sup>28</sup> The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) cooperate in regulating growth promotants for livestock. Both of these agencies maintain that hormones in beef from an implanted animal have no physiological significance for humans. All animal drug products are approved for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). Information on approved hormone products are at 21 CFR Parts 522, 556, and 558. FDA requirements for the review and approval of new animal drug applications is at http://www.fda.gov/AnimalVeterinary/GuidanceCompliance

Whereas the EU has banned the use of all hormones, other countries do allow the use of steroid hormones and hormone-like substances in various combinations with the aim to improve weight gain and feed efficiency in livestock farming. Recommended application occurs in the form of small implants or devices, containing the active hormones, into the subcutaneous tissue of the ears. Both ears are completely discharged at slaughter27 (Galbraith, 2002). Pharmaceutically, these implants represent slow-release devices, containing relatively large quantities of hormones, which are fractionally released over a period of several months. In the United States28, Canada, Australia, New Zealand and in some countries in South America, Asia and Africa the natural hormones - testosterone, 17ß-oestradiol and progesterone - and the (semi-) synthetic hormones trenbolone, zeranol and melengestrol

In particular, in the USA29 five hormones are authorized as the active component of solid ear implants (17-estradiol - as such or as benzoate, testosterone - as such or as propionate,

mummification in cattle, and for the treatment of pyometra. Commission of the European Communities

27 See European Commission, 1999. Scientific Committee on Veterinary Measures relating to Public Health (SCVPH). Assessment of potential risks to human health from hormone residues in bovine meat and meat products. Available at http://europa.eu/comm/food/fs/sc/scv/out21\_en.html Accessed

28 The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) cooperate in regulating growth promotants for livestock. Both of these agencies maintain that hormones in beef from an implanted animal have no physiological significance for humans. All animal drug products are approved for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). Information on approved hormone products are at 21 CFR Parts 522, 556, and 558. FDA requirements for the review and approval of new animal drug applications is at

29 The United States continues to maintain that U.S. beef from cattle treated with certain approved growth hormones pose no public health risk. Overall, the official U.S. position is that "there is a clear world-wide scientific consensus supporting the safety of these approved and licensed hormones when

The United States claims that this position is supported by "scientific reviews of the six hormones, international standards pertaining to their use, and a longstanding history of administering the six hormones to cattle for growth promotion purposes". Accordingly, the United States claims that the use of these hormones as growth promoters in beef production is safe, when applied in accordance with

The United States has criticized the EU's scientific opinions for focusing on only one growth promotant, estradiol-17β, and on its potential genotoxicity, while directing relatively little attention toward the other natural and synthetic hormones. The United States also claims that the "EU failed to use solid evaluative methods in their studies and completely disregarded the large body of evidence from epidemiological studies that indicate that estradiol does not contribute to any increased cancer risk and

Regarding the EU's more recent reviews, the United States claims they fail to provide any new evidence

More broadly, the United States also disputes whether the EU's scientific reviews serve as a risk assessment. The United States claims: "There has been no new risk assessment based on scientific information and reasoning presented by the EU," further claiming that the "17 studies" funded by the Commission beginning in 1998 were "not intended as a to serve as a risk assessment, but instead were

that would call into question the findings and conclusions of other authoritative reviews.

**3. Situation in other countries** 

acetate can be used to promote growth.

http://www.fda.gov/AnimalVeterinary/GuidanceCompliance

that meat from animals tested with estradiol is safe for consumers".

used according to good veterinary practice".

good veterinary practices.

Enforcement/GuidanceforIndustry/ucm123821.htm Accessed August 26, 2011.

– SEC(2005) 1303 of 11.10.2005.

August 23, 2011.

progesterone, trenbolone acetate and zeranol) and two hormones as feed additives: melengestrol acetate (MGA) for feedlot heifers30 (Berende & Ruitenberg, 1983; Meissonnier & Mitchell-Vigneron, 1983) and ractopamine for swine (Marchant Forde *et al.*, 2003).

As aforementioned, the hormone ban of the EU is currently the cause of a dispute between the EU and these third countries, led by the United States and Canada. The reason for this dispute is that those countries want to export meat to EU nations from animals treated with in their view acceptable hormones. In their opinion the EU blocks international trade on improper grounds and against international law.

The National Cattlemen's Beef Association (NCBA), the largest national group of cattle producers, has long opposed the EU's ban on imports of U.S. hormone-treated beef, claiming that the ban is scientifically unjustified and fails to satisfy the EU's WTO requirements under the SPS. Similar concerns have been expressed by other U.S. farm groups, including American Farm Bureau Federation (AFBF), the Animal Health Institute (AHI), and the American Meat Institute (AMI)31. Many trade analysts believe that the United States has a strong case against the hormone ban under WTO rules that require SPS restrictions to be based on risk assessment and to have a scientific justification. These various interest groups have continued to exert pressure on U.S. trade policy officials to hold to their position regarding the EU's meat hormone ban.

Recently, On May 13, 2009, following a series of negotiations, the United States and the EU signed a memorandum of understanding (MOU) implementing an agreement that could resolve this long standing dispute32. On July 13, 2009, the EC adopted regulations opening a tariff quota for imports of High Quality Beef, effective August 1, 200933
