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Environmental Decision Memo for Food Contact Notification No. 1789

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.


Date: August 4, 2017

To: Elizabeth Petro, Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Mariellen Pfeil, Acting Environmental Team Lead, Office of Food Additive Safety, HFS-255

From: Biologist, Environmental Team, Division of Biotechnology and GRAS Notice Review (HFS-255)

Subject: Finding of No Significant Impact for food-contact notification (FCN) 1789 for High-purity furnace black (HPFB), CAS Reg. No. 1333-86-4

Notifier: Cabot Corporation

Attached is the Finding of No Significant Impact (FONSI) for FCN 1789, for use of HPFB as a component of adhesives as described in 21 CFR 175.105(b)(5); for use as a colorant in resinous and polymeric coatings as described in 21 CFR 175.300(b)(3)(xxvi); for use as a colorant in paper and paperboard in contact with aqueous and fatty foods as described in 21 CFR 176.170(b)(2); for use as a colorant in paper and paperboard in contact with dry food as described in 21 CFR 176.180(b)(1); and for use as a colorant for polymers as described in 21 CFR 178.3297(e); except for use in contact with infant formula and human milk.

After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment (EA), dated May 17, 2017, may be made available to the public. We will post digital transcriptions of the FONSI and the EA on the agency's public website

Please let us know if there is any change in the identity or use of the food-contact substance.

Leah D. Proffitt

Attachment: Finding of No Significant Impact


FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1789), submitted by Cabot Corporation, to provide for safe use of high-purity furnace black (HPFB) as a component of adhesives as described in 21 CFR 175.105(b)(5); for use as a colorant in resinous and polymeric coatings as described in 21 CFR 175.300(b)(3)(xxvi); for use as a colorant in paper and paperboard in contact with aqueous and fatty foods as described in 21 CFR 176.170(b)(2); for use as a colorant in paper and paperboard in contact with dry food as described in 21 CFR 176.180(b)(1); and for use as a colorant for polymers as described in 21 CFR 178.3297(e); except for use in contact with infant formula and human milk.

The Office of Food Additive Safety has determined that allowing this FCN to become effective will not significantly affect the quality of the human environment and, therefore, an environmental impact statement will not be prepared. This finding is based on information submitted by the submitter in an environmental assessment, dated May 17, 2017. The EA is incorporated by reference in this Finding of No Significant Impact, and is briefly summarized below. The EA was prepared in accordance with 21 CFR 25.40.

The FCS (essentially elemental carbon) is intended to be used in all applications for which currently channel black is approved. HPFB is chemically identical to channel black except that HPFB contains fewer polycyclic-aromatic-hydrocarbon (PAH) impurities and is, therefore, better suited for food-contact use. Use levels will range from 2.5% in adhesives and polymer colorant, to 35% in paper and paperboard, and 50% or more in resinous and polymeric coatings.

Polymers/adhesives containing the FCS are expected to be land disposed or combusted at permitted municipal solid waste (MSW) landfills and combustion facilities. These are regulated by 40 CFR Parts 258 and 60, respectively. Given its negligible vapor pressure and insolubility, no environmental introductions are expected from the use of HPFB in polymers. In addition, since the FCS is essentially elemental carbon, no impacts to recycling are expected. Greenhouse gas (GHG) emissions from disposal at MSW combustion are expected to be well below the 25,000 mT reporting threshold in 40 CFR 98.2.

The highest potential for environmental exposure from use of the FCS is via discharge of white water from paper and paperboard processing. Due to its aggregating behavior and insolubility in water, most of HPFB is expected to partition to sludge. For direct dischargers, (i.e. those facilities that treat their waste water onsite and discharge directly to surface water), any remaining HPFB in water would be regulated under the Ambient Water Quality Criteria for total suspended solids (TSS) as part of the facility’s NPDES permit under 40 CFR part 402, which requires that receiving waters meet the standards established to safeguard the designated uses of the receiving water (e.g. fishing, recreational, etc.). Indirect dischargers (i.e. those facilities sending their waste water to a POTW) are prohibited from sending waste that would cause a POTW to violate its NPDES permit under 40 CFR 403.5(a)(1).

Due to its insolubility and inorganic nature, it is not possible to measure HPFB concentration in soil or to determine quantitative ecotoxicological endpoints. However, qualitative experiments show that filtrate from 100 g of carbon black shaken in one liter of water for 24 hours had no toxic effect on earthworms. Similarly, exceeding 1,000 mg/L in all studies.

No significant environmental impacts are expected from use and disposal of the FCS; therefore, no mitigation measures are needed. The alternative of not allowing the exemption request would be the continued use of channel black; such action would have no new significant environmental impact.

Consequently, we find that use of the FCS as described in FCN 1789 will not cause significant adverse impacts on the human environment. Therefore, an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 08-04-2017
Leah D. Proffitt
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: digitally signed 08-07-2017
Mariellen Pfeil
Acting Environmental Team Lead
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration