### 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 awa re 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 C FR 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. t o b e 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 defi nition 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, simil ar 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 gene rator, 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 S martER 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 comp leted was EPA method 8270B which is analysis for “Total Analytes” or “totals” analysis.

SmartER Community Assistance, Inc., 301 12 th 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 P

listed hazardous waste and disposed of at the local HHW facility in compliance with EPA regulations. SmartER Community Assistance, Inc. is an unregistered conditionall y 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. Complet e analysis located in Appendix 2

.

Based on the data in Table 1, please verify that the empty package an d 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 pac ks 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 C FR 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) an d 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 furthe r 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 12 th Ave. SW, Altoona, IA 50009 www.smartercommunityassistance.com ; 515

- 210

- 1293