[Federal Register Volume 60, Number 69 (Tuesday, April 11, 1995)]
[Rules and Regulations]
[Pages 18349-18352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8772]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 176 and 178

[Docket No. 93N-0420]


Indirect Food Additives: Paper and Paperboard Components; 
Adjuvants, Production Aids, and Sanitizers; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to correct an error in nomenclature for a food additive. 
The amendment adds alkyl mono- and disulfonic acids, sodium salts 
(produced from n-alkanes in the range of C10-C18 with not 
less than 50 percent C14-C16) as a component of paper and 
paperboard in contact with food, as an antistatic agent, and as an 
emulsifier and/or surface active agent. Additionally, because certain 
sections contain multiple entries for the additive, FDA is amending its 
food additive regulations so that all uses of the additive will be 
combined under single entries in those sections of the regulations.

DATES: Effective April 11, 1995; written objections and requests for a 
hearing by May 11, 1995.

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

FOR FURTHER INFORMATION CONTACT: Andrew Zajac, Center for Food Safety 
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3095.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 21, 1994 
(59 FR 3322), FDA published a proposed rule to correct an error in 
nomenclature for a food additive regulated in Secs. 176.170, 176.180, 
178.3130, and 178.3400 (21 CFR 176.170, 176.180, 178.3130, and 
178.3400). The agency proposed to add alkyl mono- and disulfonic acids, 
sodium salts (produced from n-alkanes in the range of C10-C18 
with not less than 50 percent C14-C16) to those sections and 
to remove: (1) The listing ``n-alkylsulfonate (alkyl group is in the 
range C10-C18 with not less than 50 percent C14-
C16)'' from Sec. 176.170; (2) the listing ``petroleum sulfonates'' 
from the list of substances in Sec. 176.180; (3) the listings for 
``sodium n-alkylsulfonate (alkyl group in the range of C10-
C18 with not less than 50 percent C14-C16)'' and 
``sodium sec-alkyl mono- and disulfonates (alkyl group in the range of 
C10-C18 with not less than 50 percent C14-C16)'' 
from Sec. 178.3130; and (4) the listings for ``n-alkylsulfonate (alkyl 
group is in the range C10-C18 with not less than 50 percent 
C14-C16)'' and ``sodium sec-alkyl mono- and disulfonates 
(alkyl group in the range of C10-C18 with not less than 50 
percent C14-C16)'' from Sec. 178.3400.
    FDA received no comments on its proposal. The agency is, therefore, 
adopting the proposal as a final rule without any changes.
    The agency has previously considered the environmental effects of 
this rule, as announced in the proposed rule (59 FR 3322, January 21, 
1994). No new information or comments have been received that would 
affect the agency's previous determination that this action will not 
have a significant impact upon the human environment and that neither 
an environmental assessment nor an environmental impact statement is 
required.
    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the final 
rule is not a significant regulatory action as defined 
[[Page 18350]] by the Executive Order and so is not subject to review 
under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because no current activity is prohibited by this 
final rule, the compliance costs to firms are zero. Likewise, because 
no increase in the health risks faced by consumers will result from 
this final rule, total costs are also zero. The agency certifies that 
the final rule will not have a significant economic impact on a 
substantial number of small entities. Therefore, under the Regulatory 
Flexibility Act, no further analysis is required.
    Furthermore, in accordance with the Regulatory Flexibility Act, the 
agency previously considered the potential effects that this rule would 
have on small entities, including small businesses, and has determined 
that no significant economic impact on a substantial number of small 
entities would derive from this action. FDA has not received any new 
information or comments that would alter its previous determination.
    Any person who will be adversely affected by this regulation may at 
any time on or before May 11, 1995, 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.

List of Subjects

21 CFR Parts 176 and 178

    Food additives, Food packaging.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR parts 176 and 178 are amended as follows:

PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

    1. The authority citation for 21 CFR part 176 continues to read as 
follows:

    Authority: Secs. 201, 402, 406, 409, 721 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 346, 348, 379e).

    2. Section 176.170 is amended in the table in paragraph (b)(2) by 
removing the entry for ``n-Alkylsulfonate (alkyl group is in the range 
C10-C18 with not less than 50 percent C14-C16)'' 
and by alphabetically adding a new entry under the headings ``List of 
substances'' and ``Limitations'' to read as follows:


Sec. 176.170  Components of paper and paperboard in contact with 
aqueous and fatty foods.

* * * * *
    (b) * * *
    (2) * * *

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         List of substances                      Limitations            
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  *                    *                    *                    *      
                   *                    *                    *          
Alkyl mono- and disulfonic acids,    For use only:                      
 sodium salts (produced from n-                                         
 alkanes in the range of C10-C18                                        
 with not less than 50 percent C14-                                     
 C16)..                                                                 
                                                                        
                                     1. As emulsifiers for vinylidene   
                                      chloride copolymer coatings and   
                                      limited to use at levels not to   
                                      exceed 2 percent by weight of the 
                                      coating solids.                   
                                                                        
                                     2. As emulsifiers for vinylidene   
                                      chloride copolymer or homopolymer 
                                      coatings at levels not to exceed a
                                      total of 2.6 percent by weight of 
                                      coating solids. The finished      
                                      polymer contacts food only of     
                                      types identified in paragraph (c) 
                                      of this section, Table 1, under   
                                      Types I, II, III, IV, V, VIA, VIB,
                                      VII, VIII, and IX and under       
                                      conditions of use E, F, and G     
                                      described in Table 2 of paragraph 
                                      (c) of this section.              
  *                    *                    *                    *      
                   *                    *                    *          
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* * * * *
    3. Section 176.180 is amended in the table in paragraph (b)(2) by 
removing the entry for ``Petroleum sulfonates'' and by alphabetically 
adding a new entry under the heading ``List of substances'' to read as 
follows:


Sec. 176.180  Components of paper and paperboard in contact with dry 
food.

* * * * *
    (b) * * *
    (2) * * *

                                                                        
[[Page 18351]]                                                          
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         List of substances                      Limitations            
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
Alkyl mono- and disulfonic acids,                                       
 sodium salts (produced from n-                                         
 alkanes in the range of C10-C18                                        
 with not less than 50 percent C14-                                     
 C16)..                                                                 
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

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

    4. 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).

    5. Section 178.3130 is amended in the table in paragraph (b) by 
removing the entries for ``Sodium n-alkylsulfonate (alkyl group in the 
range of C10-C18 with not less than 50 percent C14-
C16)'' and ``Sodium sec-alkyl mono- and disulfonates (alkyl group 
in the range of C10-C18 with not less than 50 percent 
C14-C16)'' and by alphabetically adding a new entry under the 
headings ``List of substances'' and ``Limitations'' to read as follows:


Sec. 178.3130  Antistatic and/or antifogging agents in food-packaging 
materials.

* * * * *
    (b) * * *

------------------------------------------------------------------------
         List of substances                      Limitations            
------------------------------------------------------------------------
Alkyl mono- and disulfonic acids,    For use only:                      
 sodium salts (produced from n-                                         
 alkanes in the range of C10-C18                                        
 with not less than 50 percent C14-                                     
 C16)..                                                                 
                                                                        
                                     1. As antistatic agents at levels  
                                      not to exceed 0.1 percent by      
                                      weight of polyolefin films that   
                                      comply with Sec. 177.1520 of this 
                                      chapter: Provided, that the       
                                      finished olefin polymers contact  
                                      foods of Types I, II, III, IV, V, 
                                      VIA, VIB, VII, VIII, and IX       
                                      described in Table 1 of Sec.      
                                      176.170(c) of this chapter, and   
                                      under conditions of use E, F, and 
                                      G described in Table 2 of Sec.    
                                      176.170(c) of this chapter.       
                                                                        
                                     2. As antistatic agents at levels  
                                      not to exceed 3.0 percent by      
                                      weight of polystyrene or rubber-  
                                      modified polystyrene complying    
                                      with Sec. 177.1640(c) of this     
                                      chapter under conditions of use B 
                                      through H described in Table 2 of 
                                      Sec. 176.170(c) of this chapter.  
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

    6. Section 178.3400 is amended in the table in paragraph (c) by 
removing the entries for ``n-Alkylsulfonate (alkyl group is in the 
range C10-C18 with not less than 50 percent C14-
C16)'' and ``Sodium sec-alkyl mono- and disulfonates (alkyl group 
in the range of C10-C18 with not less than 50 percent 
C14-C16)'' and by alphabetically adding a new entry under the 
headings ``List of substances'' and ``Limitations'' to read as follows:


Sec. 178.3400  Emulsifiers and/or surface active agents.

* * * * *
    (c) * * *

                                                                        
[[Page 18352]]                                                          
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         List of substances                      Limitations            
------------------------------------------------------------------------
Alkyl mono- and disulfonic acids,    For use only:                      
 sodium salts (produced from n-                                         
 alkanes in the range of C10-C18                                        
 with not less than 50 percent C14-                                     
 C16)..                                                                 
                                                                        
                                     1. As provided in Sec. 176.170 of  
                                      this chapter.                     
                                                                        
                                     2. At levels not to exceed 2       
                                      percent by weight of polyvinyl    
                                      chloride and/or vinyl chloride    
                                      copolymers complying with Sec.    
                                      177.1980 of this chapter.         
                                                                        
                                     3. As emulsifiers in vinylidene    
                                      chloride copolymer or homopolymer 
                                      coatings at levels not to exceed a
                                      total of 2.6 percent by weight of 
                                      coating solids. The finished      
                                      polymer contacts food only of the 
                                      Types I, II, III, IV, V, VIA, VIB,
                                      VII, VIII, and IX as identified in
                                      Table 1 of Sec. 176.170(c) of this
                                      chapter, and limited to conditions
                                      of use E, F, and G described in   
                                      Table 2 of Sec. 176.170 of this   
                                      chapter.                          
                                                                        
                                     4. As emulsifiers and/or surface-  
                                      active agents at levels not to    
                                      exceed 3.0 percent by weight of   
                                      polystyrene or rubber-modified    
                                      polystyrene complying with Sec.   
                                      177.1640(c) of this chapter under 
                                      conditions of use B through H     
                                      described in Table 2 of Sec.      
                                      176.170(c) of this chapter.       
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

* * * * *

    Dated: April 3, 1995.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Intitiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 95-8772 Filed 4-10-95; 8:45 am]
BILLING CODE 4160-01-F