DEA ESTABLISHES REGISTRATION FEES FOR USING CONTROLLED SUBSTANCE On 10 October 2003, following several years of legal deliberations, the Drug Enforcement Administration (DEA) established a

fee schedule, effective 1 December 2003, for registration and re-registration fees “relating to the registration and control of the manufacture, distribution and the dispensing of controlled

substances. DEA is required to adequately recover necessary costs associated with the Diversion Control Program (DCP) as mandated by the Departments of Commerce, Justice, and State, the

Judiciary, and Related Agencies Appropriations Act of 1993 (ref. 2).” Most investigators conducting research with animals using controlled substances, such as barbiturates, opioids, and

for reviewing new animal drugs. This legislation is similar to the legislation established more than a decade ago by the FDA for reviewing human drugs4. The Act will substantially reduce

the review time for new animal drugs by providing funding to increase the number of FDA Center for Veterinary Medicine employees and for improving the management system. The Act allows for

the waiving or reduction of fees for small businesses and in circumstances where payment of the fees would impede innovation. The FDA will collect four fees (sponsor, establishment, product

and an application fee) as follows: $5 million in fiscal year 2004, $8 million in fiscal year 2005, and $10 million in each fiscal year 2006 through 2008. EUROPEAN COMMISSION PROPOSES TO

REGULATE THE EUROPEAN CHEMICAL INDUSTRY On 29 October 2003, The European Commission proposed a new chemical regulation system in order to improve the protection of human health, the

environment, and to reduce the number of animals used to test the safety of chemicals, while maintaining and enhancing the competitiveness and innovation of the European Union's

chemical industry5,6,7. The proposed system, called REACH (Registration, Evaluation and Authorisation of Chemicals), would cover all scientific research and development, laboratory-scale

research and development, and work supporting reference standards. It will require that animal testing be kept to a minimum, and that companies share existing data in order to reduce the

number of animals used and the costs associated with their testing. Companies that manufacture or import more than one ton of any chemical substance a year will have to register in a

database. The proposed REACH system foresees the application of alternative methods to the testing of chemicals produced or imported in quantities above one ton. The Commission advocates the

use of non-animal testing methods, including refined exposure information, computer models, and cell culture tests. These new risk assessment strategies are essential for the implementation

of REACH and have the potential to significantly reduce the costs associated with it. REFERENCES * USDA APHIS. Determination to regulate and request for comments. Animal welfare;

transportation of animals on foreign air carriers. _Federal Register_ 68(197), 58575–58577 (10 October 2003). * DOJ DEA. Final rule. Controlled substances registration and registration

application fees. _Federal Register_ 68(197), 58587–58600 (10 October 2003). * Animal Drug User Fee Act of 2003. 108th Congress, 1st Session, S 313. (4 November 2003).

http://www.fda.gov/opacom/laws/adufa.html. * FDA. President signs new law providing user fees to improve animal drug review. _FDA News_ (19 November 2003).

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00978.html. * European Commission Press Room. Chemicals: commission presents proposal to modernize EU legislation. IP/03/1477. (29 October 2003).

http://europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.gettxt=gt&doc=IP/03/1477|0|RAPID&lg=EN&dislay. * European Commission Press Room. Chemicals: research key to new EU

chemical policy. IP/03/1631. (1 December 2003). http://europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.gettxt=gt&doc=IP/03/1631%7C0%7CRAPID&lg=EN&display. * European

Commission Press Room. REACH—new chemicals legislation. http://europa.eu.int/comm/press_room /presspacks/reach/pp_reach_en.htm. Download references Authors * M Shalev MSc, VMD View author

publications You can also search for this author inPubMed Google Scholar RIGHTS AND PERMISSIONS Reprints and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE Shalev, M. Regulation Updates.

_Lab Anim_ 33, 15 (2004). https://doi.org/10.1038/laban0104-15b Download citation * Issue Date: January 2004 * DOI: https://doi.org/10.1038/laban0104-15b SHARE THIS ARTICLE Anyone you share

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