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Poisonings caused by ingestion of toxic, wild-picked morel mushrooms have been reported to the Food and Drug Administration (FDA). Problems occur when collectors of wild mushrooms inadvertently include toxic look-alike species with the edible wild species offered for sale. A 2-year survey conducted by the FDA showed 21% of the morel and 15% of the wild mixed mushrooms were contaminated with toxic look-alike species. These contaminants contain toxins that produce symptoms ranging from dizziness and gastrointestinal distress to liver and heart damage. Present regulatory controls include FDA Import Alerts for morels contaminated with Gyromitra esculenta and Verpa bohemica , a Michigan state regulation requiring licensing of harvesters of wild mushrooms, and an Illinois state regulation prohibiting the sale of wild-picked mushrooms through retail outlets. American consumers, unable to distinguish between edible and toxic look-alike wild mushrooms, may face illness and possibly death from products purchased on the normally well-regulated U.S. consumer market.

An analytical scheme is presented to provide an overview of techniques applicable to glass contamination in a variety of consumer products. Procedures are referenced or presented in detail, with emphasis on quality assurance. References on forensic and analytical methods for the examination of glass are provided.

The problem of sound radiation from moving on finite part of speedway transport facilities in the city is considered. The attempt of mathematical modeling of the noise generation on two-side of the three-lines road with taking into account of the velocity of motion and acoustical characteristics of sound sources and road-bed was made.

For many years, the Food and Drug Administration (FDA) regulated botanical dietary-supplement ingredients, in most circumstances, under the provisions for food additives of the Federal Food, Drug, and Cosmetic Act to ensure that they were safe and wholesome. Currently, dietary supplements (such as botanical products, vitamins and minerals, amino acids, and tissue extracts) are regulated under the Dietary Supplement Health and Education Act of 1994, which includes several provisions that apply only to dietary supplements and dietary ingredients of dietary supplements. Included in these provisions was the removal of the ingredients of dietary supplements from regulation as food additives and . . .

Background Qualification of patients with advanced ovarian cancer (AOC) to treatment with primary or interval debulking surgery (IDS) is the subject of controversy. The aim of this study was to assess the expressions of selected proteins of apoptosis to the effects of neoadjuvant chemotherapy (NAC) in patients with AOC. Material and methods We evaluated 60 consecutive patients with AOS (FIGO stage IIIC-IV) treated with NAC, retrospectively. Formalin-fixed, paraffin-embedded tissue specimens were immunohistochemically stained for expression of p53 and survivin in patients given platinum-based NAC undergoing IDS. The expression of survivin was adopted dichotomization by the median expression of the protein found total score (TS) equals 2. For low expression of survivin was TS ≤ 2, while high total score TS> 2 The positive and negative expression of p53 were used to dichotomization study group. Results Median age of 60 patients was 60 years. The optimal IDS was achieved in 69.1% (38/55). We observed significant difference in the percentage of stained nuclei (PS, p = 0.0002), the intensity of staining (IS, p = 0.0003) and TS (p = 0.0001) by comparing the expression of survivin in tumor tissue taken before and after NAC. The expression of p53 in tumor tissue before and after NAC was observed and significant difference was in PS, (p = 0.0424). There were no statistically significant difference in IS and the TS. Expression of survivin and p53 was not related to the results of IDS. Survivin expression was a prognostic factor in AOC patients treated with NAC (p = 0.0484). Expression of survivin and p53 proteins was not a predictor factor in AOC patients. Adverse factors affecting the PFS for AOC patients treated with NAC were: lack of optimal IDS and the lack of an objective response by RECIST criteria (respectively HR was 3.93 (95% CI, 2.07-7.46, p Conclusions High expression of survivin is a useful prognostic factor in patients treated with neoadjuvant chemotherapy for advanced ovarian cancer. This effect is more significant in patients with positive expression of p53. Disclosure All authors have declared no conflicts of interest.

Background Study results demonstrated that IFN augments BEV activity and improves median PFS in pts with mRCC. Thus, combination BEV + IFN is a standard first-line treatment option for mRCC. Combining BEV with the mTOR inhibitor EVE may be an efficacious and well-tolerated treatment option. The open-label, phase II RECORD-2 trial compared first-line EVE + BEV and IFN + BEV in mRCC. Patients and methods: Therapy-naive pts with clear cell mRCC and prior nephrectomy were randomized 1:1 to BEV 10 mg/kg IV every 2 weeks with either EVE 10 mg oral daily or IFN (9 MIU SC 3 times/week, if tolerated). Tumour assessments were every 12 weeks. Primary objective was treatment effect on progression-free survival (PFS) per central review based on an estimate of the chance of a subsequent phase III trial success (50% threshold for phase II success). Results In EVE + BEV (n = 182) and IFN + BEV (n = 183) arms, median age was 60/60 years, 76/72% of pts were men, MSKCC risk was favourable/intermediate/poor in 36/57/7% and 36/57/7% of pts, and 43/46% of pts had >2 organs involved, respectively. For EVE + BEV and IFN + BEV, median treatment duration was 8.5/8.3 months, respectively; 23/26% of pts discontinued due to AEs. In EVE + BEV and IFN + BEV arms, median PFS by central review was 9.3/10.0 months (HRIFN/EVE, 0.91; 95% CI, 0.69-1.19; P =0.485), respectively; probability of subsequent phase III success was 5.1%. Results of central and local PFS analysis were consistent. Objective response rate was 27/28% in EVE + BEV and IFN + BEV arms, respectively. Median overall survival (OS) was not reached in the EVE + BEV arm and was 25.9 months (95% CI: 21.1, 30.2) in the IFN + BEV arm. Most frequent AEs (%) were stomatitis (63), proteinuria (49), diarrhoea (39), hypertension (38), and epistaxis (35) in EVE + BEV arm and decreased appetite (45), fatigue (41), proteinuria (37), and pyrexia (35) in IFN + BEV arm. Conclusions In RECORD-2, PFS and tolerability were similar for first-line EVE + BEV and IFN + BEV. Final OS analysis will occur after 2-year follow-up. Disclosure A. Ravaud: Alain Ravaud is a member of global, European, and/or French boards on urological tumors for Pfizer, Novartis, GlaxoSmithKline, Bayer-Schering, and Dendreon, and has received institutional grant support from Pfizer, Novartis, and Roche. O. Anak: Ozlem Anak is an employee of Novartis Pharma AG. D. Pelov: Diana Pelov is an employee of Novartis Pharmaceuticals Corporation. A. Louveau: Anne-Laure Louveau is an employee of Novartis Pharma S.A.S. T. M-H: Tay M-H is a speaker for an advisory board for Novartis Pharmaceuticals Corporation. B. Melichar: Bohuslav Melichar has received honoraria from Novartis and Roche and served on an advisory board for Roche. All other authors have declared no conflicts of interest.

Rigidity is one of the main factors decisive for the quality of machine tools, measuring instruments and many other devices. One of the principal deformation components of a machine element is contact deformation due to surface roughness. The contact rigidity can be controlled by selecting appropriate working methods and parameters, influencing directly the surface roughness characteristics. It is for this reason that many theoretical and experimental works have been devoted to the problem mentioned. As a result of the first load being applied the surface roughness undergoes elastic-plastic deformation, which has not yet been described by any consistent theory. During unloading and subsequent loading processes the deformed asperities remain elastic (if there are no tangential displacements). However, as a result of no data being available as regards the stereometric features (3-D) of roughness and their changes due to plastic deformation, the theoretical results are charged with considerable errors. In engineering problems the value of a contact deformation may be computed making use of statistical relations based on roughness models of various degrees of complication. These relations are established on the basis of the results of some tests of the surfaces of elements machined by the same methods and made of the same materials as the elements to be analysed. These methods enable us to evaluate contact deformations with an accuracy which is much better than that of the theoretical methods. Another method for ensuring the required rigidity of manufactured objects is by direct measurement of contact deformation in the course of the manufacturing process, for which a special apparatus is required. The devices which have been designed for the measurement of contact deformations of a surface enable such measurement by using a check surface of high hardness and low roughness as compared with those of the parts considered.

A national retail market survey was conducted to determine the sanitary quality of tomato products: juice, paste, puree, sauce and soup. The official methods of the Association of Official Analytical Chemists were used to count molds, rot fragments, fly eggs and maggots. The most frequently encountered defect was mold decomposition. Howard mold counts for all products ranged from 0 to 57%. Mold count means ranged from 2.0 to 9.4%. The percent of samples containing mold ranged from 55.4% for tomato soup to 98.9% for tomato paste. Rot fragment counts ranged from 0 to 560/g, fly egg counts ranged from 0 to 5 and maggot counts ranged from 0 to 2/100-g sample.

The present AOAC method for mold counts of tomato products (44.096) provides no inter-product standardization of concentration among juice, sauce, paste, puree, and catsup; no intra-product standardization of concentration for juice, sauce, and catsup; and no adjustment for degree of comminution. Use of the official method, therefore, could result in an artificially increased mold count for products which have undergone extreme comminution. A new method was developed to adjust all products to the same concentration and grind them to a uniform particle size, thereby ensuring comparable mold counts on products produced by different processes. Collaborative study results showed equal repeatability for both the official and the proposed methods and a lower coefficient of variation for the proposed method.

Two studies were done to determine the effects of processing equipment on Howard mold and rot fragment counts of tomato catsup. In a pilot plant study in 1980, batches of catsup with known cut-out rot levels were produced and processed through various types of comminution equipment. Urschel and Fitzpatrick mills and homogenizers at 500 to 700 and 1500 to 2000 psi increased mold counts more than twofold over the range of data obtained. Contrary to previous reports, Urschel mills increased rot counts significantly. A nationwide survey was conducted in 1983 to determine if similar effects would be found with well-characterized commercial products. Data were obtained on inline and finished products from 164 lots of catsup produced at 16 plants located across the country. Urschel and Fitzpatrick mills tended to increase mold counts over twofold and caused a slight increase in rot counts. High pressure homogenizers (≥2000 psi) tended to decrease mold counts; low pressure homogenizers (

The present AOAC method for mold counts of tomato products (44.096) provides no inter-product standardization of concentration among juice, sauce, paste, puree, and catsup; no intra-product standardization of concentration for juice, sauce, and catsup; and no adjustment for degree of comminution. Use of the official method, therefore, could result in an artificially increased mold count for products which have undergone extreme comminution. A new method was developed to adjust all products to the same concentration and grind them to a uniform particle size, thereby ensuring comparable mold counts on products produced by different processes. Collaborative study results showed equal repeatability for both the official and the proposed methods and a lower coefficient of variation for the proposed method.

The various mold count methods for nectars, purees, and pastes make no adjustment for concentration of the pulped liquid. Thus, mold counts of different forms of the same product (e.g., guava nectar, puree, or paste) or of the same product from different manufacturers cannot be compared. A method was developed in which the product is centrifuged under standardized conditions, then diluted to a standard pellet-to-final-volume ratio. Because variations in the concentration of fruit or vegetable tissue are corrected, comparisons of mold counts are possible. The method was adopted official first action.

The official method for the determination of Geotrichum mold in canned fruits and vegetables, 44.079, is not satisfactory for use with cream style corn. The kernels are too small to be retained by the first 2 sieves, and the presence of starch interferes. The proposed method uses a smaller series of sieves (Nos. 16, 70, and 230), which enables more of the product to be separated from the mold before the No. 230 sieve, and specifies hot (45-55 degrees C) wash water for the sieving steps to remove the starch. The method has been adopted official first action.

The sieve mesh sizes (Nos. 8, 16, and 230) specified in the official method for the Geotrichum mold count of fruits and vegetables, 44.079, are inadequate for citrus juices. Citrus tissue passes through the larger mesh screens and clogs the fine mesh No. 230 sieve. The fine citrus tissue prevents the separation of the mold from the product and the liquid. The proposed method changes the sieve series to Nos. 40, 140, and 230 mesh. A compromise is reached which permits the concentration of mold along with the citrus tissue and the elimination of the excess liquid. The method has been adopted official first action.

The present method to detect parsnip or turnip adulteration in prepared horseradish uses light microscopy and a starch stain containing iodine in potassium iodide. This method does not work well for potato adulteration because potato and horseradish starch stain similarly. A method has been developed to differentiate potato from horseradish tissue by using a polarizing microscope with crossed polars and a first order red plate. Potato starch grains show interference patterns. This method has been used to qualitatively demonstrate potato starch grains in product packing liquid and to quantitate potato adulteration in horseradish samples at levels of less than 1% potato tissue fragments.

Background The phosphatidylinositol 3-kinase (PI3K)/AKT/mTOR pathway is involved in growth regulation, proliferation control and metabolism in renal cell carcinoma (RCC). In our prospective pilot study, we determined whether common genetic variations in the AKT/ PI3K, FRAP1 (encoding mTOR) are associated with clinical outcomes in RCC patients who underwent palliative therapy with everolimus. Patients and methods Our pilot study was designed to assess everolimus efficacy in RCC patients relapsed after TKI inhibitors (sunitinib and/or sorafenib). Patients were treated with everolimus 10 mg daily orally until disease progression. The genomic DNA was extracted from formalin-fixed, paraffin-embedded primary tumor RCC tissues. 12 potentially functional SNPs in 4 key genes (AKT1, AKT2, FRAP1, PIK3CA) were determined using a real-time PCR genotyping assay and analyzed for association with response to therapy, progression free survival (PFS) and overall survival (OS). Results Median age of 45 enrolled patients was 62 years (range, 41–78). At a median follow-up duration of 8,6 months, the 6-month PFS rate was 53.3%. Partial response was observed in 4,4% (2/45) of the patients. Median PFS was significantly prolonged in the PIK3CA rs6443624 for the CC genotype in comparison to the AA/AC genotype (8.9 months versus 5.5 months, log rank, p= 0.0157). In the multivariate analysis elevated corrected serum calcium and PIK3CA rs6443624 for the AA/AC genotype were unfavorable predictors of PFS (HR 5.25; 95% CI, 1.75–15.75 and HR 3.48; 95%CI, 1.47–8.25, respectively, p Conclusion These results suggest that PIK3CA rs6443624 genetic variation in PI3K/AKT/mTOR pathway may modulate clinical outcomes in patients with RCC who undergo chemotherapy with everolimus. Further clinical studies are needed to confirm these findings. Disclosure All authors have declared no conflicts of interest.

The official method for the determination of Geotrichum mold in canned fruits and vegetables, 44.079, is not satisfactory for use with cream style corn. The kernels are too small to be retained by the first 2 sieves, and the presence of starch interferes. The proposed method uses a smaller series of sieves (Nos. 16, 70, and 230), which enables more of the product to be separated from the mold before the No. 230 sieve, and specifies hot (45–55°C) wash water for the sieving steps to remove the starch. The method has been adopted official first action.

The present method to detect parsnip or turnip adulteration in prepared horseradish uses light microscopy and a starch stain containing iodine in potassium iodide. This method does not work well for potato adulteration because potato and horseradish starch stain similarly. A method has been developed to differentiate potato from horseradish tissue by using a polarizing microscope with crossed polars and a first order red plate. Potato starch grains show interference patterns. This method has been used to qualitatively demonstrate potato starch grains in product packing liquid and to quantitate potato adulteration in horseradish samples at levels of

A survey was made to determine the level of mold contamination in jellied and whole-berry style cranberry sauce. The analytical data obtained were representative of the cranberry sauce at the national retail level. The mean and range of Howard mold counts for each style were as follows: jellied, 4.1% (0-98%); and whole berry, 1.6% (0-10%). The percentage of samples of each style found to contain mold were: jellied 85.8% and whole berry 64.9%.

The various mold count methods for nectars, purees, and pastes make no adjustment for concentration of the pulped liquid. Thus, mold counts of different forms of the same product (e.g., guava nectar, puree, or paste) or of the same product from different manufacturers cannot be compared. A method was developed in which the product is centrifuged under standardized conditions, then diluted to a standard pellet-to-final-volume ratio. Because variations in the concentration of fruit or vegetable tissue are corrected, comparisons of mold counts are possible. The method was adopted official first action.

Variation in the data obtained from the 4 slides counted in the Geotrichum mold count methods was statistically examined to determine if the number of slides could be reduced. The mean and standard deviation for 4 replicate slides for each can of carrots, green beans, and pineapple demonstrated that mold count variation is a function of the mean, that significant variations exist among lots and among cans within a lot, and that quadruplicate slide counts are unnecessary. Duplicate counts would save 50% of the analyst’s counting time.

The sieve mesh sizes (Nos. 8, 16, and 230) specified in the official method for the Geotrichum mold count of fruits and vegetables, 44.079, are inadequate for citrus juices. Citrus tissue passes through the larger mesh screens and clogs the fine mesh No. 230 sieve. The fine citrus tissue prevents the separation of the mold from the product and the liquid. The proposed method changes the sieve series to Nos. 40, 140, and 230 mesh. A compromise is reached which permits the concentration of mold along with the citrus tissue and the elimination of the excess liquid. The method has been adopted official first action.

The official AOAC method for determination of Geotrichum mold in canned fruits and vegetables (44.079) requires a series of 3 sieves, Nos. 8, 16, and 230, to separate the packing liquid from the product and the mold from the packing liquid. Although this method has been successful for whole or coarsely chopped products (e.g., green beans, potatoes, carrots, and beets), finely divided products such as fruit purees and tomato products tend to clog the sieves. A method was developed in which the product is centrifuged, diluted by volume, stained with crystal violet, and counted with the sieving steps eliminated. The proposed method was adopted official first action.