[Federal Register Volume 62, Number 90 (Friday, May 9, 1997)]
[Rules and Regulations]
[Pages 25475-25477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12156]


=======================================================================
-----------------------------------------------------------------------

 DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 95F-0163]


Indirect Food Additives: Adjuvants, Production Aids, and 
Sanitizers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of high-purity furnace 
black as a colorant for polymers intended for use in contact with food. 
This action is in response to a petition filed by Cabot Corp.

DATES: The regulation is effective May 9, 1997. Submit written 
objections and requests for a hearing by June 9, 1997. The Director of 
the Office of the Federal Register approves the incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a 
certain publication in 21 CFR 178.3297(e), effective May 9, 1997.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3081.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of July 20, 1995 (60 FR 37452), FDA announced that a food 
additive petition (FAP 5B4464) had been filed by Cabot Corp., 75 State 
St., Boston, MA 02109-1806. The petition proposed to amend the food 
additive regulations in Sec. 178.3297 Colorants for polymers (21 CFR 
178.3297) to provide for the safe use of high-purity furnace black as a 
colorant for polymers intended for use in contact with food.
    In its evaluation of the safety of this additive, FDA has reviewed 
the safety of the additive itself and the chemical impurities that may 
be present in the additive resulting from its manufacturing process. 
Although the additive itself has not been shown to cause cancer, it has 
been found to contain minute amounts of polynuclear aromatic 
hydrocarbons (PAH's), which are carcinogenic impurities resulting from 
the manufacture of the additive. Residual amounts of reactants and 
manufacturing aids, such as polynuclear aromatic hydrocarbons in this 
instance, are commonly found as contaminants in chemical products, 
including food additives.

I. Determination of Safety

    Under the general safety standard of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 348(c)(3)(A)), a food additive cannot 
be approved for a particular use unless a fair evaluation of the data 
available to FDA establishes that the additive is safe for that use. 
FDA's food additive regulations (21 CFR 170.3(i)) define safe as ``a 
reasonable certainty in the minds of competent scientists that the 
substance is not harmful under the intended conditions of use.''
    The food additive anticancer, or Delaney, clause of the act (21 
U.S.C. 348(c)(3)(A)) provides that no food additive shall be deemed 
safe if it is found to induce cancer when ingested by man or animal. 
Importantly, however, the Delaney clause applies to the additive itself 
and not to impurities in the additive. That is, where an additive 
itself has not been shown to cause cancer, but contains a carcinogenic 
impurity, the additive is properly evaluated under the general safety 
standard using risk assessment procedures to determine whether there is 
a reasonable certainty that no harm will result from the intended use 
of the additive (Scott v. FDA, 728 F.2d 322 (6th Cir. 1984)).

II. Safety of Petitioned Use of the Additive

    FDA concludes that the additive, high-purity furnace black, is 
insoluble in common solvents, including aqueous and fatty foods. As a 
consequence, there is no potential for significant levels of migration 
of the furnace black to contacted food (Ref. 1).
    FDA does not ordinarily consider chronic toxicological studies to 
be necessary to determine the safety of an additive whose use will 
result in such low exposure levels (Ref. 2), and the agency has not 
required such testing here. However, the agency has reviewed the 
available toxicological data on the additive and concludes that because 
there is no potential for significant levels of migration of furnace 
black to contacted food, there are no concerns regarding the safety of 
the additive itself.
    FDA has evaluated the safety of this additive under the general 
safety standard, considering all available data and using risk 
assessment procedures to estimate the upper-bound limit of lifetime 
human risk presented by PAH's, the carcinogenic chemicals that may be 
present as impurities in the additive. The risk evaluation of PAH's has 
two aspects: (1) Assessment exposure to the impurities from the 
intended use of the additive; and (2) extrapolation of the risk 
observed in the animal bioassay to the conditions of exposure to 
humans.

A. Polynuclear Aromatic Hydrocarbons

    FDA has estimated the worst-case exposure to PAH's from the 
petitioned use of the additive as a colorant in polymers to be no 
greater than 0.001 parts per billion (ppb) in the daily diet (3 
kilograms (kg)), or 3 nanograms per person per day (ng/person/day). 
Further, the dietary concentration of benzo[a]pyrene, one member of the 
PAH family, was estimated to be no greater than 0.01 parts per trillion 
in the daily diet (3 kg), or 30 picograms /person/day (Ref. 1).
    PAH's occur as a mixture of compounds; the toxicity of these 
compounds varies, and some members of the family have been shown to be 
carcinogenic in animal studies. In assessing the upper-bound limit of 
lifetime human risk, FDA prefers to use actual toxicity data for the 
specific contaminants. However, in the absence of such data, the agency 
believes that using the toxicity of one of the most potent cogeners in 
a family of contaminants will ensure that the upper-bound limit of 
lifetime human risk will not be underestimated. For this risk estimate, 
FDA has made the ``worst-case'' assumption that all PAH's in the 
additive have the same carcinogenic potency as benzo[a]pyrene, a member 
of the PAH family that current data show to be one of the most potent 
carcinogens of this group.
    The agency used data from a carcinogenesis bioassay on 
benzo[a]pyrene, conducted by H. Brune et al. (Ref. 3), to estimate the 
upper-bound limit of lifetime human risk from exposure to this chemical 
resulting from the petitioned use of the additive. The

[[Page 25476]]

authors reported that the test material caused treatment-related benign 
forestomach tumors or esophageal tumors in male rats.
    Based on the estimated worst-case exposure of 3 ng/person/day, FDA 
estimates that the upper-bound limit of lifetime human risk from the 
petitioned use of the additive is 9 x 10-8 , or less than 1 
in 10 million (Ref. 4). Because of the numerous conservative 
assumptions used in calculating the exposure estimate and the 
carcinogenic potency of PAH's in the additive, the actual lifetime-
averaged individual exposure to PAH's is likely to be substantially 
less than the worst-case exposure, and therefore, the probable lifetime 
human risk would be less than the upper-bound limit of lifetime human 
risk. Thus, the agency concludes that there is reasonable certainty 
that no harm from exposure to PAH's would result from the petitioned 
use of the additive.

B.  Need for Specifications

    The agency has also considered whether specifications are necessary 
to control the amount of PAH's present as impurities in the additive. 
The agency finds that specifications are necessary to ensure that the 
risk from PAH's resulting from the proposed use of high-purity furnace 
black in food-contact applications is insignificant and that use of the 
additive is safe. Therefore, the regulations set forth in this document 
prescribe that high-purity furnace black shall not contain total PAH's 
in excess of 0.5 parts per million and shall not contain benzo[a]pyrene 
in excess of 5.0 ppb.

III. Conclusion

    FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that: (1) The 
proposed use of the additive as a colorant in polymers is safe; (2) the 
additive will achieve its intended technical effect; and (3) that 
therefore, the regulations in Sec. 178.3297 should be amended as set 
forth below.
    In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that FDA considered and relied upon in reaching its 
decision to approve the petition are available for inspection at the 
Center for Food Safety and Applied Nutrition by appointment with the 
information contact person listed above. As provided in Sec. 171.1(h), 
the agency will delete from the documents any materials that are not 
available for public disclosure before making the documents available 
for inspection.

IV. Environmental impact

    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Objections

    Any person who will be adversely affected by this regulation may at 
any time on or before June 9, 1997, file with the Dockets Management 
Branch (address above) written objections thereto. Each objection shall 
be separately numbered, and each numbered objection shall specify with 
particularity the provisions of the regulation to which objection is 
made and the grounds for the objection. Each numbered objection on 
which a hearing is requested shall specifically so state. Failure to 
request a hearing for any particular objection shall constitute a 
waiver of the right to a hearing on that objection. Each numbered 
objection for which a hearing is requested shall include a detailed 
description and analysis of the specific factual information intended 
to be presented in support of the objection in the event that a hearing 
is held. Failure to include such a description and analysis for any 
particular objection shall constitute a waiver of the right to a 
hearing on the objection. Three copies of all documents shall be 
submitted and shall be identified with the docket number found in 
brackets in the heading of this document. Any objections received in 
response to the regulation may be seen in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

VI. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Memorandum from the Chemistry Review Branch, FDA, to the 
Indirect Additives Branch, FDA, concerning ``FAP 5B4464 (MATS # 819 
M2.0 & 2.1): Cabot Corp. petition, through their agent Keller and 
Heckman, dated 5-18-95. High-Purity Furnace Black as a Colorant for 
Polymers,'' dated April 2, 1996.
    2. Kokoski, C. J., ``Regulatory Food Additive Toxicology,'' in 
Chemical Safety Regulation and Compliance, edited by F. Homburger, 
J. K. Marquis, and S. Karger, New York, NY, pp. 24-33, 1985.
    3. Brune, H., R. P. Deutsch-Wenzel, M. Habs, S. Ivankovis, and 
D. Schmahl, ``Investigation of the Tumorigenic Response to 
Benzo[a]pyrene in Aqueous Caffeine Solution Applied Orally to 
Sprague-Dawley Rats,'' Journal of Clinical Research and Clinical 
Oncology, 102:153-157, 1981.
    4. Memorandum from the Indirect Additives Branch, FDA, to the 
Executive Secretary, Quantitative Risk Assessment Committee, FDA, 
concerning ``Estimation of the Upper-bound Lifetime Risk from 
Polynuclear Aromatic Hydrocarbons (PAH's) in High-Purity Furnace 
Black (HPFB): subject of Food Additive Petition No. 5B4464 (Cabot 
Corp.),'' dated May 9, 1996.

List of Subjects in 21 CFR Part 178

    Food additives, Food packaging, Incorporation by reference.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
178 is amended as follows:

PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS

    1. The authority citation for 21 CFR part 178 continues to read as 
follows:

    Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

    2. Section 178.3297 is amended in the table in paragraph (e) by 
alphabetically adding a new entry under the headings ``Substances'' and 
``Limitations'' to read as follows:


Sec. 178.3297  Colorants for polymers.

* * * * *
    (e) * * *

[[Page 25477]]



                                                                        
------------------------------------------------------------------------
             Substances                          Limitations            
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
High-purity furnace black (CAS Reg.  For use at levels not to exceed 2.5
 No. 1333-86-4) containing total      percent by weight of the polymer. 
 polynuclear aromatic hydrocarbons                                      
 not to exceed 0.5 parts per                                            
 million, and benzo[a]pyrene not to                                     
 exceed 5.0 parts per billion, as                                       
 determined by a method entitled                                        
 ``Determination of PAH Content of                                      
 Carbon Black,'' dated July 8,                                          
 1994, as developed by the Cabot                                        
 Corp., which is incorporated by                                        
 reference in accordance with 5                                         
 U.S.C. 552(a) and 1 CFR part 51.                                       
 Copies may be obtained from the                                        
 Office of Premarket Approval (HFS-                                     
 200), Center for Food Safety and                                       
 Applied Nutrition, Food and Drug                                       
 Administration, 200 C St. SW.,                                         
 Washington, DC 20204, or may be                                        
 examined at the Center for Food                                        
 Safety and Applied Nutrition's                                         
 Library, 200 C St. SW., rm. 3321,                                      
 Washington, DC, or at the Office                                       
 of the Federal Register, 800 North                                     
 Capitol St. NW., suite 700,                                            
 Washington, DC.                                                        
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------


    Dated: May 2, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-12156 Filed 5-8-97; 8:45 am]
BILLING CODE 4160-01-F