Life Sciences EH&S Community Blog

Updated Biosafety Regulation in Cambridge: Good for Research? Good for Business?

Co-Written by Matt Bauer, Marketing Intern and Kim Parker, Life Sciences Account Manager

The Cambridge Public Health Department has recently revised procedure aimed to make Biosafety regulation more stringent. The Cambridge Biosafety Committee (CBC), which was established to oversee basic scientific research involving recombinant DNA (rDNA), was granted further authority.  These revised regulations now require all high-risk labs, even those not involved with rDNA research, to apply through the city for permits as well as allow the Biosafety Committee to perform site visits. Labs used to study agents that pose a high risk of life-threatening disease with no cure known, or Level 4 biohazard labs, were officially banned with this recent Cambridge Regulation.  These updates to procedure come after rising health and safety concerns from nearby residents as well as biotech employees. 

So why does this regulation matter? Is the stricter regulation impacting your facility and how you do research and business?  Triumvirate wants to hear your thoughts!

Hazards/Symptoms of Lead Poisoning

Co-written by Matt Bauer, Marketing Intern and Andy Joy, Life Sciences Account Manager  

With the recent outbreak of lead poisoning in Nigeria which has caused over 100 fatalities in local children as well as the discovery of lead traces found in children’s fruit juices and baby foods in the U.S., you may be asking questions about the dangers of lead and what precautions the country is taking to reduce your risk.  It is clear that lead exposure is incredibly hazardous to your health, but how?  What are the symptoms of lead poisoning?   If it is evident that lead is a health threat and stringent regulations are in place, why can lead traces still be found in day-to-day life?

Lead (Pb) is bright and metallic in color when freshly cut, but its’ surface rapidly tarnishes in the air causing a dull luster.  Lead is very dense, soft, malleable, and resistant to corrosion, but it has poor electrical conductivity.  Its’ unique chemical characteristics lend itself well to many uses including corrosive liquid containment, radiometric dating, batteries, plastics, electronic insulation, as well as numerous uses in the construction industry.  Lead has been used for thousands of years, because of its’ widespread distribution, ease of extraction, and various applications.  Up until the 1950’s, Lead was commonly found in gasoline, paints, and even in pesticides, but has been banned since. 

The use of Lead has been reduced due to its’ hazardous nature, but exposure is still common. It enters the body through ingestion or inhalation, and like many other hazardous elements, bio-accumulates. Because Lead accumulates in the body, there is no minimum safe exposure limit. Lead exposure can interfere with development and damage connections in the nervous system, as well as cause brain and blood disorders.  Children and infants are especially susceptible.  Symptoms include abdominal pain, headache, anemia, irritability, and in severe instances seizure, coma, and death can occur. 

Lead exposure has health implications because Lead interferes and replaces useful metals, such as zinc, calcium, and iron in bodily biochemical reactions. This interference causes genes to turn on and off irregularly, and as a result there are changes in production and shape of proteins.  These altered proteins cannot perform their basic functions, and consequently health problems occur. 

            Even though lead exposure is incredibly dangerous, lead is still prevalent and commonly used. Lead is useful and necessary in many applications, and is not easily replaced. Until alternatives are discovered, it is necessary to take precautions and limit use and exposure of this hazardous metal.     

OSHA’s 2010 Agenda- Safety in the Workplace

By Andy Joy, Life Sciences Account Manager

At a recent ASSE Meeting (American Society of Safety Engineers) an OSHA representative spoke about OSHA's 2010 agenda . With the Obama administration upping OSHA's budget since The President's first day in office, OSHA has more initiative to help employees/employers identify controlled hazards in their workplace to prevent injuries, illnesses, and even fatalities. They include (Taken from http://www.osha.gov/dsg/2009regulatory-priorities.html):

Airborne Infectious Diseases
Airborne infectious diseases such as tuberculosis, severe acute respiratory syndrome (SARS), and influenza can be spread from person-to-person. OSHA is interested in protecting the nation's 13 million healthcare workers from airborne infectious diseases. Healthcare-acquired infections are on the rise and there are also increasing levels of drug-resistant microorganisms in healthcare settings. Most current infection control efforts are intended primarily for patient protection and not for worker protection. In March 2010, OSHA intends to publish a Request for Information to help examine how to improve worker protection from exposure to airborne diseases.

Occupational Injury and Illness Recording and Reporting Requirements (Musculoskeletal Disorders)
OSHA is proposing to revise its regulation on Recording and Reporting Occupational Injuries and Illnesses (Recordkeeping) to restore a column on the OSHA 300 Injury and Illness Log that employers will check when recording work-related musculoskeletal disorders (MSDs). The MSD data from the column will help about 750,000 employers and 40 million workers track injuries at individual workplaces, and improve the Nation's occupational injury and illness information data published by the Bureau of Labor Statistics. The MSD column was removed from the OSHA 300 Log in 2003. The Agency will issue a proposed rule in January 2010.

Cranes and Derricks
More than 80 workers lose their lives each year in crane-related fatalities. OSHA's existing rule, which dates back to 1971, is partly based on industry consensus standards that are over 40 years old. On October 9, 2008, OSHA issued a comprehensive proposed revision of the Cranes and Derricks standard. The proposed rule addresses electrocution hazards, crushing and struck-by hazards, overturning, procedures for ensuring that the weight of the load is within the crane's rated capacity, and ensures that crane operators have the required knowledge and skills by requiring independent verification of operator ability. This year, OSHA completed the public hearing and comment phase of the process and is now analyzing the public's input and preparing the final rule. OSHA plans to issue the final rule in July 2010.

Crystalline Silica
Inhalation of respirable silica dust can cause lung disease, silicosis and lung cancer. Exposure to airborne silica dust occurs in operations involving cutting, sawing, drilling and crushing of concrete, brick, block and other stone products, and in operations using sand products (e.g., in glass manufacturing and sand blasting). One study estimated that there may be as many as 7,000 new cases of chronic silicosis each year. This rulemaking will update existing permissible exposure limits and establish additional provisions to protect workers from exposures to respirable crystalline silica dust. OSHA plans to publish a Notice of Proposed Rulemaking in July 2010.

Combustible Dust
Combustible dust can cause catastrophic explosions like the 2008 disaster at the Imperial Sugar refinery that killed 14 workers and seriously injured dozens more. Deadly combustible dust fires and explosions can be caused by a wide array of materials and processes in a large number of industries. Materials that may form combustible dust include wood, coal, plastics, spice, starch, flour, feed, grain, fertilizer, tobacco, paper, soap, rubber, drugs, dyes, certain textiles, and metals. While a number of OSHA standards address aspects of this hazard, the Agency does not have a comprehensive standard that addresses combustible dust. OSHA is engaged in the early stages of rulemaking to develop a combustible dust standard for general industry. OSHA published an Advance Notice of Proposed Rulemaking in October 2009 and is preparing to hold stakeholder meetings in December 2009.

Hazard Communication Standard - Global Harmonization System of Classification and Labeling of Chemicals
OSHA and other U.S. agencies have been involved in a long-term project to negotiate a globally harmonized approach to informing workers about chemical hazards. The result is the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). OSHA is revising its Hazard Communication Standard to make it consistent with the GHS. The new standard will include more specific requirements for hazard classification, as well as standardized label components which will provide consistent information and definitions for hazardous chemicals and a standard approach to conveying information on material safety data sheets. On September 30, OSHA published the proposal and is preparing for hearings in March 2010.

Beryllium
Beryllium is a lightweight metal that has a wide variety of applications, including aerospace, telecommunications and defense applications. Chronic beryllium disease occurs when people inhale beryllium dust or fumes and can take anywhere from a few months to 30 years to develop. The disease is caused by an immune system reaction to beryllium metal, and causes symptoms such as persistent coughing, difficulty breathing upon physical exertion, fatigue, chest and joint pain, weight loss, and fevers. OSHA is developing a rule that would update the Permissible Exposure Limit and establish additional provisions to protect exposed workers. Currently, the Agency is preparing to conduct a peer review of the health effects and risk assessments and plans on initiating the peer review in March 2010.

Diacetyl
Employee exposure to diacetyl causes obstructive airway disease, including the disabling and sometimes fatal lung disease called bronchiolitis obliterans or "popcorn lung." This rulemaking will establish a Permissible Exposure Limit as well as additional provisions to protect workers from exposure to diacetyl. OSHA held a stakeholder meeting on diacetyl in 2007 and completed the small business review panel report in July 2009. OSHA is currently working on the proposed regulatory text and developing the health, risk and feasibility analysis. The Agency plans to initiate a peer review of the health effects and risk assessments in October 2010.

Walking / Working Surfaces - Subparts D & I
This proposed standard will update OSHA's rules covering slip, trip and fall hazards and establish requirements for personal fall protection systems. The rule affects almost every non-construction worker in the United States. This is an important rulemaking because it addresses hazards that result in numerous deaths and thousands of injuries every year. The proposal is expected to prevent 20 workplace fatalities per year and over 3,500 injuries serious enough to result in days away from work. The Agency plans to issue a proposal in March 2010.

What concerns you most about your workplace?

Healthcare Reform Bill with Senator Harkin

By Denise Hutchins, Executive Director of Life Sciences

Triumvirate Environmental was fortunate enough to host an intimate discussion with a handful of life sciences industry leaders and Senator Tom Harkin (D-IA) during his most recent Massachusetts visit. Senator Harkin took over for the late Senator Kennedy as Chairman of the Health, Education, Labor and Pensions Committee in 2009, and also serves as Chairman of the Appropriations Sub-committee on Labor, Health and Human Services and Education. Senator Harkin is uniquely situated as both the primary author of health sciences policy, and the point person for allocating funds in that area.

We talked with the Senator about the healthcare reform bill and its creation. We also discussed important issues surrounding:

1. the cost of pharmaceutical development and its resale cost to the consumer;
2. changing the last Small Business Innovation Research (SBIR) interpretation of the eligibility requirements and expanding the eligibility requirements to allow companies to participate that would otherwise be excluded due to the individual ownership requirement.
3. increasing the appropriation of $1 billion for tax years 2009 and 2010 in the Patient Protection and Affordable Care Act of 2010. Available tax credits/grants are set aside for small- and mid-sized biotech, pharmaceutical and medical device companies that meet the criteria and apply.

Life Science Startup Companies – Hazardous Waste Management

By Kate Carpenter, Technical Services Representative

Do you generate hazardous waste from lab work? Perhaps you generate a small volume of hazardous waste, and you don’t think that it’s enough to worry about. You may want to know that regardless of your company size, you need to manage hazardous waste in a safe manner. You are required to dispose of it properly in accordance with state and federal regulations, but there are less stringent standards if you qualify as a Very Small Quantity Generator (VSQG).

If you are new to the game of hazardous waste, the first thing you should do is to determine what type of waste streams you have. Materials that are determined to be ignitable, reactive, corrosive or toxic will need to be considered. Then you should judge how much you generate of each waste. In Massachusetts for example, if you generate less than 220 pounds (27 gallons) of hazardous waste a month and no acutely hazardous waste then you can register as a VSQG, if it is more you will have to look into becoming a Small Quantity (between 220-2,200 lb and/or less than 2.2 lb of p-listed waste) or a Large Quantity Generator (over 2,200 lb and more than2.2 lb of acutely hazardous waste). As a VSQG, you can accumulate up to 1, 000 kilograms (or 2,200 lb/ 270 gallons) onsite for an infinite amount of time, but can never store more than that onsite. You should be mindful to never exceed these limits or you will have to register as a SQG or a LQG and you should always check your state regulations for specifications. Minimizing the amount of hazardous waste generated by using non-hazardous substitutes and/or recycling and reusing alternatives whenever possible can help you stay under these limits.

If you meet the criteria for a VSQG, you are given more flexibility than the larger generators, but you still have specific requirements you must follow. You may still need to register with your state environmental agency (look on their website for registration forms) and you are still responsible for correctly managing your waste. A few of the requirements are listed below.

• Store hazardous waste on an impervious surface
• Secure the storage area against unauthorized access
• Post Hazardous Waste signs near the storage area.
• Label each container as hazardous waste with the name of the waste fully spelled out and its associated hazard(s) such as “ignitable” “corrosive” “toxic” or “reactive”
• Retain records of all hazardous waste manifests for shipment as well as any records of the type/quantity of waste generated and the date/method of treatment, recycling or disposal.
  

If you’re unsure about any step in the process, check your state’s environmental webpage or contact an environmental advisor to review your current procedures and jumpstart your environmental health and safety program.

Your Chemical Inventory – Reloaded

By Bart Nielsen, Environmental Compliance Specialist

If you're a typical safety, purchasing, or facilities manager in the Life Sciences you are probably familiar with the term "Chemical Inventory." Chances are you either have one or have had experience working with one. If you're like me then you probably learned that implementing a chemical inventory program isn't a quick setup accompanied by the hope that once it is up and running you can stand back and let it work its magic.

If you've experienced difficulties getting your inventory program off the ground or aren't generating the results you had hoped for perhaps it's time to RELOAD your program.

At Triumvirate we like to describe a chemical inventory as having a lifecycle that includes three stages:

1. Conception
2. Implementation 
3. Optimization

So what do I mean by RELOADED?

I mean get back to the basics. Revisit the drivers and goals for wanting to track your inventory. Make sure you've connected with the right folks in your organization, the ones who have a stake in making your inventory program successful: EHS professionals, end users (scientists), purchasing, facilities, shipping and receiving, and more...

If you have your nose pointed in the right direction from the outset, you have a much higher chance for implementing a successful chemical inventory program.

For more detailed information, click here for our recent chemical inventory white paper on Creating & Managing a Chemical Inventory System by Sam Hyde, Chemist II at Triumvirate Environmental.

Next up... What to do now that you've successfully implemented your chemical inventory program!

Look for our next Chemical Inventory Management Roundtable!

EH&S Positions/Placement

By Kevin Brayton, NE Director of Life Sciences

The Bio/Pharma industry is fast paced and heavily regulated - the wrong hire can upset the culture and/or position the organization for a poor audit (regulatory or corporate), public relations issues, a costly fine, or insurance situation.

Often, I am asked to refer, recommend, or give a thumbs up or down on potential EH&S candidates for life sciences organizations. Whether the position is for a director level or entry level specialist, I usually have strong feelings as to who would be an asset to that organization.

How do I make my recommendations?
Simple - I ask myself how do people rate in the following areas: Past Performances, Emotional Intelligence and Network (PEN).

(More on PEN in later Blogs)

The 3R to Toxic Waste Minimization

 By Ian Lanza, Life Sciences Operations Coordinator

The EPA identifies reduce, reuse, and recycle as the three fundamental strategies for reducing toxic waste. Generators should think of the 3R toxic waste reduction strategy as a hierarchy. When implementing the 3R toxic waste reduction strategy, generators should begin by identifying reduce opportunities, then reuse opportunities and finally recycling options.

1. Reduce - Reducing waste generation is the most environmentally sustainable solution to toxic waste reduction. Reduce opportunities should be pursued before reuse or recycle options. Toxic waste reduction strategies may include substituting less hazardous components, more efficient process, or onsite neutralization.
2. Reuse - If you cannot reduce toxic waste generation, the next best option is to Reuse waste. Reusing is a method of closing the loop, which diverts waste from disposal for other uses. Reusing is different from recycling because reuse implies that a waste product will be used for a new process without any reconditioning or putting energy towards reclaiming valuables. Toxic waste reuse strategies include reverse chemical distribution fuel blending and waste-to-energy technology.
3. Recycling - Recycling implies that a waste will go through a process (melting, compacting, reshaping) and to reclaim a resource to be used for a different purpose. Recycling requires additional energy and costs to recover valuables and is less desirable than waste reduction or reuse, but is better than traditional disposal. Toxic waste recycling includes universal waste management of light bulbs and batteries, oil recovery, and electronic waste recycling.
   

The Effect of Healthcare Reform on Life Sciences

By Kate Carpenter, Technical Services Representative

The approval of the "Health Care and Education Reconciliation Act of 2010" will significantly impact the life sciences world.

The obvious impacts are those outlined in the bill.

• Tax credit for small biotech companies. If you have less than 250 people, the company may be eligible for a tax credit for 50% of a qualified investment in clinical trials, pre-clinical research and other activities. This will help startup companies in the expensive early days.
• Pharmaceutical Manufacturer's fee. If you are in the pharmaceutical manufacturing industry, you will have to pay an annual, non-deductible fee according to market share. This does not apply to companies with sales of their pharmaceuticals $5 million or less. It could negatively affect companies who have had millions in sales but are not yet running a profit. 
• Sunshine Act. This will require drug, device and biologic manufacturers to document and report all payments and gifts to physicians, teaching hospitals, and providers that are greater than $100.
• CURES Accelerator Network. This is a $500 million fund to support research and product development in research institutions, medical schools, pharmaceutical companies and biotechs for diseases that have been mainly ignored due to expected small profits.
  

There will also be impacts from the core idea of universal medical coverage for all Americans. As more people get preventive care and insurance helps them pay for medications, drug prescriptions and usage are expected to rise. This will not only boost sales for current drugs on the market, but could open the door to a need for development of certain pharmaceuticals. With more individuals going for diagnoses, there may be new needs to pharmaceuticals that are not yet produced. The affects of this highly debated and controversial bill on the life sciences industry along with the American population still remain to be seen.

Hazards/Symptoms of Carbon Monoxide Poisoning

By Andy Joy, Life Sciences Account Manager

You might think, what is so dangerous about a gas that you can't see or smell? Well, if it's Carbon Monoxide, it can be very dangerous and deadly. We all should have carbon monoxide detectors in your house...not only because that's what the experts recommend, but because they save lives.

Carbon Monoxide (CO) becomes present when any source of fuel is burned. Examples would include, but not limited to, kerosene, gas, oil, and wood. Carbon Monoxide, when present at high levels, can kill a person very quickly...meaning within minutes. Furthermore, infants and small children, the elderly, and people with asthma are much more susceptible to CO poisoning.

To be aware of CO poisoning, you must know the symptoms; they include, headaches, becoming dizzy, nauseated, and shortness of breath. Most of these symptoms are common with the flu or food poisoning as well so be cautious of your surroundings when the symptoms occur.

How does CO poisoning work in your body? Well, when you breathe in CO, it displaces the O2 levels in your blood stream, and starves your vital organs, including your heart and brain, of O2. Without O2, your organs can't function. The reason you become short of breath is because your lungs are depleted of O2; or the reason you become dizzy, your brain becomes light-headed, because your O2 levels are diminished.

Therefore, if your house currently does not have a CO detector, I recommend installing them. For a gas that you can't see or smell, it's definitely a gas of big concern, with dire consequences. Remember, the life you save might be your own!