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.

 

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Affygility Solutions to exhibit at the 2014 Proactive Compliance Conference

Check out the latest in EHS compliance management software and OEL/ADE services

Affygility Solutions will be exhibiting at the International Society for Pharmaceutical Engineers’ Proactive Compliance Conference to be held January 13-14, 2013 at the Hilton East Brunswick, New Jersey. Stop by and visit with Peter Burke to learn more about our EHS Compliance Management and Corrective Action Software, and our OEL Fastrac service – an affordable and innovative way to obtain occupational exposure limit (OEL) and acceptable daily exposure (value) monographs for active pharmaceutical ingredients.

 

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Dean Calhoun to present on Optimizing CMO Selection for High-Potency Pharmaceutical Product Development and Manufacturing

Dean Calhoun, CIH, President and CEO of Affygility Solutions will be co-presenting on the Optimizing CMO Selection for High-Potency Pharmaceutical Product Development and Manufacturing webcast on Wednesday, January 8, 2014 at 10:00 AM – 11:00 AM Eastern Standard Time (EST) and Wednesday, January 15, 2014 at 10:00 AM – 11:00 AM Central European Time (CET). Also presenting with Mr. Calhoun will be Kenny McCleary, Senior International ESH Advisor for Evonik. To register for this event, go to the Pharmaceutical Technology registration page.

high-potency-API

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Cyclophosphamide OEL Fastrac monograph now available

Affygility Solutions is pleased to announce the immediate availability of its Cyclophosphamide OEL Fastrac monograph.

About Cyclophosphamide

Cyclophosphamide is used in the treatment of a wide variety of cancers. Cyclophosphamide is a class of medications called alkylating agents and is of the nitrogen mustard type. Cyclophosphamide is an IARC Group 1 agent as a confirmed human carcinogen. In addition, cyclophosphamide has benn associated in experimental animal studies and human case reports with adverse effects on fertility and embyro development.

About OEL Fastrac

OEL Fastrac monographs are an affordable way to obtain high-quality, credible occupational exposure limit monographs. OEL Fastrac monographs have been used by biotechnology, pharmaceutical, and medical device companies throughout the United States, Canada, Europe, Africa, and Asia.

Why OEL Fastrac?

  • Fully documented. 7-11 pages in length, with calculations and cited references.
  • Credible and reliable information. OEL Fastrac monographs are used by dozens of pharmaceutical, biotechnology and medical device companies throughout the world.
  • Expert preparation. Industry experts with advance degrees, professional certifications, and decades of experience.
  • High quality. Proprietary 18-point quality process.
  • Save time! Unsurpassed delivery with instant download.
  • Save money. Similar documents cost 5-12 times as much.
  • Stay current. Automatic notification of revisions.

Order now the cyclophosphamide OEL Fastrac monograph. Not what you are looking for? Browse our entire catalog of high-quality occupational exposure limit monographs.

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