What information is included in an OEL monograph?
The following information is included on each OEL monograph: generic name, numerical occupational exposure limit, control banding classification based on Affygility Solutions' 5-band scheme, C.A.S. number, structure, basis for classification, therapeutic indication, mechanism of action, efficacy and dose, toxicology summary, carcinogenic, reproductive and developmental hazards, OEL calculations with the uncertainty and modifying factors used, indication whether an industrial hygiene method is available, and references.
If information is either not available or unknown, Affygility Solutions will indicate so in the appropriate section.
You can request a free sample of an OEL Fastrac document to see all the information that's included when you purchase an OEL Fastrac monograph.
Can I publish the numerical OEL from an OEL Fastrac document on a company issued and publically available MSDS?
No. This violates the Terms and Conditions that you agreed to prior to purchasing or using an OEL Fastrac document.
My company has a policy where we can't buy items via credit card online. What other payment options do we have?
OEL Fastrac has been optimized to eliminate the overhead expense of invoicing and payment collection. While payment by credit card through the OEL Fastrac system is the preferred means of payment, Affygility Solutions will accept checks or wire transfers payable in $USD. However, payment must be received and cleared prior to delivery of the OEL Fastrac documents. In addition to the cost of the documents, there will be a 25% processing fee for all payments by check or wire transfer.
To request an order with payment by check or wire transfer, please contact us.
I have an occupational exposure limit (OEL) from another source, such as a material safety data sheet (MSDS), that is different than the one on the OEL Fastrac document. Which one is correct?
The difference can be due to many factors, but the most common reasons are different uncertainty and safety factors were used, or the toxicological point of departure selected is different. Many times, occupational exposure limits were established early in the drug development process and due to data gaps, large uncertainty factors were used, thus resulting in a low occupational exposure limit. In addition, the dose that was used to initially establish an OEL may have changed. Unfortunately, the OEL on the MSDS may never get revised once more current information becomes available, or that legacy MSDSs are still out in circulation. Just because one number is simply lower than the other number does not mean that the lower one is more correct. In addition, just because an OEL is published on a publically available MSDS does not mean that the OEL is based on current information.
How does Affygility Solutions determine the OEL?
The occupational toxicology professionals at Affygility Solutions calculate the OEL by using the uncertainty and modifying factor method, which is the most commonly used method for determining OELs. We begin this process by collecting available information from both public sources and licensed databases. After a thorough review of the available data, we select a toxicological point of departure (POD) based on numerous factors such as relevance to human occupational exposure, etc.
In total, there are at least sixteen factors we consider, prior to selecting the POD. Once we have determined the POD, we then determine the uncertainty factors and modifying factors to be used and the OEL is then calculated. The specific uncertainty factors and modifying factors used depend upon the completeness of the data set, whether we are considering animal or human data, whether the data is acute or chronic, and many other factors. If available, absorption and bioavailability information is also considered.
Are engineering controls and handling practices included in the OEL monograph?
No. Each OEL monograph contains a control band classification. The specific engineering controls and handling practices for each band are unique to the individual company. These controls and practices depend on the unit operation being performed, the physical form and amount of material, and previous industrial hygiene or surrogate monitoring results.
By listing the industrial hygiene method information, does that mean that Affygility Solutions developed that method and can do the industrial hygiene monitoring on site at our facility?
No. Affygility Solutions does not directly provide laboratory analytical services or method development. However, we work with key vendors that do provide this service. Affygility Solutions can do the on-site air monitoring and swipe sampling portion, but would use an outside laboratory to perform the sample analysis.
Once we purchase an OEL Fastrac monograph, is there additional support from Affygility Solutions if needed?
Affygility Solutions is a full service environmental, health and safety service provider and we are available for consulting on an ongoing basis. In order to make the OEL Fastrac monographs as affordable as possible, they do not come with any additional built-in consulting time and any follow-up or additional questions on potent compounds will be billed at standard current rates, which are available upon request.
We have an early stage compound; can we get an OEL Fastrac monograph developed for the compound?
While Affygility Solutions can develop an OEL Fastrac monograph for almost any active pharmaceutical ingredient (API), for early stage APIs, development of a robust occupational exposure limit is not always practical. This is because what is unknown about the API overwhelms what is known. Thus the uncertainty factors become large and the resulting OEL is unreasonably low. In these cases, Affygility Solutions recommends that a simple control banding classification report (without a numerical OEL) be prepared. Because data on the specific API may be extremely limited, the occupational toxicology experts at Affygility Solutions may have to use structure activity relationship information, as well as any early study information that you may have in your possession
The occupational toxicology professionals at Affygility Solutions are available to perform this initial assessment for your early stage compounds.
We need an OEL for an API not listed in your catalog. Can Affygility Solutions prepare one?
Affygility Solutions can prepare a custom OEL monograph. These documents are $5,700 USD, net of any country taxes or fees. In most cases, turnaround times for these documents are ten (10) business days or less for each document.
Can an OEL from an OEL Fastrac document be used in enforcement action against my company?
Occupational exposure limits on OEL Fastrac documents are not legal limits and Affygility Solutions does not support their use in enforcement actions. In addition, the Occupational Safety and Health Administration (OSHA) has stated in several of their letters of interpretation that exceeding a recommended OEL would not be the basis of their enforcement action, but a general duty clause citation would have to be issued on the basis of failing to mitigate a recognized hazard. OSHA has indicated that in over a two-year period, only five general duty clause violations referencing OEL have been issued.
Can't I get all this information for free from the material safety data sheet?
Not necessarily. Currently, there is no regulatory requirement to state internal occupational exposure limits (OELs) or control banding categorizations on a MSDS.
Manufacturers or importers of active pharmaceutical ingredients (APIs) are only require to state published legal exposure limits, such as OSHA permissible exposure limits (PELs), or widely-recognized professional association exposure limits, such as ACGIH Threshold Limit Values (TLVs) or AIHA WEELs, on their material safety data sheets. There are approximately 500 PELs and a similar number of TLVs, with very few of them being APIs.
To make matters worse, there are deficiencies in those exposure limit-setting processes. These deficiencies include:
In addition, manufacturers or importers of APIs may lack the internal expertise and experience to properly establish an internal OEL, or the manufacturer may choose, for a variety of legal reasons, not to indicate the internal OEL on the MSDS.
In order to protect the health and safety of your employees, and in to properly place a compound into a control-banding category, you need to understand all the important details regarding the API. OEL Fastrac documents explain these details in a concise manner. For more information about exposure limits on material safety data sheets, please view our YouTube video on this subject.
I see that the compound of interest is listed as the basic or acidic molecule, rather than the salt form. Does this make any difference in the calculation of the OEL?
A large majority of all drug molecules used in medicinal therapy are administered as salts. Often, a drug substance has certain suboptimal physicochemical or biopharmaceutical properties that can be overcome by pairing a basic or acidic drug molecule with a counterion to create a salt version of the drug. Creating a salt version of the drug can improve solubility, stability, taste, manufacturability, and other key properties. In all but a few rare cases, the toxicology of the basic or acidic drug and the salt form are the same.
Here at Affygility Solutions, when we are reviewing the scientific literature for a drug compound, we are mindful of any differences. Unless otherwise indicated, the OEL for the basic or acidic drug molecule and the salt version of the drug would be the same.
Prior to working with a service provider, the company I work for requires that all service providers sign a non-disclosure agreement, provide a statement of work, and go through an extensive vendor qualification process. Can Affygility Solutions comply with our internal service provider requirements?
The purchase of OEL Fastrac monographs should be viewed the same as purchasing a journal article, reference book, or scientific publication; much like one would do when purchasing publications from Amazon, ANSI, AIHA, ACGIH, or Elsevier Online.
In fact, many of the larger companies that purchase OEL Fastrac monographs do so through their corporate librarian or purchasing department. Others just buy the monographs themselves and expense them internally.
The purchase of an OEL Fastrac monograph should not be viewed as your company entering into a consulting agreement with Affygility Solutions. While we can go through your internal vendor qualification process, it is generally not necessary for the purchase of OEL Fastrac monographs.
Source 1: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=24632
Source 2: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=24749
HBELs are also known as health-based exposure limits and include both permitted daily exposure (PDE) and acceptable daily exposure (ADE).
Health-based exposure limits are used in risk identification of the manufacturing of different medicinal products in shared facilities.
Health-based exposure limits should be determined by a person who has adequate expertise and experience in toxicology/pharmacology, familiarity with pharmaceuticals as well as experience in the determination of health-based exposure limits such as occupational exposure levels (OEL) or permitted daily exposure (PDE).
The term permitted daily exposure (PDE), was first defined in the European Medicines Agency Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. The PDE represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime.
An acceptable daily exposure limit (ADE), is the daily dose of a substance which no adverse events are anticipated, even if exposure occurs for a lifetime.
In short? Yes, they are.
While the calculation variables provided by the European Medicines Agency (EMA) health-based exposure limit guidance differs from those provided by the International Society of Pharmaceutical Engineers (ISPE) Risk-MaPP document, as indicated in the EMA Guidance, the terms are effectively synonymous (meaning that the result will be the same).
Acceptable daily exposure (ADE) and permitted daily exposure (PDE) are exposure limits, by any route (including inhalation, ingestion, dermal, ocular, and injection), for preventing adverse health effects in the patient population due to cross-product contamination.
ADEs/PDEs must NOT be confused with occupational exposure limits (OELs) or occupational exposure bands (OEBs) that are exposure limits for preventing adverse health effects for workers.
It is important when purchasing PDEs and ADEs that you select a toxicology partner with a quality-focused process. Affygility Solutions has a team of experienced toxicologists and provides ongoing and accessible support