Importance Food allergy is common, affecting up to 8% to 10% of children and adults. Treatment options include oral immunotherapy (OIT) and omalizumab, an anti–immunoglobulin E (IgE) monoclonal antibody. Objective To compare omalizumab with OIT for the treatment of patients with multifood allergy. Design, Setting, and Participants This was a double-blind, placebo-controlled, randomized clinical trial comparing omalizumab with omalizumab-facilitated multiallergen OIT (MOIT) in participants who completed stage 1 of the Omalizumab as Monotherapy and as Adjunct Therapy to Multiallergen OIT in Children and Adults With Food Allergy (OUTMATCH) trial, which led to the approval of omalizumab. The setting comprised 10 academic centers across the US. Included in this analysis were individuals aged 1 to 55 years with an allergy to peanuts and at least 2 other foods (milk, eggs, wheat, cashews, hazelnuts, walnuts). Eligibility was based on oral food challenge thresholds, requiring dose-limiting symptoms to cumulative doses of 144 mg or less of protein for peanuts and 444 mg or less for nonpeanut allergens. Data were analyzed from October 2024 to February 2026. Interventions Participants were randomized to receive MOIT with placebo omalizumab or omalizumab with placebo MOIT. All received 16 weeks of open-label omalizumab; at week 8, active or placebo MOIT was initiated and escalated to goal doses of 1000 mg per food. At week 16, participants transitioned to blinded omalizumab or placebo injections for 44 weeks. Main Outcomes and Measures The primary end point was cumulative tolerated dose (CTD) of 4044 mg or greater for all 3 foods. Predefined secondary end points included CTDs of 1044, 2044, 4044, 6044, or 8044 mg for 1, 2, or all 3 foods. Results A total of 117 participants (median [IQR] age, 7 [1-29] years; 64 male [55%]) were randomized to receive active MOIT (n = 58) or active omalizumab (n = 59). A total of 30 participants (51%) receiving active MOIT and 51 (88%) receiving active omalizumab completed the study. In the intention-to-treat (ITT) analysis, omalizumab was superior to MOIT (21 of 58 [36%] vs 11 of 59 [19%]; odds ratio, 2.6; 95% CI, 1.1-6.3; P = .03), with no differences in per-protocol analyses. Omalizumab superiority for CTDs of 4044 mg or greater was also demonstrated for 2 or more foods and for several individual foods. More participants taking active MOIT experienced adverse events (serious adverse events in 18 of 59 [31%] vs 0%; events leading to discontinuation in 13 of 59 [22%] vs 0%; events treated with epinephrine (22 of 59 [37%] vs 4 of 58 [7%]). Conclusions and Relevance Although the ITT analysis found a higher rate of treatment success in those receiving omalizumab compared with MOIT, results suggest that the difference was largely driven by the high rate of study discontinuation in the participants treated with MOIT, mostly related to adverse events.

BACKGROUND:The IMPACT trial (NCT01867671) demonstrated strong desensitization and the potential for remission with peanut oral immunotherapy (pnOIT) in 1- to 3-year-olds. Data on long-term outcomes of early intervention oral immunotherapy (OIT) are limited. OBJECTIVE:IMPACT-PLuS sought to assess the long-term efficacy, safety, and mechanistic changes related to early-life pnOIT. METHODS:Participants randomized in IMPACT (n = 146) were recruited. The primary outcome was long-term efficacy, defined as ongoing peanut consumption. Secondary outcomes included safety, peanut serology, and skin prick tests. Participants were categorized according to IMPACT treatment (pnOIT, placebo) and participation in any additional peanut allergy intervention apart from guidance given at the end of the IMPACT trial. Patients were grouped as follows: group A, pnOIT with no subsequent intervention; group B, pnOIT with subsequent intervention; group C, placebo OIT with no subsequent intervention; and group D, placebo OIT with subsequent intervention. RESULTS:Follow-up data were available for 78 of the 146 IMPACT participants (aged 9-14 years; 8-11 years after IMPACT enrollment). Fifty-eight received pnOIT in IMPACT. Overall, 80% (32/40) of group A were eating peanut at follow-up (48/58, 83%, of the entire IMPACT follow-up pnOIT group), with 35% (14/40) eating ≥1000 mg peanut. All 15 subjects from the IMPACT remission group were eating peanut at follow-up. Peanut reactions were reported by 35% (14/40) in group A, with epinephrine therapy received by 5. Compared with group C (placebo), group A had significantly lower levels of peanut and Ara h 2 IgE, and higher peanut and Ara h 2 IgG4. CONCLUSIONS:pnOIT initiated early in life can have long-term, sustainable impact, both clinically and immunologically.

Importance:Food allergy is common, affecting up to 8% to 10% of children and adults. Treatment options include oral immunotherapy (OIT) and omalizumab, an anti-immunoglobulin E (IgE) monoclonal antibody. Objective:To compare omalizumab with OIT for the treatment of patients with multifood allergy. Design, Setting, and Participants:This was a double-blind, placebo-controlled, randomized clinical trial comparing omalizumab with omalizumab-facilitated multiallergen OIT (MOIT) in participants who completed stage 1 of the Omalizumab as Monotherapy and as Adjunct Therapy to Multiallergen OIT in Children and Adults With Food Allergy (OUTMATCH) trial, which led to the approval of omalizumab. The setting comprised 10 academic centers across the US. Included in this analysis were individuals aged 1 to 55 years with an allergy to peanuts and at least 2 other foods (milk, eggs, wheat, cashews, hazelnuts, walnuts). Eligibility was based on oral food challenge thresholds, requiring dose-limiting symptoms to cumulative doses of 144 mg or less of protein for peanuts and 444 mg or less for nonpeanut allergens. Data were analyzed from October 2024 to February 2026. Interventions:Participants were randomized to receive MOIT with placebo omalizumab or omalizumab with placebo MOIT. All received 16 weeks of open-label omalizumab; at week 8, active or placebo MOIT was initiated and escalated to goal doses of 1000 mg per food. At week 16, participants transitioned to blinded omalizumab or placebo injections for 44 weeks. Main Outcomes and Measures:The primary end point was cumulative tolerated dose (CTD) of 4044 mg or greater for all 3 foods. Predefined secondary end points included CTDs of 1044, 2044, 4044, 6044, or 8044 mg for 1, 2, or all 3 foods. Results:A total of 117 participants (median [IQR] age, 7 [1-29] years; 64 male [55%]) were randomized to receive active MOIT (n = 58) or active omalizumab (n = 59). A total of 30 participants (51%) receiving active MOIT and 51 (88%) receiving active omalizumab completed the study. In the intention-to-treat (ITT) analysis, omalizumab was superior to MOIT (21 of 58 [36%] vs 11 of 59 [19%]; odds ratio, 2.6; 95% CI, 1.1-6.3; P = .03), with no differences in per-protocol analyses. Omalizumab superiority for CTDs of 4044 mg or greater was also demonstrated for 2 or more foods and for several individual foods. More participants taking active MOIT experienced adverse events (serious adverse events in 18 of 59 [31%] vs 0%; events leading to discontinuation in 13 of 59 [22%] vs 0%; events treated with epinephrine (22 of 59 [37%] vs 4 of 58 [7%]). Conclusions and Relevance:Although the ITT analysis found a higher rate of treatment success in those receiving omalizumab compared with MOIT, results suggest that the difference was largely driven by the high rate of study discontinuation in the participants treated with MOIT, mostly related to adverse events.

BACKGROUND:Omalizumab has been shown to increase reaction thresholds to allergenic foods during treatment. Little is known about its potential to permit introduction of allergenic foods. OBJECTIVE:The aim of this study was to examine introduction of allergenic foods after stopping treatment with omalizumab. METHODS:The first 60 participants completing OUtMATCH (Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants) stage 1 entered a 24-week open label extension, followed by entry into protocol stage 3, which could include dietary consumption (DC) of retail allergenic foods, rescue oral immunotherapy, or allergen avoidance, depending on the results of the final food challenges and participant preferences. RESULTS:A total of 60 participants were included (58% male, median age 8.5 years, age range 1-20 years). The study foods included peanut (n = 60), cashew (n = 28), egg (n = 27), milk (n = 25), walnut (n = 23), wheat (n = 9), and hazelnut (n = 8). Of the initial treatment plans, 82% included DC. DC success was defined as a median daily consumption of at least 300 mg of food protein over 12 months, with the data analyzed in quarterly intervals. Overall, greater success was observed for milk, egg, or wheat (61%-70%) than for peanut or tree nuts (38%-56%). Allergenic food consumption generally declined over time, except in the cases of wheat, with greater variability in median consumption for egg and milk relative to nuts. Reduced consumption appeared to be related to both symptoms and patient preference. The only predictor of DC success was a higher screening challenge threshold. Adverse events included episodes of anaphylaxis, epinephrine use, and 2 diagnoses of eosinophilic esophagitis related to DC. CONCLUSIONS:In this first study of introduction of retail food following omalizumab treatment, most participants were able to introduce allergenic foods in a dietary form, although adverse reactions did occur and many participants returned to avoidance.

The IMPACT trial (NCT01867671) demonstrated strong desensitization and the potential for remission with peanut oral immunotherapy (OIT) in 1–4-year-olds. Data on long-term outcomes of early intervention OIT are limited. Eligible participants had previously been randomized in IMPACT (n=146). The primary outcome was long-term efficacy, defined as ongoing peanut consumption. Key secondary outcomes include safety and risk perception. Follow-up data was available for 39 participants ages 9-13 years (5-9 years after completion of IMPACT). At study completion, 25/39 were advised to introduce dietary peanut. At follow-up, 22/25 were eating peanut and 3/25 had returned to avoidance. Most reported eating a single type of peanut product, with 17/23 eating ≥ 3 times per week, 11 daily. Ingested peanut amounts varied with a maximum of: > 4000mg (n=4), 1000-4000mg (n=6), 300-1000mg (n=11), and <300 mg (n=1) in one serving. Gaps of 1-60 days (median 8 days) in exposure were reported. Compared to the initial end-of-study recommendations, the amount ingested was the same (n=15), less (n=8), or more (n=2). 9/25 reported ≥1 peanut reaction since the end of the study; 2 reported symptoms with most exposures and 5/9 needed epinephrine at least once. Overall, participants reported less perceived risk since the start of the IMPACT study. Five plus years after completing a peanut OIT trial as a young child, peanut remains in the diet for 88% of those given home recommendations, higher than seen in most prior OIT follow-up studies. Vigilance is still required with 1/3 of children reporting symptoms including those requiring epinephrine.

Background Food allergies are common and are associated with substantial morbidity; the only approved treatment is oral immunotherapy for peanut allergy. Methods In this trial, we assessed whether omalizumab, a monoclonal anti-IgE antibody, would be effective and safe as monotherapy in patients with multiple food allergies. Persons 1 to 55 years of age who were allergic to peanuts and at least two other trial-specified foods (cashew, milk, egg, walnut, wheat, and hazelnut) were screened. Inclusion required a reaction to a food challenge of 100 mg or less of peanut protein and 300 mg or less of the two other foods. Participants were randomly assigned, in a 2:1 ratio, to receive omalizumab or placebo administered subcutaneously (with the dose based on weight and IgE levels) every 2 to 4 weeks for 16 to 20 weeks, after which the challenges were repeated. The primary end point was ingestion of peanut protein in a single dose of 600 mg or more without dose-limiting symptoms. The three key secondary end points were the consumption of cashew, of milk, and of egg in single doses of at least 1000 mg each without dose-limiting symptoms. The first 60 participants (59 of whom were children or adolescents) who completed this first stage were enrolled in a 24-week open-label extension. Results Of the 462 persons who were screened, 180 underwent randomization. The analysis population consisted of the 177 children and adolescents (1 to 17 years of age). A total of 79 of the 118 participants (67%) receiving omalizumab met the primary end-point criteria, as compared with 4 of the 59 participants (7%) receiving placebo (P<0.001). Results for the key secondary end points were consistent with those of the primary end point (cashew, 41% vs. 3%; milk, 66% vs. 10%; egg, 67% vs. 0%; P<0.001 for all comparisons). Safety end points did not differ between the groups, aside from more injection-site reactions in the omalizumab group. Conclusions In persons as young as 1 year of age with multiple food allergies, omalizumab treatment for 16 weeks was superior to placebo in increasing the reaction threshold for peanut and other common food allergens.

BACKGROUND: Patients with food allergy may be advised to introduce specific foods into their diets, both to increase tolerance gradually and as next steps after completing oral immunotherapy or other therapeutic interventions. However, the safe use of retail foods depends on the ability to establish the specific allergen protein content of these foods.OBJECTIVE: To develop a systematic approach to estimate the protein content of peanut, milk, egg, wheat, cashew, hazelnut, and walnut in a variety of retail food equivalents for each allergen and associated patient education materials. METHOD: We created an algorithm that used a multistep process with information from product food labels, nutrient databases, independent weighing and measuring of foods, and information provided by manufacturers, including certificates of analysis, and e-mail communication to estimate the allergen protein content of multiple retail foods for each of seven allergens. Once a variety of retail food equivalents for each allergen and allergen serving size was determined, we developed participant education handouts, which were reviewed by study teams at 10 food allergy centers, the National Institute of Allergy and Infectious Diseases, and the Consortium for Food Al-lergy Research coordinating center. After 1 year of use, multiple queries were addressed and the retail food equiva-lents and educational materials were reviewed and edited. RESULTS: We identified a variety of retail food equivalents for seven allergens at six serving sizes, and created 48 unique patient education materials.CONCLUSION: Our results provide extensive guidance on a variety of retail equivalents for seven foods, and a method to estimate retail food protein equivalents systematically with ongoing reassessment. (c) 2022 American Academy of Allergy, Asthma & Immunology (J Allergy Clin Immunol Pract 2023;11:572-80)

Food allergies affect 32 million Americans. Restricted diets due to food allergies can be difficult to maintain especially when the household is food insecure. Food insecurity is defined as the inability to acquire food for household members due to insufficient money or resources for food. The COVID-19 pandemic has caused many people to face food insecurity for the first time with Latinx, Native American, and Black communities disproportionately affected. Because of the increase in food insecurity, this work group developed a survey regarding food insecurity screening. This survey was sent out to a random sample of American Academy of Allergy Asthma & Immunology members to assess food insecurity knowledge and practices. The majority of survey participants did not routinely screen their patients for food insecurity. The biggest barrier identified to screening was lack of knowledge of how to perform a screen and resources available when a patient screened positive. This work group report provides guidance on how to implement and perform a food insecurity screen, including federal resources and assistance programs.

Peanut allergy is estimated to occur in 1.2% to 5% of the population.1 Peanut immunotherapy is being studied as a treatment option, and 2 potential products have recently been submitted to the Food and Drug Administration.1 However, there are limited data on long-term clinical outcomes and changes in quality of life (QOL), particularly child QOL, after completion of food allergen immunotherapy.2-5 Here, we report follow-up of a study of peanut sublingual and oral immunotherapy after up to 8 years to evaluate ongoing peanut ingestion, symptoms, and changes in parent and child QOL.

Immunotherapy for food allergy is being investigated as a potential treatment. There is limited data on long-term outcomes of food immunotherapy. We contacted 21 subjects who participated in a randomized trial comparing oral versus sublingual peanut immunotherapy (NCT01084174). Follow-up data was collected by telephone questionnaire and/or clinical follow-up 3-8 years after study completion to assess long-term peanut consumption and reaction rates. Of the 21 subjects, 16 were given recommendations for home peanut consumption. Follow-up data was available on 15/16. At last contact, 57% (12/21) were ingesting peanut. 8/12 were regularly eating >1 gram of peanut protein (median 1.9 grams, range: 1 to 4.4) and 4 were eating <1 gram (1 trace amounts only, range: trace-0.75). Over the last 12 months of follow-up, the longest time without eating peanut ranged from 2-21 days (median 7 days). Symptom frequency with peanut ingestion ranged from never (1/12), rarely (9/12), regularly (1/12), or with most exposures (1/12). Most common symptoms included oral pruritus, lower respiratory issues, and gastrointestinal complaints. Reactions were treated with antihistamines (11/12 subjects), albuterol (5/12), H2 blocker (1/12), or epinephrine (2/12). One individual needed epinephrine for 2 reactions. Exercise and missed doses were the most cited factors associated with reactions. Taste was the most common reason why subjects limited peanut intake, followed by reactions and anxiety. 14/15 continue to carry epinephrine, 8 of whom also have a non-peanut food allergy. Long-term outcomes of peanut immunotherapy are mixed, with many patients returning to peanut avoidance and/or reporting symptoms with peanut ingestion.

BACKGROUND: Clinical trials of baked milk (BM) introduction have demonstrated accelerated resolution of milk allergy. OBJECTIVE: Long-term data regarding real-world introduction of BM are lacking. We sought to characterize our experience of BM introduction. METHODS: We performed a retrospective chart review of consecutive BM oral food challenges performed in our clinic from 2009 to 2014, with a minimum follow-up of 24 months. RESULTS: Of the 206 patients challenged, 99 (48%) passed and 187 were sent home with detailed instructions to incorporate BM into their diets. After a median of 49 months of follow-up, 43% of the 187 had progressed to direct milk, 20% to less-cooked forms of milk, 10% remained ingesting BM, and 28% were strictly avoiding milk. Higher milk IgE levels were associated with decreased odds of passing a BM challenge and advancing to less-cooked forms of milk. Predictors of progressing to less-cooked forms of milk were passing the challenge and younger age. There were 79 reported milk reactions involving 68 patients (33% of total) during follow-up. Of these, 78% were classified as mild, 14% severe, and 6 patients developed eosinophilic esophagitis. Of 11 severe reactions, 4 were accidental exposures, 3 were planned escalations, and 4 occurred with previously tolerated doses. CONCLUSIONS: The majority of patients who underwent a BM challenge, including those who failed their challenge, were able to progress to direct or less-cooked forms of milk. However, adverse reactions were common, and even a successful BM challenge does not guarantee future tolerance of BM or preclude later reactions, even to previously tolerated doses. (C) 2018 American Academy of Allergy, Asthma & Immunology

Introduction of baked milk (BM) is a mainstay in the management of cow's milk allergy. We sought to characterize predictors of BM tolerance and progression to baked cheese and direct milk among patients undergoing BM oral food challenges (OFC). 126 patients challenged to BM from 2009-2011 were reviewed. OFC success was defined as consumption of ¼ cup BM. Logistic regression was performed utilizing milk-IgE level (log-transformed), age, gender, duration of follow-up, and OFC outcome to determine predictors of subsequent milk intake. 99 patients (4 months-18 years) old were included. Median duration of follow-up was 51 months (range 1.9-85 months). 65% passed the BM OFC. Among those failing, 91% were permitted to introduce specified quantities of BM. Of those passing, 75% progressed to unlimited BM or more, 61% advanced to baked cheese or more, and 38% advanced to direct milk, compared to 48%, 40%, and 26% of those failing the BM challenge (p=0.004,0.046, and 0.234, respectively). Milk-IgE was significantly associated with OFC outcome (OR 0.19, p=0.001) and progression to unlimited BM (OR 0.35, p=0.046) or baked cheese (OR 0.38, p=0.05) but not direct milk (OR 0.96, p=0.16). Patients with milk-IgE >10kU/L were less likely to tolerate unlimited BM (10% vs 54%, p=0.015), baked cheese (8% vs 45%, p=0.04), or direct milk (4% vs 29% p=0.06). Gender, duration of follow-up, and age were not significant predictors. OFC outcome and milk-IgE were the most important predictors of persistent tolerance to BM or more concentrated forms of milk.

Little is known about long-term outcomes following peanut immunotherapy. Peanut allergic children (7-13years) participated in a randomized peanut immunotherapy trial. Subjects who completed ≥12 months of maintenance underwent a desensitization food challenge (d-OFC), and those passing the d-OFC stopped treatment for 4 weeks with re-challenge to determine sustained unresponsiveness (SU-OFC). Follow-up occurred at 9-month intervals over 27-28 months to assess peanut ingestion (PI) and adverse reactions. 14/21 subjects completed maintenance. 4/14 failed the d-OFC but continued with individually prescribed PI. Of these 4, one returned to avoidance due to aversion/intermittent oral symptoms; three continued PI: one 300-500mg/day with intermittent oral symptoms and a reaction requiring epinephrine, one 300-900mg/day with intermittent oral symptoms, and another 3900mg/day with intermittent coughing. 6/10 subjects failed the SU-OFC but continued PI. Two returned to avoidance, one with severe anxiety and one after a reaction requiring epinephrine. Four continued PI: one 1400mg/day with intermittent wheezing/pruritus and a reaction with wheezing/hives/abdominal pain, one 3000mg/day with intermittent oral symptoms, one 3000mg/day with a reaction with hives/shortness of breath, and one 9000mg/day with intermittent pruritus/throat/chest tightness. All 4 who passed the SU-OFC continued PI: one 1500-3000mg/week with intermittent oral symptoms, one 1800-2100mg/day with intermittent oral symptoms and a reaction requiring epinephrine for syncope/vomiting/chest-tightness/hives, and two (2000mg/week and 4800mg/week) with no symptoms. Of the original 21 subjects, eleven were still ingesting peanut after 27 months. However, two of the eleven experienced reactions requiring epinephrine and nine reported at least intermittent symptoms, underscoring the need for additional long term follow-up studies.

RationaleStratifying the health risk posed by allergic responses at threshold doses has important value in food allergy risk assessment.MethodsPeanut challenge data with both eliciting dose (ED) and symptom information were collected from published challenge studies and unpublished Consortium of Food Allergy Research (CoFAR) data. Symptoms were independently graded by a panel of 12 health professionals according to risk score [yes (Y) or no (N) to whether symptoms posed risk to human health] and severity score (1 to 5). Threshold distributions of cumulative EDs for health risk consensus groups (defined as ≥ 7/12 reviewers reporting either a Y or N risk score) were modeled by interval censored analysis to assess intergroup differences.Results302 ED symptom data points from 18 different studies were identified and scored. Although lack of scoring consistency was noted between reviewers, symptoms associated with consensus Y risk (N=104; 34% of total) had mean severity score, 3.37 +/- 0.57, significantly higher than consensus N risk (N=167) score, 1.74 +/- 0.43, p<0.001. 31 data points with no consensus (6 Y/ N) were excluded from analysis. Applying this consensus grading approach to threshold data, ED01/ED05/ED50 values for consensus N risk (.0003/.02/22 mg) were significantly lower than those for consensus Y risk (.01/.4/86 mg; Weibull model; p<.0001).ConclusionsBased on health professional consensus, Y grading of ED symptoms posing risk to human health had significantly higher mean severity scores and was associated with higher peanut threshold doses. Refinement of this grading mechanism is ongoing as a tool to stratify threshold health risk. RationaleStratifying the health risk posed by allergic responses at threshold doses has important value in food allergy risk assessment. Stratifying the health risk posed by allergic responses at threshold doses has important value in food allergy risk assessment. MethodsPeanut challenge data with both eliciting dose (ED) and symptom information were collected from published challenge studies and unpublished Consortium of Food Allergy Research (CoFAR) data. Symptoms were independently graded by a panel of 12 health professionals according to risk score [yes (Y) or no (N) to whether symptoms posed risk to human health] and severity score (1 to 5). Threshold distributions of cumulative EDs for health risk consensus groups (defined as ≥ 7/12 reviewers reporting either a Y or N risk score) were modeled by interval censored analysis to assess intergroup differences. Peanut challenge data with both eliciting dose (ED) and symptom information were collected from published challenge studies and unpublished Consortium of Food Allergy Research (CoFAR) data. Symptoms were independently graded by a panel of 12 health professionals according to risk score [yes (Y) or no (N) to whether symptoms posed risk to human health] and severity score (1 to 5). Threshold distributions of cumulative EDs for health risk consensus groups (defined as ≥ 7/12 reviewers reporting either a Y or N risk score) were modeled by interval censored analysis to assess intergroup differences. Results302 ED symptom data points from 18 different studies were identified and scored. Although lack of scoring consistency was noted between reviewers, symptoms associated with consensus Y risk (N=104; 34% of total) had mean severity score, 3.37 +/- 0.57, significantly higher than consensus N risk (N=167) score, 1.74 +/- 0.43, p<0.001. 31 data points with no consensus (6 Y/ N) were excluded from analysis. Applying this consensus grading approach to threshold data, ED01/ED05/ED50 values for consensus N risk (.0003/.02/22 mg) were significantly lower than those for consensus Y risk (.01/.4/86 mg; Weibull model; p<.0001). 302 ED symptom data points from 18 different studies were identified and scored. Although lack of scoring consistency was noted between reviewers, symptoms associated with consensus Y risk (N=104; 34% of total) had mean severity score, 3.37 +/- 0.57, significantly higher than consensus N risk (N=167) score, 1.74 +/- 0.43, p<0.001. 31 data points with no consensus (6 Y/ N) were excluded from analysis. Applying this consensus grading approach to threshold data, ED01/ED05/ED50 values for consensus N risk (.0003/.02/22 mg) were significantly lower than those for consensus Y risk (.01/.4/86 mg; Weibull model; p<.0001). ConclusionsBased on health professional consensus, Y grading of ED symptoms posing risk to human health had significantly higher mean severity scores and was associated with higher peanut threshold doses. Refinement of this grading mechanism is ongoing as a tool to stratify threshold health risk. Based on health professional consensus, Y grading of ED symptoms posing risk to human health had significantly higher mean severity scores and was associated with higher peanut threshold doses. Refinement of this grading mechanism is ongoing as a tool to stratify threshold health risk.