HORIZONS
REGULATORY AFFAIRS UPDATE
 Tenth Issue
Fall 1999

INTRODUCTION
In recent editions of HORIZONS, we have focused on the Regulatory Affairs and Standardization department's capabilities, which we believe are unrivaled in addressing the environmental, health and safety information needs of our customers. In this, issue we are shifting our focus to emerging regulatory topics. The first is the reporting for lead and leaded compounds proposed under the Emergency Planning and Community Right to Know Act (EPCRA), Section 313. The second is the reporting of regulated substances under the export notification requirements of the Toxic Substance Control Act, Section 12(b).

Emergency Planning and Community Right to Know Act, Section 313
On August 3, 1999, the United States Environmental Protection Agency (USEPA) proposed moving to a sharply reduced threshold for reporting lead from 10,000 pounds to 10 pounds under Section 313 of EPCRA. The proposed rule changes would also eliminate the de minimus exemption for lead, eliminate range reporting and eliminate the half-pound rule for reporting lead releases. This change is an outgrowth of the regulation of chemicals determined to be persistent and bioaccumulative toxins (PBT's), such as dioxin and mercury. In this proposed rulemaking, the USEPA reviewed data for two lead compounds, tetramethyl lead and tetraethyl lead. These compounds are unlikely to ever be found in printing inks. However, extending the proposed rules to all lead compounds may create larger implications across the printing industry sector.

Most, if not all, U.S. based printing ink manufacturers have put in place programs to eliminate inorganic pigments with chemistries based on lead (i.e. Chrome Yellows, Molybate Oranges). More than ten years ago, GPI removed from inventory and prohibited the subsequent purchase and use of lead based compounds in all of its manufacturing facilities. However, the background contaminant levels of lead in organic pigments supplied from all sources is a reality, and it is not going to go away. All of the changes the USEPA has proposed in the reporting of lead and lead compounds under Section 313 of EPCRA, coupled with the reality that all organic pigments contain trace contaminant levels of lead, is the dilemma the printing ink industry faces if this rule is made final as proposed.

Presently, the de minimus level for inorganic lead compounds is 0.1%. Any mixture that does not contain inorganic lead above this de minimus level is exempt from product notification for EPCRA Section 313 reporting requirements. All printing ink products supplied by Sun Chemical, therefore, do not contribute to threshold reporting levels for lead since trace contaminant levels of lead in finished printing ink products are orders of magnitude below this 0.1% de minimus level. If the rule is finalized, the elimination of this de minimus exemption would seemingly require testing of products to determine statistical part per million (ppm) levels of lead contamination in finished printing ink products as a prelude to tracking.

Numerous studies have shown that analyses to quantify part per million levels of lead in finished ink products are inaccurate and highly variable. Several years ago, a National Printing Ink Research Institute (NPIRI) Task Force on Heavy Metals was formed to investigate the accuracy and reproducibility of quantifying trace levels of the regulated heavy metals in printing inks. As we all know, lead is one of the CONEG regulated toxic heavy metals. This study showed that analysis of spiked ink samples at 150ppm and 300ppm resulted in inaccurate data with high variability between testing laboratories. Sample preparation techniques, analyst skill and experience and printing ink matrix effects all contribute to the variability and inaccuracy in the quantitation of trace contaminant levels of lead and the other CONEG regulated heavy metals.

Cognizant of the problems inherent in the analysis of printing inks and to determine trace levels of lead, Sun Chemical has had a program to analyze random batches of manufactured printing inks for lead in order to have statistical data on which to base CONEG compliance. Elemental lead has consistently been non-detectable. Based on our data and dilution factors, Sun Chemical can conservatively report that lead content in our printing ink products is less than 10ppm.

As a result, under the current rules no MSDS reporting for lead or leaded compounds for EPCRA Section 313 (MSDS Section 13) is necessary. Should the current proposed rule became a final rule, customer notification may be required. However, even with part per million contaminant considerations factored into the threshold planning for this elemental metal, we anticipate that only our very largest customers may be impacted by the 10 pound threshold quantity. Therefore few, if any printing ink customers would be required to file a USEPA Form R for lead and/or lead compounds.

Toxic Substance Control Act - Section 12(b) Export Notification
TSCA Section 12(b) requires companies to file export notices with the USEPA when they ship certain chemicals abroad. Chemicals that must be tested under TSCA Section 4 and chemicals that are the focus of consent orders under TSCA Section 5 constitute the majority of substances subject to export notification.

Prior to June 1, 1999, any first time violation of TSCA Section 12(b) qualified for an automatic notice of non-compliance (NON) from the USEPA but no financial penalty. Under the amended enforcement policy the USEPA discontinued the practice of issuing NON's for first time export notification violations.

TSCA Section 12(b) violations discovered or disclosed to the agency on or after the above date are now subject to a $6,600 civil penalty per regulated chemical per country each calendar year.

Once again, the capabilities of the SUN/1 Regulatory Module will allow Sun Chemical to monitor and maintain on-going compliance with all aspects of this revised enforcement policy. Look for the TSCA 12(b) notification as a modification within the Regulatory Information Section of our MSDS, (MSDS Section 13).