[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]
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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.
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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]]
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Substances Limitations
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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.
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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
