Washington, DC
June 11, 2009
The U.S. Department of
Agriculture’s Animal and
Plant Health Inspection Service (APHIS) is seeking public
comment on the draft standard developed for its pilot of the
biotechnology quality management system (BQMS). The BQMS is a
voluntary program that aims to enhance compliance with the
regulatory requirements for field trials and interstate
movements of certain genetically engineered (GE) organisms.
Participants in the pilot program used the draft standard to
develop and review sound management practices that help improve
compliance with APHIS’ biotechnology regulations for
environmental releases, importations and interstate movements of
regulated articles. The standard is expected to provide a
management framework that users can apply to base their current
regulatory practices. The standard is flexible enough to address
the specific needs of the entire regulated community, including
large corporations, small businesses and academia, and allow
them to develop a BQMS that suits their scope and scale of work
while demonstrating their commitment to regulatory compliance.
This notice was published in the June 4 Federal Register. APHIS
is soliciting comments on the draft audit standard as a whole,
and particularly a portion of the standard (element 7) that
requires participants develop:
- Procedures that address
critical control points for the introduction of regulated
articles;
- Measures for the
identification of regulated articles in storage, being
moved, imported or transferred and, in field locations;
- Procedures for planning
and monitoring environmental releases of regulated articles;
- Methods for post-harvest
handling activities and maintaining labeling or some other
form of identification of regulated material;
- Procedures for the safe
disposal of regulated articles; and,
- Procedures for the
submission of regulatory compliance incidents to the
appropriate regulatory authorities.
Participants have applied the
standard to their organization’s regulated biotechnology program
to plan, implement, document and examine the efficacy of quality
assurance and quality control measures related to introductions
of regulated articles. APHIS is soliciting comments for a period
of 60 days on the above standard currently used in the BQMS
pilot project. Upon conclusion of the BQMS pilot project, APHIS
will consider all comments received during the comment period to
revise the draft standard to improve the efficacy of this
project. This feedback, as well as comments from the
participants on the BQMS pilot project, will be used to inform
the development of a BQMS audit standard and any future BQMS
initiative.
Consideration will be given to comments received on or before
Aug. 3. Send two copies of postal mail or commercial delivery
comments to Docket No. APHIS-2008-0098, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit
118, Riverdale, MD 20737-1238. Please state that your comment
refers to Docket No. APHIS-2008-0098. If you wish to submit a
comment using the Internet go to the Federal eRulemaking portal
at
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0098.
Comments are posted on the Reglations.gov Web site and also can
be reviewed at USDA, Room 1141, South Building, 14th St. and
Independence Ave., S.W., Washington, D.C., between 8 a.m. and
4:30 p.m., Monday through Friday, excluding holidays. To
facilitate entry into the comment reading room, please call
(202) 690-2817. |
|
