ACGIH approves new occupational exposure limit for Peracetic Acid

New ACGIH STEL for Peracetic Acid

The American Conference of Governmental Industrial Hygienists (ACGIH) Board of Directors has approved the 2014 occupational exposure limits. Included in these limits is a new short-term exposure limit (STEL) for peracetic acid (PAA, C.A.S 79-21-0). This new STEL is 0.4 ppm over a rolling 15-minute period.

Peracetic acid is a strong oxidant and is often contained in disinfectants that are used in the biotechnology, pharmaceutical, medical device and healthcare industries. In particular, in combination with hydrogen peroxide and acetic acid, peracetic acid is contained in a product called Spor-Klenz. It should be noted, that legacy material safety data sheets for this product do not list the new STEL for peracetic acid. It should be anticipated, in the near future, that the new limit will be included on revised MSDS.

What are the acute health effects of peracetic acid?

Acute exposures to peracetic acid can cause irritation of the eyes, skin irritation (including oxidation), mild irritation to the upper respiratory tract (including sore throat, nasal irritation).

Performing industrial hygiene air monitoring for peracetic acid?

The preferred method to monitor for peracetic acid is to use a combination sampler for both hydrogen peroxide and peracetic acid. This combination sampler consists of a treated filter and treated tube that is sampled a one (1) liter per minute. Sampling can then be performed for the STEL, or for the OSHA PEL for hydrogen peroxide of 1 ppm as an 8-hour time-weighted average (TWA).

With the publication of the new STEL for peracetic acid, it is important to understand what airborne concentrations are being generated. This is to ensure that either engineering or administrative controls are implemented to reduce exposures below the STEL; or if engineering or administrative controls are not feasible, that proper respiratory protection is selected and used. 3M has done a great job in preparing a technical bulletin on respiratory protection for both hydrogen peroxide and peracetic acid. Go to technical bulletin 185.

About Affygility Solutions

Affygility Solutions provides environmental, health and safety consulting services and EHS software to the pharmaceutical, biotechnology, medical device, and healthcare industries. EHS services include potent compound safety, potent compound safety webinars, potent compound safety assessments by professionals with advanced certifications, occupational toxicology, industrial hygiene monitoring. Affytrac, our EHS software contains modules for EHS task management, corrective actions, and qualitative exposure assessments. To learn more, visit our website at affygility.com

Share and Enjoy:
  • Print
  • email
  • PDF
  • Twitter
  • LinkedIn
  • Google Buzz
  • del.icio.us
  • Digg
  • Posterous
  • Reddit
  • StumbleUpon
  • Propeller
  • Technorati
Posted in industrial hygiene pharmaceuticals | Comments Off

Why your co-workers think “You s#ck as an EHS Manager!”

I’ve been in this field for over 28 years, and have been fortunate enough to have spent a lot of time traveling throughout the globe working with a wide variety of environmental, health and safety managers (EHS). Most are really good at what they do, but some need a drastic upgrade in a few areas. Here’s my top ten list:

  1. You are horrible at email. This comes first because I encounter this all too frequently. You don’t respond to people, or worse yet you never open their email and leave it sitting in your Inbox for weeks. Yes, I understand that you get a lot of email, but I know many individuals that that get way more email that you can imagine (800 emails/day) and know how to effectively manage it. Take a look at your email Inbox, if you have to scroll down to see the end of the messages, you need to improve your email ninja skills. With email there’s only a couple things you can do: 1) Delete: If you know it’s not relevant, delete without opening. If it’s a FYI, read then delete or archive; 2) Delegate: If you have staff and it’s best suited for them, forward to them to handle, but don’t wait till that last minute to let them know. If you need to follow-up to make sure it’s done, set up a “Waiting on others” folder; 3) Respond: Most email responses can be handled in one sentence, such as “got it” or “will respond tomorrow.” Those that require more thought might need to go to a “defer” folder, which is covered next; 4) Defer: This should be a folder that is for those responses that require greater thought, research, or detail than you can do in a minute or less; or 5) Do. Take care of the email request right then. After it’s done, file in the archive folder. It takes a while to get used to it, but once you starting using the “Inbox Zero” or other similar email management strategy, you will never go back.
  2. Lack of vision. You are just trying to get by with the day-to-day tasks and don’t provide direction to where you want the EHS program to go. The management of most day-to-day tasks can be handled by EHS software. Set some goals and let your people run with it. People want to work with leaders. They don’t want to feel like the janitorial staff and make a daily routine of cleaning up the mess someone else created.
  3. You have meetings that aren’t necessary or too long. This wastes people’s precious time. Enough said.
  4. You are a conference groupie. We all need to expand our knowledge and know about the latest regulations and requirements, but when you are never in the office and always out giving presentations to volunteer groups, your coworkers will begin to resent you. You will become disconnected from them.
  5. You always refer to the ways you did it at your former company. We can all appreciate experiences from different companies and perspectives. However, when all people hear is, “Back when I worked at [x], we did it this way.” Well guess what, you don’t work at [x] anymore, and if it was so great back there, why aren’t you still working for them? People want to know about the future and how it’s going to be better for them, not how it was so much better at your former company.
  6. Constantly negative. EHS is a tough field because we are always dealing with the potential for injuries, accidents, and regulatory violations. Unfortunately, these are all negative topics, which others hope that never happen. So, if you’re going to be an outstanding EHS manager, try to think about the things that can be framed in a positive light. Celebrate the positive things with the rest of your team. Give credit to others for achievements.
  7. You are boring. Your social and presentation skills are lacking and you don’t show any passion for what you do. The presentations that you do provide are essentially the same ones you gave ten years ago. Don’t be afraid to have a personality. While you don’t have to be best friends with all your co-workers, act like you care about them as a person. If you need to brush up on your skills on how to become more interesting, go here to listen to this talk by Jessica Hagy.
  8. You never leave your office, except for meetings. Great EHS managers get out and see the real world. They see the way that the company really operates. They make it a point to dedicate hours a month out visiting facilities, manufacturing and laboratory employees. People know who the is EHS manager and they are a resource.
  9. You refuse to get your hands dirty. You don’t help out when things get bogged down, or you make your staff work long hours and weekends while you go play golf.
  10. You are just trying to hang in there till retirement. Lately I’ve been seeing this way too often. EHS managers that are late in their career are afraid to rock the boat or do anything that might be risky. So instead they go to the other extreme and don’t set goals that are challenging for members of your team.

So what are the signs that your co-workers will give you when they think you suck as an EHS manager. According to Forbes magazine, the 3 signs that your employees think you stink as a manager are:

  1. They act like you’re not there. When you walk by, they don’t even acknowledge your presence. They just keep on working.
  2. They don’t keep you in the loop.
  3. Your team doesn’t play by the rules.

If you recognize a couple of those item in the list in yourself, then an upgrade in leadership skill might be needed. It takes work and there’s no free ticket. Love to hear comments and feedback.

Share and Enjoy:
  • Print
  • email
  • PDF
  • Twitter
  • LinkedIn
  • Google Buzz
  • del.icio.us
  • Digg
  • Posterous
  • Reddit
  • StumbleUpon
  • Propeller
  • Technorati
Posted in compliance management software, corrective action software, ehs software | Comments Off

Potent Compound Safety 2014 Webinar Schedule is Posted

Affygility Solutions is pleased to announce that its Advanced Topics in Potent Compound Safety webinar series is now posted on its website. In this highly visual, 5-module series, the industry experts from Affygility Solutions will cover the following topics:

  • Module 1 will cover an introduction to potent compound safety and will review case studies where occupational exposures to active pharmaceutical ingredients have caused adverse effects in pharmaceutical and laboratory workers.
  • Module 2 will cover an introduction to occupational toxicology.
  • Module 3 will cover industrial hygiene, as it relates to potent compound safety.
  • Module 4 will cover advanced toxicology including numerous examples on how occupational exposure limits for APIs are determined.
  • Module 5 will cover control banding and engineering controls.

Avoid costly and time consuming travel by attending from the convenience of your own office. Group discounts are available. To view the schedule and register for the series, go to the Affygility Solutions’ website.

Share and Enjoy:
  • Print
  • email
  • PDF
  • Twitter
  • LinkedIn
  • Google Buzz
  • del.icio.us
  • Digg
  • Posterous
  • Reddit
  • StumbleUpon
  • Propeller
  • Technorati
Posted in potent compound safety, potent compound series | Comments Off

Ten OSHA and EPA Trends and Regulatory Changes for 2014

What OSHA and EPA trends do you need to pay attention to in 2014

Environmental, health and safety professionals in the biotechnology, pharmaceutical and medical device industries need to pay attention to the following trends and potential OSHA and EPA regulatory changes in 2014:

1. Injury and Illnesses Reporting

On November 8th, 2013, the Occupational Safety and Health Administration published its Proposed Rule on Improve Tracking of Workplace Injuries and Illnesses. The proposed rule would amend existing recordkeeping regulations to add requirements for electronic reporting of occupational injuries and illnesses. If you are not already an exempt SIC code and you’re greater than 10 employees, expect this to have an impact on what you need to do. In particular, if you had over 250 employees in the previous year, you will have to electronically report on a quarterly basis. For additional details, go the Federal Register for the proposed rule. Final rule expected April 2014.

2. Review of the continuing need for the Bloodborne Pathogens Standard

By May of 2014, OSHA will issue its findings to determine if there still is a need for the Bloodborne Pathogens standard, and if the Rule duplicates, overlaps, or conflicts with other Federal, State, or local regulations.

3. Infectious Diseases

OSHA is concerned about employees in health care and other high-risk environments that they may face infectious disease hazards such as tuberculosis, chickenpox, shingles, measles, and pandemic influenza, and severe acute respiratory syndrome (SARS). By the end of January, 2014, OSHA should begin its SBREFA (Small Business Regulatory Enforcement Fairness Act) review. Stay tuned for details after their review has been completed.

4. Injury and Illness Prevention Program

OSHA is developing a rule to require employers to develop and implement a formal Injury and Illness Prevention Program. Expect the requirements to be very similar to OSHA’s Voluntary Protection Program (VPP) or AIHA’s 18001. Expect a Notice of Proposed Rule-Making in September, 2014. If you haven’t started already, you may want to consider how you, from an EH&S perspective, manage organizational change at your company. You will also want to make sure that you have a robust risk or hazard assessment process, and a corrective action process in place. EH&S software is the way to go with either of these issues.

5. Combustible Dust

This one has been around since October, 2009 when the ANPRM (Advanced Notice of Proposed Rule-Making) was issued. EH&S professionals involved in solid-dose pharmaceutical manufacturing should pay close attention to this one. Go to OSHA’s Combustible Dust webpage for more information.

6. Changes to Personal Protective Equipment

Expect the Agency to continue to update rules with references to the more recent ANSI standards. For most companies this will have little impact.

Environmental Protection Agency Priorities

7. Electronic Hazardous Wastes Manifests

Rejoice for those companies that have been dealing with file cabinets full of hazardous wastes manifests. Electronic tracking will be forthcoming from the EPA. Hopefully, their electronic system will work better than the one for healthcare insurance system. For more information, go to the EPA’s webpage on Manifests.

8. TSCA Reform

Reform of the Toxic Substance Control Act (TSCA) is running into snags with disagreements between the various stakeholder groups. It appears that much of the disagreement has to deal with the ability of the federal government regulations to preempt the state regulations. This whole process gives me a headache just thinking about it and I don’t expect a Bill to be on the table anytime soon. For more information go to the EPA’s New Chemicals webpage.

Cross-Agency and Consensus Organization Actions

Listed below are regulatory actions that are expected to impact numerous EH&S agencies.

9. Chemical Facility Safety

In response to the West Texas fertilizer plant explosion, and other chemical facilityCorrective Action Software incidents, on August 1st, 2013, President Obama issued an Executive Order 13650 to various EH&S agencies requiring them to take a variety of steps to improve safety and security at chemical facilities. This was a cross-agency Executive Order and couple these incidents with the recent release of 4-methylcyclohexane methanol from the Freedom Industries facility in Charleston, West Virginia, expect to see increased regulatory activity in this area. See Federal Register Notice for Request for Information. Items of interest in the Federal Register Notice include an update of the list of highly hazardous and reactive chemicals, the requirement for management of change procedures, and a requirement for independent third-party audits.

10. Revisions to ISO 14001

Revisions to ISO 14001 are expected to be release either late 2014 or early 2015. Two key changes include: 1) a high-level structure for management systems; and 2) “Future Challenges for Environmental Management Systems and ISO 14001.” This will likely include how do you effectively manage changing stakeholder expectations.

As always, it continues to be important for EH&S professionals to stay connected with what is happening from a regulatory standpoint. As we all know, OSHA and EPA regulations change frequently and we must have systems in place to proactively identify those regulatory changes and adapt as necessary.

 

Share and Enjoy:
  • Print
  • email
  • PDF
  • Twitter
  • LinkedIn
  • Google Buzz
  • del.icio.us
  • Digg
  • Posterous
  • Reddit
  • StumbleUpon
  • Propeller
  • Technorati
Posted in corrective action software, regulations, risk assessments | Comments Off