[Federal Register Volume 61, Number 27 (Thursday, February 8, 1996)]
[Rules and Regulations]
[Pages 4816-4820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2665]



     

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Part II





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Part 189



Tin-Coated Lead Foil Capsules for Wine Bottles; Final Rule

  Federal Register / Vol. 61, No. 27 / Thursday, February 8, 1996 / 
Rules and Regulations  
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[[Page 4816]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 189

[Docket No. 91N-0326]
RIN 0910-AA06


Tin-Coated Lead Foil Capsules for Wine Bottles

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to prohibit the use of tin-coated lead foil capsules (i.e., 
coverings for the cork and neck area) on wine bottles. Lead in these 
capsules may, as a result of their intended use, become a component of 
the wine. FDA is taking this action to reduce exposure to lead to the 
extent feasible.

DATES: Effective February 8, 1996. Wine is adulterated under the 
Federal Food, Drug, and Cosmetic Act (the act) if a tin-coated lead 
foil capsule is applied to the wine bottle on or after February 8, 
1996.

FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food 
Safety and Applied Nutrition (HFS-306), Food and Drug Administration, -
200 C St. SW., -Washington, DC 20204, 202-205-4681.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 25, 1992 (57 FR 55485), FDA 
published a proposed rule to prohibit the use of tin-coated lead foil 
capsules on wine bottles (hereinafter referred to as the 1992 
proposal). The 1992 proposal was based on evidence from studies on 
bottled wine capped with tin-coated lead foil capsules that showed that 
the lead in the foil becomes a component of food. No food additive 
regulation exists for this use of tin-coated lead foil, nor is there a 
prior sanction for this use. Moreover, this use of tin-coated lead foil 
is not generally recognized as safe (GRAS). Therefore, FDA tentatively 
found that tin-coated lead foil capsules used on wine bottles are an 
unsafe food additive under section 409 of the act (21 U.S.C. 348), and 
wine is adulterated under section 402 (a)(2)(C) of the act (21 U.S.C. 
342(a)(2)(C)), if a tin-coated lead foil capsule is applied to the wine 
bottle on or after February 8, 1996. Given the longstanding use of tin-
coated lead foil capsules as a packaging material for wine, the agency 
proposed to prohibit use of this capsule by regulation to make its 
regulatory status clear. FDA proposed to make any final rule that 
issued based upon the 1992 proposal effective on its date of 
publication.

II. Summary of and Response to Comments

A. Summary of Comments

    The agency received 16 comments in response to the 1992 proposal. 
Thirteen comments were from domestic and imported wine merchants, 
associations representing domestic winemakers, and a foreign national 
trade association representing exporters of wine. In addition, one 
comment was received from an international trade commission, and two 
were received from foreign governments.
    All comments supported the proposal in principle. However, some 
comments sought clarification of what the proposal was intended to 
prohibit. Some comments raised issues concerning other types of 
capsules that may contain lead used on wine bottles. Some comments 
raised concerns about regulatory action by individual States concerning 
capsules used on wine bottles.
    The majority of the comments reacted favorably to the proposed 
effective date, but two comments expressed the need for further 
clarification on this issue.
    One comment asserted that the wine industry is being charged with 
an extraordinary share of the lead-reduction burden.

B. Responses to Comments

    1. Several comments stated that the 1992 proposal did not clearly 
identify the specific type of capsule that FDA proposed to prohibit. 
One comment requested that the 1992 proposal be amended to provide a 
clearer definition of what is prohibited. The comment also stated that 
if the prohibition is to be based on the amount of lead that is present 
in the capsule, then fairness requires that reasonable notice be given 
of the precise requirement of the final rule before it becomes 
effective. Another comment stated that since some traces of lead may 
appear in alternative types of capsules, the final rule should be 
written in such a way that no ambiguity is possible concerning the 
amount of lead that the capsule may contain.
    These comments apparently derive in large measure from the fact 
that the State of California has acted to prohibit the use of capsules 
that contain more than 0.3 percent lead. These comments are responding 
to the 1992 proposal's lack of a quantitative level of lead in a 
capsule that would subject it to prohibition, inasmuch as the State's 
action included such a level.
    In response to these comments, FDA emphasizes that the intent of 
the 1992 proposal was not to set a maximum permissible level of lead in 
a capsule. The intent was to prohibit the use of tin-coated lead foil 
capsules as a covering for the cork and neck areas of wine bottles. In 
the preamble to the 1992 proposed rule, FDA defined ``tin-coated lead 
foil capsules'' as ``capsules composed of lead foil coated on both 
sides with a thin layer of tin.'' This identification is not ambiguous. 
It clearly differentiates between tin-coated lead foil capsules, in 
which lead is intentionally used, and other types of capsules known to 
be used in the bottling of wine (e.g., all tin capsules) that may 
unavoidably contain some lead as an impurity.
    Nonetheless, given the concerns expressed by the comments, to 
eliminate the possibility of any ambiguity in the final regulation, the 
agency is modifying proposed Sec. 189.301(a) to incorporate the 
definition of ``tin-coated lead foil'' as it appeared in the preamble 
of the 1992 proposal.
    2. Several comments requested that the agency define ``all tin-
capsules'' (an alternative to tin-coated lead foil capsules) to include 
the amount of lead that may be present in the capsule as an unintended 
impurity.
    As stated above, this final rule is a prohibition of, and applies 
exclusively to, tin-coated lead foil capsules.
    It is not FDA's intent in this rulemaking to address the regulatory 
status of any other type of capsule (e.g., tin, aluminum, or plastic). 
However, FDA recognizes that it is conceivable that materials, both 
metallic and nonmetallic, used in other types of capsules could become 
components of wine, thus subjecting these capsules to the provisions of 
the act. FDA provides the following guidance in response to the 
comments that sought an opinion on the status of various types of 
capsules that may be used in the bottling of wine.
    If a substance, such as tin or aluminum, has a history of use as a 
capsule for wine bottles predating January 1, 1958, and the substance 
could become a component of food as a result of its intended use, the 
use may be GRAS based on common use in food or food contact. The 
criteria for determining whether the use is GRAS are described in 
Sec. 170.30(c) (21 CFR 170.30(c)). Any substance whose use in capsules 
for wine bottles began after January 1, 1958, would either have to be 
GRAS for such use on the basis of scientific procedures described in 

[[Page 4817]]
Sec. 170.30(b) or would be required to be used in accordance with a 
food additive regulation that prescribes safe conditions of use. In 
either case, the substance must be of a purity suitable for its 
intended use.
    FDA is aware that the occurrence of some amount of lead in tin is 
unavoidable because lead is a naturally occurring impurity in tin ore. 
Manufacturers are expected to take steps to control this source of 
exposure to lead by securing raw materials of the highest purity 
practicable.
    3. Several comments expressed concern that the States have or may 
enact inconsistent and conflicting laws that restrict the amount of 
lead that may be present in ``all-tin capsules.'' Therefore, the 
comments requested that FDA establish a national definition of ``all-
tin capsules'' based on the California definition \1\ to eliminate 
inconsistencies and conflicts, to level the playing field among States, 
and to protect imported wine from State-imposed nontariff trade 
barriers.

    \1\ The ``California definition'' refers to a definition agreed 
to by the State of California and several wine producers and 
importers in a December 6, 1991, consent decree (People of the State 
of California v. Gallo Vineyards, Inc. et al., No. 640951, San Diego 
County Superior Court). This decree states in part that ``lead 
foil'' or ``tin-lead foil'' capsules are ``* * * any foil capsules * 
* * containing lead as an intended constituent at concentrations 
greater than .3% by dry weight.''
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    The agency understands that some comments may wish to have a 
preemptive Federal regulation defining ``all-tin capsules.'' However, 
this final rule is a prohibition of, and applies exclusively to, tin-
coated lead foil capsules as defined by this agency.
    It appears that the comments contemplate that some States may 
promulgate regulations that are different from, or more restrictive, 
than the ``California definition'' of ``all-tin capsules.'' The agency 
recognizes that if individual States establish variable limits on the 
lead content of capsule materials, burdens on interstate commerce can 
result. However, the potential for such action by individual States, 
and the question of what would be an appropriate course of action by 
the Federal government in such a case, is outside the scope of this 
rulemaking. The prohibition of tin-coated lead foil capsules is 
absolute. More restrictive action by the States with respect to such 
capsules is not possible. As for other materials used to make wine 
capsules, interested persons may wish to petition the agency to 
establish limits on lead in such materials that have preemptive effect. 
Agency action on such petitions would be based on the merits of the 
petition and the availability of agency resources.
    4. One comment stated that it is unfair for FDA, and for other 
agencies of the United States, to place excessive responsibility on the 
wine industry to achieve lead reduction in food and not require similar 
efforts from other industries.
    FDA disagrees with the comment's allegation that the agency is 
imposing excessive responsibility on the wine industry to achieve lead 
reduction. The prohibition on the use of tin-coated lead foil capsules 
is only one of the actions that the agency has taken to implement its 
policy to reduce exposure to lead in food to the maximum extent 
practicable. Other actions include a recently published final rule 
formally banning lead-soldered food cans (60 FR 33106, June 27, 1995), 
a final rule lowering the allowable level of lead in bottled water (59 
FR 26933, May 25, 1994), the lowering of action guidelines for 
leachable lead from ceramicware (57 FR 29734, July 6, 1992), and a 
final rule requiring a warning label on decorative ceramicware, which 
could be mistakenly used to hold food, in order to exempt it from the 
action guidelines for leachable lead (59 FR 1638, January 12, 1994). 
FDA is also considering action to reduce the specifications for lead in 
food and color additives and in GRAS ingredients, as described in an 
advance notice of proposed rulemaking that was published in 1994 (59 FR 
5363, February 4, 1994).
    5. Several foreign comments sought assurance that wines capped with 
tin-coated lead foil capsules before January 1, 1993, will be permitted 
to enter the United States, and that marketing of wines capped with 
tin-coated lead foil capsules and imported before January 1, 1993, will 
be permitted.
    FDA's 1992 proposal specifically stated that the prohibition on the 
use of tin-lead foil capsules is applicable to products capped after 
the effective date of this final rule. Thus, this prohibition will not 
be retroactively applied to any product capped before February 8, 1996, 
nor is any action required to recall and retrofit any product capped 
before that date. Consequently, European wines capped before the 
European Commission (EC) ban of January 1, 1993, will not be prohibited 
from being imported into the United States or marketed in the United 
States by this rule.
    In the 1992 proposal, FDA proposed that the effective date of this 
final rule be the date that it is published in the Federal Register. In 
the 1992 proposal, the agency stated that information that it had 
already received indicated that the industry anticipated the 
availability of adequate supplies of alternative capsules by no later 
than November 1992. The industry desired that the prohibition of the 
use of tin-coated capsules not precede the availability of adequate 
supplies of alternative capsules. No comments indicating that the 
industry would not be able to comply with the effective date were 
received.

III. Conclusions

    After review and consideration of the comments received in response 
to the 1992 proposal, FDA concludes that no evidence or information has 
been presented that would cause the agency not to adopt Sec. 189.301, 
which prohibits the capping of bottled wine with ``tin-coated lead foil 
capsules.''
    Therefore, FDA is amending 21 CFR part 189 as proposed with the 
exception that the agency has modified Sec. 189.301 to include the 
definition of ``Tin-coated lead foil capsules'' as discussed in comment 
1 of this document and made minor editorial changes.

IV. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule (57 FR 55485, November 25, 
1992). No new information or comments have been received that would 
affect the agency's previous determination that there is no significant 
impact on the human environment and that an environmental impact 
statement is not required.

V. Economic Impact

    FDA has examined the impacts of this final rule to prohibit the use 
of tin-coated lead foil capsules for wine bottles as required by 
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 Regulatory 
Flexibility Act requires agencies to analyze regulatory options that 
would minimize any significant impact of a rule on small entities. 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 economic impact on a substantial number of small 
entities.

[[Page 4818]]

    On November 25, 1992, FDA published an analysis of the economic 
impacts of the proposed requirements under the previous Executive Order 
(Executive Order 12291). In that analysis the agency stated that 
banning the use of tin-lead capsules for wine bottles would require the 
wine industry to use other materials for capsules, such as 
polyvinylchloride (PVC), aluminum, or tin. The cost estimates reported 
in this regulation did not include costs to the wine industry in 
California because California State law already prohibited the use of 
these capsules in wine bottles.
    The impact of the proposed regulation was expected to be an 
increase in the cost of capsule material and bottling equipment to the 
portion of the industry that still used tin-lead capsules. At the time 
of publication of the proposal it was assumed that the most likely 
alternative to tin-lead foil capsules to be used was tin capsules at a 
total cost to the industry of $4.5 million annually.

A. Costs

    Since the publication of the 1992 proposal to ban tin-lead foil 
capsules, several new alternatives have emerged and existing ones have 
been improved through better quality, lower prices, or both. According 
to a recent trade publication, there are four basic capsules that may 
be used, which are listed in the chart below (Ref. 1).

                                                                        
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PVC (polyvinylchloride)................  $40 per 1,000 capsules         
Polylam (aluminum/plastic laminate)....  $60 per 1,000 capsules         
Aluminum...............................  $85 per 1,000 capsules         
Tin....................................  $90 per 1,000 capsules         
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    It is assumed in this analysis that only imported wines still 
continue to use tin-lead foil capsules, not including those imported 
from the European Union (EU). Approximately 15 percent of wines 
consumed in the United States are imported and 5 percent of all wines 
are from countries other than the EU. Thus, if all such wines used tin-
lead foil capsules, 8.6 million bottles of imported wine would be 
expected to be converted away from tin-lead foil capsules as a result 
of this final rule. Since tin-lead foil capsules cost the same as 
polylam capsules, only those wineries who choose tin or aluminum will 
incur additional costs. Assuming that all conversions will be evenly 
distributed between the four options above, costs of using different 
capsules are expected to be approximately $90,000 per year.

B. Benefits

    Benefits of this regulation will be realized in reduced exposure to 
lead by children and pregnant women (fetuses), groups that are 
particularly sensitive to exposure to lead. Adverse health effects of 
lead exposure in these population groups occur at lower blood lead 
levels than in adults. Exposure to very low levels of lead can 
adversely affect the production of the iron-containing component of 
hemoglobin in children and can cause neurobehavioral and growth 
deficits at prenatal (maternal) stages. The agency has previously 
stated that for infants and children, the lowest observed effect level 
of lead in blood is 10 micrograms per deciliter (g/dL) (57 FR 
55485 at 55487, November 25, 1992).
    The following table shows estimates of the current blood lead 
incidence levels in the two population groups predicted to exceed 10 
g/dL (Ref. 2).

  TABLE 1.--Background Incidence of Blood Lead Levels >10 g/dL 
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           Population Group                   Estimated Incidence       
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Children, age 2 years................  10%                              
Women of child-bearing age...........  1%                               
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1. Benefit Estimation for Children Ages 3 through 6
    Using the estimates in Table 1 and assuming that the same incidence 
levels apply for children ages 3 through 6 as for 2-year olds, then 
approximately 1.4 million children between the ages of 3 and 6 have 
blood lead levels greater than 10 g/dL.
    Wine consumption data were obtained from the United States 
Department of Agriculture (USDA) Nationwide Consumption Survey. This 
survey provided the percentage of children who consumed wine at least 
once in a 3-day period and the daily consumption distribution (in grams 
(g)) for each group. Approximately 0.12 percent of the children ages 3 
through 6 in this survey, or 1,680 children (1.4 million x 0.0012 = 
1,680), consumed wine once in 3 days. The average daily consumption of 
wine for children ages 3 through 6 is 51 g/day per child.
    Assuming that children who consume imported wine do so in the same 
proportion as national consumption (e.g., 5 percent of the total wine 
consumed is imported from non-EU countries), then an estimated 84 
children (5 percent of 1,680) may be at risk.
    The capsule contribution of lead from imported wine is, on average, 
6 g lead (Pb)/day (120 parts per billion (ppb)). By using an 
absorption rate factor of 0.16 for children, the blood lead level 
increase attributable to the consumption of imported wine by these 
children is estimated to be 1 g Pb/dL (Ref. 3).
    To assess monetary benefits from reducing this lead intake, this 
analysis uses a study by the Centers for Disease Control (CDC) that 
looked at the effect of lead reduction on the lifetime earnings of 
consumers. The CDC study used three ``pathways'' with associated 
parameter estimates to measure the change in lifetime earnings that 
would result from a change in 1 g Pb/dL blood. Each pathway 
included an estimate of a quarter of an intelligence quotient (IQ) 
point decrease for each 1 g Pb/dL of blood increase.
    The CDC study measured the impacts of a change in blood lead on IQ 
through changes in wages, educational attainment, and labor force 
participation rates. Because each of these effects are highly 
correlated (wages, education, and labor force participation), FDA will 
conservatively use only the strongest effect, education. FDA used a 
similar 

[[Page 4819]]
approach in the economic impact analysis of the proposed rule to ban 
lead soldered food cans (58 FR 33860, June 21, 1993). For this factor, 
it is estimated that an increment of 1 g Pb/dL blood decreases 
lifetime earning levels by approximately 0.2 percent.
    Starting from an average expected lifetime earnings rate of 
$260,000, the decrease in the net present value of lifetime earnings 
from a 1 g/dL change in blood lead levels will be $512 (.00197 
x 260,000). For the 84 children estimated to be at risk, the lower 
bound annual benefit of reducing blood lead levels by 1 g Pb/
dL from domestic wine consumption is estimated to be $43,000 (512 per 
child). It should be noted that the amount may be understated to the 
extent that this estimate, a human capital approach, does not represent 
utility from a higher IQ in nonlabor activities which would be included 
in a willingness-to-pay estimate.
    The above calculations are also considered to be lower bound, as 
they only estimate benefits for children with blood lead levels above 
10 g/dL. Using the same wine consumption levels as above (51 
g/day), but allowing for effects (linear) below 10 g Pb/dL 
blood, the annual benefit of reducing blood lead levels by 1 
g/dL would be $4.6 million.
    Assuming that half the problem is solved each year, over the next 
20 years total discounted benefits may range between $81,000 and $5.7 
million.
2. Benefit Estimation for Fetuses
    There are approximately 58 million women between the ages of 
childbearing age (15 to 44 years). Each year, approximately 3 million 
(6 percent) are pregnant at any given time. Using the incidence 
estimates in Table 1 (1 percent of 3 million), 30,000 of these women 
(pregnancies) are estimated to have blood lead levels above 10 
g/dL.
    Dietary exposure to lead (from tin-lead foil capsules) for pregnant 
women has been evaluated in a manner similar to that used for children. 
The USDA food consumption survey (1977-1978) reported average wine 
intake per day for individuals who drank wine on 1, 2, and 3 days over 
a 3-day period. It also provided the wine consumption data for women of 
different age groups, including those of childbearing age (15 to 44 
years). After eliminating the tin-lead capsules in wine bottles, the 
lead levels in imported wine would be reduced by an average of 120 ppb. 
A 120 ppb reduction is equivalent to 120 g/kilogram of wine. 
Thus, if a pregnant woman consumes 100 g of wine per day, the lead 
intake from wine will be reduced by 12 g Pb/day. Using the 
maternal (adult) absorption rate of 0.04, the blood lead level in the 
fetus would be reduced by 0.50 g Pb/dL blood (Ref. 3).
    The figures in the following table were derived from the USDA food 
consumption survey data utilizing data on lead levels in imported wine 
attributable to the use of tin-lead foil capsules and the maternal 
absorption rate factor just noted. Blood lead level reductions for each 
group of wine consumers are the result of eliminating the capsule's 
lead contribution.

                    TABLE 2.--Blood Lead Level Reductions After Eliminating Tin-Lead Capsules                   
      (Pregnant women who consume wine and are at risk of reaching blood lead levels over 10 g/dL)     
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                                                                                                      Blood Pb  
                                                                       Number of      Number of        level    
                            Age females                                   wine      imported wine    reduction  
                                                                       consumers      consumers1    (g/
                                                                                                     dL blood)  
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Drink once in 3 days                                                                                            
15-18..............................................................       37              1.8            0.29   
19-34..............................................................    1,542             77              0.37   
35-44..............................................................       74              3.7                   
Drink two of 3 days                                                                                             
15-18..............................................................        3              1.4            0.37   
19-34..............................................................      411             20              0.70   
35-44..............................................................       28              1.4            0.54   
Drink all 3 days                                                                                                
15-18..............................................................        0              0              0      
19-34..............................................................      179              8.9            1.34   
35-44..............................................................       26              1.3            0.94   
TOTAL..............................................................    2,300           1152                     
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\1\ Excludes consumers of wine imported from the EC.                                                            
\2\ Pregnancies resulted in live births only.                                                                   

    Assuming 115 fetuses have their blood lead levels reduced by the 
amounts shown in Table 2 above, the increase in the value of lifetime 
earnings is estimated to be $16,000.
    Again, assuming the relationship between IQ and income is linear 
benefits are estimated for all fetuses with nonzero blood lead levels. 
The annual upper bound benefit in terms of an increase in the value of 
lifetime earnings is estimated to be $1.6 million.
    Thus, the benefit of reducing maternal blood lead levels ranges 
from $16,000 to $1.6 million.
    Assuming half of the lead problem is solved each year, the total 
discounted benefits (at 6 percent) to pregnant women (fetuses) is 
estimated to be $30,000 to $3 million.

C. Summary

    For this analysis, FDA has assumed that only imported wines still 
continue to use tin-lead foil capsules, excluding those imported from 
the EU. Costs of conversion are expected to be approximately $90,000 
annually. Total discounted costs (6 percent) are estimated to be $1.2 
million.
    Assuming that, (1) the population growth rate in the United States 
continues to be near the replacement rate, and (2) half of the lead 
problem is reduced each year, the reduction of blood lead levels due to 
ingestion of wine is expected to result in discounted benefits ranging 
from $97,000 to $8.7 million.

VI. References

    The following references have been placed on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
    1. Walker, L., ``What's Next in the Wine Capsule Department?,'' 
Wine & Vines, 74(3):20(3), March 1993.
    2. Carrington, C., P. M. Bolger, and R. J. Scheupleia, ``Risk 
Analysis of Dietary Lead Exposure,'' in press.

[[Page 4820]]

    3. FDA memorandum, ``Provisional Tolerable Exposure Levels for 
Lead,'' Clark D. Carrington, Division of Toxicological Review and 
Evaluation, to Elizabeth Campbell, Division of Regulatory Guidance, 
November 16, 1990.

List of Subjects in 21 CFR Part 189

    Food ingredients, Food packaging.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, as 
amended, 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. 189.301 is added to subpart C to read as follows:


Sec. 189.301  Tin-coated lead foil capsules for wine bottles.

    (a) Tin-coated lead foil is composed of a lead foil coated on one 
or both sides with a thin layer of tin. Tin-coated lead foil has been 
used as a capsule (i.e., as a covering applied over the cork and neck 
areas) on wine bottles to prevent insect infestation, as a barrier to 
oxygen, and for decorative purposes. Information received by the Food 
and Drug Administration establishes that the use of such a capsule on 
wine bottles may reasonably be expected to result in lead becoming a 
component of the wine.
    (b) The capping of any bottles of wine after February 8, 1996, with 
a tin-coated lead foil capsule renders the wine adulterated and in 
violation of section 402(a)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act because lead from the capsule, which is an unsafe food 
additive within the meaning of section 409 of the act, may reasonably 
be expected to become a component of the wine.

    Dated: January 29, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-2665 Filed 2-7-96; 8:45 am]
BILLING CODE 4160-01-F