Attachment No. 6 - Statement of workdocx.pdf

Attachment No. 6 - Statement of Work

Specifications and Statement of Work

1. General Description

The U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), and its various offices nationwide, including the Office of Regulatory Science (ORS), the Office of Food Safety (OFS), the Office of Food Additive Safety (OFAS) and the Office of Compliance (OC), has a need to obtain information about the concentrations of chemicals in a wide variety of foods, dietary supplements and cosmetics, through the collection of food, dietary supplements and cosmetic samples, and their subsequent analysis by chemical analytical methods to be specified in each task order.

2. Background

CFSAN is required to produce information about the nature of chemical contaminants in food. Over the past several years, the agency has faced a wide range of issues related to direct and indirect contamination of food that have required information on the concentrations of specific chemicals. In many cases, the type of information required is a survey of the concentrations of contaminants to provide CFSAN with information necessary to formulate policy and to assess potential risks. In the past, this information has been provided by scientists within CFSAN:

i) Through small scale in-house surveys;

ii) Through contracts with outside laboratories and

iii) Through surveys conducted by the FDA's Office of Regulatory Affairs on behalf of CFSAN.

The information from these surveys is not used for direct regulatory action but is instead used to make decisions about scientific issues associated with food safety problems and to guide policy. For example, surveys in the past were used to inform the agency about the nature of acrylamide concentrations in food, and were followed in 2011-2014 by a larger study, done by a contract laboratory, which established the concentrations of acrylamide in a larger set of representative types of foods. This information was used to develop guidance about ways to reduce the occurrence of acrylamide in foods.

Future studies shall examine how guidance and policy have affected the concentrations of this chemical in foods. In 2011-2014, contract laboratory analysis was also used to assess concentrations of inorganic arsenic in rice and rice products, as well as fruit juices, to obtain information used in developing risk assessments. Similar surveys were conducted to assess concentrations of 4- methylimidazole (4-MEI), potassium bromate, semicarbazide and color additives in various foods, to address different programmatic needs within CFSAN. It is anticipated that CFSAN will continue to have such needs over the next five years.

3. Scope

The objective of this contract is to develop a capability to support CFSAN's research by rapidly assessing the quantities of specified chemicals in foods, dietary supplements, and cosmetics through surveys of these commodities. The purpose of these surveys is to develop a better understanding of the quantities of chemicals and their distribution. The types of samples to be collected for these studies include food products from across the United States, including fresh fruits and produce, packaged and processed foods of all types, dietary supplements, and cosmetics. The analytical targets of these studies include chemical contaminants in foods (e.g. pesticides, industrial chemicals), direct food additives and indirect food additives (those produced by processing or transfer from packaging), deliberate adulterants, nutrients, naturally occurring chemical components (such as metallic elements), as well as the chemical constituents of dietary supplements, botanical extracts and cosmetics. The analytical methodology for any specified study will be established and provided by CFSAN, and shall include methods based upon state-of-the-art analytical techniques, including many based on instrumental analysis with various types of separation techniques and spectrometers. The Contractor shall at all times, throughout the life of this contract, possess an ISO 17025 Accreditation or equivalent.

4. Technical Requirements; Chemical Analysis:

The Contractor shall provide all services necessary or incidental to the chemical analysis services requested by the FDA at CFSAN. In addition, the Contractor shall furnish the necessary professional personnel, materials, services, facilities, and do all things necessary for or incidental to the performance of the work.

Task orders shall include, but not be limited to the following:

CFSAN will specify the types of samples, quantities (between 50 and 1500), analytical methodology and data reporting requirements with each specified task.

The Contractor shall perform the following tasks:

A. Sample Collection: Collect raw, minimally processed (e.g. bagged), and processed/packaged foods, dietary supplements and cosmetics from local supermarkets and stores in major metropolitan areas in some parts of the United States. Cities chosen may include the metropolitan areas of Atlanta, Chicago, Dallas, Denver, Los Angeles, New York, San Francisco, Seattle and Washington, DC. CFSAN shall specify the type of commodity, the brand distribution, lot number and manufacturing date distribution, quantity and geographic location of the samples. While the geographic distribution is not expected to be extensive, the ability to obtain samples from major metropolitan areas is required.

1. Collection of food samples:

(1) Samples may be collected with specific requirements as to geographic location.

(2) Sample collection may occur in different geographic areas in cases where there are significant regional variations in the way foods are processed.

(3) In some cases, there may not be a requirement to collect samples at different locations.

For some types of questions, it is sufficient that national brands be purchased from multiple lots, but as long as the lot requirements are met, they could all be purchased from the same place.

(4) Sample Collection Costs: Sample collection costs are to be priced in a way that the cost per sample is known at the time the task is awarded.

(5) Sample logging: When samples are collected, the following information will be obtained.

(a) Sample numbers assigned by FDA or by the Contractor.

(b) Name of the product and size of the package (e.g., Diet Coke, 2 liters).

(c) Date and location of sampling.

(d) Readable digital photographs or photocopies of the food packaging, as purchased, to include front of package, nutrition information panel and ingredient list. The Contractor shall retain all product packages for the analyzed food products until FDA deems the digital photographs to be acceptable.

(e) Record of lot numbers/production codes and expiration dates (where applicable).

(f) Serving size from product label.

(g) Sampling portion where applicable ( e.g., center or heel slice of bread, whole breaded fish fillet as packaged, a composited frozen dinner).

(6) When samples are collected, digital photographs shall be obtained for each item collected:

(a) Collected items shall be assigned a sample ID #, which shall be carried throughout the entire analysis process.

(b) Photographs shall be taken of the front of the items so that the specific items and brand are clearly identifiable.

(c) Photographs shall be taken of the ingredients panel and the Nutrition Facts label, as well as the Uniform Product Code (UPC).

(d) Photographs shall be taken of preparation instructions, if the samples are to be prepared by the vendor.

(e) All digital photographs shall be available in BMP, JPG or similar digital format. Each digital photograph shall be named in such a way that the Sample Identification Number (SIN) occurs at the beginning of the file name.

(f) The Contractor shall be able to upload the digital photographs to an FDA-selected site using FTP or similar protocol.

ii) In some cases, the Contractor shall be asked to prepare foods, according to package instructions, prior to analysis. Minimum suggested food preparation facilities (or access thereto) include mixers, pans, cookie sheets, utensils, fryers and ovens to prepare cakes, cookies, not ready to eat foods that shall be cooked in the oven (French fries, snack foods, etc).

In such cases, foods will be prepared as they would normally be consumed (e.g., all frozen meals cooked, and dry mixes prepared according to package directions prior to analysis), unless otherwise directed by CFSAN. Food preparation steps should be documented. A brief description of the sample processing (e.g., homogenization, filtration, extraction, sample size) of each sample, prior to analysis, shall be recorded and included in sample data.

iii) If CFSAN sends samples to the Contractor directly, CFSAN shall be responsible for the cost of shipping.

(1) An update of the sample collection status for any particular task shall be provided in a spreadsheet at the end of each month, together with the monthly reports requested in Section 4 (c).

B. Standard analyte analysis per price list. The Contractor shall perform analysis of samples for analytes specified in the standard price list. The number of analyses identified in the task order shall include the maximum number of collected samples to be analyzed. The Contractor shall use a Quality Control plan or similar method that shall be specified with each task order.

1. A calibration curve shall be generated before, during or after each set of analyses, per the Contractor's usual procedures (which shall be outlined in the response). The Contractor shall bear the cost of generating the calibration curve (s).

2. Spike recoveries shall be performed by addition of standards to the food matrix every 20th sample. If less than 20 samples are analyzed for a food category, spike recoveries shall be determined on at least one sample in the food type category. Spike concentrations shall be specified in the task order under the QA/QC plan, but in general spike concentrations will be at the midpoint for the working range for the contaminant in question. At a minimum, the value calculated for the recovery must be within ± 25% of the expected recovery. If the recoveries are not acceptable, appropriate actions should be taken and the spike recovery should be re-determined (vendor to assume the cost). The amount (concentration or mass) of analyte added to the sample shall be reported with the results in order to allow an independent determination of the recovery.

3. A calibration check standard shall be analyzed every 10th sample to monitor retention time and quantitative accuracy. (At a minimum, calibration check samples shall fall within the 95% confidence limits determined from the standard curve). The calibration check standard shall be run at a concentration that is near the mid-point of the analytical calibration curve. If there is a failure to meet this criterion, appropriate actions shall be taken and the standard shall be re-analyzed. Additional failures require that a new calibration curve (Contractor assumes the cost) be prepared and all samples prior to the QC failure to be re-analyzed. The true value (i.e., expected value) of the calibration check should be reported with the results to allow for an independent determination of the QC result.

4. For each separate food category (as defined by CFSAN when the task order is placed), replicate (duplicate or triplicate) analysis of a sample will be perfom1ed as specified in the task order. The replicate analyses will occur at either the 20th sample within the food category or approximately mid-way through the list of samples for a particular food category (if a food category contains less than 20 samples). The relative standard deviation for the results shall be less than 15%.

5. The Contractor, for purposes of quality control, may run their own standardized QC spike sample (at their own expense).

6. Failure of any of QA/QC samples to meet method performance measures shall require an explanation of what was done to conect the method and shall require reanalysis of the samples analyzed prior to loss of method control measures.

7. The Contractor shall provide CFSAN with a control chart for the QC samples.

C. Data reporting. In general, the Contractor shall report data from analysis according to the procedures outlined below, on a monthly basis. The Monthly Report shall also include an update of the sample collection status for any particular task. More information on data reporting shall be provided in each task order.

1. Reports (as specified in the assigned analytical method requested) shall be provided to CFSAN at the end of each month (on the Last Business Day). Description of report format and content shall be specified at the time of order but will be similar to that described below. Whenever possible, all samples for a particular food category should be purchased, analyzed, and results provided together. The following minimum data rep011ing requirements shall be met:

a. Results and Certificates of Analysis (COA). At the end of each month (on the Last Business Day), a results Spreadsheet (Excel), raw data files, quantitation files and photocopies or photographs of product packaging, and analysis of a specified sample set (food type, group, etc, as specified in each task order, shall be provided. COAs, spreadsheets, raw data and product package photos will be uploaded to a server that CFSAN will provide and identify.

b. The Contractor's Results Spreadsheet (in Excel described above) shall include the following information:

1. Assigned Sample Number (ASN).

2. COA number on which the sample appears

3. Name of the product (For quantitation check standards, concentration or quantity can be used in place of the product name or a separate column can be used to show this information).

4. Size of the package.

5. Date of purchase.

6. Location of purchase.

7. Lot number or production code.

8. Expiration date (if applicable).

9. Serving size from product label.

10. Sampling portion where applicable ( e.g., center or heel slice of bread, whole breaded fish fillet as packaged, a composited frozen dinner).

11. Analytical results in appropriate units (typically mg/kg or µg/kg) of the analyte in the food as consumed.

12. For each spike analysis, information on the amount spiked, the result, and the percent recovery

13. File name or link for digital photographs of product label (front of package, nutrition information panel and ingredient list).

14. Raw data file name for each sample number (may be the same for multiple samples, but shall include raw data for calibration curves used to generate quantitative results)

15. Quantitation file name if separate quantitation files are generated

D. Reports/Deliverables

The Contractor shall provide the reports (including an update of the sample collection status for any particular task) on the Last Business Day of each month, and reported to FDA on Certificates of Analysis (COA) and in results spreadsheets, to the FDA Contracting Officer's Technical Point of Contact (TPOC). Task Orders shall specify the collection of a number of samples and the analysis of those samples. The deliverables shall be certificates of analysis and results spreadsheets for the specified analyses. For example, a task order might specify the collection of 400 samples and analysis of 400 samples plus the associated QA/QC samples (80 additional analyses).

E. Format of Monthly Report (MPR):

A report of results shall be submitted (as Certificates of Analysis, on a spreadsheet containing results to date, data files and photos) on monthly intervals by the (Last Business Day .of the month), beginning from the contract award date unless otherwise stated on the task order. The report shall be in the following format:

a. A cover page containing:

a. Contract Number and Title; and Task Order Number

b. Type of report, sequence number of repo11, and period of performance being reported;

c. Contractor's name and address;

d. Name of Author(s); and

e. Date of report

b. A summary of the samples collected to date for each task, CO As, results spreadsheets, raw data files, quantitation files and photographs submitted in the current report, with the files names and the type of analysis performed.

c. Spreadsheets with summaries of the results obtained in the previous month, to be fom1atted as noted in section 2.4.C. l .b (Contractors Results Spreadsheet), Certificates of Analysis, Raw Data Files, Quantitation files and label photographs.

Fl. Marking Instructions for Reports

The Contractor shall mark each shipment with its organizational name, contract number, item number, and quantity (indicate partial or final shipment). As appropriate, note on the face page of the report and when feasible on the binding (1) "one volume only" or (2) "volume 1 of 2, volume 2 of 2" etc.

F2. Payment of Postage and Fees

All postage and fees related to distribution of deliverables, including forms, reports, etc. shall be paid by the Contractor.

G. Analytical Methods

The following table is provided for informational purposes regarding the analytical methods required:

Test description

LIMS code

Metho d

Detection

Limit

2-acetyl-4-tetrahydroxy-butylimidazole (THI) (impurity in caramel color)

4M

EI

Global Internal Method

1 ppb-liquids 5-solids

Acrylamide

ACRYLA

M-LC

US FDA

July 23, LC/MS/

MS

pp b

Amino Acid analysis

AMINO-CMPL

(Includes standard profile plus cystine, praline, hydroxyproline, tryptophan)

USDA

MSS2

(1993)

0.

AMINO-STD

(Includes alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, isoleucine, leucine, lysine, phenylalanine, methionine, serine, threonine, tyrosine, valine)

USDA MSS2

(1993)

0.01%

Arsenic (total)

ARSENIC-MS

FDA EAMS 4.7

0.01 ppm

Arsenic (Inorganic)

AS-SPECIAT

FDA EAMS

4.10, 4.11

LODs: Total Arsenic:

lOppb, Organic Arsenic: 3ppb, Inorganic Arsenic: 6ppb

Benzene

SOLV-SINGL

Internal GC Headspace

0.1 ppm

BHA/BHT (antioxidants)

BHA-T-TBHQ

JAOAC 1996

79(6):1459-

1 ppm

Bisphenol A

BISPHENOLA

CFSAN

LC/MS/MS

5 ppb

Cadmium

CADMIUM-MS

1 ppb

Caffeine

CAFFEINE

Internal Method

Chloramphenicol/Nitrofura n metabolites

NFCAP-MS

LIB4597

1 ppb

Chondroitin sulfate

CHOND-HPLC

JAOAC Int 90:659

(200/lnternal)

49 mg/kg

Cyanuric acid

MELAMINE

FDA 4421/Mod

CFIA LC-

MS/MS

0.25 ppm

Deoxynivalenol (DON)

VOMl-LC-HI

CFSAN

Method (LC-

MS/MS)

10 ppb

DHEA or 7-keto DHEA

Miscellaneous

Ephedrine alkaloids

EPHEDRINE

USP/NF

Current Ver.

0.05 mg/g

I

I

FD&C Color Additives

COLOR-FDA

Liquid chromatograph y;

"Determination of Seven Certified Color Additives in Food Products Using Liquid Chromatograph y"; Harp, BP;

Miranda- Bermudez, E;

Barrows, JN;

Journal of Agricultural

<1 ppm and Food

Chemistry, 61(15), 3726-3736

Glucosamine

GLUCOSAMIN

AOAC 2005.01

Gluten

ALLERGLIAD

r-Biopharm RS Ridascreen

Test, MIOBS

ELISA

2.5 / 40 ppm gliadin, 5 ppm gluten

Hexanal

HEXANAL

Internal GC

0.2 ppm

5-hydroxymethyl-2-furfural

(5- HMF) (impurity in caramel color)

4MEI

Global Internal

1 ppb-liquids 5-solids

Inorganic elements (multiple, up to 5 per analysis); option for multiple element pricing

ICPMS-HMS

EPA

3050/6020, USP730

Iodine

IODINE-MS

FDA EAMS

4.13

0.1 ppm

Lead

LEAD-MS

Melamine

MELAMINE

FDA 4421/Mod

CFIA LC-

0.25 ppm

4-methylimidazole (4-MEI)

4MEI

Global Internal

1 ppb-liquids 5-solids

Mercury

MERCURY-MS

0.005 ppm

Milk Allergens

ALLERG-MLK

Neogen

Veratox Test, MIOBS ELISA

2.5 / 25 ppm

Multiple mycotoxins (aflatoxin Bl, deoxynivalenol-DON, fumonisin Bl, ochratoxin A, T-2 toxin, zearalenone

CFSAN LC-

Varies per Compound:

Aflatoxin Bl - 0.5 ppb Aflatoxin B2 - 0.3 ppb Aflatoxin Gl - 0.7 ppb Aflatoxin G2 - 0.9 ppb

Deoxynivalenol (DON) - 10 ppb

Fumonisin Bl - 4 ppb Fumonisin B2 - 10 ppb Ochratoxin A (OTA) •

0.8 ppb

MYCOTOXIN

CSAN Method

(LC-

MS/MS)

T-2 Toxin - 9 ppb Zearalenone (ZEA) - 7 ppb

Multi-class aquaculture: phenicols, beta lactams, fluoroquinolones, quinolones, sulfonamides, tetracyclines, macrolides, lincosamide, triphenyl methane dyes, and anthelmintics

VETDRUGS-MS

LIB 4653

1-100 ppb

Nitrate/nitrite

N02-N03

ISO 14673

0.1 ppm, 0.2 ppm

Perfluorooctanoic acid

(PFOA)/Perfluorooctanesul fonate (PFOS)

Miscellaneous

CFSAN LC-

Pesticides (chlorinated/organophospha te)

PEST-MR

FDA GC-

MS/MS and

LC-MS/MS

<0.005 ppm

Peanut allergens

ALLERGPNUT

Veratox Test, Phthalates (BBP, DBP, DEHP, DNOP, DINP, DIOP, DHEXP and

DCHP)

PHTHAL-EST

Internal Method

0.3-lowfat liquids, 1.5 ppm- solids & high fat liquids

Potassium bromate

BROMATE-MS

CFIA SOM-

DAR-CHE

043-02

4 ppb

Semicarbazide

SEM-LCMS

JAFC 2008, 56,

2064-

5 ppb

Sesame allergens

ALLERGSES

and rBiopharm

ELISA

10 ppm

Sodium benzoate

BENZ-SORB

JAOAC

1985:68 488

1 ppm

Soy allergens

ALLERG-SOY

Veratox Test

Thallium

THALLIUM-MS

Trans-fat and fatty acid profiles

FAT-BY-FAP

AOAC 996.06

0.10%

Thiamine (vitamin Bl)

THIAMN-USP

USP/NF

Current Ver.

0.1 mg/lOOg

Vitamin D

VIT-D2-D3

AOAC 2011.11

Vitamin D2 = 9.1 mcg/100g

Vitamin D3 = 6.6 mcg/lOOg