[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29711-29714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14889]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 170, 171, 172, 173, 175, 176, 177, 178, 182, and 184
[Docket 96N-0177]
RIN 0910-AA58
Reinvention of Certain Food Additive Regulations
AGENCY: Food and Drug Administration, HHS.
[[Page 29712]]
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (FDA) is seeking public
comment on possible ways to streamline various food additive
regulations as the result of a page-by-page review of the agency's
regulations. This regulatory review is part of the administration's
``Reinventing Government'' initiative which seeks to streamline
Government and to ease the burden on regulated industry and consumers.
DATES: Written comments by September 10, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Regarding information concerning the regulations: George H. Pauli,
Center for Food Safety and Applied Nutrition (HFS-205), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202-418-3090.
Regarding general information on FDA's ``reinventing initiative'':
Lisa M. Helmanis, Regulations Policy and Management Staff (HF-26), Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
443-3480.
SUPPLEMENTARY INFORMATION: On March 4, 1995, President Clinton
announced plans for reforming the Federal regulatory system as part of
his ``Reinventing Government'' initiative. In his March 4 directive,
the President ordered all Federal agencies to conduct a page-by-page
review of all of their regulations and to ``eliminate or revise those
that are outdated or otherwise in need of reform.'' This notice, which
seeks public comment on possible ``reinventions'', represents FDA's
continuing effort to implement the President's plan. In previous issues
of the Federal Register, FDA proposed revoking or revising other
regulations, and the agency expects to issue future reinvention
proposals in upcoming issues.
In this document, FDA is seeking comments on ways in which the
following food additive regulations could be updated or revised in
order to make them more understandable. The agency is also seeking any
other comments regarding parts 170-184 that would assist FDA in
fulfilling its mission to protect the interest of consumers. The
following is a section-by-section analysis of the regulations that FDA
is considering ``reinventing.''
I. Section-by-Section Analysis:
The agency's section-by-section analysis of the regulations listed
in parts 170, 171, 172, 173, 175, 176, 177, 178, 182, and 184 (21 CFR
parts 170, 171, 172, 173, 175, 176, 177, 178, 182, and 184) has
identified candidate regulations to be considered for change, according
to the similarity of the regulatory action. The consolidation of
multiple listings under one heading would be intended to make the
regulations easier to find and use by the regulated industry.
Eliminating required analytical methodology would allow more
flexibility to use improved methods. Rewriting some sections would be
intended to make the regulations easier to understand.
The agency recognizes, however, that apparently simple revisions
can inadvertently change the original intent of a regulation.
Therefore, care must be taken when revising language to avoid
unintended changes. Also, while revising the regulations would not
entail reevaluation of the scientific data underlying an approval, it
would require agency resources that would otherwise be spent on
reviewing petitions and promulgating regulations authorizing uses of
other food additives. Additionally, the agency recognizes that while
simplification or shortening of the regulations is a useful goal, some
users may prefer the detail currently in the regulations. Therefore,
before committing further resources to develop proposed changes, FDA is
seeking comment on the importance to the regulated community of the
various actions under consideration so that the agency can establish
appropriate priorities for its reform efforts. The agency is interested
in comments both on whether the regulatory actions should be pursued
and, for those changes that are needed, any recommendations regarding
the specific changes to be made in the regulation and the relative
importance of these revisions to interested persons. The agency notes
that, due to their technical nature, some of the changes suggested
below could be accomplished in a final rule; others may require both a
proposed rule and a final rule stage. In some instances, the agency has
suggested a reinvention approach.
II. Consolidate and Delete Regulations
The following additives have been selected as candidates possible
for single listing to minimize redundancy.
A. Food Additives
Glycine is listed in Secs. 170.50 Glycine (aminoacetic acid) in
food for human consumption, 172.320 Amino acids, and 172.812 Glycine.
Should these regulations be consolidated and, if so, how?
B. Food Additives Permitted for Direct Addition to Food for Human
Consumption
Sections 172.836 Polysorbate 60, 172.838 Polysorbate 65, 172.840
Polysorbate 80, and 172.842 Sorbitan monostearate could be simplified
by deleting references to specific combinations of entries of
substances listed within the regulation.
Sections 172.860 Fatty acids, 172.862 Oleic acid derived from tall
oil fatty acids, and 172.863 Salts of fatty acids could be combined and
simplified under one section. Tests and methods could also be
simplified.
Section 172.866 Synthetic glycerin produced by the hydrogenolysis
of carbohydrates could be combined with Sec. 182.1320 to eliminate the
apparent redundancy.
C. Secondary Direct Food Additives Permitted in Food for Human
Consumption
Sections 173.160 Candida guilliermondii and 173.165 Candida
lipolytica could be combined and simplified under one section.
D. Indirect Food Additives: Adhesives and Components of Coatings
Sections 175.360 Vinylidene chloride copolymer coatings for nylon
film and 175.365 Vinylidene chloride copolymer coatings for
polycarbonate film could be combined and simplified under one section.
E. Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
Section 178.2010 Antioxidants and/or stabilizers for polymers
contains a listing of antioxidants. Thus the information in
Sec. 178.2550 4-Hydroxymethyl-2,6-di-tert-butylphenol could be added to
the listing in Sec. 178.2010.
Sections 178.3530 Isoparaffinic petroleum hydrocarbons, synthetic
and 178.3650 Odorless light petroleum hydrocarbons are related
substances which could be combined under one section.
Section 178.3600 Methyl glucoside-coconut oil ester could be
deleted and the substance listed as a processing aid under 21 CFR
172.816 and 178.3520.
Sections 178.3610 Methylstyrene-vinyltoluene resin, hydrogenated
and 178.3930 Terpene resins could be deleted and the substances listed
as components for use in olefin polymers under Sec. 177.1520.
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Sections 178.3700 Petrolatum, 178.3710 Petroleum wax and 178.3720
Petroleum wax synthetic could be simplified and combined under one
section.
Section 178.3860 Release agents contains a listing of release
agents. Thus, the information in 21 CFR 178.3290 could be added to the
listing in Sec. 178.3860.
F. Direct Food Substances Affirmed as Generally Recognized as Safe
Sections 184.1271 L-Cysteine and 184.1272 L-Cysteine
monohydrochloride could be simplified under one section.
III. Proposed Deletion of Descriptions of Analytical Methods
Lengthy descriptions of the analytical methods may not be
necessary. Each reference to a method could state that copies are
available from the Center for Food Safety and Applied Nutrition (CFSAN)
and could also specify that equivalent methods are acceptable. Thus,
the descriptions of methods could be deleted from the following
regulations:
A. Indirect Food Additives: Paper and Paperboard Components
Section 176.170 Components of Paper and Paperboard in Contact with
Aqueous and Fatty Foods.
B. Indirect Food Additives: Polymers
Section 177.1010 Acrylic and modified acrylic plastics, semirigid
and rigid.
Section 177.1050 Acrylonitrile/styrene copolymer modified with
butadiene/styrene elastomer.
Section 177.1315 Ethylene-1, 4-cyclohexylene dimethylene
terephthalate copolymers.
Section 177.1330 Ionomeric resins.
Section 177.1500 Nylon resins.
Section 177.1520 Olefin polymers.
Section 177.1640 Polystyrene and rubber-modified polystyrene.
Section 177.1950 Vinyl chloride-ethylene copolymers.
Section 177.1970 Vinyl chloride-lauryl vinyl ether copolymers.
Section 177.1980 Vinyl chloride-propylene copolymers.
C. Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
Section 178.1010 Sanitizing solutions.
Section 178.3620 Mineral oil.
Section 178.3770 Polyhydric alcohol esters of oxidatively refined
(Gersthofen process) montan wax acids.
Section 178.3910 Surface lubricants used in the manufacture of
metallic articles.
IV. Methodology
The methodology in the following regulations could be simplified.
A. Food Additives Permitted for Direct Addition to Food for Human
Consumption
The method and descriptions in Sec. 172.133 Dimethyl dicarbonate
could be simplified.
The analytical specification in Sec. 172.250 Petroleum naphtha
could be simplified.
In Sec. 172.695 Xanthan gum, the tests as specified in paragraph
(d) could be eliminated.
In Sec. 172.820 Polyethylene glycol (mean molecular weight 200-
9,500), the analytical method referenced for determining ethylene
glycol and diethylene glycol could be simplified.
Section 172.859 Sucrose fatty acid esters could be rewritten to
clarify preparation and methods.
In Sec. 172.864 Synthetic fatty alcohols paragraphs (a) and (c)
could be revised, and refer to analytical methods that are available
from CFSAN.
Section 172.886 Petroleum wax could be simplified and refer to the
analytical procedures that are available from CFSAN.
B. Secondary Direct Food Additives Permitted in Food for Human
Consumption
Section 173.350 Combustion product gas could be simplified and
could state that analytical procedures were available from CFSAN.
V. General provisions applicable to indirect additives
The statement on good manufacturing practice and the general list
of acceptable components in articles that contact food, as referenced
in Sec. 174.5, are applicable to indirect food additives in general.
Therefore, similar statements could be deleted in the following
individual regulations:
A. Indirect Food Additives: Adhesives and Components of Coatings
Section 175.105 Adhesives.
Section 175.125 Pressure-sensitive adhesives.
Section 175.230 Hot-melt strippable food coatings.
Section 175.300 Resinous and polymeric coatings.
Section 175.320 Resinous and polymeric coatings for polyolefin
films.
Section 175.350 Vinyl acetate/crotonic acid copolymer.
Section 175.390 Zinc-silicon dioxide matrix coatings.
B. Indirect Food Additives: Paper and Paperboard Components
Section 176.130 Anti-offset substances.
Section 176.170 Components of paper and paperboard in contact with
aqueous and fatty foods.
Section 176.200 Defoaming agents used in coatings.
Section 176.210 Defoaming agents used in the manufacture of paper
and paperboard.
Section 176.300 Slimicides.
C. Indirect Food Additives: Polymers
Section 177.1010 Acrylic and modified acrylic plastics, semirigid
and rigid.
Section 177.1030 Acrylonitrile/butadiene/styrene/methyl
methacrylate copolymer.
Seciton 177.1040 Acrylonitrile/styrene copolymer.
Section 177.1200 Cellophane.
Section 177.1210 Closures with sealing gaskets for food containers.
Section 177.1240 1,4-Cyclohexylene dimethylene terephthalate and
1,4-cyclohexylene dimethylene isophthalate copolymer.
Section 177.1310 Ethylene-acrylic acid copolymers.
Section 177.1320 Ethylene-ethyl acrylate copolymers.
Section 177.1350 Ethylene-vinyl acetate copolymers.
Section 177.1400 Hydroxyethyl cellulose film, water-insoluble.
Section 177.1520 Olefin polymers.
Section 177.1550 Perfluorocarbon resins.
Section 177.1630 Polyethylene phthalate polymers.
Section 177.1635 Poly(p-methylstyrene) and rubber-modified poly(p-
methylstyrene).
Section 177.1640 Polystyrene and rubber-modified polystyrene.
Section 177.1650 Polysulfide polymer-polyepoxy resins.
Section 177.1660 Poly(tetramethylene terephthalate).
Section 177.1970 Vinyl chloride-lauryl vinyl ether copolymers.
Section 177.1980 Vinyl chloride-propylene copolymers.
Section 177.1990 Vinylidene chloride/methyl acrylate copolymers.
Section 177.2000 Vinylidene chloride/methyl acrylate/methyl
methacrylate polymers.
Section 177.2400 Perfluorocarbon cured elastomers.
Section 177.2460 Poly(2,6-dimethyl-1,4-phenylene) oxide resins.
Section 177.2470 Polyoxymethylene copolymer.
Section 177.2480 Polyoxymethylene homopolymer.
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Section 177.2550 Reverse osmosis membranes.
Section 177.2600 Rubber articles intended for repeated use.
Section 177.2800 Textiles and textile fibers.
D. Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
Section 178.1005 Hydrogen peroxide solution.
Section 178.3120 Animal glue.
Section 178.3570 Lubricants with incidental food contact.
Section 178.3850 Reinforced wax.
VI. Regulations Reinvented for Clarity
The agency has noted that some of its food additive regulations
could be rewritten to provide clearer guidance.
A. Food Additives Permitted for Direct Addition to Food for Human
Consumption
The labeling directions in Sec. 172.725 Gibberellic acid and its
potassium salt could be rewritten for clarity.
Section 172.177 Sodium nitrite used in processing smoked chub could
be revised to achieve greater consistency with 21 CFR 172.175.
B. Secondary Direct Food Additives Permitted in Food for Human
Consumption
Section 173.357 Materials used as fixing agents in the
immobilization of enzyme preparations could be revised to give a
clearer statement of components that may be safely used.
Section 173.395 Trifluoromethane sulfonic acid could be revised for
clarity.
C. Indirect Food Additives: General
Section 174.5 General provisions applicable to indirect food
additives could be revised to achieve greater clarity in paragraph
(d)(l) and in the restrictions placed on GRAS substances authorized for
use in this part.
D. Indirect Food Additives: Polymers
In Sec. 177.1560 Polyarylsulfone resins, the agency could add a
definition for ``normal baking temperature.''
In Sec. 177.2490 Polyphenylene sulfide resins, the agency could add
a definition for ``normal baking and frying temperature.''
E. Direct Food Substances Affirmed as Generally Recognized as Safe
In Secs. 184.1257 Clove and its derivatives and 184.1259 Cocoa
butter substitute primarily from palm oil, the description of the
additives could be simplified.
Section 184.1287 Enzyme-modified fats does not contain general
requirements for enzyme preparations. FDA could reinvent this section
to be consistent with the agency's general enzyme provisions.
In Sec. 184.1333 Gum ghatti, the agency could eliminate the
specifications under paragraph (b) and incorporate by reference the
specifications in the Food Chemicals Codex.
In Sec. 184.1408 Licorice and licorice derivatives could be revised
to achieve greater clarity and the regulation could state that methods
of analysis are available from CFSAN.
The description of the additives in Sec. 184.1685 Rennet (animal-
derived) and chymosin preparation (fermentation-derived) could be
simplified.
VII. Request for Comments
Interested persons may, on or before, September 10, 1996, submit to
the Dockets Management Branch (address above) written comments
regarding this notice. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 6, 1996.
William B. Schultz,
Deputy Commissioner for Policy
[FR Doc. 96-14889 Filed 6-7-96; 3:02 pm]
BILLING CODE 4160-01-F