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.



About Dean Calhoun

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Dean is the President and CEO of Affygility Solutions. Affygility Solutions provides environmental, health and safety software, potent compound safety, industrial hygiene, containment validation services to the pharmaceutical, biotechnology, and medical device industry. "Dean's Google+ Profile"

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