[Federal Register Volume 59, Number 249 (Thursday, December 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-32010]


[[Page Unknown]]

[Federal Register: December 29, 1994]


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DEPARTMENT OF THE TREASURY
Bureau of Alcohol, Tobacco, and Firearms

27 CFR Part 5

[T.D. ATF-360; Re: Notice Nos. 782, 780, 91F009P]
RIN: 1512-AB22

 

Alteration of Class and Type: Vodka

AGENCY: Bureau of Alcohol, Tobacco, and Firearms (ATF), Department of 
the Treasury.

ACTION: Final rule, Treasury decision.

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SUMMARY: ATF is amending the distilled spirits regulations, 27 CFR 
5.23(a)(3), to authorize the use of a trace amount (defined as up to 
300 milligrams per liter or 300 ppm) of citric acid in the production 
of vodka, without changing its designation as vodka. This level is 
intended to ensure that distillers may continue to use citric acid as a 
smoothing agent to correct objectionable tastes which might result from 
such things as the water used in reducing the proof, the charcoal used 
in distillation, or the glass in which packaged. This level is also 
intended to protect the integrity of the standard of identity for 
vodka, a product, which by definition, may not have any distinctive 
character, aroma, taste, or color. Pursuant to this document, T.D. ATF-
306 [55 FR 49994, December 4, 1990] is rescinded.

DATES: This document is effective on January 30, 1995.

FOR FURTHER INFORMATION CONTACT: David W. Brokaw, Wine and Beer Branch, 
(202) 927-8230.

SUPPLEMENTARY INFORMATION:

Background

    The standard of identity for vodka was promulgated in 1949 in TD 
5707, 1949-2 C.B. 252. The hearing record indicates that a standard of 
identity for vodka was proposed because many different types and 
qualities of vodka were being offered for sale in the United States. 
With the proliferation of vodka products, the Alcohol Tax Unit of the 
Internal Revenue Service (IRS), a predecessor to ATF, was concerned 
that, consistent with the mandate of section 105(e) of the Federal 
Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), consumers were 
adequately informed regarding the identity and quality of such 
products. The standard for vodka provided that it was to be defined as 
neutral spirits distilled from any material at or above 190 proof, 
reduced to not more than 110 proof and not less than 80 proof and, 
after such reduction in proof, so treated as to be without distinctive 
character, aroma, or taste. Although no explicit definition of the term 
``distinctive'' could be found in the hearing record, the testimony 
indicates that vodka is to be as tasteless and odorless as possible.
    In 1956, Revenue Ruling 56-98, 1956-1 C.B. 811, concluded that 
citric acid and sugar were not considered to be flavoring ingredients 
which would materially affect the taste of vodka or change its basic 
character so long as the sugar did not exceed two-tenths of 1 percent 
and citric acid was only added in a ``trace amount.'' The ruling did 
not quantify ``trace amount.''
    Revenue Ruling 56-98 was issued after testing of a vodka sample 
prepared by the IRS' Alcohol and Tobacco Laboratory pursuant to a 
formula submission which contained two-tenths of 1 percent of sugar and 
13 ppm of citric acid. The Alcohol and Tobacco Laboratory stated that 
the addition of such amounts of sugar and citric acid were advantageous 
from the consumer-standpoint, in that such addition would make a 
smoother and more neutral product. The Alcohol and Tobacco Laboratory 
further stated that the use of two-tenths of 1 percent of sugar and 13 
ppm of citric acid would in no way render vodka flavored but, rather, 
would correct objectionable tastes which might be obtained from the 
water used in reducing the proof, the charcoal used in distillation, or 
the glass in which packaged. The Alcohol and Tobacco Laboratory 
concluded that the use of sugar and citric acid in the amounts stated 
was in conformance with the standard of identity for vodka in that such 
amounts were not considered to be flavoring materials and would not 
materially affect the taste of the product, or change its basic 
character.
    The Alcohol and Tobacco Laboratory therefore stated that the use of 
these ingredients in the amounts prescribed would conform with a method 
of production of vodka outlined in T.D. 5707, supra, which stated that 
vodka could be produced ``[b]y purifying or refining the distillate by 
any other method which the Deputy Commissioner finds will result in a 
product equally without distinctive character, aroma, or taste, and 
which has been approved by him.'' Simply stated, the addition of up to 
two-tenths of 1 percent of sugar and ``trace amounts'' of citric acid 
was allowed because those ingredients act as a smoothing agent which 
results in rendering vodka without distinctive character, aroma, taste, 
or color. ``Trace amounts'' was not quantified in view of the fact that 
the Alcohol and Tobacco Laboratory recognized that the appropriate 
amount of citric acid would vary on a case by case basis depending on 
the extent of the treatment used to neutralize the product.
    The issue of citric acid took on a new dimension in 1980, when 26 
U.S.C. 5010 was enacted. The section 5010 credit created an incentive 
for industry to add additional amounts of flavors to distilled spirits 
products for the purpose of reducing the effective rate of tax. Under 
current law, distilled spirits products are taxed at the rate of $13.50 
a proof gallon, with a credit under section 5010 for the flavor 
content. The credit for alcohol derived from flavors is equal to the 
distilled spirits tax, but only 2 1/2 percent of the alcohol content of 
a distilled spirits product qualifies for the credit. The net effect of 
this credit is to reduce the tax rate applicable to such product.
    Vodka producers apparently began to use citric acid as a method to 
receive the credit. The ATF Laboratory has stated that 1,000 ppm 
represents, as a practical matter, the amount of citric acid on which 
the maximum section 5010 credit may be claimed. Moreover, the use of 
1,000 ppm of citric acid reduces the effective rate of tax on a proof 
gallon of neutral spirits by 34 cents. Such a reduction can result in a 
tax benefit of hundreds of thousands, if not millions of dollars a year 
for the vodka industry.

Notice No. 403

    With the increasing use of citric acid, the ATF Laboratory tested 
various vodka samples produced in accordance with Revenue Ruling 56-98 
and found that vodka which contained sugar and citric acid within 
levels authorized by the ruling had a measurable solids content due to 
the presence of sugar, and displayed a change in the titratable acidity 
due to the presence of citric acid. The ATF Laboratory stated that such 
changes in the physical and chemical characteristics of the samples 
resulted in a vodka having impermissible distinctive character even if 
an organoleptic examination indicated no distinctive character, aroma, 
taste, or color. Based on the conclusions of the ATF Laboratory with 
respect to sugar and citric acid, ATF subsequently issued an Advance 
Notice of Proposed Rulemaking (ANPRM) on January 11, 1982, Notice No. 
403 (47 FR 1148), requesting comments on whether ATF should revoke 
Revenue Ruling 56-98 and prohibit the treatment of vodka with sugar and 
citric acid, or whether ATF should establish a separate class and type 
of vodka containing specified quantities of sugar and citric acid. 
Additionally, the ANPRM noted that a conflict seemed to exist between 
the provisions of Revenue Ruling 56-98 authorizing treatment of vodka 
with sugar and citric acid, and 27 CFR 5.23(a)(3) which prohibits any 
addition of harmless coloring, flavoring, and blending materials to 
neutral spirits. The ANPRM, therefore, requested comments on clarifying 
the standard of identity for vodka to preclude the addition of any 
ingredients to vodka, such as sugar and citric acid, that would 
materially affect its chemical and physical characteristics and 
comments on establishing another class of vodkas authorizing the 
addition of sugar and citric acid within specified amounts.

Comments on Notice No. 403

    ATF received 16 comments pursuant to the ANPRM. Eight respondents 
opposed the addition of citric acid and sugar to vodka, and favored 
revoking Revenue Ruling 56-98 for the following reasons: It is 
inconsistent with 27 CFR 5.23(a)(3), the public perceives vodka as a 
pure material spirit, there is no purpose to the addition of sugar and 
citric acid, and allowing sugar and citric acid will allow other 
materials to be added to vodka. Seven respondents favored permitting 
the use of sugar and citric acid in the production of vodka by 
retaining Revenue Ruling 56-98. These comments indicated mainly that 
the standard of identity should be based on sensory factors such as 
taste, aroma, and color, and not on physical and chemical 
characteristics because consumers judge vodka by taste. These comments 
further stated that consumers have not been harmed or deceived by the 
addition of sugar and citric acid and would not benefit by a 
prohibition on such ingredients. In addition, eight of the sixteen 
respondents objected to the proposed establishment of a new class and 
type of vodka containing sugar and citric acid for various reasons.

Notice No. 583

    Based on the comments on Notice No. 403, ATF issued an NPRM on 
February 19, 1986, Notice No. 583 (51 FR 6009), proposing to revoke 
Revenue Ruling 56-98, incorporate its provisions into 27 CFR 5.23, and 
define a ``trace amount'' as 150 ppm. The NPRM noted that trace amounts 
varied widely with different formulas. The notice explained that 150 
ppm was being proposed because it is sufficient to neutralize residual 
alkalinity derived from charcoal treatment of some vodkas, or from the 
use of certain glass in manufacturing bottles. The NPRM sought comments 
on the appropriate level of citric acid, both above and below 150 ppm.

Comments on Notice No. 583

    ATF received 10 new comments pursuant to the NPRM. Five commenters 
opposed the addition of citric acid and sugar to vodka even though ATF 
had previously decided to continue to allow the use of sugar and citric 
acid in vodka based on comments received pursuant to the ANPRM. The 
remaining commenters favored allowing the use of sugar and citric acid 
so as not to interfere with eligibility for the section 5010 credit. 
The comment received from the LeVecke Corporation included the results 
of organoleptic tests which showed that the test panelists could 
consistently detect the presence of citric acid at 400 ppm. 
Accordingly, the company recommended that citric acid be allowed up to 
400 ppm.

T.D. ATF-306

    On December 4, 1990, ATF issued a Final Rule, T.D. (T.D. ATF-306, 
55 FR 49994), that vodka with more than 150 ppm of citric acid has a 
distinctive character, in violation of the standard of identity, and 
must be labeled as flavored vodka. T.D. ATF-306, amended 27 CFR 
5.23(a)(3) to authorize the use of up to 2 grams per liter (2,000 parts 
per million) of sugar, and a trace amount (defined as 150 milligrams 
per liter or 150 parts per million) of citric acid in the production of 
vodka. T.D. ATF-306 was effective January 3, 1991, with a formula and 
label cancellation date of March 4, 1991, for products not made within 
the limitations of the Treasury decision.
    The TD incorporated the comment received by the LeVecke Corporation 
which showed that the test panelists could consistently detect the 
presence of citric acid at 400 ppm. The TD states that ATF agrees that 
the presence of citric acid is detectable at 400 ppm but that ``ATF's 
Laboratory conducted similar tests and found that 150 ppm is 
approximately the threshold at which the presence of citric acid in 
vodka can be detected.'' The TD, therefore, concluded that any amount 
of citric acid higher than 150 ppm was distinctive in violation of 27 
CFR 5.22(a)(1) based on the position that citric acid, as with any 
other ingredient, should not be present at a level at which it is 
detectable to a consumer, irrespective of whether the consumer can 
specifically identify the ingredient as citric acid.

Petition for Reconsideration

    On March 4, 1991, in response to a petition from Heublein, Inc., 
(Heublein) for the reconsideration of T.D. ATF-306, ATF issued T.D. 
ATF-311 (56 FR 8922). T.D. ATF-311 deferred the compliance date with 
respect to the citric acid limitation set forth in 27 CFR 
5.23(a)(3)(ii) by T.D. ATF-306 to December 4, 1991. Heublein's petition 
was based on a representation that new scientific information and data 
not previously available had come to their attention concerning maximum 
levels for the use of citric acid in vodka. The compliance date set 
forth in T.D. ATF-306 regarding a maximum level for the use of sugar in 
vodka remained unchanged.

Notice No. 716

    On April 29, 1991, ATF issued Notice No. 716 (56 FR 19623) to 
gather additional information with respect to the 150 ppm limitation 
set forth in T.D. ATF-306. Notice No. 716 was issued in conjunction 
with Heublein's request for reconsideration which was granted in T.D. 
ATF-311. Notice No. 716 proposed to retain the reasoning and conclusion 
of T.D. ATF-306 as set forth above. The purpose of the Notice was to 
solicit comments from the public and industry concerning the 
appropriateness of sensory threshold citric acid levels higher and 
lower than the proposed maximum level of 150 ppm.

Comments on Notice No. 716

    In response to Notice No. 716, ATF received nine comments. All of 
the comments were opposed to setting a maximum limitation as low as 150 
ppm for the addition of citric acid to vodka. However, the only 
commenter submitting substantiating test data was Heublein. In January 
1991 and July 1991, Heublein submitted results of sensory (taste and 
smell) testing which it claimed demonstrate that the majority of 
consumers could not detect a difference between vodka containing 150 
ppm and vodka containing 480 ppm. The purpose of these tests was not to 
determine the level at which citric acid can be detected by the 
consumer, but rather whether a statistically significant difference 
could be detected between two levels of citric acid in vodka. For 
example, if a panel were asked to determine whether there was a 
difference between 1,000 ppm and 1,110 ppm of citric acid, the 
statistical analysis of the results of such testing would only show 
whether the two samples can be reliably distinguished but would not 
generate any information concerning the threshold level at which citric 
acid could be detected.
    Heublein relied on these tests to support the conclusion that 480 
ppm is not detectable. That is, if vodka at 480 ppm tastes, smells, and 
looks no different than 150 ppm, then it is no more distinctive. 
Heublein also tested vodka containing 528 ppm of citric acid and stated 
that several of its tests showed significant and perceptible difference 
between vodka containing 150 ppm of citric acid and vodka with 528 ppm 
citric acid. Heublein further stated that changing the formulation of 
the product from 528 ppm to 150 ppm would ``significantly change the 
sensory character'' of their product. The ATF Laboratory interpreted 
Heublein's tests as concluding that, while the majority of consumers 
could not detect a change in the level of citric acid from 150 ppm to 
480 ppm, such a change could be detected from 150 ppm to 528 ppm. As 
discussed later, ATF does not believe that these tests can be relied 
upon in setting a citric acid limitation.

Independent Testing

    During the comment period, ATF secured an outside testing firm, 
Odor Science and Engineering (OS&E), to conduct independent testing on 
sensory threshold levels for citric acid addition to vodka. The outside 
testing firm was secured in order to provide data for comparison to the 
results secured by ATF and industry members.
    OS&E was requested to conduct a test which would produce results 
with respect to the taste threshold of citric acid in vodka. The 
initial tests were conducted on April 25 and 29, 1991. Various 
concentrations of ethanol solution and citric acid were presented to a 
taste panel comprised of ten experienced sensory panelists familiarized 
with the taste of the ethanol solutions. The initial ethanol solutions 
were supplied to OS&E by ATF and consisted of 40 percent ethanol in 
water (80 proof). The flasks were stoppered to prevent any opportunity 
of interference because of odor perception. The initial levels of 
citric acid in the various ethanol solutions were: 50 ppm, 100 ppm, 150 
ppm, 200 ppm, and 1,000 ppm.
    The presentations consisted of two flasks containing only ethanol 
solution and one flask containing ethanol solution mixed with one of 
the levels of citric acid described above. One panelist at a time 
entered the sensory laboratory and tasted each of the three flasks. 
Each of the panelists tasted each of the three flasks and indicated to 
the panel moderator which of the three samples was different, thus 
requiring the panelist to guess if he or she expressed uncertainty. 
This procedure is known as the forced-choice ascending concentration 
method and was repeated for each of the citric acid concentrations 
described above. The forced-choice ascending method is stacked against 
guessing which sample contains the citric acid because two out of three 
choices do not contain citric acid.
    As results of the initial trials were inconclusive, repeat trials 
were conducted with eleven panelists using citric acid concentrations 
of 100 ppm, 250 ppm, and 500 ppm. However, as with the initial tests, 
the ethanol solution had a pronounced anesthetic effect which precluded 
accurate determinations of taste thresholds. As a result, the ethanol 
solution was diluted to 20 percent ethanol in water (40 proof) as 
directed by American Society for Testing and Materials he American 
Society for Testing and Materials (ASTM) methodology and three 
concentrations of citric acid in the diluted solution were evaluated: 
25 ppm, 50 ppm, and 500 ppm. The anesthetic effect discussed above was 
presumably eliminated because all of the panelists detected taste 
differences at lower concentrations of citric acid.
    An additional test was run on May 28, 1991, using twelve series (2 
by each panelist) in order to develop more representative data using a 
20 percent ethanol in water (40 proof) solution. The concentrations of 
citric acid in the diluted solution were 25 ppm, 50 ppm, 100 ppm, 200 
ppm, and 400 ppm. The threshold of citric acid in vodka could then be 
determined using the forced-choice ascending concentration method. OS&E 
concluded that a majority of people could detect the presence of citric 
acid in vodka at a level of approximately 180 ppm.
    However, such test results collected by OS&E were not calculated in 
accordance with the methodology prescribed by the ASTM. ASTM Procedure 
E-679 is entitled ``Standard Practice for Determination of Odor and 
Taste Thresholds By a Forced-Choice Ascending Concentration Series 
Method of Limits.'' This method requires use of a geometric progression 
of concentrations, i.e., each concentration of citric acid is a factor 
or multiple of the previous concentration. In this test, the factor was 
two. In order to calculate the mean of such a progression, one must 
take the geometric mean. This is calculated by taking the nth root of 
the product of the numbers. This differs from the familiar arithmetic 
mean which is found by dividing the sum of the numbers by n. In both 
cases, n is the number of values under consideration.

ATF Analysis of Independent Test Data

    The OS&E tests were supported by the ATF Laboratory in lieu of the 
tests relied on in setting the 150 ppm limit in T.D. ATF-306 because 
those earlier tests did not fully conform to the methodology 
established for sensory threshold testing established by the ASTM. 
However, although the OS&E tests were conducted in accordance with the 
ASTM methodology, OS&E did not calculate results from the data it 
generated in the ASTM prescribed method. The ATF Laboratory therefore 
used the data generated by OS&E and recalculated the results according 
to the approved ASTM method. The detection threshold of citric acid in 
vodka was determined using the best-estimate criterion, or the group 
geometric mean of all the panelists' thresholds. Each panelist's 
threshold is the geometric mean of the last missed concentration (the 
last concentration of citric acid not detected) and the next higher 
concentration. This kind of analysis is considered most reliable when 
most of the panelists have had at least two hits in a row at the high 
concentration end. For those panelists who have a miss at the highest 
concentration, it is assumed by the ASTM method that they would have 
had a hit at the next higher concentration had there been one more 
sample in the series (800 ppm citric acid for this test). For those 
panelists who have no misses, it is assumed by the ASTM method that, 
had the testing begun one sample lower in the series (12.5 ppm citric 
acid for this test), they would have missed it.
    For normally distributed data, half of the population lies on each 
side of the center of the data curve. Using the OS&E data, the ATF 
laboratory determined that two-thirds of the population lies within the 
range of citric acid concentrations between 202 ppm and 700 ppm and 
one-sixth lies outside this region in each tail of the distribution. A 
normal distribution did not exist because the data were skewed toward 
lower concentrations of citric acid. Because of this, the geometric 
mean (which is calculated from the average of the log of the values) 
would not yield as accurate a measure of where the majority of people 
would detect the presence of citric acid in vodka as the median, or 
middle point, of the distribution ordered from lowest point to highest 
point.
    The ATF Laboratory also utilized the OS&E data to determine that 
the actual range of concentrations of citric acid that would include 
two-thirds of the population results in a geometric mean of 376 ppm and 
a range of 202 ppm to 700 ppm at 40 percent alcohol or 80 proof. The 
results of the OS&E testing also show that a majority of the panelists 
were able to detect citric acid at the median level of 282 ppm in 80 
proof vodka. That is, the OS&E data revealed that 282 ppm was the 
initial point of detection for the majority of panelists. The median 
level of 282 ppm is lower than the group geometric mean of 376 ppm 
because the data are skewed away from a normal distribution toward 
lower concentrations of citric acid.
    The sample size of the OS&E study was sufficient to be 
statistically valid based on the ASTM method in place at the time of 
the testing. As is always the case, a larger sample size would have 
certainly given a distribution more closely representative of the total 
population. ATF has allowed for the uncertainty inherent in any 
determination where the entire population is not sampled. The standard 
of identity for vodka would prescribe that the lower limit of 
detectability be used to ensure that a majority of the population could 
not detect the presence of citric acid.

Disparity in Test Results

    Heublein was provided with the opportunity to comment on the data 
secured on behalf of ATF by OS&E. Heublein acknowledged the 
discrepancies in the OS&E report in their comments to ATF when they 
stated that ``we were unable to reproduce some * * * values in the 
report.'' Nevertheless, Heublein used the incorrect OS&E calculations 
and represented to ATF that the level at which the majority of people 
could detect citric acid in vodka is 734 ppm. This level is much higher 
than the 282 ppm level generated by ATF from the OS&E data because the 
value of 734 ppm was erroneously based on the calculation of the 
arithmetic mean.
    The citric acid level of 734 ppm proposed by Heublein would be the 
concentration at which greater than two-thirds of the population would 
detect the presence of citric acid in vodka. In addition, the tests 
submitted by Heublein were designed to determine whether there is a 
statistically significant difference between two solutions of different 
concentrations of citric acid in vodka, not the threshold level of 
citric acid. Accordingly, ATF does not believe that the tests submitted 
by Heublein are germane to the issue of setting a level of citric acid 
that will not be in conflict with the current standard of identity for 
vodka which defines the product as being without distinctive character, 
aroma, taste, or color. Indeed, ATF believes that the use of a level of 
citric acid which greater than two-thirds of the population could 
detect is inconsistent with the above-stated standard of identity for 
vodka. ATF believes instead that it is in the interest of preserving 
the standard of identity for vodka that any statistical treatment be 
applied in the opposite direction, i.e., where most of the population 
would not detect the presence of citric acid.

Deferrals of Compliance Date

    A significant disparity existed between the methodologies of the 
studies done by ATF and Heublein, and the conclusions reached by 
Heublein and OS&E with respect to the study conducted by OS&E. Based on 
these disparities, ATF concluded that more time would be needed to 
properly evaluate the sensory tests and results derived from Heublein 
and the outside firm hired by ATF. The compliance date of December 4, 
1991, with respect to citric acid, set forth in T.D. ATF-311 was 
subsequently deferred to September 3, 1992, by T.D. ATF-319 (56 FR 
63398, December 3, 1991) in order to allow for time to resolve the 
disparity in the test results. As ATF had not yet completed its review 
of all data submitted relative to the citric acid limitation as of 
September 3, 1992, ATF issued T.D. ATF-333 (57 FR 40323, September 3, 
1992), which deferred the compliance date with respect to the citric 
acid limitation set forth in 27 CFR. 5.23(a)(3)(ii) until September 3, 
1993. On August 27, 1993, ATF issued T.D. ATF-348 (58 FR 45251) 
deferring the compliance date set forth in T.D. ATF-333 until August 
28, 1995, with respect to the citric acid limitation set forth in 27 
CFR 5.23(a)(3)(ii) by T.D. ATF-306. The two year compliance date 
deferral was necessary in order to allow ATF to analyze the comments 
received during the comment period relative to the issuance of Notice 
No. 780 and to allow for additional unforeseen contingencies.

Notice No. 780

    Upon consideration of both the OS&E and Heublein tests, ATF 
published Notice No. 780 (58 FR 46141) on September 1, 1993, proposing 
to amend the regulations authorizing the use of a trace amount (defined 
as up to 300 milligrams per liter or 300 ppm) of citric acid in the 
production of vodka, without changing its designation as vodka. The 
NPRM was issued in order to provide the public with an opportunity to 
comment on the OS&E study. Notice No. 780 contains the detailed 
description and analysis of the OS&E study and the critique of the 
Heublein tests submitted in response to Notice No. 716 set forth above. 
The NPRM proposed a level of 300 ppm as a rounding off of the 282 ppm 
level derived by OS&E in order to facilitate regulatory administration 
and consumer understanding. Because citric acid is not an essential 
component of vodka, the NPRM proposed amending 27 CFR. 5.23 which 
regulates additions of substances to distilled spirits, rather than 27 
CFR 5.22(a)(1) which is the standard of identity of vodka. Under this 
proposal, vodka made with a greater concentration of citric acid would 
be designated ``flavored vodka'' or labeled with a fanciful name under 
27 CFR part 5.
    The comment period for Notice No. 780 ended on October 18, 1993. At 
that time, Notice No. 782 [58 FR 53682] was published in the Federal 
Register extending the comment period for Notice No. 780 until January 
3, 1994. Notice No. 782 was issued in response to a request from the 
Distilled Spirits Council of the United States (DISCUS) for an 
extension of the comment period in order to provide sufficient time for 
all interested parties to respond to the issues addressed in the NPRM.

Comments on Notice No. 780

    In response to Notice No. 780, 8 comments were received. Seven of 
the commenters felt that the maximum authorized level for the addition 
of citric acid to vodka should be 1,000 ppm without changing the 
product's designation as vodka. The remaining commenter, Mr. David A. 
Owen, did not object to the proposed 300 ppm level but felt that the 
level of all such ingredients should be indicated on the label.
    Three of the commenters, the President's Forum of the Beverage 
Alcohol Industry, the David Sherman Corporation, and Barton 
Incorporated, while opposed to setting a maximum limitation as low as 
300 ppm, did not submit any substantiating data to support their 
recommended level of 1,000 ppm.
    Jim Beam Brands Co., another of the seven commenters supporting 
1,000 ppm, felt that consumer response to vodka produced with citric 
acid is the most important issue. Jim Beam pointed out that the actual 
presence of citric acid has not raised any health or safety issues, nor 
has it resulted in any consumer deception since being introduced in 
vodka production in 1956. Rather, Jim Beam argued that consumers would 
be confused by requiring vodka containing greater than 300 ppm to be 
labeled as a ``flavored vodka'' when such products traditionally have 
been marketed as ``vodka.'' Jim Beam notes that in decreasing the 
allowable amount of citric acid, ATF must depend on valid scientific 
studies which demonstrate that consumers can reliably detect a 
distinctive difference between vodkas at or above that threshold and 
vodkas below that threshold. Jim Beam also includes in its comment a 
critique of the OS&E study which Beam believes was neither reliable nor 
valid. As such, Jim Beam believes that ATF is fulfilling its statutory 
mandate in this matter without further action.
    The comment submitted by United Distillers also criticizes the OS&E 
study. In addition, United Distillers argues that there are detectable 
differences even amongst vodkas that are untreated. These differences 
are said to result from ingredients, manufacturing processes, and the 
subjective tastes of the consumer. Therefore, based on the historical 
acceptance of vodkas with up to 1,000 ppm of citric acid, international 
practices, and product standardization, United Distillers supports a 
level of 1,000 ppm.
    Heublein argues in its comment that the OS&E study was unreliable. 
Heublein also states that ATF should not determine a minimum threshold 
level since they believe that it has no relevance to the 
distinctiveness requirements of the vodka standard of identity. 
Similarly, Heublein states that the test results it submitted in 
response to Notice No. 716 demonstrate the insufficiency of the minimum 
threshold standard and the appropriateness of distinctiveness standard. 
Heublein argues that ATF misinterpreted the test results it submitted 
in connection with Notice No. 716. Heublein maintains that those tests 
do in fact demonstrate that vodkas containing 480 ppm and 528 ppm are 
not distinguishable from vodka containing 150 ppm. Heublein further 
argues that ``the effort being expended to justify an additive limit 
below 1,000 ppm is in clear conflict with the instruction of the 
President to ATF and other agencies,'' as stated in the President's 
Executive Order on Regulatory Planning and Review dated September 30, 
1993 (58 FR 51735 (Oct. 4, 1993)). The President stated, in part, that 
Federal agencies should promulgate only such regulations as are 
required by law, are necessary to interpret the law, or are made 
necessary by compelling public need, such as the material failure of 
private markets to protect or improve the health and safety of the 
public. The President further stated that, in deciding whether and how 
to regulate, agencies should assess all costs and benefits of available 
regulatory alternatives, including the alternative of not regulating.
    Heublein therefore asserts that since there is no compelling public 
health or safety reason for the change proposed, ATF should allow up to 
1,000 ppm. Heublein supports its conclusion by arguing that no reliable 
evidence exists in support of 300 ppm, and that it has provided 
evidence in support of 1,000 ppm,
    Finally, DISCUS submitted substantive comments which were supported 
by Heublein in its comment. Initially, DISCUS reiterates the argument 
that a maximum level of citric acid can be based only on distinctive 
differences between vodkas with levels of citric acid at or above a 
specific level and vodkas without citric acid. DISCUS also argues that 
ATF's longstanding approval of formulas containing up to 1,000 ppm and 
the confusion that would result from the adoption of 300 ppm militate 
toward allowing 1,000 ppm.
    In support of its conclusions, DISCUS issued a critique of the OS&E 
study. It criticized OS&E for, in general, using too few test subjects, 
failing to verify the qualifications of the testers that it did use, 
apparently using the study authors as test subjects, collecting too few 
test responses, and failing to use proper testing procedures. DISCUS 
states that these criticisms demonstrate the unreliability of the OS&E 
study.
    DISCUS also submitted the results of an independent test conducted 
by the Tragon Corporation (a sensory testing and marketing research 
company) which purports to demonstrate that vodka containing up to 
1,000 ppm has no distinctive character, aroma, taste, or color. This 
test was not ``threshold testing'' in which the minimum amount of 
citric acid which could be detected by a test subject is determined 
but, rather, ``difference testing'' in which a test subject is asked 
whether a difference can be detected between vodka containing 0 ppm, 
500 ppm, and 1,000 ppm of citric acid. This test also inquired as to 
whether test subjects could ascribe any characteristics of citric acid, 
such as tartness, to any of the test samples and concluded that such 
characteristics could not be identified. These tests were characterized 
as ``reliable scientific evidence'' in Heublein's and DISCUS' comments 
and both commenters now urge ATF to set a limit of 1,000 ppm.
    The substantive comments on Notice No. 780 related in large part to 
the relative merits of the OS&E and DISCUS studies. With respect to the 
test data submitted by DISCUS, ATF has several criticisms which serve 
as the basis to discount its conclusions. Initially, ATF does not 
believe that DISCUS' study conforms with ASTM procedures. For example, 
the DISCUS study utilizes commercially available vodkas which contain 
80 proof alcohol while the ASTM procedures require that distilled 
spirits used in testing be diluted to 25 proof or 45 proof. In 
addition, ATF believes that the inclusion of a flavored vodka and a 
vodka with two tenths of 1 percent sugar added in the testing samples 
cast doubt on the validity of the study's conclusions. Most 
importantly, ATF believes that the DISCUS study improperly involved 
``difference testing'' while the proper focus should be ``threshold 
testing'' as those terms are described above. With respect to the 
criticisms of DISCUS and all other commenters of the OS&E study, ATF 
believes that the study conformed with ASTM procedures. For example, 
although the size of a testing panel and the number of test responses 
collected could always be larger, both were within acceptable ASTM 
procedures. Moreover, ATF ensured that the data collected by OS&E was 
calculated in accordance with ASTM procedures. As such, ATF believes 
that the criticisms of the OS&E study by seven of the commenters on 
Notice No. 780 do not diminish the validity of the study.
    Based on all of the above, ATF believes that its reliance on the 
OS&E study in reaching a conclusion in this matter is justified. In 
that regard, no commenter during the course of this rulemaking 
submitted a study which both involved threshold testing and conformed 
with ASTM procedures. As the OS&E study did meet these criteria, and 
its results are scientifically valid and reliable, it is reasonable to 
utilize the data from that study rather than data submitted by 
commenters that are in favor of 1,000 ppm.
    The other principal contentions of the comments on Notice No. 780 
are that the acceptable level of citric acid should be based on 
distinctiveness rather than on detectability and that, in essence, 
there is no reason not to allow 1,000 ppm because that level represents 
the status quo regarding citric acid. ATF believes that detection is 
the appropriate standard because the standard of identity for vodka 
states that vodka should be without distinctive character, aroma, 
taste, or color. If an ingredient is present in an amount at which it 
can be distinguished from other ingredients in the product, then its 
presence contravenes rather than supports the standard of identity. 
Indeed, the ingredient in question would itself become distinctive in 
violation of the standard of identity. With respect to the argument in 
favor of maintaining the status quo, ATF believes that its statutory 
mandate to protect consumers is best served by adhering as closely as 
possible to the standard of identity. Moreover, ATF does not believe 
that consumers would be misled or confused by the setting of a citric 
acid limitation. Indeed, consumers receive no information as to the 
level of citric acid in vodka products. Thus, the setting of a citric 
acid limitation, which will require that vodkas above 300 ppm be 
labeled as ``flavored'' while vodkas below that level retain the 
designation ``vodka,'' will prohibit deception in that consumers will 
be able to relate such terms to the level of citric acid contained in 
vodkas. Consumers will, therefore, be better informed as to the 
identity and quality of the products in question. ATF believes that the 
preservation of the standard of identity is best served by ensuring a 
change in labeling for vodkas over 300 ppm. As such, ATF believes that 
its regulation of citric acid is in accordance with the Executive Order 
on Regulatory Planning, and Review because it is a necessary 
interpretation of the law. Stated another way, ATF believes that 
regulating citric acid is necessary to maintain both the original 
intent and integrity of the standard of identity for vodka.

Discussion

    Any discussion of a citric acid limitation must begin with the 
premise that the standard of identity for vodka contemplates a neutral 
product. The addition of any ingredient to such neutral spirits must 
not only be clearly justified, but must not contravene the standard of 
identity for vodka by contributing distinctiveness to the product. No 
comments since the inception of this rulemaking have offered such a 
justification for the use of more than 300 ppm of citric acid.
    In that regard, ATF has historically maintained that the use of 
citric acid should be for the purpose of correcting deficiencies in 
vodka; i.e., acting as a smoothing agent to correct objectionable 
tastes which might be obtained from the water used in reducing the 
proof, the charcoal used in distillation, or the glass in which 
packaged. ATF has viewed vodka as a product which, in essence, was 
neutral in character, aroma, taste, and color for forty-five years; 
although this policy has been deferred during the pendency of the 
rulemaking. While sugar and citric acid are recognized as acting as 
smoothing agents in vodka, it was very clear that they were authorized 
only for the purpose of correcting objectionable tastes which might 
result from such things as the water used in reducing the proof, or 
from the glass in which packaged. The ATF Laboratory has further stated 
that it believes that such use of citric acid should not be detectable 
to a majority of consumers. ATF therefore takes the position that the 
addition of citric acid to a level equal to or greater than that of 
detection would contribute a distinctive character to the product in 
violation of the standard of identity.
    ATF is fulfilling its statutory mandate in 27 U.S.C. 205(e) by 
ensuring adherence to the standard of identity for vodka. That is, ATF 
is setting a citric acid limitation in order to ensure that consumers 
are adequately informed as to identity and quality of vodka; a product 
which is understood to be without distinctive character, aroma, taste, 
or color. The addition of sugar, citric acid, or any other ingredient 
for that matter, has and should be allowed only to facilitate rendering 
vodka without distinctive character, aroma, taste, or color. Therefore, 
there is a strong presumption against the use of any ingredients, in 
any amount, particularly where they are likely to contribute to 
distinctiveness rather than neutrality. Moreover, the point at which 
the amount of such an ingredient begins to contravene the standard of 
identity, as in the point at which citric acid can be detected by a 
majority of consumers, is the maximum allowable level of that 
ingredient in vodka.
    ATF therefore believes that the rulemaking record in this case 
supports a level of 300 ppm of citric acid in vodka without changing 
the product designation. The current standard of identity mandates 
consideration of not only differences attributable to taste, but also 
differences attributable to character, aroma, or color. To that end, 
the ATF Laboratory has conducted tests based upon chemical and physical 
characteristics and designed the OS&E tests based upon organoleptic 
factors, all of which lend support to a level of 300 ppm.
    This position is clearly supported not only by an examination of 
the history of 27 CFR 5.22(a)(1), but also by 27 CFR 5.23(a)(1), which 
provides that no material whatsoever may be added to neutral spirits 
(which encompasses vodka). ATF believes that this section clearly 
reflects the original intent of the regulations in that vodka was 
presumed to be a product which was not altered in any way by the 
addition of any material, and would, therefore, be as tasteless and 
odorless as possible. Thus, sugar and citric acid were recognized as 
acting as smoothing agents in vodka, which were authorized only for the 
purpose of correcting objectionable tastes which might result from such 
things as the water used in reducing the proof, the charcoal used in 
distillation, or the glass in which packaged.
    In light of this purpose, ATF believes that this interpretation 
correctly applies the standard of identity for vodka since the level of 
detection to a majority of consumers would demonstrate that the amount 
of citric acid used reached a point with regard to the product that was 
no longer viewed only as corrective. That is, the addition of citric 
acid to a level equal to or greater than that of detection would 
contribute a distinctive character to the product in violation of the 
standard of identity.
    It is apparent that the reason for the increased use of citric acid 
in vodka has been directly tied to the tax credit savings available by 
virtue of the 26 U.S.C. 5010 wine/flavor credit enacted in 1980. While 
ATF recognizes that such a rationale is not, in and of itself, a basis 
for denial of citric acid in vodka production, it certainly can be used 
to determine whether the amounts that are currently used reflect the 
levels which were initially contemplated by Revenue Ruling 56-98. That 
is, the inquiry becomes whether the level of citric acid proposed by 
vodka producers whose comments support the use of greater than 300 ppm 
is necessary to correct objectionable tastes, etc., in vodka or whether 
such levels are merely a tax saving mechanism used to reduce the 
effective tax rate on vodka products. Commenters supporting the use of 
greater than 300 ppm have offered no rationale for the use of citric 
acid in amounts up to 1,000 ppm since the initiation of this rulemaking 
effort. To the contrary, it is apparent that the use of up to 1,000 ppm 
of citric acid is directly related to the section 5010 flavors credit. 
Absent such a rationale, ATF is unable to conclude that the addition of 
that quantity of citric acid serves a corrective purpose in the 
production of vodka. Even assuming it has such a purpose, the 
detectability of 1,000 ppm would preclude the authorization of such a 
level. As such, 27 CFR 5.23(a)(1) precludes, as it would the addition 
of any other material whatsoever, the addition of greater than 300 ppm 
of citric acid.
    ATF recognizes in setting a limit of 300 ppm that formulas 
containing up to 1,000 ppm have been approved for several years. 
Rulemaking with respect to this issue was initiated in January 1982. 
ATF has therefore allowed the use of up to 1,000 ppm during the 
pendency of the rulemaking. Vodka producers began submitting formulas, 
for the most part, after the enactment of section 5010 and ATF did not 
believe that it was equitable to deny such formulas until an ultimate 
decision was reached in this matter. Moreover, ATF has only now 
obtained reliable scientific data in support of 300 ppm, allowed 
interested parties the opportunity to comment on this data, evaluated 
the comments on such data, and reached a final conclusion in this 
matter.
    ATF notes that two options exist with respect to vodka products 
containing more than 300 ppm of citric acid that are currently in the 
marketplace. First, such products may continue to be produced in their 
current form and relabeled as ``flavored vodka'' or labeled with a 
fanciful name, followed by a truthful and adequate statement of 
composition under 27 CFR part 5. In addition, the level of citric acid 
can be reduced to 300 ppm and thereby retain the designation ``vodka.'' 
ATF does not believe that such a reduction is unreasonable in light of 
the fact that the use of citric acid in vodka must serve a purpose 
relative to maintaining the product's standard of identity and no 
commenter advocating the use of greater than 300 ppm has, since the 
inception of this rulemaking, offered such a purpose, or indeed any 
purpose, for the use of such a level of citric acid.
    ATF believes that the 300 ppm figure demonstrates sensitivity to 
the amounts of citric acid used in the marketplace in that it is closer 
to the level of citric used by some producers than the 282 ppm level 
that the ATF Laboratory derived from the OS&E data. The 300 ppm level 
also recognizes the uncertainty inherent in any determination where the 
entire population is not sampled. Moreover, a level of 300 ppm is 
acceptable to the ATF Laboratory because that level of citric acid 
represents a de minimis difference from its conclusions with respect to 
the OS&E tests and because it believes that the integrity of the 
standard of identity for vodka continues to be maintained at that 
level. That is, the 300 ppm level is within a reasonable range of the 
initial point of detection for the majority of people. As such, a level 
of 300 ppm is a reasonable interpretation in light of both the OS&E 
data and the practical considerations surrounding the marketplace.
    ATF believes that a level of 1,000 ppm as suggested by several 
commenters throughout the rulemaking can only be supported if the 
standard of identity for vodka is changed. Thus, ATF believes that a 
limit of 300 ppm is reasonable for all of the above-stated reasons.
    Accordingly, ATF is amending 27 CFR 5.23(a)(3)(ii) to authorize the 
use of a trace amount (defined as up to 300 milligrams per liter or 300 
ppm) of citric acid in the production of vodka, without changing its 
designation as vodka.

Formula and Label Approvals

    Vodka products bottled or imported for sale or distribution in the 
United States on or after December 29, 1995 must comply with the 
standards set forth in this final rule. It is the responsibility of 
domestic bottlers to provide, upon request, sufficient evidence to 
establish that the vodka product was bottled in the United States prior 
to December 29, 1995. It is the responsibility of importers to provide, 
upon request, sufficient evidence to establish that the vodka product 
was bottled in a foreign country prior to December 29, 1995.
    Existing formulas and corresponding labels that are not in 
compliance with the standards set forth in this final rule are 
effectively canceled December 29, 1995, and where necessary, new 
formulas and affected labels should be re-submitted to the Product 
Compliance Branch, Bureau of Alcohol, Tobacco and Firearms, Room 5408, 
650 Massachusetts Avenue., NW., Washington, DC 20226.

Regulatory Flexibility Act

    It is hereby certified that this regulation will not have a 
significant economic impact on a substantial number of small entities. 
No new recordkeeping or reporting requirements are proposed. 
Accordingly, a regulatory flexibility analysis is not required.

Executive Order 12866

    It has been determined that this regulation is not a significant 
regulatory action as defined in E.O. 12866 because (1) it will not have 
an annual effect on the economy of $100 million or more or adversely 
affect in a material way the economy, productivity, competition, jobs, 
the environment, public health or safety, or state, local, or tribal 
communities; (2) create a serious inconsistency or otherwise interfere 
with an action taken or planned by another agency; (3) materially alter 
the budgetary impact of entitlement, grants, user fees, or loan 
programs, or the rights and obligations of recipients thereof; or (4) 
raise novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in Executive Order 
12866.

Paperwork Reduction Act

    The provisions of the Paperwork Reduction Act of 1980, Public Law 
96-511, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR 
Part 1320, do not apply to this final rule because no requirement to 
collect information is imposed.

Drafting Information

    The principal author of this document is David W. Brokaw, Wine and 
Beer Branch, Bureau of Alcohol, Tobacco, and Firearms.

List of Subjects in 27 CFR Part 5

    Advertising, Consumer protection, Customs duties and inspection, 
Imports, Labeling, Liquors, Packaging and Containers

Authority and Issuance

    27 CFR Part 5--Labeling and Advertising of Distilled Spirits, is 
amended as follows:

PART 5--LABELING AND ADVERTISING OF DISTILLED SPIRITS

    Paragraph 1. The authority citation for 27 CFR, Part 5 continues to 
read as follows:

    Authority: 26 U.S.C. 5301, 7805, 27 U.S.C. 205.

    Par. 2. Section 5.23(a)(3)(ii) and (iii) are revised to read as 
follows:


Sec. 5.23  Alteration of class and type.

    (a) Additions. * * *
* * * * *
    (3) * * * (ii) any material, other than caramel, infusion of oak 
chips, and sugar, in the case of Cognac brandy; or (iii) any material 
whatsoever in the case of neutral spirits or straight whiskey, except 
that vodka may be treated with sugar in an amount not to exceed 2 grams 
per liter, and, on and after December 29, 1995, with citric acid in an 
amount not to exceed 300 milligrams per liter.
* * * * *
    Par. 3. Section 5.23(c) is revised to read as follows:


Sec. 5.23  Alteration of class and type.

* * * * *
    (c) Exceptions. (1) This section shall not be construed as in any 
manner modifying the standards of identity for cordials and liqueurs, 
flavored brandy, flavored gin, flavored rum, flavored vodka, and 
flavored whisky or as authorizing any product which is defined in 
Sec. 5.22(j), Class 10, as an imitation to be otherwise designated.
    (2) Vodka products bottled in the United States or a foreign 
country prior to December 29, 1995 are exempt from the citric acid 
limitation set forth in Sec. 5.23(a)(3)(iii). It is the responsibility 
of the bottler or importer to provide, upon request, sufficient 
evidence to establish that the vodka was bottled prior to such date.

    Signed: November 11, 1994.
Daniel R. Black,
Acting Director.
    Approved: November 23, 1994.
John P. Simpson,
Deputy Assistant Secretary (Regulatory, Tariff, and Trade Enforcement).
[FR Doc. 94-32010 Filed 12-28-94; 8:45 am]
BILLING CODE 4810-31-P