21 Code For Federal Regulation Parts 1305, 1311 Page 17
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67approving new technologies. DEA understands the commenters’ concern, but approval of any
new technology would be subject to the Administrative Procedure Act requirements for public
notice and comment prior to adoption. Beyond the statutory mandates, DEA thinks it is vital that
the regulated community have an opportunity to consider and discuss new methods to ensure that
any new rules can be accommodated by existing systems. Although the development of this rule
took several years, DEA believes that the time was well spent because discussions that DEA and
industry held made it possible for all parties to identify potential problems and find solutions
prior to publishing a regulation. DEA does not anticipate that review and recognition of suitable
alternative technologies should take that long.
Audits. Comments expressed concern about the scope of the third-party audits and DEA
audits. They specifically stated that the reports to DEA should not be included in the third-party
audits.
DEA agrees with the commenters that the reports to DEA would not be part of third-party
audits. The independent third-party audit is intended to ensure that the digital signature system
functions properly for both the supplier and purchaser.
Reverse Distributors. Several commenters asked how the electronic order system will
work for reverse distributors. DEA recognizes that the ordering system has different
characteristics in reverse distribution and intends to address issues related to those distributions
in a separate rulemaking.
Other Issues. Commenters objected to the mention of biometrics and smart cards. DEA
notes that certificate holders may want to consider using biometric passwords or smart cards, but
DEA is not requiring them to do so. Keys may be stored on any secure system provided that the
storage module is approved under FIPS 140-2.
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