Environmental Health and Safety Blog | EHSWire

aula Kaufman, CIH

If you are a foreign or domestic business in the US who is either a chemical importer (resells for use in blending, repackaging) or chemical manufacturer (make new chemicals out of chemicals purchased from others with the exception for pharmaceutical companies), this update is about mandatory compliance with the EPA’s Toxic Substances Control Act (TSCA), specifically filing the 2012 TSCA Form U “Chemical Data Report”.

Emilcott recently participated in an industry preview (the unveiling!) of the e-CDRweb tool.  Based on this peek, we are optimistic that the tool will be functional and surmountable IF all the required information is gathered together prior to preparing the submission.  As a test run, we entered simulated data and found the online tool to be logical and the built-in validation system should assist submitters with identifying inconsistent or incomplete entries.

Our conclusion: The difficulty will most likely not be the use of the e-CDRweb tool, the greater challenge will be the effort and time required to gather the right data needed for the submission.

Our advice: START GATHERING THE REQUIRED DATA NOW!!

Start with the following 2010 and 2011 inventory and volume data:

• Review the Form U data needed, consider the time you will need to obtain these data, and then allow additional time for getting follow-up, incomplete or missing information.


• Determine Co-Submitters for chemicals that are toll manufactured.


• Get the CAS number for all chemicals at or above the 25,000 lb threshold. Prescient warning:  the need to submit a CAS number or accession number for each chemical may require significant effort and time for submitters with suppliers that list “confidential” for the component.
  
  
  
  • Define which suppliers will need to be joint submitters.
  
  
  • Discuss and agree upon this with the supplier.
  
  
  
  

Get the CDX registration and authorizations completed… a multi-step, multi-party and possibly lengthy process.

• CDX registration for e-CDRweb will be available on November 1, 2011.


• Primary Authorized Official must be registered first as this activates the account.
  
  
  
  • Designate the Primary Support
  
  
  
  


• Establish the Secondary Authorized Officials (joint submitters) by chemical substance

In summary, if you were to compare filing the EPA’s TSCA submission to the IRS’s income tax form, the e-CDRweb tool is definitely going to be easier. However, understanding what to get and where to get it and then digging up the required information for the TSCA submission is going to be challenge.

If you need guidance with what data you should for the EPA TSCA 2012 CDR Submission, please contact Emilcott!

You can also subscribe to our free TSCA e-newsletter which delivers information right to your mailbox. Want more info? Enroll for our free Dec webinar by sending an email to pkaufmann@emilcott.com.

Feel free to post any questions below in the comments section and we will respond quickly.

by Paula Kaufmann

We just had our first cold weather snap in the northeast reminding me that 2012 is just around the corner.  A change in the seasons is our cue to ask Emilcott clients that manufacture or import chemicals:   Have you gathered the 2010 chemical volume data AND are you collecting the 2011 data needed for the 2012 TSCA Chemical Data Report?

In a previous blog we summarized the basic requirements of the inventory, production volume and use i nformation that needs to be collected for the EPA’s TSCA 2012 Chemical Data Report (CDR). You can find this “bare bones chart” by clicking here.  The EPA recently presented the following key requirements  in this document  “ Instructions for the 2012 TSCA Chemical Data Reporting.”

HIGHLIGHTS OF 2012 TSCA CHEMICAL DATA REPORTING (CDR)

• The determination of the need to report is based on production volume during calendar year 2011.


• Information on the reportable chemical substance must be reported during the 2012 CDR submission period, February 1, 2012 to June 30, 2012 (40 CFR 711.20).


• All reporting companies must report CDR data electronically, using e-CDRweb, the CDR web-based reporting tool, and EPA’s Central Data Exchange (CDX) system. Prior to submitting data, submitters must register with CDX.


• Reporting is required for all chemical substances listed on the TSCA Inventory, both organic and inorganic, other than polymers, microorganisms, naturally occurring chemical substances, certain forms of natural gas, and water (40 CFR 711.5 and 711.6) when manufacture (including import) of those chemical substances meets the other reporting requirements. Chemical substances that are the subject of any of certain listed TSCA actions may not be eligible for partial or full exemptions (40 CFR 711.6).


• Manufacturers (including importers) are required to report full manufacturing data, for calendar year 2011, and production volume only, for calendar year 2010, for all reportable chemical substances, when 2011 site-specific production volume equals or exceeds 25,000 lb (40 CFR 711.15(b)).


• Manufacturers (including importers) are required to report processing and use data, for calendar year 2011, for all reportable chemical substances, when 2011 site-specific production volume equals or exceeds 100,000 lb (40 CFR 711.15(b)). Inorganic chemical substances are no longer exempt from the reporting of processing and use information.


• Small manufacturers are exempt from CDR requirements unless they manufacture (including import) 25,000 lb or more of a chemical substance that is the subject of a rule proposed or promulgated under sections 4, 5(b)(4), or 6 of TSCA, or is the subject of an order in effect under section 5(e) of TSCA, or is the subject of relief that has been granted under a civil action under sections 5 or 7 of TSCA (40 CFR 711.9) and (TSCA §8(a)(3)(A)(ii)). See Appendix B for further information.


• Information submitted under CDR may be claimed as confidential; however, such claims must be made at the time of submission and substantiated in accordance with the CDR rule. Submitters must provide upfront substantiation of confidentiality claims for processing and use information as well as for confidentiality claims for site or chemical identity. A blank response or a response that is designated as “not known or reasonably ascertainable” may not be claimed as confidential (40 CFR 711.30).

The EPA is frequently adding information to their Inventory Update Reporting and Chemical Data Reporting Resource page.  And Emilcott will continue to update our TSCA Resource Center with helpful information -- check in often!

If you need guidance with the information that you should be gathering (starting now!) for the EPA TSCA 2012 CDR Submission, please contact Emilcott!.You can also subscribe to our TSCA newsletter to be kept up to date and enroll for our free webinar (date to be announced soon) by sending an email to pkaufmann@emilcott.com.  Feel free to post any questions below in the comments section and we will respond quickly.

by Paula Kaufmann

Upcoming TSCA Reporting Period:  February 1 - June 30, 2012.

As of August 6, the EPA has finalized the TSCA IUR -- now named the Chemical Data Reporting (CDR) – Rule. There are many changes with the TSCA IUR to CDR  … some of these will be in place for the 2012 reporting submission and many more for the 2016 submission.

The final rule adopted many of the requirements included in the proposed rule (see What are the Changes?) -- and, thankfully, the majority are not retroactive. At Emilcott, we are asking our clients to define what needs to be collected for the 2012 submission period with 2011 as the Principal Reporting Year. If your facility uses chemicals or is an importer who falls under TSCA’s CDR guidelines (remember, they’ve changed!), your company will need to collect more data and information than that originally planned for the 2011 IUR submission. The chart below is a bare bones list of the inventory, production volume and use information that needs to be collected for the 2012 Chemical Data Report (CDR). And, as stated earlier, your 2016 submission will have even more requirements.

Submit Your Form U Electronically

For the 2012 CDF, all submissions will be required to use the EPA’s free, web-based reporting tool, e-CDRweb, for completion of Form U. In preparation, the EPA will schedule another informational webinar on the electronic submission tool in late September with beta trials completed by early October. Please ask Emilcott if you will need help with the Form U filing.

Additional TSCA Information

Emilcott has set up an online “ TSCA Resource Center” and over the next few weeks will be creating a dedicated TSCA landing page to contain all the information related to both the CDR Final Rule and other TSCA New and Existing Chemicals topics. Links to all EHSWire TSCA blogs will also be located there for quick reference. If you have any questions or would like to consider Emilcott as a TSCA consultant, please give us a call at 973-538-1110 or send an email to pkaufmann@emilcott.com

Did you miss the TSCA 2006 Form U submission?

You must notify the EPA that you missed reporting for the 2006 IUR within 21 days of your discovery.  The EPA has an Audit Policy for Self-Disclosure in which drastic fine reduction is possible if the requirements outlined by the Agency are met.  This policy is presented on the EPA Compliance Incentive and Auditing web site ( http://www.epa.gov/compliance/incentives/auditing/auditdisclose.html). If you would like help, Emilcott has been brought in to work with multiple US and International clients with US facilities that inadvertently missed the Form U deadline due to either misunderstanding or ignorance of the regulations. Our advice is to not wait!

Paula Kaufmann, CIH

It’s time for an update on the EPA’s proposed changes to the Inventory Update Reporting Rule.  As of January 24, 2011, the EPA has been silent as to what changes will be included in the final rule.  A list of the proposed changes is presented on the Emilcott EHSWire.com blog: “ EPA Proposed Changes to the TSCA Inventory Update Rule ” .  

The EPA has stated that the Agency “expects to finalize the modifications to the chemical information reporting rule in time for the next reporting period, scheduled for June 1 - Sept. 30, 2011. EPA will make the electronic reporting software and associated guidance materials available before the start of the submission period.”  If you’re like me, “expects to finalize” is not very helpful for planning purposes or for engendering confidence.

Pull out the professional crystal ball!

As someone who has been working with the EPA for a long time, I am “reading between the regulatory lines” to forecast that the final rule will be published in April.  I’ve based this guess on information provided at the EPA's November webinar that introduced the new, electronic TSCA Reporting Tool, e-IURweb:

• During the question and answer period  an EPA representative said that the final rule should be published in the Spring 2011-- at least 30 days prior to the start of the reporting period.  So… if the reporting period starts on June 1, then I expect the final rule to be published by May 1st at the latest.


• The electronic tool designers said that a test version of the tool would be available for industry testing in April 2011.  (Emilcott will be posting a blog about this new tool in the next few weeks.)

What to do while we wait for the final rule to be published?

We are advising Emilcott clients to proceed with the collection of 2010 inventory data with a threshold of 25,000 lbs.  Additional data that may be needed for the 2011 reporting are listed below.  Depending upon how you gather your information, you may want to request this along with the import or manufacturing volume information.

• Production volumes at or above 25,000 lbs directly exported and not domestically processed or used.


• All quantities of substances subject to rules and orders in the following sections:
  
  
  
  • Section 5(a)(2) Significant New Use Rules (SNURs)
  
  
  • Section 5(b)(4) Chemicals of concern to EPA
  
  
  • Section 6 Prohibitions for chemicals with unreasonable risks
  
  
  • Section 5(e) Requirements or restrictions on chemical production or use
  
  
  • Section 5(f) Chemical with an unreasonable risk
  
  
  
  

What to do if you need help?

If you need assistance related to the TSCA New Chemicals regulatory requirements or the potential changes due to the Inventory Update Reporting Rule, Emilcott can guide you through the reporting. We can also help you navigate the maze of  reporting a potential Form U violation from prior filing years to the EPA (See http://www.emilcott.com/services/svcenvcompliance.asp).  As more information becomes available from the EPA regarding the IUR and as testing of the electronic tool begins, Emilcott will keep you up-to-date via EHSWire and our “Regulatory Updates” Newsletter. If you have any TSCA IUR questions or concerns, feel free to contact Emilcott or post your question below!

Charles Peruffo

The Pollution Prevention Act (PPA) of 1990 (42 U.S.C. §13101 et seq. (1990)) was a paradigm shift in the control of pollution (and hazardous waste). While previous regulations emphasized the “end of the pipeline”, the PPA moved the control of pollution upstream in the manufacturing process to prevent the waste from being generated in the first place. Closely related to the PPA is the NJ Pollution Prevention Act.  Passed in 1991, the NJ PPA implements the concept of reduction in waste production “upstream” by requiring affected companies to develop and submit a 5-year pollution reduction strategy and file  a Release and Pollution Prevention Report (RPPR). The NJ Release and Pollution Prevention Report collects data for New Jersey Right to Know Act ( NJRTK).

What does the Federal PPA require?

Facilities must account for their use of toxic chemicals  and, where feasible, reduce their use.  Toxic pollution that cannot be reduced should be recycled, and pollution that cannot be recycled should be disposed of in an environmentally safe manner. 

EHS professionals must have a firm understanding of the processes that use toxic chemicals in order to reduce their use.  Documenting these activities is an important step in PPA compliance and must include an accounting for the final disposal of toxic chemicals.  Generally this is done using the EPA’s Toxic Release Inventory (TRI) Reporting Form R.  

For facilities in New Jersey, what else is required?

The New Jersey Pollution Prevention Act (NJ PPA), enacted in August of 1991, requires a Pollution Prevention (“P2”) Plan for facilities that meet specific requirements:

• A facility in New Jersey that files a Form R and a Release and Pollution Prevention Report (RPPR) under the New Jersey Worker and Community Right to Know Act for the same chemical(s) in two consecutive years.  Note that in New Jersey any employer required to submit a TRI Form R is also required to submit the RPPR.


• The chemicals listed in the Form R and RPPR remain at or above the TRI activity thresholds.

The facility must  prepare a five-year Pollution Prevention (P2) Plan and submit a P2 Plan Summary by July 1 once they become covered (the second year they submit an RPPR for the same chemical).  This becomes the “base year”.  For each of the following years that the facility remains at or above the TRI activity thresholds, the facility completes the P2-115 which compares pollution prevention progress for the reporting year to the base year.

The PPA Filing Process by an EHS Professional

When recently preparing PPA paperwork for a small biotech site, I had to collect a variety of information for preparing a New Jersey P2 Plan.  A brief review of the steps is listed below.  For detailed instructions, look at NJDEP Form DEP-113.

1. Contacted the company’s purchasing department to find out how much of each toxic chemical had been delivered to the facility. 


2. Contacted the company’s hazardous waste management contractor to confirm that the amount purchased (Step 1) equaled the amount that was disposed. 


3. Compare the purchased to disposed amounts. The amounts did not match. 


4. Investigate the discrepancy.  It turned out the waste management contractor was using a less accurate method for calculating the percentage of toxic chemical in our waste stream.  Their laboratory data indicated that the company was disposing of more toxic chemical than purchased.  Ultimately, the volume data from the company’s purchasing department was used since no new toxic chemicals could be produced by the company’s processes. 


5. Reviewed the company’s air permit for an estimation of the toxic chemicals lost to the air.


6. Calculated the chemical remaining as residue in the empty drums, which were also removed by our hazardous waste management contractor.


7. Contacted the site Controller for the facility SIC code.


8. Prepared a “Five-Year Use Reduction Goal” based on pollution prevention activities such as process improvements after a review of documentation of meetings where possible improvements were discussed with personnel who work with toxic chemicals as well as process engineering diagrams. (Sets site five year pollution prevention goals).
   
   
   
   • Progress towards these goals needs to be reviewed yearly and documented on the site P2 Plan.
   
   
   
   


9. Obtain signatures for plan from the “highest ranking corporate official with direct operating responsibility” and the “highest ranking corporate official at the facility”.

Note --- A P2 Plan Summary needs to be updated and submitted every five years for the chemicals referenced in the original P2 Plan submission.

This process needs to be repeated for each toxic chemical at each applicable facility in New Jersey with all of the information included as part of one P2 Plan regardless of the number of toxic chemicals reported.  The facility does need to file one RPPR for each chemical. Does this seem like a lot of work? Consider this:  In the twenty years since adoption, the PPA and NJ PPA have helped to substantially reduce the use and improper disposal of toxic chemicals by requiring industry to examine their work processes.

How about your facility?

As a facility, are you tracking your toxic chemicals and filing the appropriate PPA/NJ PPA documentation? Have you noticed that a mindful approach to the processes and paperwork have resulted in reduced usage and better, more healthful disposal of chemicals?

About Our Guest Blogger:  Charles Peruffo is an EHS professional specializing in laboratory health and safety. Prior to his EHS career, Charles spent many years as chemist in the pharmaceutical industry with responsibilities ranging from laboratory safety to analyst training.  He holds a Bachelor of Science in Biology from Montclair State University and is pursuing his Master of Science in Occupational Safety Health Engineering from New Jersey Institute of Technology.

Dian Cucchisi, PhD, CHMM

Has your facility received a phone call from the Department of Homeland Security (DHS) asking you to provide information on the chemicals that you use and what measures you have in place to ensure that those chemicals do not fall into the wrong hands?  If so, you are not alone.  (If not, read on to be prepared!) The DHS is currently reviewing other government databases to determine what facilities in the United States are using “chemicals of interest.”

Prior to September 11, 2001 our nation concentrated on nuclear bombs and chemical/biological warfare as potential weapons of mass destruction that could be used against us.  On September 11, 2001 we watched as two jet airplanes were flown into the World Trade Center causing the deaths of more than 3,000 people.  Rewind the clock back to February 26, 1993.  Most of us remember the first bombing of the World Trade Center when nitroglycerin, ammonium nitrate, and smokeless powder were mixed together to create the bomb.  These are just two examples of the use of common industrial chemicals to create weapons of mass destruction.

In response to the growing awareness that chemical manufacturing facilities (as well as other facilities that store certain chemicals) may be potential targets for attack or theft by individuals wishing to use the chemicals in terrorist acts, the U.S. Department of Homeland Security (DHS) passed the Chemical Facility Anti-Terrorism Standards (CFATS) on April 9, 2007. On November 20, 2007, DHS published Appendix A to CFATS providing a list of chemicals known as Chemicals of Interest (COI) and their threshold quantities. 

The CFATS require all facilities that manufacture, use, store, or distribute chemicals above the threshold quantities listed in Appendix A to complete a screening process known as the “ Top Screen” within 60 days.  The Top Screen is used by the DHS to assign the facility to one of four risk-based tier levels ranging from Tier 1 (high) to Tier 4 (low).  The DHS will notify the facility of the need to complete and submit a Security Vulnerability Assessment (SVA) and a Site Security Plan (SSP).

The DHS reviews the databases maintained by agencies such as the U.S. Environmental Protection Agency (EPA) to determine if there are other facilities that may be required to submit a Top Screen.  Facilities that have not submitted a Top Screen may be notified by the DHS.  The facility will then be required to complete the Top Screen or notify the DHS in writing that the CFATS do not apply to their facility.

If you are a chemical manufacturer or perhaps just a user of qualifying amounts of chemicals, have you heard from the Department of Homeland Security? What did you think when you did hear from them?  If you haven’t even heard of CFATS, are you going to do anything to be prepared?

Paula Kaufmann, CIH

In a recent blog about the rapidly approaching Toxic Substance Control Act (TSCA) Form U submission in 2011, I mentioned that the EPA published a Proposed Rule detailing TSCA Inventory Update Reporting Modifications. The EPA anticipates promulgating a final rule by the spring of 2011 as the next scheduled IUR submission period is currently scheduled to run from June 1, 2011 through September 30, 2011.

Some of these modifications are really a big deal and will require a lot additional effort for most submitters. We should be seeing some commentary in response to the proposed rule about the cost of compliance with the modifications along with the benefits of having this collection of information about chemical importation, manufacture and use in the US. Hopefully this will be a spirited discussion and we will keep you posted on the outcomes and what they mean to you.

Although we don’t know what the final rule will look…the following is a list of the proposed changes that may affect many of our clients and you:

• Electronic reporting of the IUR data, using an Agency-provided, web-based reporting software
  
  
  
  • After the final rule’s effective date, paper submissions would no longer be accepted.
  
  
  
  


• Form U submission every 4 years (instead of every 5 years)


• All submissions would require processing and use information (Part III of Form U)


• No minimum manufacture (or import) quantity for certain chemical substances
  
  
  
  • This an elimination of the 25,000 lb. threshold for the chemical substances that are subject to rules or orders in following TSCA sections:
    
    
    
    • Section 5(a)(2) Significant New Use Rules (SNURs)
    
    
    • Section 5(b)(4) Chemicals of concern to EPA
    
    
    • Section 6 Prohibitions for chemicals with unreasonable risks
    
    
    • Section 5(e) Requirements or restrictions on chemical production or use
    
    
    • Section 5(f) Chemical with an unreasonable risk
    
    
    
    
  
  
  
  


• IUR exemption changes for the following chemical substances:
  
  
  
  • No exemption for those with an enforceable consent agreement (ECA) to conduct testing.
  
  
  • Full exemption water.
  
  
  • Removal of polymers that are already fully exempt from the partially exempt list of chemical substances.
  
  
  
  


• Significant new reporting requirements Form U completion:
  
  
  
  • Name and address belonging to the parent company.
  
  
  • Current Chemical Abstracts (CA) Index Name, as used to list the chemical substance on the TSCA Inventory, as part of the chemical identity.
  
  
  • Production volume for each of the years since the last principal reporting year. For the 2011 report this would include 2006, 2007, 2008 AND 2009 in addition to 2010.
  
  
  • Production volume directly exported and not domestically processed or used.
  
  
  • Volume of manufactured chemical substance (such as a by product) that is recycled, remanufactured, reprocessed, reused, or reworked .
  
  
  • Company Business Information (CBI)
    
    
    
    • Submission of substantiation for CBI claims in Section III (processing and use information).
    
    
    
    
  
  
  
  


• Proposed changes for AFTER 2011 Form U submissions
  
  
  
  • Require reporting if the production volume of a substance met or exceeded the 25,000 pound threshold in any calendar year since the last principal reporting year.
  
  
  
  

With this significant list of proposed changes, Emilcott is paying close attention to TSCA-related news so that we can advise and guide our clients to be in compliance. We have worked with multiple U.S. and International clients with U.S. facilities that have misunderstood or ignored TSCA regulations resulting in a big problem that could have been avoided. If your facility falls under the TSCA guidelines, are you paying close attention to modifications to the TSCA IUR program? What do you think of the company cost vs. informational and monitoring benefits? What are you doing to be a part of the debate or prepare for submission?

Paula Kaufmann, CIH

August 2011 Update:   Information from the EPA regarding TSCA requirements and submission has changed significantly since this post was originally written in August 2010. Please also read BREAKING NEWS: New EPA TSCA Inventory Update Requirements (IUR) for 2012   and additional posts following to ensure that you have the most up-to-date information.

-PKaufmann

Is your facility a manufacturer or importer of chemicals in amounts of 25,000 pounds or greater?  If so, your company may need to participate in the next round of the EPA’s Toxic Substance Control Act (TSCA) Inventory Update Rule (IUR) program and submit a Form U to the EPA.

Here’s how the EPA explains this rule:  “The IUR  requires manufacturers and importers of chemical substances included on the TSCA Chemical Substance Inventory to report site and manufacturing information for chemicals manufactured (including imported) in amounts of 25,000 pounds or greater at a single site.  Additional information on domestic processing and use must be reported for chemicals manufactured in amounts of 300,000 pounds or more at a single site. EPA uses the IUR data to support many health, safety, and environmental protection activities.”  For more information go to http://www.epa.gov/oppt/iur/

When Is the Next Reporting? THIS IS IMPORTANT!!!

The next submission period is currently planned for June 1 - September 30, 2011 when manufacturers and importers will report information on their 2010 production (and the EPA has proposed adding data for years 2006, 2007, 2008 and 2009) . See revised information post:   BREAKING NEWS: New EPA TSCA Inventory Update Requirements (IUR) for 2012

How is IUR Changing for 2011 Reporting?

1. Inorganic chemicals are no longer partially exempt from the IUR rule. This was a one-time exemption for 2006 reporting only.


2. On August 13, 2010 the EPA published its proposed IUR Modifications Rule, beginning a 60-day comment period. The proposal would require electronic reporting and expanded manufacturing, processing, and use information.  The EPA anticipates promulgating a final rule by the spring of 2011. As aspects of the proposed rule have yet to  be finalized, Emilcott will  provide a definitive, easy-to-read list here on EHSWire.

So…stay tuned to EHSwire.com or www.emilcott.com to stay informed about any IUR reporting developments and reporting obligations in 2011 for the calendar year 2010.   If you have any questions about the upcoming IUR reporting or TSCA compliance question, please comment below, contact us directly or read more at http://www.emilcott.com/services/svcenvcompliance.asp.  Emilcott provides comprehensive support for TSCA compliance, including assisting with inventory and chemical substance use information subject to the IUR program.

Some interesting Form U questions and facts -

Did you know that 1,541 companies submitted a Form U in 2006?

Some submitted multiple Forms because as each manufacturing site that originates a chemical substance is required to report. The 2006 IUR public data are available on the IUR web site (www.epa.gov/iur).