[Federal Register Volume 60, Number 123 (Tuesday, June 27, 1995)]
[Rules and Regulations]
[Pages 33106-33109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15593]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 189

[Docket Nos. 82P-0371 and 91N-0165]


Lead-Soldered Food Cans

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its food 
additive regulations to prohibit the use of lead solder to manufacture 
cans for packaging foods. FDA concludes that the available 
toxicological and exposure data for lead demonstrate that the use of 
lead solder to manufacture cans for packaging food may be injurious to 
the public health, particularly that of fetuses, infants, and children. 
This final regulation also responds to a citizen petition requesting 
that the agency require that warning labels be placed on food cans that 
contain lead solder.

DATES: Effective: December 27, 1995. Written objections and requests 
for a hearing by July 27, 1995. Compliance date for affected products 
initially introduced or initially delivered for introduction into 
interstate commerce is December 27, 1995. Existing stocks of lead-
soldered canned foods will be allowed to be offered for sale until June 
27, 1996, so long as the level of lead in the food packaged in such 
cans is not such that the food may be rendered injurious to health.

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: Sandra L. Varner, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3093.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 21, 1993 (58 FR 33860), FDA 
published a proposal to prohibit the use of lead solder to manufacture 
food cans. The proposal was in response to the agency's determination 
that: (1) The current daily dietary lead intakes of infants and 
children approach or may exceed the provisional total tolerable intake 
level (PTTIL) that the agency has established for lead for these 
population groups; (2) the use of lead solder in food cans adds lead to 
food which may render it injurious to health, particularly that of 
fetuses, infants, and children; and (3) lead solder is not required to 
manufacture food cans and can be avoided. Therefore, the agency 
proposed not to codify in its regulations the prior sanction for lead 
solder used in food cans but to prohibit this use.
    In a notice published in the Federal Register of April 1, 1993 (58 
FR 17233), the agency announced emergency action levels for lead in 
food packaged in lead-soldered cans. These action levels are an interim 
measure to protect infants and young children from adverse effects that 
could result from regular consumption of foods packaged in lead-
soldered cans, pending completion of the rulemaking to prohibit the use 
of lead solder in food cans. After the 1-year period allowed for sale 
of existing stocks of lead-soldered canned foods, these emergency 
action levels will no longer be needed and will be considered as 
withdrawn by the agency.
    This final rule amends the food additive regulations to prohibit 
the use of lead solder in cans to package food. In addition, with 
completion of this rulemaking, FDA is responding to a citizen petition 
requesting that the agency require warning labels on food 
[[Page 33107]] cans that contain lead solder, because the ban on the 
use of lead solder in food cans renders the labeling issue moot.

II. Discussion of Comments

    In response to the notice of proposed rulemaking to prohibit the 
use of lead solder in food cans, FDA received eight comments. The 
comments were from a labor union, a State Government, an individual, 
two nonprofit public interest organizations, and three trade 
associations representing the can manufacturing industry, the food 
industry, and the Danish meat-canning industry.
    One comment agreed that documentation clearly supports FDA's 
finding that a prior sanction exists for lead solder used in metal food 
packaging. All eight comments supported FDA's proposal to prohibit the 
use of lead solder in cans that are used to hold food. One comment 
submitted economic data on the cost to Danish meat canners of switching 
to other canning technologies. This comment is discussed in section IV. 
of this document. Other issues raised by the comments, and the agency's 
responses to them, are set forth below.
    1. One comment stated that lead solder is incorrectly described in 
the proposed regulation as being ``* * * used in the construction of 
the metal ends of food cans.'' The comment explained that, although 
lead solder was historically used to seal both the end and side seams 
of metal cans, current production of lead-soldered containers involves 
use of lead solder only to seal side seams of the container. The 
comment suggested that the regulation state that ``Lead solders * * * 
are used in the construction of the side seams of food cans.''
    The agency agrees that the language in the regulation should be 
clarified. However, even though lead solder is currently used to seal 
only side seams of containers, FDA is prohibiting all uses of lead 
solder in food cans. Therefore, FDA is modifying the regulation to 
read: ``Lead solders are alloys of metals that include lead and are 
used in the construction of metal food cans.'' This language 
clarification does not affect the intent or scope of the regulation.
    2. One comment disagreed with language in the June 21, 1993, 
proposed rule, characterizing the agency's proposed action to ban the 
use of lead solder in food cans as a proposal to ``revoke'' the prior 
sanction for this use of lead solder. The comment contended that 
although Secs.  181.1(b) and 181.5(c) (21 CFR 181.1(b) and 181.5(c)) 
provide that the agency may prohibit the use of a prior-sanctioned 
ingredient if scientific data or information show that use of the 
ingredient may be injurious to health, the agency cannot ``revoke'' a 
prior sanction. The comment stated that a prior sanction for the use of 
a food ingredient is based solely on its recognized use prior to 
enactment of the Food Additives Amendment of 1958 (to the Federal Food, 
Drug, and Cosmetic Act (the act)), and that revocation of a prior 
sanction is inconsistent with the meaning and intent of the law.
    FDA considers the comment to be making a semantic point that 
ultimately has no effect on the agency's action. As the comment 
recognizes, FDA's regulations in Sec. 181.1(b) provide that if 
scientific data or information show that use of a prior-sanctioned food 
ingredient may be injurious to health, and thus is in violation of 
section 402 of the act (21 U.S.C. 342), FDA can prohibit use of the 
ingredient in food. If the agency prohibits use of a prior-sanctioned 
food ingredient, this action has the effect of revoking the prior 
sanction for that use of the ingredient.
    Further, Sec. 181.5(c) states that known prior sanctions for food 
ingredients shall be the subject of a regulation, and that this 
regulation may be revoked to prohibit use of the ingredient to prevent 
adulteration of food in violation of section 402 of the act. If a 
regulation for the prior-sanctioned use of a food ingredient is revoked 
to prevent such adulteration, the prior sanction for that use is in 
effect also revoked.
    Thus, the agency believes that revocation of a prior-sanctioned use 
is consistent with the intent of the regulations and the act. To 
disagree with this conclusion is tantamount to saying that FDA does not 
have the authority to determine whether a food ingredient can be used 
safely. This is obviously not true.
    3. One comment requested that the effective date for the ban on the 
introduction or delivery for introduction of lead-soldered canned foods 
into interstate commerce be extended to 24 months after publication of 
a final rule in the Federal Register. The comment requested the 
extension to allow conversion of the meat can soldering lines in 
Denmark to other canning technologies. The comment estimated that the 
conversion of the meat can lines would be completed by the end of 1995.
    The effective date for banning the use of lead solder in food cans, 
that FDA proposed in the document published in the Federal Register of 
June 21, 1993 (58 FR 33860), was based on a recognition that it might 
take some time for the domestic and foreign food industries to convert 
their equipment. However, the agency's primary concern in establishing 
an effective date for this action is the protection of the public 
health. As stated in the June 21, 1993, proposed rule, FDA has 
determined that there is a need to control dietary lead intake, 
especially for fetuses, infants, and children, because exposure to very 
low lead levels has been associated with adverse health effects. The 
current daily dietary lead intakes of infants and children approach or 
may exceed the PTTIL that the agency has established for lead for these 
population groups. (Lead levels that exceed the PTTIL are likely to 
result in adverse health effects.) The use of lead solder in food cans 
adds lead to food, and available toxicological and exposure data 
establish that the lead may render the food injurious to health and, 
therefore, adulterated under section 402(a)(1) of the act. Further, 
lead solder is not required to manufacture food cans, and therefore, 
its use is avoidable.
    Over the years, the agency has expressed its concern about dietary 
exposure to lead resulting from the use of lead-soldered cans for food. 
In the 1970's, the agency worked with the evaporated milk industry, the 
infant food industry, and manufacturers of juices for infants to 
establish voluntary quality assurance programs to reduce the levels of 
lead in their canned products. These efforts were discussed in an 
advanced notice of proposed rulemaking (ANPRM) published in the Federal 
Register of August 31, 1979 (44 FR 51233). In this ANPRM, FDA also 
announced its intent to establish action levels for food packaged in 
lead-soldered cans. The agency's goal was to reduce the dietary lead 
intake resulting from use of lead-soldered food cans by at least 50 
percent within 5 years.
    FDA has been in direct contact with foreign countries, including 
Denmark, that might export food in lead-soldered cans to the United 
States. Beginning in mid-1990, the agency sent letters to over 65 
nations, reminding U.S. trading partners that FDA has made efforts over 
the past two decades to reduce the levels of lead in the U.S. food 
supply, and that U.S. food manufacturers were voluntarily discontinuing 
the use of lead solder in cans for packaging food. The agency also said 
that it was concerned about dietary lead exposure from lead-soldered 
canned foods imported from other countries. The agency has also held 
numerous discussions at world forums over the past few years regarding 
the need to reduce dietary exposures to lead, particularly that 
resulting from use of lead-soldered cans for food. [[Page 33108]] 
    At a meeting held on July 7, 1992, the Mexican Government informed 
FDA that its food industry intended to eliminate use of lead-soldered 
cans by October, 1992. (In a followup letter dated June 8, 1993, the 
agency was informed that 90 percent of Mexican can manufacturers do not 
use lead solder (Ref. 1).) In response to our letters of 1990 and 1991 
sent to U.S. trading partners, Brazil projected that lead-soldered cans 
would not be used in that country by early 1991 (Ref. 2). Information 
received from Poland (Ref. 3) and Guatemala (Ref. 4) indicated that 
their food industries were intending to convert to nonlead packaging in 
1992. The Hungarian Government estimated that no foods would be 
packaged in lead-soldered cans in its country by the end of 1993, at 
the latest (Ref. 5).
    Thus, through cooperative programs with food industries, notices 
and proposed rules published in the Federal Register, letters to 
foreign nations, and discussions held at world forums, FDA has provided 
adequate notice of its concerns about the use of lead solder in cans 
used for food. In addition, U.S. food manufacturers have already 
eliminated use of lead solder in cans for food, and several foreign 
governments have stated that their food industries intended to 
discontinue use of lead-soldered cans by the end of 1993, at the 
latest. The agency therefore concludes that the effective date of 6 
months after the publication of a final rule for the ban on the use of 
lead solder in food cans is achievable and equitable. The agency also 
notes that, given the date of publication of this final rule, the ban 
will not be effective any earlier than the beginning of 1996. This 
timeframe coincides with the time in which the comment predicted that 
conversion of the meat can lines in Denmark would be completed.
    Based on the above considerations, in particular the need to 
protect the public health, the agency concludes that the effective date 
for the final rule prohibiting the use of lead solder in food cans from 
being introduced or delivered for introduction into interstate commerce 
should not be extended to 24 months after publication of a final rule 
in the Federal Register, as requested by the comment.
    4. One comment from a trade association supported FDA's proposal to 
prohibit foods in lead-soldered cans from being introduced or delivered 
for introduction into interstate commerce 6 months after publication in 
the Federal Register of a final rule on this action and to allow 
existing stocks of lead-soldered canned foods to be offered for sale 
within 1 year of the date of publication of the final rulemaking. The 
comment stated that if the 6-month effective date applies to initial 
introduction or initial delivery for introduction into interstate 
commerce, the proposed effective dates are equitable for both domestic 
and foreign food manufacturers.
    The agency confirms that the 6-month effective date is applicable 
to initial introduction and initial delivery for introduction into 
interstate commerce of foods in lead-soldered cans. Based on this 
comment and the issues raised in addressing comment 3 above, the agency 
concludes that the ban on the initial introduction and initial delivery 
for introduction into interstate commerce of foods in lead-soldered 
cans should be effective 6 months after publication of a final rule in 
the Federal Register, and that existing stocks of lead-soldered canned 
foods should be allowed to be offered for sale within 1 year of the 
date of publication of the final rulemaking, so long as the level of 
lead in the food packaged in such cans is not such that the food may be 
rendered injurious to health. Guidance on the level of lead in food 
that may render the food injurious to health is provided by the 
emergency action levels, that were announced in the April 1, 1993, 
notice, of 80 micrograms per kilogram (80 parts per billion (ppb)) for 
lead in fruit beverages packed in lead-soldered cans and 250 ppb for 
all other foods packed in lead-soldered cans.

III. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule published in the Federal 
Register of June 21, 1993. No new information or comments have been 
received that would affect the agency's previous determination that 
prohibiting the use of lead solder in food cans will not have a 
significant impact on the human environment, and that an environmental 
impact statement is not required.

IV. Economic Impact and Comment on the Economic Issues Raised in the 
June 21, 1993, Proposed Rule

    FDA has examined the economic impacts of this final rule to amend 
the food additive regulations to prohibit the use of lead solder to 
manufacture cans that contain food, as required by Executive Order 
12866 and the Regulatory Flexibility Act. 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 effects; distributive impacts; 
and equity). The Regulatory Flexibility Act (Pub. L. 96-354) requires 
analyzing options for regulatory relief for small businesses.
    FDA finds that this final rule is not a significant regulatory 
action as defined by Executive Order 12866. In compliance with the 
Regulatory Flexibility Act, the agency certifies that the final rule 
will not have a significant impact on a substantial number of small 
businesses.
    The June 21, 1993, proposed rule included an analysis of the 
economic impact of the proposed ban on the use of lead-soldered food 
cans under the previous Executive Order (E.O. 12291). FDA determined 
that this rule would result in little or no additional cost to domestic 
can manufacturers and food processors. In addition, the agency 
estimated that the one-time, upper-bound cost for foreign countries, 
that export lead-soldered canned foods to the United States, to convert 
to cans without lead solder would be from $33 million to $70 million. 
The total benefit gained from the reduction in blood lead levels 
resulting from the ban on the use of lead-soldered food cans was 
estimated to be $80 million for the next 20 years (discounted at a 6 
percent interest rate).
    The agency received one comment on the June 21, 1993, proposed rule 
that supplied data on the cost to Danish meat canners of switching from 
lead-soldered cans to other canning technologies. The agency's 
evaluation of the data submitted is set forth below:
    5. The comment from the Danish meat-canning industry estimated that 
the conversion of the meat-can soldering lines in Denmark to other 
canning technologies would cost approximately 30 million Danish kroner 
(approximately $4.4 million using the exchange rate quoted in the 
Washington Post of November 24, 1993). As discussed in comment three 
above, this industry also requested that the effective date for the ban 
on the initial introduction or delivery for introduction of lead-
soldered food cans into interstate commerce be extended to 24 months 
after publication of a final rule in the Federal Register. The comment 
stated that meat packaged in large cans is wrapped in a plastic bag 
inside the can, which would effectively inhibit lead migration into the 
meat.
    FDA analyzed the economic impact of the request to extend the 
effective date for the ban on the use of lead-soldered food cans and 
determined that granting an extension to Danish canned meat exporters 
would not be necessary [[Page 33109]] because the effective date of the 
ban and the requested date coincide. Because FDA's estimate of the one-
time, upper-bound cost for the conversion of canning lines in foreign 
countries was so broad ($33 million to $70 million), the cost 
information supplied by the Danish industry would not significantly 
alter the previous estimate.

V. Conclusions

    FDA finds that a prior sanction exists for the use of lead solder 
in food cans. However, the available toxicological and exposure data on 
lead demonstrate that this use of lead solder may be injurious to the 
public health, particularly that of fetuses, infants, and children. 
Therefore, the agency is not codifying in its regulations the prior 
sanction for lead solder used in food cans and is instead amending its 
food additive regulations to prohibit this use of lead solder.
    For clarification, FDA is modifying the language in proposed 
Sec. 189.240(a) to read ``Lead solders are alloys of metals that 
include lead and are used in the construction of metal food cans.''
    The ban on the initial introduction and initial delivery for 
introduction into interstate commerce of foods in lead-soldered cans 
will be effective 6 months after publication in the Federal Register of 
a final rule on this action. Existing stocks of lead-soldered canned 
foods will be allowed to be offered for sale within 1 year of the date 
of publication of the final rulemaking, so long as the level of lead in 
the food packaged in such cans is not such that the food may be 
rendered injurious to health.
    FDA has now responded to a citizen petition (Docket No. 82P-0371/
CP) requesting that the agency require warning labels on food cans that 
contain lead solder because the labeling issue will be moot with 
completion of this rulemaking.

VI. Objections

    Any person who will be adversely affected by this regulation may at 
any time on or before July 27, 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.

VII. 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. Letter from Mercedes Juan (Secretariat of Health, Mexico) to 
Jane E. Henney (FDA), dated June 3, 1993.
    2. Letter from Myrna Sabino (Secretariat of Health, Brazil) to 
Jerry A. Burke (FDA), dated August 9, 1990.
    3. Letter from Kazimierz Karlowski (National Institute of 
Hygiene, Poland) to Jerry A. Burke (FDA), dated December 21, 1990.
    4. Letter from Alberto Rodas Maltez (Alimentos Kern, Guatemala) 
to Economics Staff (FDA), dated April 24, 1991.
    5. Letter from Judith Sohar (National Institute of Food-Hygiene, 
Hungary) to Jerry A. Burke (FDA), dated September 26, 1990.

List of Subjects in 21 CFR Part 189

    Food ingredients, Food packaging.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
189 is amended as follows:

PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD

    1. The authority citation for 21 CFR part 189 continues to read as 
follows:

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).

    2. New Sec. 189.240 is added to subpart C to read as follows:


Sec.  189.240  Lead solders.

    (a) Lead solders are alloys of metals that include lead and are 
used in the construction of metal food cans.
    (b) Food packaged in any container that makes use of lead in can 
solder is deemed to be adulterated in violation of the Federal Food, 
Drug, and Cosmetic Act, based upon an order published in the Federal 
Register of June 27, 1995.

    Dated: June 17, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-15593 Filed 6-26-95; 8:45 am]
BILLING CODE 4160-01-F