48102 Federal Register / Vol. 61, No. 178 / Thursday, September 12, 1996 / Proposed Rules

List of Subjects DEPARTMENT OF HEALTH AND to extend the comment period to October 10, 1996, to allow additional 19 CFR Part 123 HUMAN SERVICES time for the submission of comments on Administrative practice and Food and Drug Administration whether the regulations discussed in the procedure, Aliens, Canada, Customs advance notice should be revised. duties and inspection, Fees, Forms, 21 CFR Parts 70, 71, 80, 101, 107, 170, Interested persons may, on or before Immigration, Imports, Mexico, 172, 173, 174, 175, 177, 178, 184, and October 10, 1996, submit to Dockets Reporting and recordkeeping 1250 Management Branch (address above) requirements, Test programs. [Docket No. 96N±0149] written comments regarding this Amendments to the Regulations proposal. Two copies of any comments RIN 0910±AA69 are to be submitted, except that For the reasons stated above, it is individuals may submit one copy. proposed to amend part 123 of the Reinvention of Regulations Needing Comments are to be identified with the Customs Regulations (19 CFR part 123), Revisions; Request for Comments on docket number found in brackets in the as set forth below: Certain Regulations heading of this document. Received comments may be seen in the office PART 123ÐCUSTOMS RELATIONS AGENCY: Food and Drug Administration, WITH CANADA AND MEXICO above between 9 a.m. and 4 p.m., HHS. Monday through Friday. ACTION: Advance notice of proposed 1. The authority citation for part 123 Dated: September 9, 1996. continues to read as follows: rulemaking; extension of comment period. William B. Schultz, Authority: 19 U.S.C. 66, 1202 Deputy Commissioner for Policy. (General Note 20, Harmonized Tariff SUMMARY: The Food and Drug [FR Doc. 96–23481 Filed 9–10–96; 11:02 am] Schedule of the United States (HTSUS)), Administration (FDA) is extending the BILLING CODE 4160±01±F 1431, 1433, 1624. comment period on the advance notice * * * * * of proposed rulemaking to reinvent 2. In § 123.1, it is proposed to amend certain regulations; the advance notice 21 CFR Part 101 the first sentence in paragraph (a) by appeared in the Federal Register of June [Docket No. 96N±0244] adding the words ‘‘, unless excepted by 12, 1996 (61 FR 29701). The agency is voluntary enrollment in and compliance taking this action in response to several Food Labeling; Declaration of Free with PORTPASS—a joint Customs requests for an extension of the Glutamate in Food Service/Immigration and Naturalization comment period. This extension is Service facilitated entry program (See, intended to allow interested persons AGENCY: Food and Drug Administration, Immigration and Naturalization additional time to submit comments to HHS. Regulations at 8 CFR 235.13),’’ after the FDA on the proposed reinvention of ACTION: Advance notice of proposed words ‘‘Individuals arriving in the certain regulations. rulemaking. United States’’; and, to amend DATES: Written comments by October paragraph (b) by removing the second 10, 1996. SUMMARY: The Food and Drug and third sentences and adding, in their Administration (FDA) is considering place, the sentence that reads as follows: ADDRESSES: Submit written comments establishing requirements for label to the Dockets Management Branch information about the free glutamate § 123.1 Report of arrival from Canada or (HFA–305), Food and Drug Mexico and permission to proceed. content of foods. The recent finding of Administration, rm. 1–23, 12420 the Federation of American Societies for * * * * * Parklawn Dr., Rockville, MD 20857. Experimental Biology (FASEB) that oral (b) Vehicles. * * *. Upon arrival of the FOR FURTHER INFORMATION CONTACT: ingestion of 3 or more grams (g) of vehicle in the U.S., the driver shall, Corinne L. Howley, Center for Food monosodium glutamate (MSG) without unless he or she and all of the vehicle’s Safety and Applied Nutrition (HFS–24), food can cause adverse reactions in occupants are excepted by enrollment 200 C St., SW, Washington, DC 20204, certain otherwise healthy individuals in, and in compliance with, 202–205–4272. has prompted the agency to consider PORTPASS—a joint Customs Service/ SUPPLEMENTARY INFORMATION: In the what action is necessary to protect Immigration and Naturalization Service Federal Register of June 12, 1996 (61 FR consumers from inadvertently ingesting facilitated entry program (See, 29701), FDA issued an advance notice levels of MSG or other forms of free Immigration and Naturalization of proposed rulemaking to reinvent glutamate that could cause an adverse Regulations at 8 CFR 235.1 and 286.8), certain regulations that appear to need reaction. Thus, the agency seeks public immediately report such arrival to revision. These regulations were comment on whether additional Customs, and shall not depart or identified by FDA as candidates for labeling requirements are necessary to discharge any passenger or merchandise revocation following a page-by-page protect glutamate-intolerant consumers (including baggage) without review of its regulations that the agency from adverse reactions, and, if so, how authorization by the appropriate conducted in response to the such labeling requirements should be Customs officer. Administration’s ‘‘Reinventing implemented. The agency also solicits * * * * * Government’’ initiative. Interested comment on establishing formal criteria Approved: July 29, 1996. person were given until September 10, for the use of claims about the absence George J. Weise, 1996, to comment on the advance of MSG to ensure that labels bearing Commissioner of Customs. notice. such claims are not misleading. The Dennis M. O’Connell, FDA received several requests for an agency solicits comment on whether Acting Deputy Assistant Secretary of the extension of the comment period on its such criteria should be based on a Treasury. advance notice of proposed rulemaking defined threshold level of free glutamate [FR Doc. 96–23361 Filed 9–11–96; 8:45 am] to reinvent certain regulations. After in a finished food, on the ingredients BILLING CODE 4820±02±P careful consideration, FDA has decided used in the food, or both. Federal Register / Vol. 61, No. 178 / Thursday, September 12, 1996 / Proposed Rules 48103

DATES: Written comments by November MSG is described in 21 CFR 182.1 as an ingredients like hydrolyzed soy protein, 12, 1996. example of a common food ingredient autolyzed yeast extract, tomato paste, ADDRESSES: Submit written comments that is generally recognized as safe and parmesan cheese contain free to the Dockets Management Branch (GRAS) under section 201(s) of the glutamate or that free glutamate is (HFA–305), Food and Drug Federal Food, Drug, and Cosmetic Act essentially equivalent to MSG, Administration, 12420 Parklawn Dr., (the act) (21 U.S.C. 321(s)). When used declaration of these ingredients by their rm. 1–23, Rockville, MD 20857. as an ingredient in a food, MSG must be common or usual names does not FOR FURTHER INFORMATION CONTACT: declared in the ingredient statement by indicate to the consumer that an MSG- Felicia B. Satchell, Center for Food its common or usual name, in like substance is present in the food. Safety and Applied Nutrition (HFS– accordance with section 403(i) of the act A number of consumers, particularly 158), Food and Drug Administration, (21 U.S.C. 343(i)) and 21 CFR part 101. consumers who report adverse reactions 200 C St. SW., Washington, DC 20204, Thus, ‘‘monosodium glutamate’’ must to MSG, have stated to FDA (Ref. 3) 202–205–5099. appear in the ingredient list of any food their belief that manufacturers use SUPPLEMENTARY INFORMATION: to which MSG has been added (21 CFR ingredients such as hydrolyzed proteins 101.22(h)(5)). This is true even when and autolyzed yeast extracts for the I. Background MSG has been added indirectly as part express purpose of adding free A. Introduction of another ingredient to which MSG has glutamate to a food while hiding its been added (e.g., a spice blend that presence. These consumers report the Glutamic acid, one of the amino acids includes MSG). same types of adverse reactions to foods found in nature, is a building block of While MSG is the most well-known containing hydrolyzed proteins, virtually all proteins and is a normal and widely used form of free glutamate autolyzed yeast extracts, and forms of component of the human body. In the used to enhance the flavor of foods, ‘‘manufactured’’ glutamate (other than human body and in most foods, other salts of free glutamate, such as MSG) that they experience when they glutamic acid exists primarily in its salt monopotassium glutamate and inadvertently consume foods that have form, glutamate. Glutamate is a monoammonium glutamate also have MSG declared in the ingredient list. naturally occurring component of many flavor-enhancing properties. GRAS uses Consequently, FDA has received foods, including tomatoes, cheese, meat, of glutamic acid, glutamic acid numerous requests that labels of all mushrooms, and milk. ‘‘Free’’ glutamate hydrochloride, monoammonium foods containing these ingredients be is glutamate that is not incorporated glutamate, and monopotassium required to declare the presence of free into a protein; ‘‘bound’’ glutamate is glutamate are codified in 21 CFR glutamate in the finished food, on the glutamate that is a component of an 182.1045, 182.1047, 182.1500, and ground that free glutamate presents a intact protein. Meat and milk contain 182.1516, respectively. Like MSG, these health concern to consumers. Some primarily bound glutamate, while substances must be declared in the consumers have also requested that FDA tomatoes, mushrooms, and certain ingredient statement of any food to require that the amount of free cheeses contain, in addition to bound which they are added. glutamate be declared on the label. Until glutamate, relatively high levels of free Free glutamate occurs naturally in recently, the agency’s response has been glutamate. various foods and in food substances that the scientific literature does not It is the free form of glutamate that that are used as ingredients in finished provide a public health basis on which has been shown to have flavor- foods, or it can be produced by to impose special labeling requirements enhancing properties in food. As noted hydrolysis of proteins; in such cases, the for such ingredients or for foods that previously, some foods contain presence of free glutamate in the food is contain free glutamate. However, in relatively high levels of naturally not required to be declared on the label light of the recent findings of the Life occurring free glutamate. Free glutamate under existing regulations. Naturally Sciences Research Office (LSRO) of may be introduced into foods as a occurring free glutamate is not required FASEB, the agency is reconsidering the component of various food ingredients, to be declared in the ingredient need for labeling to inform individuals such as tomato sauce and hydrolyzed statement because it is not an added who experience adverse reactions to protein products, or it may be added in ingredient; rather, it is a natural glutamate about its presence in a food. one of its various salt forms, such as constituent of the food, like protein or (The agency notes that in the Federal MSG. a vitamin. Similarly, when a food that Register of January 6, 1993 (58 FR MSG is the most commonly used form contains naturally occurring free 2950), it proposed to require the term of free glutamate added to food for glutamate is used as an ingredient in ‘‘(contains glutamate)’’ as part of the flavor-enhancing purposes. It is a white, another food, the free glutamate is not common or usual name for autolyzed practically odorless, free-flowing required to be declared in the ingredient yeast extracts and highly hydrolyzed crystalline powder (Ref. 1), similar in statement of the finished food. Rather, proteins. That proposal was not based appearance to salt or sugar. MSG has the ingredient containing the free on any health concern regarding the use been used for many years as a flavor glutamate is declared in the ingredient of these ingredients in food; therefore, enhancer for a variety of foods prepared statement by its common or usual name. the comments to that proposal and the in homes and restaurants and by food The principle that it is the ingredients agency’s decision with respect to those processors. MSG is manufactured and not the constituents of a food that comments will not be addressed in this commercially by a fermentation process must be declared also applies when a document.) using starch, beet sugar, cane sugar, or food that contains free glutamate molasses. The American food produced by protein hydrolysis is used B. Previous Safety Reviews processing industry has used MSG as an ingredient in another food. In that Until the recent findings of the widely since the late 1940’s (Ref. 2), and situation too, the glutamate-containing FASEB report (discussed in section I.C. consumption in the United States is ingredient must be declared in the of this document) that a subgroup of estimated to be 28,000 tons per year. As ingredient statement of the finished otherwise healthy individuals a food ingredient, MSG is used to food, but free glutamate need not be experiences a complex of symptoms enhance the flavor of meat, poultry, declared as an ingredient. Because the following ingestion of 3 or more (g) of vegetables, and many processed foods. average consumer is not aware that MSG without food, FDA relied on 48104 Federal Register / Vol. 61, No. 178 / Thursday, September 12, 1996 / Proposed Rules previous safety review studies in Medical Association (Ref. 14) stated that hydrolyzed protein products, as used in deciding that special labeling for free- glutamate in any form has not been the American food supply, contribute to glutamate-containing (hereinafter shown to be a ‘‘significant health the presentation of a complex of referred to as ‘‘glutamate-containing’’) hazard.’’ Also, the 1987 Joint Expert symptoms (initially described as the foods was not warranted. These studies Committee on Food Additives of the Chinese Restaurant Syndrome) after oral indicated that while anecdotal reports of United Nations Food and Agriculture ingestion of levels up to or beyond 5 g adverse reactions to MSG and other Organization and the World Health per eating occasion (i.e., a meal or glutamate-containing ingredients Organization (Ref. 15) placed MSG and snack), and/or the elicitation of other existed, there were no verifiable other glutamate salts in the safest reactions, including more serious scientific data establishing that the category of food ingredients. adverse reactions that have been levels of these ingredients used in the Although the general consensus of the reported to occur following ingestion of food supply could cause adverse many safety reviews that have been 25 to 100 milligrams per eating reactions in the general population. done on the use of MSG and other occasion; (2) to determine whether MSG Historically, the agency has not issued glutamate-containing ingredients in and hydrolyzed protein products, as labeling requirements on the basis of foods is that they are safe for the general used in the American food supply, have anecdotal reports alone because such population, the use of these ingredients the potential to contribute to brain reports do not by themselves establish a has been very controversial. FDA has lesions in neonatal or adult nonhuman cause-and-effect relationship between received many anecdotal reports of primates and whether there is any risk the suspected substance and the adverse reactions following ingestion of to humans ingesting dietary MSG; (3) to occurrence of an adverse reaction. glutamate-containing foods. Between assess whether hormones are released MSG and other glutamate-containing 1980 and 1995, the Adverse Reaction from the pituitary of nonhuman ingredients have been the subject of Monitoring System in FDA’s Center for primates following ingestion of MSG or numerous safety reviews during the past Food Safety and Applied Nutrition hydrolyzed protein products and decade. In 1969, largely as a result of a received 661 reports of complaints whether any comparable risk to humans recommendation by the White House about adverse reactions to MSG (Ref. ingesting food containing these Conference on Food, Nutrition and 16). Headache was the most frequently substances exists; and (4) to define the Health, FDA proceeded to reevaluate the reported symptom. However, other metabolic basis that might underlie any safety of all GRAS substances for food symptoms, such as a ‘‘burning adverse reactions to MSG and use. The Select Committee on GRAS sensation’’ on the back of the neck, hydrolyzed protein products. Substances (SCOGS), convened by forearms, and chest, facial pressure or FASEB convened an ad hoc expert FASEB in 1972 under a contract with tightness, neck and chest pain, panel to perform a comprehensive FDA, independently reviewed the palpitations, numbness, nausea, and review of the scientific literature and health aspects of MSG and of glutamate- vomiting, were also reported. These adverse report submissions to both FDA containing protein hydrolysates in 1978 symptoms were transient, typically and LSRO. The expert panel also and 1980 (Refs. 4, 5, 6, and 7). Although beginning within 25 minutes after considered oral and written testimony protein hydrolysates are not listed as consumption of MSG or of a glutamate- received at a 2-day open meeting held GRAS food ingredients by regulation, containing food and subsiding within in 1993. The expert panel used a weight they are described as GRAS in a number about 2 hours. Initially many of these of evidence approach in reaching its of FDA opinion letters (Refs. 8, 9, 10, symptoms became known popularly as conclusions about the evidence of and 11). SCOGS concluded that MSG ‘‘Chinese Restaurant Syndrome.’’ As adverse effects of MSG. In other words, and hydrolyzed proteins were safe for discussed in section I.C. of this the expert panel analyzed the data by the general population at then-current document, FASEB refers to these considering the totality of the scientific levels of use but recommended symptoms collectively as the ‘‘MSG evidence in a given area rather than additional evaluation to determine their symptom complex.’’ weighing one interpretation against safety at significantly higher levels of another. C. The FASEB Report consumption. The expert panel reported its findings In 1986, FDA’s Advisory Committee Because of the agency’s concern to FASEB, which reviewed the expert on Hypersensitivity to Food regarding the continued reports of panel’s work and prepared a report Constituents (Ref. 12) concluded that adverse reactions to MSG and other entitled ‘‘Analysis of Adverse Reactions MSG posed no threat to the general glutamate-containing ingredients and to Monosodium Glutamate (MSG)’’ (Ref. public but that reactions of brief because of the expanding base of 17). The FASEB report was submitted to duration might occur in some people. scientific knowledge on the role of FDA on July 31, 1995. While FASEB Other reports gave similar findings. A glutamate in brain function, FDA found no scientifically verifiable 1991 report by the European decided that an up-to-date review of the evidence of adverse effects in most Community’s (EC) Scientific Committee safety of MSG and other glutamate- individuals exposed to high levels of for Foods (Ref. 13) reaffirmed the safety containing ingredients was warranted. MSG, it concluded that there is of MSG and other forms of free Thus, as part of its ongoing evaluation sufficient documentation to define an glutamate and classified the ‘‘acceptable of GRAS ingredients and in response to acute, temporary, and self-limiting daily intake’’ for MSG as ‘‘not the concerns raised by consumers, FDA ‘‘MSG symptom complex’’ in a specified,’’ the most favorable contracted with FASEB in 1992 to do an subgroup of the population. The designation for a food ingredient. In up-to-date scientific safety review of the symptoms characteristic of the complex addition, the EC committee said, effects of the use of MSG and include: (1) A burning sensation of the ‘‘infants, including prematures, have hydrolyzed protein products as food back of the neck, forearms, and chest; been shown to metabolize glutamate as ingredients. The agency announced the (2) facial pressure or tightness; (3) chest efficiently as adults and, therefore, do study in the Federal Register of pain; (4) headache; (5) nausea; (6) upper not display any special susceptibility to December 4, 1992 (57 FR 57467). As body tingling and weakness; (7) elevated oral intakes of glutamate.’’ discussed in that document, the palpitation; (8) numbness in the back of A 1992 report from the Council on objectives of the review were to: (1) neck, arms and back; (9) bronchospasm, Scientific Affairs of the American Determine whether MSG and i.e., constriction of the bronchial tubes Federal Register / Vol. 61, No. 178 / Thursday, September 12, 1996 / Proposed Rules 48105 resulting in difficulty in breathing linking adverse effects associated with the rise in blood glutamate levels and (observed in asthmatics only); and (10) consuming free glutamate in food to perhaps the effect, at least with regard drowsiness. These symptoms were changes in brain function or to levels of to the potential for any direct central judged to be related to the amount of glutamate in the bloodstream. nervous system effect. However, FASEB MSG consumed and whether the MSG Consequently, FASEB concluded that was unable to identify any studies that was consumed with or without food. no evidence exists to support a role for have effectively compared blood FASEB identified this group of dietary MSG or other forms of free glutamate levels between responders symptoms as the ‘‘MSG symptom glutamate consumed in food in causing (i.e., persons who experience adverse complex,’’ stating that the previously or exacerbating serious, long-term reactions following exposure to MSG) used term, ‘‘Chinese restaurant medical problems resulting from and nonresponders, or any studies in syndrome,’’ was pejorative and did not degenerative nerve cell damage, such as which responders have been given a reflect the extent or nature of the Alzheimer’s disease, Huntington’s dose of MSG with a meal or 20 to 30 symptoms that have been associated chorea, or amyotrophic lateral sclerosis, minutes before a meal. with the myriad of exposure scenarios. or to any other long-term or chronic FDA has reviewed the findings and FASEB concluded that ‘‘Based on illness. However, FASEB recommended conclusions contained in the FASEB scientifically verifiable evidence, there that future efforts to explain reported report (Ref. 19). Based on FASEB’s is a subgroup of presumably healthy adverse effects from ingested MSG be findings, FDA has tentatively concluded individuals within the general designed to test potential relationships that requirements for label information population that responds, generally between dietary glutamate and the about glutamate content may be within one hour of exposure, with physiological functions of the central warranted under certain conditions. manifestations of the MSG Symptom nervous system. II. The Agency’s Response Complex to an oral bolus [dose] of MSG FASEB also reviewed the chemical ≥ 3 g in the absence of food.’’ characteristics of various forms of free FASEB’s conclusion that oral FASEB also identified a subgroup of glutamate to determine if there was ingestion of 3 or more grams of MSG asthmatics reported to respond to oral some structural or chemical difference without food can cause adverse doses of MSG with bronchospasm. The in free glutamate occurring in the form reactions in certain otherwise healthy study conducted by Allen, Delohery, of MSG or hydrolyzed protein products, individuals has prompted the agency to and Baker (Ref. 18) described severe as compared to free glutamate that consider what action is necessary to bronchospasm in individuals with naturally occurs in foods. FDA asked protect these consumers from unstable asthmatic conditions in FASEB to include this issue in its inadvertently ingesting levels of free conjunction with symptoms of the MSG review because of the contention by glutamate that could trigger an adverse symptom complex following an oral some consumers that manufactured reaction. The agency believes that it dose of MSG. In addition, the study forms of glutamate, such as MSG and may be appropriate to establish labeling reported that some asthmatic subject hydrolyzed protein products, are in requirements to alert free-glutamate- experienced a 6 to 12 hour delayed some way different from naturally intolerant (hereinafter referred to as bronchospasm without other MSG- occurring glutamates, and that the ‘‘glutamate-intolerant’’) consumers to related symptoms. While FASEB manufactured forms of glutamate are the the presence of free glutamate in a food. recognized and described limitations in only forms that trigger adverse The agency has carefully evaluated the study design used by Allen, et al., reactions. FASEB’s findings and has reached it concluded that the study was a Free glutamate can exist in two several tentative conclusions regarding reasonably well-designed scientific oral possible stereoisomeric forms: D- the basis on which any labeling policy dose study in asthmatic subjects, and glutamate and L-glutamate. L-glutamate to alert glutamate-intolerant consumers that the study provided evidence to is the predominant natural form and the should be established. support the existence of a subgroup of only form with flavor-enhancing A. Total Free Glutamate asthmatic responders to MSG. activity. FASEB concluded that MSG With regard to hydrolyzed proteins, symptom complex reactions are related Based on FASEB’s findings that it is FASEB identified no scientific reports of to L-glutamate exposure and that the the free glutamate component of MSG glutamate-related adverse effects of chemical nature of L-glutamate is the that appears to be linked to the ingesting protein hydrolysates, whether same regardless of the source, i.e., occurrence of the MSG symptom microbial, vegetable, or animal in origin. whether manufactured or naturally complex, that free glutamate is the same Protein hydrolysates are used at very occurring in the food. Thus, FASEB chemically in both its natural and low levels, typically constituting only a found no evidence to support the manufactured forms, and that free small percentage (less than 1 percent) of contention that adverse reactions occur glutamate has the same function a finished food. with manufactured but not naturally regardless of source, i.e., free glutamate Because of glutamate’s role as a occurring glutamate. in MSG functions the same as free stimulatory neurotransmitter in the FASEB further concluded that with glutamate in hydrolyzed proteins or brain, the scientific community has regard to determining glutamate levels tomato products, the agency tentatively speculated about the potential influence and assessing risk from consumption of finds that any labeling policy it of dietary glutamate on brain glutamate specific foods, a clear distinction must establishes should be based on the total metabolism and the potential role of be made between free glutamate and amount of free glutamate in a serving of dietary glutamate in provoking or glutamate as a component of protein food, rather than on the number or kind exacerbating long-term illnesses. At (i.e., bound glutamate). Free glutamate of glutamate-containing ingredients in FDA’s request, FASEB reviewed the is readily available for use in the body, the food. scientific literature on these issues. whereas bound glutamate becomes FDA has received correspondence Although FASEB acknowledged the available to body tissues more slowly, as suggesting that adverse reactions result neurotoxic potential of glutamate the intestines chemically break down only from exposure to manufactured produced in the body (as opposed to foodstuffs. FASEB also noted that the free glutamate in food (Ref. 3). Based on glutamate consumed in food), it found presence of food, as when MSG is FASEB’s findings, the agency rejects no studies or corroborating evidence consumed as part of a meal, attenuates this view. As previously discussed, 48106 Federal Register / Vol. 61, No. 178 / Thursday, September 12, 1996 / Proposed Rules

FASEB reported that all free glutamate respect to consequences which may (not otherwise defined), but lacked data found in food is the same regardless of result from the use of the article to with regard to patient compliance with the source. Further, in examining the which the labeling or advertising relates the pretest diet; (2) ingestion of scientific reports relating to under the conditions of use prescribed unidentified substances other than physiological mechanisms of action, in the labeling * * * or under such MSG; (3) limited placebo-control FASEB found no evidence indicating conditions of use as are customary or testing; and, most importantly, (4) the that manufactured free glutamate usual.’’ Thus, a food label is misleading withdrawal of asthma medication that functions differently in the body than if it does not disclose consequences that could have prevented or delayed an free glutamate naturally occurring in may result from consumption of the asthmatic response. Because of the foods. The agency agrees with FASEB food. questions raised by the study design and that all forms of free glutamate are The agency believes that information the limited data in this area, FDA’s chemically and functionally the same. on the presence of free glutamate in a current view is that a cause-and-effect Moreover, the agency notes that the food becomes a material fact for the relationship has not been established available analytical methodology glutamate-intolerant consumer in the between exposure to MSG at levels of measures the total amount of free decision to purchase a food (and in the 0.5 to 2.5 g and adverse reactions in this glutamate in a finished food and does subsequent use of the food) when free subgroup of asthmatics. The agency not distinguish among free glutamate glutamate is present at a level such that requests comments on this aspect of the occurring in the form of MSG, as a a glutamate-intolerant person who FASEB report, as well as any new data constituent of ingredients such as consumes the food alone or as part of a demonstrating a relationship between hydrolyzed proteins, or as a natural meal that includes other glutamate- exposure to free glutamate at levels constituent of food such as cheese, containing foods may suffer an adverse below 2.4 g (3 g of MSG) and adverse mushrooms, or meat. Accordingly, the reaction. The presence of free glutamate reactions in asthmatics. If such data are agency tentatively finds that any below this level is not material because received, FDA will be better able to labeling requirement for glutamate- it would not cause a reaction or evaluate the need for a labeling policy containing foods should apply to foods contribute significantly toward a total to enable glutamate-intolerant that contain free glutamate from any intake of free glutamate that might cause asthmatics to protect themselves from source. a reaction. Moreover, special glutamate adverse reactions. labeling on products that contain levels FDA’s preliminary view is that a B. Food Matrix of free glutamate below the material policy requiring glutamate labeling Although FASEB noted that the level could cause the label statement to should be based on the amount of free presence of food may attenuate the rise lose its significance for glutamate- glutamate in a serving of a food. Foods of blood glutamate levels, the FASEB intolerant consumers, especially if such are labeled individually to reflect the report cited no scientific evidence labeling appeared on products nutrient content and other establishing a relationship between the previously consumed by such characteristics of the particular food. occurrence of MSG symptom complex consumers without subsequent Because a food’s contribution to the diet reactions and metabolic responses to occurrence of any adverse reaction. is based on an individual serving of the ingestion of MSG, such as changes in The level shown to elicit adverse food, current regulations require foods blood glutamate levels. The agency reactions in glutamate-intolerant to be labeled with nutrition information requests data describing the effect of the individuals is 3 g of MSG, according to on a per-serving basis. Since the food matrix (i.e., the food in which free the FASEB report. Based on this data, regulations implementing the Nutrition glutamate is present or with which it is the agency tentatively finds that the Labeling and Education Act (Pub. L. eaten) on the occurrence of the MSG presence of free glutamate in a serving 101–445) became effective in 1994, symptom complex. If the food matrix of the food in an amount such that consumers have become adept at using does have an effect, does the effect vary consumption of the food as part of a label information to monitor their intake depending on the type of food? meal may expose the consumer to the of certain nutrients (Ref. 20). A In the absence of sound scientific data equivalent of 3 g of MSG is a material glutamate labeling policy based on the demonstrating that the food matrix fact under section 201(n) of the act. amount of free glutamate in a serving of reduces the risk or severity of adverse Using a conversion factor of 0.787 to a food would be consistent with current effects following ingestion of free correct for the inactive portion of the labeling regulations, and FDA glutamate, the agency’s likely approach MSG molecule (MSG consists of free tentatively finds that such a policy would be to assume that the food matrix glutamate plus sodium and water), 3 g would be useful to consumers who wish has no predictable mitigating effect on of MSG converts to approximately 2.4 g to avoid intake of free glutamate at the occurrence of the MSG symptom of free glutamate. Accordingly, an levels that may cause an adverse complex and to develop a labeling effective labeling policy should assist reaction. policy based on the level of free glutamate-intolerant consumers in D. Labeling Threshold Approach glutamate reported to cause reactions restricting their consumption of free when consumed without food. Because glutamate during a meal or snack to Applying these principles, the the agency does not yet have such data, levels below 2.4 g. question then becomes how to calculate this assumption is adopted for purposes As discussed in section I. of this an appropriate labeling threshold, i.e., of the preliminary discussion in this document, FASEB identified a subgroup the level of free glutamate in a serving document. of asthmatics reported to respond to oral of an individual food that should trigger doses of MSG at levels of 0.5 to 2.5 g. a labeling requirement because C. Materiality The agency believes that the limitations consumption of the food as part of a Section 403(a) of the act (21 U.S.C. of the Allen study cited by FASEB in meal that may include other glutamate- 343(a)) states that a food is misbranded reaching this conclusion are containing foods could result in overall if its labeling is false or misleading in considerable, however (Ref. 19). For intake of free glutamate at levels that any particular. Under section 201(n) of example, the study design included: (1) have been demonstrated to cause an the act, labeling is misleading if it ‘‘fails A 5-day pretest diet excluding adverse reaction. That is, what is the to reveal facts material * * * with chemicals known to provoke asthma appropriate mechanism to relate a total Federal Register / Vol. 61, No. 178 / Thursday, September 12, 1996 / Proposed Rules 48107 intake of 2.4 g of free glutamate (from the effects of free glutamate exposure for free glutamate that might cause a all servings of foods consumed at the certain individuals, the agency is reaction. Suggestions for other meal) to the contribution of an concerned that a label trigger of 0.4 g approaches should include data or other individual food? would not sufficiently protect high- information to substantiate the One possible approach is to assume intake consumers. The agency believes, effectiveness of the approach. In that the average daily consumption of a therefore, that it is prudent to build in particular, the agency solicits comments U.S. consumer is 20 servings per day, a safety factor to ensure that high-intake on whether the labeling threshold spread over approximately 3 meals and consumers are adequately informed of should be set higher or lower than 0.2 a snack. A snack is considered roughly any potential risk. g free glutamate per serving, and on the two servings and a meal five to six Allowing for intakes up to twice the costs and benefits of labeling policies servings. (The agency used a similar mean intake, to provide an additional using different possible labeling approach in determining disclosure margin of safety, would result in a thresholds. The agency notes that levels for nutrient content claims and labeling threshold of 0.2 g free regulations based on this ANPRM may disqualifying levels for health claims. glutamate (0.4 divided by 2) per serving have a significant impact on a (56 FR 60426, 56 FR 60543–60544, 58 of food. If the agency were to take this substantial number of small entities. FR 2492, and 59 FR 24239)). Assuming approach and require a glutamate label Therefore, the agency particularly that a meal consists of approximately statement for foods that contain 0.2 or requests information on the costs to six servings, the glutamate-intolerant more grams free glutamate per serving, small businesses of alternative MSG consumer would be at risk if the total additional foods such as blue cheese, labeling policies and on policy options amount of free glutamate from all six spaghetti sauce, and some brands of soy that would reduce the burden on small servings in the meal were equal to or sauce and tomato paste would be businesses while meeting the objectives greater than 2.4 g. Spreading this required to bear a label statement about of MSG labeling. Recognizing that foods amount equally over each of the six free glutamate content (Ref. 21). would have to be chemically analyzed servings would suggest that each serving FDA notes that the use of labeling to determine the free glutamate content of food should contain no more than 0.4 thresholds is not new. Existing and that labels would have to be g of free glutamate. Thus, one approach regulations establish labeling thresholds changed for some foods, the agency could be to require any food containing for certain ingredients that have been solicits data and comments on the 0.4 g or more free glutamate per serving identified as causing adverse reactions economic impact associated with to bear a label statement about its free either in sensitive individuals or in the various labeling policies. glutamate content. Such labeling would general population. These regulations 2. The agency solicits data on the alert the glutamate-intolerant consumer require special labeling for foods that levels of glutamate in foods to assist it to foods that contribute significant exceed the labeling threshold. For in determining how many and what levels of free glutamate to a meal. With example, the statement ‘‘Excess kinds of foods would be affected by such information, the consumer could consumption may have a laxative various regulatory approaches. avoid foods with significant levels of effect’’ is required on foods that contain 3. The agency also solicits comments free glutamate or, as an alternative, sorbitol when ‘‘reasonably foreseeable’’ on the advantages or disadvantages of a include limited quantities of a labeled consumption of the food could result in simple label statement that the food food in the meal while being careful not a daily sorbitol intake of 50 g or more contains free glutamate, as compared to to eat other glutamate-containing foods. (21 CFR 184.1835). To cite another a quantitative statement of the amount Using 0.4 g as a labeling threshold example, the label statement ‘‘Sensitive of free glutamate in a serving of the food would require foods like tomato juice individuals may experience a laxative either in absolute terms (i.e., g) or as a and some soup mixes and canned soups effect from excessive consumption of percentage of the intake level that might to bear glutamate labeling (Ref. 21). this product’’ is required when a single lead to adverse reactions in some Although a labeling threshold or serving of a food contains more than 15 consumers. As a preliminary matter, ‘‘trigger’’ of 0.4 g per serving based on grams of polydextrose (21 CFR 172.841). FDA’s view is that quantitative labeling average consumption estimates would To the best of the agency’s knowledge, is not necessarily any more useful than adequately protect most glutamate- the use of a labeling threshold has a general label statement alerting the intolerant consumers, it might not be worked well in protecting consumers glutamate-intolerant consumer to the sufficient to protect those whose food from adverse reactions caused by presence of free glutamate in the food intake is in the high range, that is, at or excessive consumption of sorbitol and when the level is significant. The above the 90th percentile. According to polydextrose. agency notes that because almost all food consumption and food frequency foods contain trace levels of free surveys (Refs. 22 and 23) conducted in E. Request for Comments glutamate, quantitative labeling for all the United States, intake at the 90th FDA is soliciting comments on all foods with detectable levels of free percentile for most commonly aspects of this advance notice of glutamate might cause confusion among consumed foods is roughly 2 times the proposed rulemaking (ANPRM), and glutamate-intolerant consumers about mean intake for that food (Ref. 24). specifically requests comments on the which foods could be consumed Thus, a high-intake consumer could be following: without risking a reaction. Consumers exposed to levels close to 0.8 g from a 1. The agency invites comments on might unnecessarily limit their food single food if a regular-size serving of whether additional labeling choices by assuming that they should the food contained just under 0.4 g of requirements should be established to not eat any food labeled to contain any free glutamate. In such a case, the food protect glutamate-intolerant consumers amount of free glutamate, however would not be required to bear a from adverse reactions. The agency also small. FDA’s preliminary view is that, if glutamate content statement, yet the solicits comments on the effectiveness quantitative labeling is required, a amount eaten by high-intake consumers of the regulatory approach described labeling threshold should be established would contain a significant level of free previously, as well as suggestions for to prevent this problem. The agency glutamate. Taking into consideration the other approaches that would adequately solicits comments on this view and on number of products that may contain inform and assist glutamate-intolerant whether the optimal threshold for free glutamate and the acute nature of consumers to avoid exposure to levels of quantitative free glutamate labeling 48108 Federal Register / Vol. 61, No. 178 / Thursday, September 12, 1996 / Proposed Rules would be the same as the optimal proteins, autolyzed yeast extracts, or certain spice blends) that are added to threshold for a label statement that the other flavor-enhancing ingredients that the product in lieu of MSG itself. They food contains free glutamate. contain substantial amounts of free then modify the ingredient list on the 4. Finally, the agency solicits glutamate. product label to delete MSG and replace comments on the following questions Based on correspondence submitted it with a generic term such as ‘‘spices.’’ regarding the content, wording, and to the agency and arguments raised in (As noted in section I. of this document, placement of labeling for glutamate- a citizen petition submitted on behalf of this practice violates existing ingredient containing foods, and on any other Jack L. Samuels, Adrienne Samuels, labeling requirements; when MSG is aspects of such labeling: John Olney, et al., (Docket No. 94P– added to a food as an ingredient of a (a) What information should be 0444), FDA recognizes that many spice blend, MSG must still be declared included in labeling for glutamate- consumers, especially those who report in the ingredient statement by its containing foods? How should any having adverse reactions to MSG, refer common or usual name, monosodium required label statement be worded? to all forms of manufactured glutamate glutamate.) In some cases, these Should the scientifically accurate term as MSG. As previously discussed, the manufacturers also add a ‘‘No MSG’’ ‘‘free glutamate’’ be used in such scientific evidence does not support the claim to the label. labeling, or should the term ‘‘MSG’’ be assertion that manufactured free A related problem is the use of claims used for all forms of free glutamate glutamate functions differently in the such as ‘‘No MSG’’ and ‘‘No added because consumers are more familiar body than naturally occurring free MSG’’ on foods that contain substantial with it? glutamate. Moreover, even though FDA amounts of naturally occurring free (b) Should a label statement such as has attempted to clarify the distinction glutamate, such as tomato paste and ‘‘contains free glutamate’’ be included between the ingredient monosodium certain cheeses. Although such foods do in the ingredient list because consumers glutamate (MSG) and other ingredients not contain MSG itself, they contain traditionally use the ingredient list to that contain free glutamate in ingredients with concentrations of free determine if the food contains correspondence and other FDA glutamate that function as flavor ingredients they wish to avoid? documents, such as FDA’s enhancers like MSG. Because of their Alternatively, should such a label Backgrounder on MSG (Ref. 25), free glutamate content, these foods are statement be placed adjacent to the consumers either do not fully as likely to cause or contribute to an ingredient list or elsewhere on the understand or do not acknowledge this MSG symptom complex reaction as a information panel, or should the label distinction. Consequently, consumers food that contains a comparable amount statement be placed on the principal continue to use the term ‘‘MSG’’ to of MSG. A claim such as ‘‘No MSG’’ is display panel? Suggestions for mean all forms of free glutamate that are misleading because it implies that the placement of the label statement should added to food. For example, FDA has food may be consumed by glutamate- include the comment’s rationale for received numerous written and oral intolerant consumers without risk of a choosing one location over another. complaints (Ref. 3) charging reaction. (c) Is a separate label statement about manufacturers with hiding the presence A food that bears a false or misleading free glutamate content necessary when of ‘‘MSG’’ by declaring the substance claim about the absence of MSG is MSG is an ingredient in the food and is under other names such as ‘‘flavorings,’’ misbranded under section 403(a) of the therefore declared in the ingredient list? ‘‘hydrolyzed protein,’’ ‘‘autolyzed yeast act. FDA has repeatedly advised Current information in the agency’s extract,’’ and similar terms. consumers and industry that it possession suggests that glutamate- FDA tentatively finds that consumers considers such claims as ‘‘No MSG’’ and intolerant consumers already identify are likely to perceive a ‘‘No MSG’’ or ‘‘No added MSG’’ to be misleading and avoid foods that declare MSG as an ‘‘No added MSG’’ claim on a label as when they are used on the labels of ingredient, although they often fail to indicating the absence of all forms of foods made with ingredients that recognize the presence of free glutamate free glutamate in the food. Such claims contain substantial levels of free when it occurs in forms other than MSG encourage consumers wishing to avoid glutamate (Refs. 25, 26, and 27). FDA (Ref. 3). Thus, the agency solicits free glutamate to purchase a food by has authority to take action against such comments on the need for a statement representing the food as free of MSG. misbranded foods under existing law, Moreover, manufacturers of hydrolyzed about free glutamate content in foods but because of the proliferation of such proteins and other glutamate-containing that contain MSG as a declared claims on products made with ingredients often promote them to ingredient. ingredients that contain substantial manufacturers of finished foods as levels of free glutamate, the agency III. The ‘‘No MSG’’ Labeling Policy functional substitutes for MSG that believes that formal criteria would be permit a ‘‘clean’’ ingredient statement A. Current Label Claims useful to define more precisely the and a ‘‘No MSG’’ claim on the label of circumstances under which labels The controversy over the use and the finished food. In this context, bearing claims about the absence of safety of MSG in foods has prompted ‘‘clean’’ means an ingredient list that MSG are misleading. While such criteria some food manufacturers to make label does not include ‘‘monosodium are being developed, however, FDA will claims such as ‘‘No MSG’’ or ‘‘No added glutamate.’’ Thus, while technically continue to take regulatory action as MSG’’ when MSG is not used as an such foods bearing a claim about the appropriate against false or patently ingredient in the food. Several absence of MSG do not contain the misleading claims about the absence of manufacturers have opted to ingredient monosodium glutamate, they MSG, such as ‘‘No MSG’’ claims on reformulate their products to remove frequently contain levels of free products made with MSG-containing MSG as an ingredient, or to substitute glutamate that cause claims like ‘‘No ingredients, hydrolyzed proteins, or for MSG other ingredients that have MSG’’ and ‘‘No added MSG’’ to be autolyzed yeast extracts. similar flavor-enhancing properties. misleading. Some manufacturers Many of these reformulated foods bear attempt to evade the ingredient B. Approaches Under Consideration label claims about the absence of MSG. declaration requirement for MSG by The agency is considering a variety of In some cases manufacturers replace reformulating their products with MSG- approaches to address misleading MSG with ingredients like hydrolyzed containing ingredients (for example, claims about the absence of MSG. As a Federal Register / Vol. 61, No. 178 / Thursday, September 12, 1996 / Proposed Rules 48109 starting point, a food that contains MSG, MSG’’ label statement on most raw or 500 ppm (Ref. 31), or in some other or ingredients to which MSG has been minimally processed foods that way? added, is misbranded if it bears a ‘‘No naturally contain free glutamate, while Further, is an approach that prohibits MSG’’ or similar claim. Such claims are prohibiting such claims on MSG a ‘‘No MSG’’ claim if an ingredient in a false and, therefore, their regulatory substitutes like protein hydrolysates and food contains a ‘‘substantial’’ amount of status needs no further clarification. The autolyzed yeast extracts. Under this free glutamate equitable in all cases, or discussion below concerns the approach, foods such as canned peas should the amount of an ingredient development of criteria to prevent and canned corn would be permitted to added to a food also be considered in misbranding because of misleading ‘‘No bear a ‘‘No MSG’’ claim. However, determining whether a claim is MSG’’ and ‘‘No added MSG’’ claims on tomato sauce and fresh tomatoes, misleading? For example, could foods that contain free glutamate but to because of their relatively high natural ingredients like tomato paste or soy which MSG itself has not been added, free glutamate content, would be protein isolate be added to a food in directly or indirectly. prohibited from bearing such a claim, as trace amounts without rendering a ‘‘No 1. Cutoff levels would parmesan cheese. MSG’’ claim misleading? c. Labeling threshold. As discussed in One strategy the agency is considering section II. of this document, the agency 3. Combination or Other Approaches involves establishing a ‘‘cutoff level’’ for is considering whether to require a label claims about the absence of free The agency also invites comments on statement about free glutamate content possibilities for combining any of the glutamate. If the finished food contains on foods that contain 0.2 g or more free free glutamate above the cutoff level, a approaches described in this section to glutamate per serving. For consistency, ‘‘No MSG’’ or similar label statement develop a comprehensive labeling the cutoff for claims about the absence would be prohibited. There are several policy to ensure that ‘‘No MSG’’ claims of MSG could be set at the same level. ways in which such a level could be are truthful and not misleading. For Under this approach, a ‘‘No MSG’’ claim defined: example, would a labeling policy that a. Quantitation limit for free would be permitted on foods like allowed a ‘‘No MSG’’ or similar claim glutamate. One approach would be to canned peas and canned corn. However, only on foods that: (1) Contain no use the analytical limit of quantitation bacon flavored toppings made from ingredients that have a ‘‘substantial’’ (LOQ) for free glutamate as the cutoff hydrolyzed vegetable protein would amount of free glutamate, and (2) level. The enzymatic procedure of also qualify to bear a ‘‘No MSG’’ claim contain levels of total free glutamate per Hattula and Wallin (Ref. 28), a because the serving size for toppings is serving below a cutoff level of 0.2 g, be commonly used, collaboratively studied so small. Claims about the absence of more desirable than a policy that relied analytical method for determining free MSG would be prohibited on any food on one criterion alone? This approach glutamate content, has an estimated required to bear a label statement about would permit claims about the absence quantitation limit of 100 parts per the presence of free glutamate. of MSG on foods like canned peas and million (ppm) (Ref. 29). Under this The agency solicits comment on canned corn, but prohibit such claims approach, any food with a level of free whether an approach based on a cutoff on foods like bacon flavored toppings glutamate above the LOQ, i.e., a level level of free glutamate in the finished made with hydrolyzed protein and on above 100 ppm using the Hattula and food should be adopted to determine foods that have a relatively high natural Wallin method, would be disqualified whether a food may bear a ‘‘No MSG’’ free glutamate content, including tomato from bearing a ‘‘No MSG’’ claim. or ‘‘No added MSG’’ claim. Further, the sauce and parmesan cheese. However, because glutamate is agency solicits comment on whether Alternatively, is there another ubiquitous in the food supply and low such a cutoff level should be: (a) The combination of approaches that would levels of free glutamate typically occur analytical limit of quantitation for free be more effective in ensuring that label in many raw or minimally processed glutamate; (b) the level at which free claims about the absence of MSG are not foods, using the LOQ as the cutoff level glutamate functions as a flavor misleading? Suggestions for other would disqualify almost all foods from enhancer; (c) the level of free glutamate approaches or combinations of bearing a ‘‘No MSG’’ claim. For that would trigger a label statement approaches should include data or other example, typical levels of free glutamate about the food’s glutamate content; or information to substantiate the in canned peas and canned corn are 320 (d) some other level. effectiveness of the approach. ppm (.032 g) and 470 ppm (.047 g) 2. Ingredients respectively (Ref. 30). Although these IV. References levels are lower than the level generally The second approach the agency is The following references have been associated with flavor-enhancing considering would prohibit ‘‘No MSG’’ placed on display in the Dockets function (500 ppm) and lower than the and similar claims on foods made from Management Branch (address above) amount of free glutamate found in most ingredients that contain substantial and may be seen by interested persons foods containing monosodium amounts of free glutamate. In the between 9 a.m. and 4 p.m., Monday glutamate, hydrolyzed proteins, or yeast agency’s opinion, ingredients like through Friday. extracts, they are above the LOQ of 100 hydrolyzed vegetable proteins, 1. National Academy of Science, ‘‘Food ppm. Consequently, relying on a ‘‘limit autolyzed yeast extracts, soy sauce, Chemicals Codex,’’ 4 ed., 1996, p. 260. of quantitation’’ criterion would parmesan cheese, and tomato paste 2. Taliaferro, P. T., ‘‘Monosodium disqualify foods like canned peas and contain enough free glutamate to cause Glutamate and the Chinese Restaurant canned corn from bearing a ‘‘No MSG’’ a ‘‘No MSG’’ label claim to be Syndrome: A Review of Food Additive claim. misleading. To adopt this approach, the Safety,’’ Journal of Environmental Health, b. Functional level. According to the agency would have to define what vol. 57, No. 10, pp. 8–12, 1995. 3. Satchell, F. B., Division of Programs and scientific literature (Ref. 31), free constitutes a ‘‘substantial’’ amount of Enforcement Policy (HFS–158), Center for glutamate has a flavor-enhancing effect free glutamate in an ingredient. Should Food Safety and Applied Nutrition, at levels as low as 500 ppm. Using 500 a ‘‘substantial’’ amount of free glutamate memorandum to file: ‘‘Consumer ppm as the cutoff level for claims about be defined as the amount reported to Correspondence to FDA Regarding the Use the absence of MSG would allow a ‘‘No have flavor-enhancing properties, i.e., and Labeling of MSG in Foods,’’ July 3, 1996. 48110 Federal Register / Vol. 61, No. 178 / Thursday, September 12, 1996 / Proposed Rules

4. Select Committee on GRAS Substances, 19. FDA memorandum concerning and 6 of the Fair Packaging and Labeling Life Sciences Research Office, Federation of evaluation of the Federation of American Act (15 U.S.C. 1454, 1455), sections 201, American Societies for Experimental Biology, Societies for Experimental Biology (FASEB) 301, 403, 701 of the Federal Food, Drug, ‘‘Evaluation of the Health Aspects of Certain (July 1995 Report) from the Director, Division and Cosmetic Act (21 U.S.C. 321, 331, Glutamates as Food Ingredients-Report 37a,’’ of Health Effects Evaluation to Lawrence Lin, (PB 283–475/AS), 1978. ‘‘Analysis of Adverse Reactions to 343, 371), and under the authority of the 5. Select Committee on GRAS Substances, Monosodium Glutamate (MSG),’’ August 30, Commissioner of Food and Drugs. Life Sciences Research Office, Federation of 1996. Dated: August 29, 1996. American Societies for Experimental Biology, 20. Levy, A. S., B. M. Derby, Consumer William B. Schultz, ‘‘Evaluation of the Health Aspects of Protein Studies Branch, Center for Food Safety and Deputy Commissioner for Policy. Hydrolysates as Food Ingredients- Report Applied Nutrition, FDA, ‘‘The Impact of the 37b,’’ (PB 283–440/AS), 1978. NLEA on Consumers: Recent Findings From [FR Doc. 96–23159 Filed 9–5–96; 4:43 pm] 6. Select Committee on GRAS Substances, FDA’s Food Label and Nutrition Tracking BILLING CODE 4160±01±F Life Sciences Research Office, Federation of System,’’ 1996. American Societies for Experimental Biology, 21. Warner, C., and D. Daniels, FDA ‘‘Evaluation of the Health Aspects of Certain memorandum, August 14, 1996. DEPARTMENT OF THE INTERIOR Glutamates as Food Ingredients, 22. United States Department of Supplemental Review and Evaluation-Report Agriculture, ‘‘Continuing Survey of Food 37a-Suppl.,’’ (PB 178635), 1980. Office of Surface Mining Reclamation Intake by Individuals’’ (1989–90, 1990–91, and Enforcement 7. Select Committee on GRAS Substances, 1991–92), Nationwide Food Consumption Life Sciences Research Office, Federation of Survey, 1987. 30 CFR Part 946 American Societies for Experimental Biology, 23. Market Research Corporation of ‘‘Evaluation of the Health Aspects of Protein America (1992), 5-Year Menu Census, 1982– [VA±106±FOR] Hydrolysates as Food Ingredients, 87, FDA Contract No. 223–87–2088. Supplemental Review and Evaluation-Report 24. DiNovi, M., FDA memorandum, ‘‘Basis Virginia Regulatory Program 37b-Suppl.,’’ (PB80–178643), 1980. for High-Intake Estimates,’’ July 1, 1996. 8. FDA opinion letter from Einar T. 25. FDA Backgrounder (BG95–16), AGENCY: Office of Surface Mining Wulfsberg, Food and Drug Officer to Mr. ‘‘Monosodium Glutamate (MSG),’’ August 31, Reclamation and Enforcement (OSM), Ratton B. Rogers, the Nestle Co., November 1995. Interior. 12, 1959. 26. FDA Warning Letter from Elaine C. ACTION: 9. FDA opinion letter from Einar T. Proposed rule; notice of Messa, District Director, Irvine, CA to Patricia opportunity for hearing or public Wulfsberg, Food and Drug Officer to Mr. J. Bragg, President, Live Food Products, May Ter Marsch, August 25, 1961. 29, 1996. meeting. 10. FDA opinion letter from D. R. Kleber, 27. FDA correspondence from John E. SUMMARY: OSM is announcing a hearing Jr., Division of Advisory Opinions Bureau of Thomas to Sonja L. Valiulis, October 14, Enforcement to Yeast Products, Inc., January 1992. (or public meeting if only one person 22, 1962. 28. Hattula, M. T., and H. C. Wallin, requests a hearing) on a portion of a 11. FDA opinion letter from Virgil O. ‘‘Enzymatic Determination of Free Glutamic proposed amendment to the Virginia Wodicka, Director, Bureau of Foods to Mr. Acid in Dried Soups and in Minced regulatory program (hereinafter referred William H. Honstead, The ESU Research Sausages: NMKL1 Collaborative Study,’’ to as the Virginia program) under the Foundation, Kansas State University, 1972. Journal of the Association of Official Surface Mining Control and 12. Advisory Committee on Analytical Chemists, vol. 74, No. 6, pp. 921– Reclamation Act of 1977 (SMCRA). The Hypersensitivity to Food Constituents— 925, 1991. Proceedings Ad Hoc, May 8, 1986, pp. 13– amendment for which the hearing is 29. Facsimile from H. C. Wallin to C. being announced concerns the proposed 28. Warner, May 6, 1996. 13. Reports of the Scientific Committee for 30. Daniels, D. H., F. L. Joe, and G. W. use of a 28-degree angle of draw with Food on a First Series of Food Additives of Diachenko, ‘‘Determination of Free Glutamic the rebuttable presumption of causation Various Technological Functions, Acid in a Variety of Foods by High- by subsidence provision. The Commission of the European Communities, Performance Liquid Chromatography,’’ Food amendment is intended to revise the Reports of the Scientific Committee for Food, Additives and Contaminants, vol. 12, No. 1, State program to be consistent with the 25th series, 1991. pp. 21–29, 1995. Federal regulations as amended on 14. Report of the Council on Scientific 31. Yamaguchi, S., and A. Kimizuka, March 31, 1995 (60 FR 16772). Affairs, American Medical Association, ‘‘Psychometric Studies on the Taste of DATES: The hearing is scheduled for ‘‘Food and Drug Administration Regulations Monosodium Glutamate,’’ Glutamic Acid: Regarding the Inclusion of Added L-Glutamic Advances in Biochemistry and Physiology, Wednesday, September 18, 1996, at 7:00 Acid Content on Food Labels,’’ Report: D (A– Raven Press, New York, pp. 35–54, 1979. p.m. at the Big Stone Gap Field Office. 92), 1992. Requests to speak at the hearing must be 15. The Joint Food Agriculture V. Comments received by 4:00 p.m., on September 16, Organization/World Health Organization Interested persons may, on or before 1996. If a public meeting is held instead Expert Committee on Food Additives, ‘‘L- November 12, 1996, submit to the of a hearing, it will be held on Glutamic Acid and its Ammonium, Calcium, Wednesday, September 18, 1996, at the Monosodium and Potassium Salts- Dockets Management Branch (address Toxicological Evaluation of Certain Food above) written comments regarding this Big Stone Gap Field Office at a time to Additives,’’ WHO Food Additive Series, No. ANPRM. Two copies of any comments be determined. 22, pp. 97–161, 1988. are to be submitted, except that ADDRESSES: Request to offer testimony 16. Gray, D., FDA memorandum, May 23, individuals may submit one copy. at the hearing should be mailed or hand 1996. Comments are to be identified with the delivered to Mr. Robert A. Penn, 17. Life Sciences Research Office, docket number found in brackets in the Director, Big Stone Gap Field Office at Federation of American Societies for heading of this document. Received the first address listed below. Experimental Biology, ‘‘Analysis of Adverse comments may be seen in the Dockets Copies of the Virginia program, the Reactions to Monosodium Glutamate (MSG),’’ Report, 1995. Management Branch (address above) proposed amendment, a listing of the 18. Allen, D. H., J. Delohery, and G. Baker, between 9 a.m. and 4 p.m., Monday scheduled public hearing (or public ‘‘Monosodium L-Glutamate-Induced through Friday. meeting if only one person wishes to Asthma,’’ Journal of Allergy and Clinical This advance notice of proposed provide testimony), and all written Immunology, vol. 80, pp. 530–537, 1987. rulemaking is issued under sections 5 comments received in response to the