r 11, 2010

Mr. Edwin G. Buckner, PE

EPA Region 7

Waste Enforcement and Materials Management Branch

901 N. 5th St.

Kansas City, KS 66101

January 18, 2011

Dear Mr. Buckner,

I have been assisting several customers with RCRA compliance in Iowa. Some of these 

customers regularly manage p-listed pharmaceutical waste from nicotine patches, nicotine gum, 

warfarin single-dose bubble packs and physostigmine ampoules. As you are aware and in our 

previous correspondence on Thursday August 5, 2010, ”waste wrappers and bubble packs that 

once contained a P-listed substance, such as nicotine, that is now a waste would be subject to 

the container requirements of the P-listing found at 40 CFR 261.7(b)(3).” I have copied our 

email exchange in Appendix 1 of this document. 

Also in this email exchange, you responded that “Region 7 would consider a demonstration that 

insignificant amounts of the P-listed material remain on the wrapper, etc. to be sufficient to 

prove the equivalence of an alternative method.” Within the past several months, I have 

worked with Keystone Laboratories, Newton, IA to establish that the wrappers, bubble packs 

and ampoules from these specific containers meet the definition of “RCRA empty” by just simply 

removing the product from the single use packaging for individual use of the product as 

intended. Packages emptied through common use can be shown analytically to contain 

insignificant amounts of P-listed waste, similar in levels of contamination when the packaging is 

triple-rinsed. 

I believe that the data attached in Appendix 2 and summarized in Table 1 below demonstrate 

compliance with 40 CFR 261.7(b)(3)(ii) which states that “A container or an inner liner removed

from a container that has held an acute hazardous waste listed in 261.31, 261.32 or 261.33(e) is 

empty if: The container or inner liner has been cleaned by another method that has been 

shown in the scientific literature, or by tests conducted by the generator, to achieve equivalent 

removal.” 

Samples of individual single unit dose containers of nicotine gum and patches, warfarin and 

physostigmine were obtained by SmartER Community Assistance, Inc. from a local hospital 

client. Packages were opened by SmartER Community Assistance, Inc and product was 

removed. Samples labeled (T) were triple rinsed prior to submittal to Keystone Laboratories and 

samples with no (T) were submitted to the laboratory as empty packaging with no triple-rinsing. 

Analysis completed was EPA method 8270B which is analysis for “Total Analytes” or “totals” 

analysis.

SmartER Community Assistance, Inc., 301 12th Ave. SW, Altoona, IA 50009

www.smartercommunityassistance.com; 515-210-1293
r 11, 2010

All rinsate and products were collected by SmartER Community Assistance, Inc., labeled as Plisted hazardous waste and disposed of at the local HHW facility in compliance with EPA 

regulations. SmartER Community Assistance, Inc. is an unregistered conditionally exempt small 

quantity generator and generates less than 2.2 lbs of P-listed waste per calendar month and less 

than 220 lbs of hazardous waste per calendar month.

Name of constituent tested Empty package 

contamination (ug)

Triple-rinsed empty package 

contamination (ug)

Nicotine gum- single piece bubble pack ND ND

Nicotine patch- single use package 35.8 ND

Warfarin- single unit dose bubble pack 6.4 ND

Physostigmine- single dose ampoule ND ND

Table 1: Data comparison of Totals analysis in ug units from P-listed empty and triple-rinsed, 

empty packaging study conducted by SmartER Community Assistance, Inc. Note that ND = non 

detect. Complete analysis located in Appendix 2.

Based on the data in Table 1, please verify that the empty package and the triple-rinsed empty 

packages are equivalent in containing insignificant amounts of P-listed contamination and, 

therefore, in the case of nicotine gum single piece bubble packs, nicotine patch single use 

packages, warfarin single unit dose bubble packs and physostigmine single dose ampoules, the 

waste packaging may be managed as a RCRA empty container and is not subject to regulation 

under parts 261-265, 267, 268, 270 or 124 of 40 CFR or to the notification requirement of 

section 3010 of RCRA per 40 CFR 261.7 (a)(1)(ii).

Verification of this interpretation will allow many facilities to achieve compliance in 

management of these particular challenging P-listed waste streams; nicotine single dose 

packaging (P075), warfarin single dose packaging (P001) and physostigmine single dose 

packaging (P204). Due to the nature of these particular waste streams, achieving compliance 

with proper disposal as a hazardous waste is nearly impossible given that patients, family 

members or other personnel are unaware that disposal of such waste streams in places such as 

hospitals, clinics, restaurants, hotels or a variety of other facility types requires that they be 

managed by the facility as hazardous waste under 40 CFR. 

If you have any questions or require any further information, please don’t hesitate to contact 

me at 515-210-1293 or via email at becky.wehrman@gmail.com. Thank you for your 

consideration and response.

Sincerely,

Becky Wehrman

Becky Wehrman, Owner

SmartER Community Assistance, Inc.

www.smartercommunityassistance.com

SmartER Community Assistance, Inc., 301 12th Ave. SW, Altoona, IA 50009

www.smartercommunityassistance.com; 515-210-1293