[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
