[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]
[[Page 4815]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
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