PHARMACEUTICAL PROCESSING | NOVEMBER/DECEMBER 2015 21 n
n Q&A: HAZARDOUS WASTE n PHARMPRO.COM
ment requirements better suited for manufacturers. Under
the proposed regulations, small quantity generators (SQGs)
and LQGs no longer need to count HWPs towards the facility’s hazardous waste generator calculations. Removing
HWPs may enable healthcare facilities to more easily shift
generator categories and be subject to generator requirements under RCRA that are more appropriate for healthcare
HWPs, which will be outside of the traditional hazardous waste count at SQGs and LQGs, will be subject to
management standards in an entirely new subpart in the
Resource Conservation and Recovery Act (RCRA) hazardous waste regulations—Subpart P of 40 CFR Part 266.
These sector-specific regulations will significantly ease the
compliance burden for healthcare facilities and will include
reduced storage and labeling requirements for HWPs.
WELLS: For the hazardous waste
generator rules, the proposed changes
primarily have to do with increased
recordkeeping requirements, more
specific labelling, the potential for
expanded employee training, and
updates to contingency plans. In addi-
tion, two proposals for conditionally
exempt small quantity generators
(CESQGs) have the potential for eas-
ing regulatory burdens for those generators under two
1. First, the proposed rules create an episodic event exemption, which allows a company to maintain its generator status even if a one-time event causes it to exceed the quantity thresholds. This would allow a company to respond to
an accidental spill or have a one-time laboratory clean-out
without having to create and develop more procedures that
are now required for higher quantity generators.
2. The second proposed change would allow a CESQG to
send its waste to a large quantity generator under the
control of the same entity as the CESQG. This has the
potential to be very beneficial to companies that have
one central location that generates large quantities of
waste along with satellite locations generating minor
quantities because waste can be more efficiently accumulated and disposed of from the central location.
Q: How would these proposed regulations impact how
companies in the healthcare sector—including pharmaceutical manufacturers, hospitals, retail pharmacies, veterinary clinics, reverse distributors, and more—identify
and manage waste?
WELLS: Under the proposed regulations, there would
be no accumulation time limits, container requirements,
or labeling for potentially creditable HWPs generated at Jonathan Wells