The CEM Comprehensive Industrial Hygiene Laboratory (CEM CIHL) recommends no longer using the OSHA 52 method for formaldehyde. CEM recommends using the NIOSH 2016 method for formaldehyde. Therefore, formaldehyde sampling will now have to be performed using a 2,4-DNPH-treated Silica Gel (SKC ST 226-119) tube, this change is being recommended because NIOSH 2016 is more sensitive and more reliable. Questions regarding the NIOSH 2016 method can be directed to CEM’s AIHA CIHL at 800.252.2236 in Salina, Kansas or 785.823.0492 Bruce Fast, Laboratory Director.

Mold remediation is a leading topic concerning Indoor Environmental Quality. AIHA guidance for mold assessment, sampling and remediation is now available through CEM at 800.252.2236 Indoor Air Quality Documents. Call to discuss your Indoor Environmental Quality Concerns by contacting Brenda Tolson-Markas, Director of Services.

Skin diseases of occupational origin outnumber all other work-related illnesses. Airborne exposures often receive more attention because they are easier to measure and compare to standards and guidelines. However, safety and health professionals should not neglect the evaluation and control of chemical exposures that cause dermatitis and/or systemic effects through skin contact and/or absorption. A short summary of significant items and resources related to these issues is provided in this discussion. Protective equipment manufacturers also provide good information on this topic.

The American Industrial Hygiene Association has published guidelines for assessing your occupational concerns in the dermal arena.

Certified Environmental Management, Ltd. (CEM), have web-based tools and electronic based evaluation tools that allow for Dermal Hazard Assessments following the latest published guidelines and color charting. See below for criterion language and tools utilized by CEM to conduct a detailed Dermal Exposure Assessment.

Dermal Contact Area (DCA) - Assuming the absence of dermal PPE:

1. Unexpected/unlikely.
2. Very small area of skin contact.
3. Contact possible to hands and forearm.
4. Contact possible to significant area of skin.

Dermal Concentration (DC):

1. Negligible concentration of agent likely to contact the skin.
2. Low concentration of agent likely to contact the skin.
3. Moderate concentration of agent likely to contact the skin.
4. High concentration of agent likely to contact the skin.

Dermal Contact Frequency (DCF):

1. Minimal contact with skin; one or two incidental contacts; contact during less than 5% of work shift.
2. Up to 10 incidental contacts with skin; contact during less than 10% of work shift.
3. Up to 50 incidental contacts with skin; contact during less than 50% of work shift.
4. Routine incidental contact with skin throughout the shift; contact during 50-100% of work shift.

Dermal Retention Time (DRT):

1. Amount transferred unlikely to remain on skin for any period of time (i.e., high volatility, dry and powdery).
2. Amount transferred may remain on skin for some time (i.e., some volatility or adherence to skin).
3. Amount transferred is likely to remain on skin for a significant period of time (i.e., low volatility, high MW, sticky or consolidated on skin even if not visible).
4. Amount transferred very likely to remain on skin (i.e., substance not volatile, MW > 100, substance very likely to stick to skin).

Dermal Penetration Potential (DPP):

1. Rare (large, insoluble particles).
2. Less likely (small insoluble particles > 1 micron in size, or both poor lipid solubility and poor water solubility).
3. Possible or slow (very small insoluble particles < 1 micron, or some lipid solubility and some water solubility, or marginal skin health).
4. Probable or likely (good lipid solubility and good water solubility, or poor skin health).

Exposure Potential Rating (Dermal Exposure Rating):

Exp. Potential Rating = (DCA) (DC) (DCF) (DRT) (DPP)

The Dermal Exposure Rating is determined by multiplying each of the above five Ratings together to provide a value between 1 and 1024.

Dermal Hazard Rating:

1. Reversible or very low skin or systemic toxicity.
2. Moderate but reversible skin or systemic toxicity.
3. Irreversible/chronic skin or systemic toxicity or sensitization.
4. Life threatening skin or systemic toxicity or sensitization.

Risk Rating Levels (Color Code):

1. Green - Low risk.
2. Yellow - Moderate risk.
3. Orange - High risk.
4. Red - Very high risk.

For more information see http://www-nmcphc.med.navy.mil/IH/GeigerSkinExposure.doc.

In September of 2008 NIOSH Published a NIOSH Criteria Document Update involving Hexavalent Chromium.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) is conducting a public review of the NIOSH draft document "NIOSH Criteria Document Update: Occupational Exposure to Hexavalent Chromium." This draft NIOSH document provides a review of the available literature and an update of NIOSH policies on occupational exposure to hexavalent chromium compounds including an assessment of:

1. Critical animal, human, and in vitro studies on occupational exposure to hexavalent chromium.
2. Relevant quantitative risk assessments about occupational exposure to hexavalent chromium.
3. Appropriate methods for sampling and analysis of hexavalent chromium compounds in the workplace.
4. Basis for the NIOSH revised Recommended Exposure Limit for hexavalent chromium compounds
5. Other NIOSH recommendations for protecting workers from occupational exposure to hexavalent chromium.

This guidance document does not have the force and effect of law.

The purpose of the public review of the draft document and public meeting is to obtain public comments to ensure that:

1. This hazard identification is an accurate reflection of the available scientific studies.
2. The NIOSH recommendations for protecting workers from occupational exposure to hexavalent chromium compounds are appropriate and justified.
3. NIOSH has a transparent and scientific basis for its revised Recommended Exposure Limit for hexavalent chromium compounds.

The overall goal of the review is to enhance the quality and credibility of agency recommendations by ensuring that the scientific and technical work underlying these recommendations receives appropriate review by independent scientific and technical experts.

Please see http://www.cdc.gov/niosh/review/public/144/ and be sure to make your comments by March 31, 2009 or feel free to contact Certified Environmental Management, Ltd., laboratory director, Mr. Bruce Fast, or senior industrial hygiene analyst, Ms. Carolyn Robinson, at 800.252.2236 to discuss this docket in detail.

Most importantly CEM want all clients to know that the OSHA ID-215, Version 2 Method utilized at our AIHA laboratory has been determined to be the most accurate method and technology available to date. CEM is proud of the advisement that we have provided through our technical support hotline at 800.252.2236.

Ototoxicy for the past several years has gained research and ACGIH publication space within the annual TLV and BEI book along within the European and German community.

The term "ototoxicity" refers to the damaging effect of certain substances on the hearing, vestibular organ but also the seventh cranial nerve. In the clinical field, there are a number of drugs that have ototoxic side-effects--certain antibiotics (aminoglycoside), cytostatic agents (cis-platinum), loop diuretics but also salicylates (aspirin) and quinine. To a large extent, their mechanisms of action within the inner ear are known. The main area to come under attack is the organ of Corti with its hair cells and the adjacent tissue. The ototoxic side-effects of such drugs can be avoided by means of targeted dosage, coupled with monitoring of the inner-ear function.

Some hazardous substances are also known to have ototoxic effects though only a fraction of the knowledge required for a toxicological risk assessment is available. The following list shows substances with ototoxic potential that play an important role in the world of work:

• Arsenic
• Cadmium
• Carbon disulfide
• Carbon monoxide
• Cyanide
• Ethyl benzene
• Lead
• Mercury
• n-heptane
• n-hexane
• n-propylbenzene
• Styrene
• Toluene
• Trichloroethylene
• Xylene

Although there are noisy workplaces in the chemical-manufacturing industry, relevant exposure to potentially ototoxic hazardous substances is not likely as a rule. To date, the regular hearing tests have not identified any ototoxic effects without their having been exposure to noise.

In the metal industry, where there are a considerable number of workplaces in noise zones, a wide range of ototoxic industrial chemicals are used. A preliminary risk analysis in work areas with this type of combined exposure identified the activities in which the occupational exposure limits for specific substances were adhered or, in some cases, exceeded. This information can be used to derive risk groups and to develop targeted protection measures.

The construction industry also uses potentially ototoxic substances and is no stranger to noisy workplaces. However, the data on audiometric findings and health screenings for persons exposed to specific hazardous substances do not give any clear indication of the way in which ototoxic industrial chemicals influence the hearing.

In Germany, during the period from 1993 to 2002, the Berufsgenossenschaft ("BG") institution for statutory accident insurance and prevention in the printing and paper-processing industry conducted a field study on the subject of toluene in gravure printing works. The study specifically examined the issue of ototoxic effects combined with noise and also recorded exposure levels extremely meticulously. It did not find any toluene-induced reduction of the hearing threshold, nor was there any evidence of hearing damage being intensified due to interaction between noise and toluene. It can be assumed that there is no ototoxic effect if the limit value of 50 ppm is adhered to.

Additionally, the effect of occupational exposure to noise and industrial chemicals was the topic of the multinational EU research project "NoiseChem". Based on animal experiments and epidemiological studies, it concluded that occupational exposure to organic solvents meant a higher probability of hearing loss developing. The risk posed by combined exposure is combined exposure.

Furthermore, the current limit values might not provide adequate protection. There is evidence that ototoxic effects on balance could be early indicators of neurotoxicity. The Federal Institute for Occupational Safety and Health (BAuA) examined the literature on ototoxicity of solvents to check it for meaningfulness and comparability. The results showed that the findings of the epidemiological studies were inconsistent. There are however a great many indications that low concentrations of solvents can be ototoxic. Knowledge of this area is extremely scant due to numerous problems and weaknesses in the published studies. With regard to the ototoxicity of styrene, the data available from animal experiments shows that damage to the hair cells is irreversible. It can be caused by relatively short, high levels of exposure. The mechanisms of action for noise and styrene are different. Below styrene’s effect level, the effect of the noise does not increase. The level of styrene in the blood is the crucial internal dose. A limit value with an adequate safety factor has been derived as 50 ppm (current occupational exposure limit = 20). Uncontrolled exposure at laminating workstations can result in a risk of hearing damage.

A critical analysis of the results of major international working groups, particularly in relation to current conditions at workplaces, indicates significant weaknesses in the way that exposure is handled. For instance, the dose/response relationships have not yet been determined, nor has there been any discussion of effect levels. The effects of occupational exposure, some of which are considerable, relate to cohorts that were exposed both to noise and hazardous substances above the limit values. If the current limit values are adhered to, hearing losses of >25 dB are not very probable.

Ototoxic industrial chemicals comprise a variety of chemicals with different properties, of which the toxicology and potential risk for the hearing are not adequately known. In particular, there has not been much investigation of pathomechanisms, dose/response relationships or effect levels.

With regard to scientific findings relating to human beings, a point worthy of criticism is that a precise recording of exposure is problematic and there is hardly any knowledge about ototoxic effects in the lower exposure conditions at today's workplaces. There is also no reliable data on the possible combined effects of noise and ototoxic industrial chemicals. The knowledge presently available is so incomplete that it is currently not possible to determine with the necessary accuracy whether the chemicals suspected of posing a risk do constitute substantial risks in the world of work and, if so, which chemicals cause the risks and under which working conditions risks might occur.

During national/international panel discussions, the participants agreed the following conclusions regarding the current workplace situation:

1. If the current limit values are adhered to, the probability of significant hearing loss is low.
2. There can be a higher risk in activities involving ototoxic industrial chemicals if the limit values are exceeded.
3. Noise is the highest risk factor for hearing damage. Ototoxic effects are of a similar proportion to those caused by other confounders, such as cigarette smoke or a genetically determined heightened sensitivity.

Measures to combat noise-induced hearing loss need to continue to have top priority. At CEM we have the capability through our Occupational Health Hazard Assessment tool to provide you with chemicals, tasks, and percentages that the chemical exists in the product so that every customer has the capability to target and screen ototoxic chemicals.

Please feel free to contact Brenda Tolson-Markas, Director of Services, to discuss this application and product in detail at 800.252.2236.

Over the past several months numerous clients of Certified Environmental Management, Ltd. (CEM) have been contacting us to ask questions about ECHA, DNELs, and NOAELs. To answer many of these questions, we are providing some critical information based on our team's continuing education training through ACGIH in 2010. Please view the PDF link below to see a presentation given by ACGIH on these issues. You may also contact our staff at 800-252-2236 to discuss and ask any other questions.

What are NOAELs/NOELs?

The Agency for Toxic Substances and Disease Registry (ATSDR) is a federal public health agency with headquarters in Atlanta, Georgia, and 10 regional offices in the United States. ATSDR's mission is to serve the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent harmful exposures and diseases related to toxic substances. ATSDR is not a regulatory agency, unlike the U.S. Environmental Protection Agency (EPA), which is the federal agency that develops and enforces environmental laws to protect the environment and human health. NOAELs (no observed adverse effect level) and NOELs (no observed effect level) describe the highest tested dose of a substance that has been reported to have no harmful (adverse) health effects on people or animals. This can apply to a particular study, species (e.g. rat, dog), or all studies on a particular substance. The difference between NOAEL and NOEL rests on the definition of adverse effect only, that is, an experimental study that produced a NOAEL will have stated the adverse effect to be observed before initiation.

What is REACH?

In the November 2006 Newsletter the Europeans previewed the new European Regulation on Registration Evaluation and Control of Chemicals (REACH). REACH was passed by the European Parliament on 13 December 2006 and entered into force in June 2007. It heralds the largest shake-up of occupational hygiene practice since the introduction of COSHH. Not least among the changes will be the creation of Derived No-Effect Levels (DNELs).

What is a DNEL?

The Derived No-Effect Level (DNEL) is defined in Annex 1 of REACH as the level of exposure above which humans should not be exposed. Manufacturers and importers are required to calculate DNELs as part of their Chemical Safety Assessment (CSA) for any chemicals used in quantities of 10 tons or more per year. The DNEL is to be published in the manufacturer’s Chemical Safety Report and, for hazard communication, in an extended Safety Data Sheet (SDSs). The DNEL is used in the risk characterization part of the CSA as a benchmark to determine adequate control for specified exposure scenarios. Risk to humans can be considered to be adequately controlled if the exposure levels estimated do not exceed the appropriate DNEL.

REACH specifies that DNELs shall reflect the likely routes, duration and frequency of exposure. If more than one route of exposure is likely to occur, (oral, dermal or inhalation), then a DNEL must be established for each route of exposure and for the exposure from all routes combined. It may also be necessary to identify different DNELs for each relevant human population (e.g. workers, consumers and humans liable to exposure indirectly via the environment) and possibly for certain vulnerable sub-populations (e.g. children, pregnant women).

Manufacturers and importers must give a full justification for the DNEL, explaining their choice of the information used, the route of exposure, and the duration and frequency of exposure to the substance for which the DNEL is valid. They must take into account the uncertainty arising from the variability in the experimental data, intra- and inter-species variation, the nature and severity of the effect and the sensitivity of the human (sub-) population to which the quantitative and/or qualitative information on exposure applies. The resulting value can be considered as an overall NOAEL/NOEL for a given chemical based on an integration of all available and relevant human health hazard data.

REACH then requires the manufacturer or importer to perform a risk characterization (RC) for the leading health effect, i.e. for the toxicological effect that results in the most critical DNEL. The exposure/DNEL ratio in principle presents a simple tool for RC, especially for downstream users who do not have the hazard data at their disposal. For any exposure scenario the risk to humans can be considered to be adequately controlled if exposure levels do not exceed the appropriate DNEL.

For some endpoints, especially mutagenicity and carcinogenicity, the available information may not enable a threshold, and therefore a DNEL, to be established. This is the case when the available data do not allow reliable identification of a threshold, or when a substance exerts its effect by a non-threshold mode of action. In such cases it is assumed that even at very low levels of exposure, residual risks cannot be excluded.

What Are the implications of DNELs?

The DNEL methodology is intended to harmonize the approach to occupational health risk assessment with those used for other types of risk. It can be compared, for example, with the Predicted No-Effect Concentration (PNEC) used to assess environmental risks. This is important under REACH, as manufacturers must assess not only human health risks but environmental and physical safety risks as well. However, HSE’s WATCH committee has looked at the comparability of risk assessment approaches for different purposes and has concluded that there are good reasons for the OEL process being different.

DNELS are more precautionary than conventional Occupational Exposure Limits (OELs). The calculation of DNELs follows a rule-based approach in which a series of standardized assessment factors are applied to the toxicological endpoints to allow for uncertainties and inter-/intra -species differences. This can result in a very conservative figure, perhaps one or two orders of magnitude lower than that from the traditional OEL setting process. While the extra margin of safety in DNELs will be welcomed by some, it raises the question of practicability. How would industry handle, say, a 10-fold reduction in exposure limits?

Some people hope, and expect, that DNELs will eventually replace OELs because they are more stringent. The European process for setting Indicative Occupational Exposure Limit Values (IOELVs) is well established, involving experts from member countries on a scientific committee (SCOEL) and providing an opportunity for stakeholders in industry and government to comment on the proposals. In contrast, these democratic safeguards will not be there under REACH. DNELs calculated by individual manufacturers and importers are not subject to any requirement for consultation or opportunity for input by interested parties.

Debate is also underway to decide what to do when a DNEL cannot be established. Is it possible to set a Derived Minimum Effect Level (DMEL), based on some concept of acceptable or negligible risk, (such as the “Threshold of Toxicological Concern”), or should such materials automatically be banned because they cannot be adequately controlled?

The methodologies, tools and technical guidance needed for REACH are currently being developed by the European Chemicals Bureau through a series of REACH Implementation Projects (RIPs). RIP 3.2 is focused on technical guidance for preparing the Chemical Safety Report and has a sub-group tasked with looking at the derivation of DNELs. Further information can be found on the ECB website at www.ecb.jrc.it/reach.

ISO (the International Organization for Standardization) and IEC (the International Elecrotechnical Commission) form the specialized system for worldwide standardization. ISO/IEC 17025:2005(E) states that the laboratory shall be willing to cooperate with customers in clarifying the customer’s request and in monitoring the laboratory’s performance in relation to the work performed, provided that the laboratory ensures confidentiality to other customers. Such cooperation may include: a) providing the customer reasonable access to relevant areas of the laboratory for the witnessing of tests and/or calibrations performed for the customer b) preparation, packaging, and dispatch of test and/or calibration items needed by the customer for verification purposes. The laboratory shall seek feedback, both positive and negative, from its customers. The feedback shall be used and analyzed to improve the management system, testing and calibration activities and customer service.

To comply with this regulation Certified Environmental Management, Ltd. (CEM) notifies our customers by email when their samples are received. The email informs the customer to contact CEM if there are any questions, concerns, comments or suggestions. When necessary the email will also alert the customer that one (1) or more of their samples will be sent to another AIHA accredited laboratory. The email includes attachments of the chain-of-custody which was provided by the customer with the samples and a letter for each analyte that includes the customer’s file number, order number, PO #, expected completion date and the method of the analysis. CEM also provides in the email a link to our survey which gives our customers the opportunity to easily provide feedback.

Samples can be submitted through the CEM website. Chain-of-Custodies are available and can be printed from the CEM website. For questions call CEM Technical Support at 800-252-2236.

References

ISO/IEC 17025:2005(E) Section 4.7 and 4.8

OSHA has issued a revised version of the OSHA ID-215 method for hexavalent chromium sampling--Method Number ID-215 (version 2). The significant modification (related to sample collection) in the method is that when using the 37 or 25 mm PVC filter with cellulose back-up pad for welding operations, or chromium plating operations, special handling requirements have been added.

A summary of the new special handling requirements follows:

1. Samples collected on PVC filters must be shipped overnight to the laboratory within 24 hours of sampling.
2. Samples collected on PVC filters from welding operations must be analyzed within 8 days of sampling.
3. Samples collected on PVC filters from chromium plating operations must be analyzed within 6 days of sampling or be stabilized at the laboratory upon receipt.

The Salt Lake Technical Center has done studies, since the original fully validated method was promulgated, that show sample loss/degradation on welding operation samples due to interaction of the Cr(VI) and Fe(II) after collection. They also found that chromium plating operations typically had significant amounts of sulfuric acid that reacts with the Cr(VI) after collection to form Cr(III). These interferences have caused OSHA to modify the method to reduce potential bias. If the samples are not treated according to these requirements--the results may be biased low. Their studies show up to approximately 25% negative bias after 14 days.

For more information, see http://www.osha.gov/dts/sltc/methods/inorganic/id215/id215.pdf.

Certified Environmental Management (CEM) has been recommended as a VPP Star Work Site!

"The Voluntary Protection Programs (VPP) promote effective worksite-based safety and health. In the VPP, management, labor, and OSHA establish cooperative relationships at workplaces that have implemented a comprehensive safety and health management system. There are three ways to participate in VPP: Site-based, mobile workforce, and corporate. Approval into VPP is OSHA’s official recognition of the outstanding efforts of employers and employees who have achieved exemplary occupational safety and health." (OSHA, http://www.osha.gov/dcsp/vpp/index.html)

For more information about CEM's VPP Star Recommendation, please see the following presentation (PDF file).

Now is the time to make a change involving your companies 29 CFR 1910.1200 Hazard Communication Standard of managing your Material Safety Data Sheet. If your company strategically determines that an electronic web-based system will be available to all of your employees the total integration of your company’s safety and health program will be ready to address the Global Harmonized System (GHS) for Safety Data Sheets (SDS’s). See the following PDF file for a presentation from OSHA discussing the new GHS system and how it will impact you.

As many safety professionals know, the OSHA permissible exposure limits (PELs) cover approximately 500 chemicals. However, most of these 500+ PELs are based on toxicological data from 1968. Alternatively, ACGIH has about 600 TLV standards that are updated annually, but the ACGIH standards are not mandatory. Given this situation, are the OSHA and ACGIH limits truly protecting U.S. workers? Further complicating this is that thousands of chemicals are used in workplaces for which the United States has no standards. Are there other sources of occupational exposure limits that safety and health professionals can access to insure adequate protection of their workers?

Over 35 countries worldwide regulate over 3,500 occupational chemicals. Most of them are updated with the latest toxicological data every 2 to 3 years. How might this affect the safety professional in the United States? How might it affect U.S. manufacturing facilities overseas? Exposure standards that are promulgated globally can include no effect levels, 8-hour exposure standards, 15-minute exposure standards, ceiling limits, or levels that are immediately dangerous to life and health.

Certified Environmental Management, Ltd. can provide a summary of this body of knowledge by listing the lowest standard, the mean standard, and the highest standard for chemicals in each classification. Significant legal liability questions are starting to be raised for CIHs and CSPs who are unaware of these global regulatory standards for chemicals that are unregulated in the United States. This is occurring in both the United States and in corporate manufacturing facilities around the world. The Code of Ethics for CIHs and CSPs requires professionals to be updated on current information. Questions regarding both legal and ethical practice implications of this information will be included.