[Pharmwaste] Selling and receiving controlled substances (drugs)

[randsney at comcast.net]

Subject: Selling and receiving controlled substances (drugs) 

 

I have questions on disposal of controlled substances like pharmaceuticals waste by households, which I hope you can provide a response. These questions concern homeowners that dispose of their pharmaceuticals in their trash that goes to a solid waste facility and than into landfills or to incinerators, and in the wastewater disposal system. 

  1.. If a county or city is paid to have trash picked up containing controlled substances, isn’t the county being paid to receive controlled substance or to collect controlled substances like pharmaceuticals that have been disposed of in the trash?
  2.. Are residents selling or dispensing controlled substances to a county or city via trash pickup?
  3.. If a county or city pays to incinerate the waste containing pharmaceuticals is the county or city dispensing controlled substances to the incinerating company?
    a.. Will or does the USEPA enforce emissions from an incinerator burning pharmaceuticals in trash?
  4.. Is an incinerator company collecting controlled substances in trash that it is paid to receive from a solid waste facility?
  5.. If a solid waste facility receives pharmaceutical disposed of by homeowners, is the facility responsible for what happens to the pharmaceuticals they have been paid to receive?
  6.. If a county or city is paid to take sewage and that sewage has controlled substances, are they receiving and collecting controlled substances?
  7.. If a county or city that discharges controlled substances via wastewater into waters disposing of controlled substances?
  8.. If a county or city sales reclaimed wastewater containing controlled substances used for irrigation dispensing controlled substances?
  9.. If a county or city that uses or sales wastewater sludge containing controlled substances as a soil conditioner or fertilizer dispensing controlled substances? 
  10.. Can or will the DEA go after the sellers, dispensers and receivers of controlled substances in trash, sewage, sewage sludge and treated wastewater? 
  11.. Can or will FDA go after the sellers of prescription drugs sold and dispensed by homeowners to a county through trash or sewage collection fees?
  12.. If food crops and food animals are contaminated with controlled substances via use of sewage sludge, reclaimed water or water from lakes and rivers, will the residues in the crops be enforced by the FFDCA (Federal Food and Drug and Cosmetic Act), USDA or the USEPA?
  13.. If food crops or food animals containing controlled substance are sold is that dispensing controlled substances?
  14.. If endangered species or migratory birds were contaminated with discarded and discharged controlled substances and will the Acts be enforced?
  15.. Will children be endangered from the disposal or discharged of controlled substances by homeowners and receivers of such, and their discharge of the controlled substances into the environment?
 

Last but probably not least there may be no validated extraction methods for parent and degradates that form in the environment, in plants and animals.

 

Are chemical extraction methods valid?

 

Are chemical extraction methods valid to extract chemicals from soil, sediment, sewage sludge, plants and animals? These methods may be solid waste (SW) methods or pesticide methods used to extract chemicals and degradation products from soil, sediment, sewage sludge, plants and animals. Do the methods extract residues that have a high Koc (organic carbon partition coefficient) value in soil or a high Kow (octanol water partition coefficient) value in fat tissue? If you want to know these values read my book. Bottom line answer is almost all the methods have not been validated. Fortifying a matrix and extracting does not prove that an extraction procedure will work for chemicals aged in the matrix over time (i.e. 30, 60 & 120 days).

 

By validation, I mean using procedures like those that I wrote in 40 CFR § 158:290 and § 158.1300 Subpart N, which FIFRA requires by aging of pesticides in soil to discern bound residues, extraction of parent and degradates and analytical efficiency. These data requirements were started in the USDA around 1967 because radiotracer studies for petition for tolerances indicated pesticide residues were not being totally extracted and where showing up in crops (rotational crops) when they shouldn’t have been. This does not mean that those residues determined by other methods were incorrect. Please remember that residues under FIFRA include parent and degradation products.

·        It means that the total amount or residues extracted is questionable and that there may have been a lot more not extracted. 

·        It means that many other chemicals may not been have been extracted and thus not determined. 

·        It means that there may be chemical residues not extracted, which could be available for plant and animal uptake.

·        It means that a hazard assessment cannot be accurate without knowing total exposure via inhalation, absorption and ingestion of total residues (extractable and un-extractable).

 

Here are examples of some questions that I have asked concerning residues in sediment, plants, sewage sludge, water, etc.

1.      Do the extraction procedures/methods extract residues bound in the organic matter of soil or sediment?

2.      Do the extraction procedures/methods extract residues bound in fat in animals?

3.      Do the extraction procedures/methods provide a material balance for residues in each of the following matrices soil, plants and animals, that is total residues of parent, degradates, and bound (non-extractable residues) residues?

4.      Where radiotracer methods used to obtain data as question in three above?

 

So what could all this mean? 

1.      It could mean that all the residues (parent and degradates) are not determined in the food we eat.

2.      It could mean that all the residues (parent and degradates) are not determined in soil, animals, sediment, and sewage sludge and residues are much higher in environmental matrixes than extracted and determined. 

3.      It means that exposure may be greater than expected.

Many may say exposure to chemicals and/or biologicals in consumer products, in the environment, etc. is so small there is little chance of risk.  While this may be true in many cases, safety cannot be judged on one chemical or one biological alone.  Humans and other animals are a mixture of chemicals and biologicals, and we take in hundreds of different chemicals and biologicals a year.  How safe are these chemicals and degradates (pesticides, hormones, metals, etc.) and biologicals when the aggregate, synergistic, antagonistic, co-metabolism and co-biometabolism effects are never mentioned or studied to any extent, if at all and, they are not used in risk assessments?  In other words, the total picture is never known or considered for hazards to adults, child endangerment and environmental safety when it should be required.

 

The bottom line is that USEPA, FDA and other enforcement methods do not account for total residues of parent chemical and their degradation products. Safety cannot be determined.

 

Regards,  

 

Dr. Ron Ney
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