MassMEDIC and CAPACCIO to host free webinar on MedTech Environmental Disclosure, Questions and Scorecards Reply

massmediclogoOn April 30 from 12 noon to 1 p.m., MassMEDIC and CAPACCIO are presenting a free EnviroForum Webinar: MedTech Environmental Disclosure, Questions and Scorecards: A Manufacturer/Supplier’s Role.

Register at: https://attendee.gotowebinar.com/register/4950487689854705410

The healthcare sector has had on‐going initiatives to practice environmentally sustainable purchasing and it has looked to group purchasing organizations (GPOs) and suppliers for support in this effort. The medical device industry is a part of that supplier network that provides healthcare organizations and GPOs with environmental sustainability information through vehicles such as questionnaires and scorecards.

During the webinar on April 30, we will discuss Environmentally Preferable Purchasing, common obstacles for suppliers, what’s coming in the near future, the Kaiser Permanente scorecard for medical products, and how manufacturers and suppliers can help.

The session will be moderated by:
Linda Swift, Senior Associate and Practice Area Leader for the Biotechnology, Life Science and Medical Device Industries at Capaccio Environmental Engineering, Inc.

The presenters are:
Beth Eckl is Director of the Environmental Purchasing Program for Practice Greenhealth. She provides consulting, education, and training services on environmental purchasing to purchasers in health care systems and hospitals and works closely with Group Purchasing Organizations. Beth has over 20 years of environmental purchasing experience both as a consultant, leading implementation of purchasing strategies with over a dozen government agencies, and as a manager of one of the earliest programs in the country to include environmental criteria in the supply chain process.

Vanessa Lochner, Director of Environmentally Preferable Purchasing (EPP) at Kaiser Permanente (KP), is responsible for providing strategic direction, and the operations management of the EPP program. In this key role, Vanessa works with KP’s Finance Operations organization in collaboration with its GPO, to identify enterprise‐wide EPP opportunities linked to improving the environment for its workforce and members.
After registering, you will receive a confirmation email containing information about joining the webinar.

For more information on the webinar, please call Linda Swift at 508.970.0033 ext. 119 or lswift@capaccio.com.

Enforcement Discretion Extended for New Dischargers not currently covered under MSGP2008 Reply

CAPACCIO recently received the notices in the link below from the Environmental Protection Agency (EPA). The Notices extend the date that EPA will use enforcement discretion for companies that have a new stormwater discharge and are not covered under the Stormwater Multi-Sector General Permit (MSGP) that expired September 29, 2013.The date has been extended out to the end of September 2014, HOWEVER, new dischargers need to take some actions to meet the enforcement discretion conditions:

1. Eligibility-Meet the MSGP 2008 eligibility criteria
2. Prior Notification-Prior to discharge, notify the EPA of operator status and intent to operate in accordance with MSGP 2008
3. Compliance-Meet obligations of MSGP 2008
a.Develop a Stormwater Pollution Prevention Plan
b.Install Best Management Practices
c.Perform SW monitoring, if necessary
d.Conduct Site Inspections
e.Implement corrective actions
f.Meet Sector-Specific Criteria
g.Submit appropriate reports to EPA

Here’s the link to the memos-

http://www.epa.gov/npdes/pubs/sw_msgp_naa2014.pdf

For more information, please contact Travis Wheeler at 508-970-0033 ext. 115 or twheeler@capaccio.com.

CONFLICT MINERALS REPORTING – SECOND ROUND OF Q&A’s RELEASED Reply

On May 31, companies who report to the Securities and Exchange Commission (SEC) and manufacture products containing conflict minerals will need to submit their disclosures for 2013 to the SEC. With the deadline looming and this being the first reporting year, the SEC issued a second set of conflict minerals Q&A’s last week.

The link to the Q&A’s is located here.

http://www.sec.gov/divisions/corpfin/guidance/conflictminerals-faq.htm

There are 21 Q&A’s in the new document. The newly issued Q&A’s provide:

• further clarification on applicability of the reporting
• the extent to which organizations must investigate and disclose information
• clarification of terms and definitions
• further information on the necessary content of the reporting, audit
qualifications, and requirements and
• clarification of “due diligence”

In August 2012, the SEC issued a final rule on Section 1502 of the 2010 U.S. Dodd-Frank Wall Street Reform Act stating that publically-traded companies in the United States must evaluate and disclose their usage of conflict minerals (tin, tantalum, gold, and tungsten) throughout their manufacturing supply chain, track quantities purchased, and report on the origin of these products.

Companies who are not publically-traded are also affected as they need to address these requirements in order to maintain market-share with their customers who are publically traded. They must also be prepared to respond to customer requests regarding conflict minerals usage.

Some companies have been delaying action, anticipating successful attempts by a group of Original Equipment Manufacturers (OEMs) to repeal all or a portion of the law. Although some progress is being made, nonetheless, most companies still face customer supply chain inquiries and also need to be prepared to respond to meet initial regulatory deadlines.

Many companies are either using or considering using the International Electrotechnical Commission Quality Assessment System for Electronic Components (IEQC) QC 080000:2012 “Hazardous Substance Process Management System” (HSPM) standard to facilitate incorporating conflict minerals management into existing environmental and quality management systems.

For those companies affected by the Conflict Minerals regulations, the deadline to file a form SD with the SEC is just weeks away. If you require help with your reporting or need further assistance with developing and implementing systems to management conflict minerals and other product related reporting requirements, please contact Julie Muszalski at 508.970.0033 ext.124 or jmuszalski@capaccio.com.

Higher Hazardous Substances Important Update Reply

Until 2011, all chromium compounds, both hexavalent and non-hexavalent, were reported under the same category under the Toxics Use Reduction Act (TURA). However, because hexavalent chromium compounds pose much greater health risks to humans and are both chronically and acutely toxic, the Massachusetts Department of Environmental Protection (MassDEP) designated them as Higher Hazardous Substances (HHS) and their threshold was decreased to 1,000 pounds per year for otherwise used, processed, or manufactured as a by-product. Non-hexavalent compounds continue to be counted towards the 10,000 pounds otherwise used, and 25,000 pounds processed or manufactured thresholds.

Companies that exceeded the 1,000-pound threshold for hexavalent chromium compounds for reporting year 2012 were required to file a Form S to the MassDEP for the first time by July 1, 2013. If they also exceed the 1,000-pound threshold in reporting year 2013, they are required to file a Form S and develop a TUR plan for hexavalent chromium compounds by July 1, 2014.

The Toxics Use Reduction Institute (TURI) developed a fact sheet that explains the differences between hexavalent and non-hexavalent chromium compounds, hazards associated with hexavalent chromium compounds, examples of compounds that contain hexavalent chromium, uses of hexavalent chromium compounds, and alternatives that should be considered. Hexavalent chromium is often listed as “CrVI” on safety data sheets (SDS). Non-hexavalent chromium used in industry is predominantly, although not exclusively, trivalent chromium, which is often listed on an SDS as “CrIII.”

You can find the fact sheet on the TURI’s web-site. http://www.turi.org/TURI_Publications/TURI_Chemical_Fact_Sheets/Hexavalent_Chromium_Fact_Sheet

Click here for further explanation regarding higher and lower hazard substances. http://www.turi.org/Our_Work/Chemicals_Policy/Chemical_Lists/Higher_and_Lower_Hazard_Substances

The MassDEP developed a fact sheet that provided guidance on how to calculate threshold determinations for various uses of hexavalent chromium compounds. You can find the fact sheet on the Executive Office of Energy and Environmental Affairs’ website. http://www.mass.gov/eea/docs/dep/toxics/laws/crviguid.pdf

Formaldehyde

The MassDEP also designated formaldehyde as a HHS in 2012 because of its links to cancer and potential adverse reproductive outcomes. Companies that exceeded the 1,000-pound threshold for formaldehyde for reporting year 2012 were required to file a Form S to the MassDEP for the first time by July 1, 2013. If they also exceed the 1,000-pound threshold in reporting year 2013, they are required to file a Form S and develop a TUR plan for formaldehyde by July 1, 2014.

The Toxics Use Reduction Institute (TURI) developed a fact sheet that includes hazards associated with formaldehyde, common uses of formaldehyde, and alternatives that should be considered. http://www.turi.org/TURI_Publications/TURI_Chemical_Fact_Sheets/Formaldehyde_Fact_Sheet/Formaldehyde_Fact_Sheet

The MassDEP developed a fact sheet that provided guidance on how to calculate threshold determinations for various uses of formaldehyde. You can find the fact sheet on the Executive Office of Energy and Environmental Affairs’ website. http://www.mass.gov/eea/docs/dep/toxics/laws/frmlguid.pdf

Methylene Chloride

The MassDEP designated methylene chloride as a HHS in 2013. This means that companies need to start tracking usage, processing and manufacturing of methylene chloride in 2014. If the 1,000-pound threshold is exceeded in 2014, companies will have to file a Form S to the MassDEP by July 1, 2015.

The Toxics Use Reduction Institute (TURI) developed a fact sheet that includes, hazards associated with formaldehyde, common uses of formaldehyde, and alternatives that should be considered. http://www.turi.org/TURI_Publications/TURI_Chemical_Fact_Sheets/Methylene_Chloride_Fact_Sheet

If you have any questions regarding the above noted Higher Hazardous Substances designations and the required reporting and planning, please contact Travis Wheeler at 508.970.0033 ext. 115 or twheeler@capaccio.com.