GENTECH archive


Congressional Record continued, Protest of National Soft Drink Association - Coke and Pepsi knew the gun was loaded before they put aspartame in their products.

Continuation.  Also it should be noted that this was written in l983 and
put in the Congressional Record in l985.  After protesting the NSDA turned
around and lobbied for NutraSweet.

>*                 *                 *                 *                 *
>     The inability to account for as much as thirty-nine (39) percent of
>decomposition products is significant.  With such a high unknown factor,
>judgements about the safety of APM in soft drinks cannot be made confidently.
>Possible explanations for, and speculation about, the material balance
>discrepancies abound: secondary reactions may be occurring (possibly with the
>flavor components in the beverages): additional, but unidentified
>decomposition products may exist, (as occurred in the case of PM and beta-
>APM): or the inaccuracy and inadequacies of the analytical methods may
>for the gaps in the data.  No explanation for the discrepancies in material
>balances--that is, for the high percentage of unknown material--can, however,
>be supported on the basis of the data submitted by Searle.  The significance
>of the unknown decomposition products simply cannot be determined in the
>absence of complete, careful and reliable analyses--analyses which are not
>currently available because the petitioner failed to conduct or submit them.
>     2.  Searle Has Not Characterized The Decomposition Products of APM in
>Soft Drinks Under Temperature Conditions To Which the Beverages Are Likely To
>Be Exposed In the United States.
>    A suitable assessment of the stability of APM in soft drinks can be
>conducted.  Such (continued on Page S 5509)
>(2)  The availability of HPLC to detect and quantify APM's decomposition
>products is demonstrated by, among other things, a paper presented by three
>representatives of Searle, (LeVon, Mazur and Ripper "Aspartame (APM) as a
>Sweetener in Carbonated Soft Drinks") (Appendix).  In that paper, Searle
>stated that HPLC was currently used to detect APM. DKP and AP and PHE.
>Nevertheless, the petition does not contain HPLC generated data for AP or
>(3)  Section 171.1 (c) of the agency's regulations. 21 C.F.R. 171.1 (c),
>required that an analytical method for detection of a food additive and
>substances formed in or on food because of its use be practicable and one
>which "can be applied with consistent results by any property equipped and
>trained laboratory personnel." HPLC is clearly such a method.
>(4) FN w examples.
>(5)  This figure is derived as follows from Searle data: 13 percent AOM, 21
>percent DKP, 3 percent AP, 8 percent PHE, and 5 percent PM.

>(6)  The increase comes from 10 percent AA and 4 percent methanol.
>(7)  A material balance accounts for the quality of the starting material,
>quantity of identified decomposition products (or by-products, reaction
>produtcs, etc.) and the quantity of unkown material. Because of the
>inadequacies in the analyses documented in section --- above, the figures in
>this table may be inaccurate. Nevertheless, the discrepanices in the material
>balance raise the possibility of significant unknown decomposition products.
>(8)  A tempting, but unsatisfactory, resolution of the material balance
>discrepancy is to assume that the safety of the decomposition products were
>determined in the chronic studies in laboratory animals which Searle
>conducted. This putative resolution does not hold, however, because these
>degradation products would not have undergone testing, since the APM in the
>feeding regimen was in freshly prepared doses.
>May 7, 1985                CONGRESSIONAL RECORD -- SENATE                 S
>an assessment would necessarily involve the use of sample beverages in a
>variety of flavors and varying pH, and, most importantly, involve exposure of
>the beverages to temperature conditions which approximate those which are
>reasonably expected to occur in practice (or under conditions which permit
>reasonable projections to be made to actual conditions). (9)  Unless the
>sample APM-sweetened beverages are exposed to realistic temperature
>conditions, the temperature-sensitive degradation characteristics of APM, and
>in particular its potentially significant decomposition products, cannot be
>known.  The data submitted by Searle are not derived from appropriate test
>conditions.  Judgements about the extent of APM instability and its
>degradation products in soft drinks under actual conditions of use cannot,
>therefore, be inferred from the limited laboratory data.
>     To assess APM's instability in soft drinks, Searle exposed bottles of
>ready-to-drink beverages in four flavors (cola, root beer, lemon-lime and
>orange) to consistent temperatures of 55, 40, 50, 20 and 5 degrees C. (10)
>According to Searle's petition, "(I)n each flavor a loss of APM occurred with
>the rate of degradation directly related to the storage temperature for the
>carbonated beverages.  The rate of APM loss from beverages was pH dependent."
>Moreover, Searle noted that "as the temperature increases, the rate of
>degradation becomes more pronounced." (11)  Some of the effects on APM
>degradation in soft drinks are illustrated in a table in the Searle petition.
>(12)  In that table, for example, after 20 weeks at 30 degrees C (86 degrees
>F), a beverage with a pH between 2.5 and 3.0 contained less than 40
percent of
>the original amount of APM.  For beverages with similar pH, but kept at 40
>degrees C (104 degrees F) for 20 weeks, less than ten percent of the original
>APM remained.  Less pronounced degradation is seen at higher pH and/or at
>lower temperatures.
>     Although these stability tests shown signification degradation of APM at
>consistent temperatures over relatively short time periods, they shed

>virtually no light on the probably degradation rate and products for soft
>drinks exposed to a variety of temperatures--including temperatures higher
>than any used in Searle's studies--during storage, handing, sale and use,
>temperatures which are known to occur and to which sof drinks are known to be
>exposed.  Without stability studies conducted under such conditions, APM
>cannot be said to be appropriately stable in soft drinks, nor can its
>degradation products be considered to be adequately identified (assuming that
>analytical techniques were used which would yield complete and reliable
>results) nor can it be considered to have been shown to be safe.
>     The range of temperature conditions to which soft drinks are exposed
>during the summer months in the southern United States (13) is illustrated by
>a study conducted by the Coca-Cola Company's Corporate Packaging
Department in
>1976 and submitted to the Consumer Product Safety Commission. (14)    That
>study shows that during the summer months, soft drinks are often exposed to
>relatively high temperatures for certain time periods in the course of
>distribution from the bottling plant to the consumer.  High temperatures do,
>of course, routinely occur in much of the United States, including the
>southern regions; conditions of storage and distribution for soft drinks can
>elevate these temperatures signficiantly.
>     In summary, the study assessed: (1) warehouse temperatures in Marietta,
>Georgia and Wichita Falls, Texas: (2) route truck temperatures in Wichita
>Falls; (3) full sun and outside ambient temperatures in Wichita Falls; (15)
>and (4) parked car temperatures in Atlanta, Georgia and Wichita Falls.
Each of
>these test environments is known to occur in practice and the tests were
>performed under actual, as opposed to laboratory conditions.
>     Several significant conclusions can be drawn from this study.  First, in
>those situations where the bottled beverage is heated only by conduction from
>the surrounding air (shaded location in a warehouse or in the automobile
>parked indoors) the ratio of product temperature to the temperature of the
>surrounding air would be 0.92 to 0.94.  In enclosed environments exposed to
>sunlight, however, ratios much greater than one would be expected.  For
>example, a ratio of product temperature to air temperature of 1.45 was found
>for a test car parked in full sunlight. In other situations where sunlight
>a direct heating factor (e.g., open air service station promotions or open
>delivery trucks) typcial ratios were 1.10 to 1.15.
>     The effects of these ratios on product temperature are demonstrated by
>using summer temperatures for Phoenix, Arizona, where the average daily high
>in July is 40 degrees C (104 degrees F).  During July in Phoenix, a soft
>in full sunlight coud reach a temperature of 49 degrees C (120 degrees F)
>degrees x 1.15).  The same product in a car parked in full sunlight could
>reach 66 degrees C (151 degrees F) (104 degrees F x 1.45) (16); soft
drinks in
>a warehouse with an ambient temperature of 110 degrees could reach
>temperatures of 38 degrees C (101 degrees F) to 39 degrees C (103 degrees F)

>(0.92-0.94 x 110 degrees F).
>     Overall, the study, considered together with representative historical
>temperature data (Appendix ___) show that soft drinks will frequently be
>exposed to temperatures of 32 degrees C (90 degrees F) to 49 degrees C (120
>degrees F).  In some cases product temperatures as high as 66 degrees C (151
>degrees F) (especially n the southwestern United States) can be reached.
>     The effects of these high product temperatures on APM degradation and
>formation of degradation products, and the effects of temperature variation
>(for example, soft drinks displayed at a service station may reach
>temperatures of 49 degrees C (120 degrees F) for most of the afternoon, drop
>in termpature overnight, and heat up again during the following day)
cannot be
>determined from the data submitted by Searle to the FDA.
>     What those data do suggest, however, is that significant APM degradation
>at high temperaures occurs within a short period of time.  For exmaple, in
>Searle's stability tests, an orange beverage held at 40 degrees C (104
>F) average daily high for Phoenix during July) for eight weeks, contained
>fifty (50) percent of the original amount of APM.  A cola beverage held under
>the same conditions contained only forty (40) percent of the original APM
>amount. And beverages exposed to higher temperatures degrade even more
>rapidly.  And, or course, because of the temperature elevation ratios,
>temperatures could easily be much higher during actual conditions than the
>stable temperatures used in the Searle laboratory studies.
>     Thus, it is known that APM will degrade rapidly at high temperatures,
>including temperatures to which soft drinks are known to be exposed
>intermittently during the summer.  What is now known, although the FDC Act
>requires the proponent of use to demonstrate it, is what effects of
>degradation occur by virtue of exposure to these temperatures. 
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