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U.S. Department of Health and Human Services

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FDA Collection and Analysis of Food for Perchlorate - High Priority - DFP # 05 - 09

Memorandum

Date:      

February 23, 2005

From:

Consumer Safety Officer, Compliance Programs Branch, HFS-636
CFSAN, Office of Compliance, Division of Field Programs
Thru: Team Leader, HACCP and Chemical Safety Team, _________

 

Collection and Analysis of Food for Perchlorate - High Priority
DFP Assignment # 05-09 ORA Concurrence # 2005012802
FACTS # 614821

 

FOI Version

To:

[Addressees Redacted]

Info:

[Info Redacted]

Background

Perchlorate is both a naturally occurring and man-made chemical. Naturally occurring perchlorate, for example, is found in nitrate fertilizer deposits from Chile. Most of the perchlorate manufactured in the U.S. is used as the primary ingredient of solid rocket propellant. Perchlorate is also used in pyrotechniques, such as fireworks, gun powder, explosives, and highway flares. In addition, perchlorate is used in a wide variety of industrial processes, including, but not limited to, tanning and leather finishing. In recent years there has been increasing interest in perchlorate levels in soil, ground water, drinking water, and irrigation water around the country and what health effects it may have.

Perchlorate at high doses can interfere with iodide uptake into the thyroid gland, disrupting its functions. In adults, the thyroid helps to regulate metabolism. In children, the thyroid plays a major role in proper development in addition to metabolism. Impairment of thyroid function in expectant mothers may impact the fetus and newborn and result in effects including delayed development and decreased learning capability. Chronic lowering of thyroid hormones due to high perchlorate exposure may also result in thyroid gland tumors.

The FDA is investigating the ways that plants take up perchlorate. Perchlorate may get into plants when they are irrigated with perchlorate-containing water or when plants are grown in soil that has been previously exposed to perchlorate-containing water or fertilizer. Perchlorate in water used for food processing might also be a source of contamination in finished food products. Only certain agricultural areas appear to have perchlorate in water sources or the soil, and only those areas would be expected to potentially have perchlorate in crops.

In order to better determine the potential risk from exposure to perchlorate, the FDA needs information on the presence and levels of perchlorate in foods that are expected to contain perchlorate. The FDA has developed its own method for measuring perchlorate in different foods and is planning to collect foods nationwide for perchlorate analysis. Collection and analysis will focus on foods that are suspected to contain perchlorate.

Objective

  1. To collect a variety of food samples for perchlorate analysis
  2. To generate information on the incidence and levels of perchlorate contamination in selected food items. The data will be used to determine the need for future monitoring and/or enforcement strategies.

Investigational Approach

Sample collections are planned for two phases. A total of 450 samples are planned overall. Product selection will be based on the availability of an appropriate method for measuring perchlorate in each commodity. Method testing for potential foods for Phase II is presently being conducted at CFSAN.

The first phase of this assignment calls for collection and analysis of a total of 240 samples. Foods to be collected include; corn meal, oat meal, spinach, carrots, cantaloupes, tomatoes, broccoli, oranges, orange juice, apples, apple juice and grapes. Samples will be analyzed by [Laboratory Name Redacted].

For the second phase of this assignment, CFSAN's Office of Plant and Dairy Foods will develop a list of foods for collection and analysis as appropriate sample preparation methods for measuring perchlorate in other foods become available. CFSAN, Compliance Programs Branch will issue Phase II of this assignment near the end of the 2nd quarter FY 05 to the districts selected for sampling.

Sample Collection

The attachment to this assignment lists the foods (and number) and the collecting districts for Phase I of this assignment.

Broccoli, Oranges, Orange Juice, Apples, Apple Juice, Spinach, Carrots, Cantaloupe, Tomatoes, Grapes, Cornmeal, and Oatmeal.

Samples are surveillance and are either domestic or domestic import as indicated in the attachment. No 702(b) portions are required. Affidavits and extensive interstate documentation need not be collected.

  • [Instructions to Districts Redacted]
  • Oatmeal, cornmeal, juice samples (not frozen or from a concentrate) as well as other domestic import samples may be collected at retail establishments.
  • Domestic produce samples (apples, broccoli, tomatoes, spinach, cantaloupes, carrots, oranges and grapes) should be collected fresh from the grower or packing sheds when harvested. Record in the C/R the name of the growing areas (e.g. counties and cities) and whether or not the sample was collected directly from the growing area or from the packing shed. When available attempt to collect a mix of organically and non-organically grown products.
  • Do not collect domestic produce samples at retail establishments.
  • Samples should be shipped intact. [Analyzing Laboratory Name Redacted] will prepare the samples for storage/analysis as appropriate.

Sample Size

Follow the IOM Sample Schedule Chart 3 for minimum sample sizes.

Sample Shipment

Refer to IOM subchapter 454 for sample shipment instructions.

Mark the outside of each parcel PERISHABLE. Ship samples packed in ice by overnight service. Refer to IOM 452.06 for instructions on shipping refrigerated samples.

Do not ship samples on Fridays.

Ship samples to:

[Analyzing Laboratory Address Redacted]

Sample Analysis

Sample Storage:

Sample storage will only be necessary if [Analyzing Laboratory Name Redacted] does not have their equipment up and running upon arrival of samples.

Chop produce samples in a grinder or food processor and store in glass jars. Composite the sub-samples to represent a sample for analysis. Hold samples at -20ºC, bring to room temperature before perchlorate analysis.

Store juice samples under refrigeration. Corn meal and oat meal can be stored at room temperature.

Determine perchlorate in all samples by using the following method (a copy of the method will be provided electronically to the participating laboratory):

Draft "Rapid Determination of Perchlorate Anion in produce samples by IC/MS/MS".

Please contact Alex Krynitsky at 301-436-2098 (Updated contact number: 240-402-2098), should you have questions regarding the method.

Limit of quantitation (LOQ):

Produce = 1.0 ppb (µg/kg) perchlorate;
Whole fruit (oranges, apples, grapes) = 1.0 ppb (µg/kg) perchlorate
Juice = 1.0 ppb (µg/kg) perchlorate;
Corn meal and oat meal = 3.0 ppb (µg/kg) perchlorate
 

Sample Disposition:

Upon completion of analysis, the lab should maintain all reserve samples (both positive and negative) until advised by CFSAN of disposition.  Selected samples may be requested to be sent to CFSAN.  Please contact Alex Krynitsky, DPIC, CFSAN, for disposition guidance.

Regulatory/Administration Follow-Up

No regulatory follow-up is anticipated. Data is being generated to increase FDA's understanding of the presence, levels, and public health impact of perchlorate. Samples with unusually high levels of perchlorate will be assessed on a case-by-case basis.

Reporting/Resources

  1.  Data Reporting:
    • Report all analytical results including blanks, reference materials and recoveries into the FACTS Data Reporting System using the PAC: 04F800
    • Report analytical results into FACTS using PAF: PES
    • Method Code: 998
    • In the Remarks file of the Method Applied Screen, please enter: CFSAN IC/MS/MS Method, draft 1.0
    • Product Codes:

      a) Cantaloupe22A[] []01
      b) Carrot25J[] []01
      c) Spinach24T[] []25
      d) Tomatoes24F[] []50
      e) Grapes20A[] []09
      f) Orange20G[] []06
      g) Broccoli24T[] []05
      h) Orange juice20K[] []06
      i) Corn meal02B[] []02
      j) Oat meal05B[] []02
      k) Apples20N[] []01
      j) Apple Juice20S[] []01
  2. Resources:

Resources are to be obtained from the "Field Assignments for Chemical Contaminants" 04F800 (CFSAN Initiated Field Assignments, FY 05).

Summary/ Evaluation

The Office of Plant and Dairy Foods will prepare a summary and evaluation of the findings within 60 days of the completion of this assignment.

Start/Completion Dates:

  • Sample Collections
     

    Begin: upon receipt
    End: August 31, 2005

  • Sample Analysis
     

    Begin: upon receipt
    End: September 30, 2005

Contacts

CFSAN Assignment Contact:

Kaniz Shireen, CFSAN, Office of Compliance, Division of Field Programs Compliance
Programs Branch, HFS-636, 301-436-2775 (Updated contact number: (240) 402-2775)
Email: kaniz.shireen@fda.hhs.gov

CFSAN Scientific (Survey Information) Contacts:

Jennifer Burnham, CFSAN, Office of Plant and Dairy Foods, Division of Plant Product
Safety, Regulatory Policy Branch, HFS-306, 301-436-2030 (Updated contact number: (240) 402-2030)
Email: jennifer.burnham@fda.hhs.gov

Henry Kim, CFSAN, CFSAN, Office of Plant and Dairy Foods, Division of Plant
Product Safety, Regulatory Policy Branch, HFS-306, 301-436-2023 (Updated contact number: (240) 402-2023)
Email: henry.kim@fda.hhs.gov

CFSAN Scientific (Chemical Analysis) Contact:

Alex Krynitsky, CFSAN, Office of Plant and Dairy Foods, Division of Pesticides and
Industrial Chemicals, HFS-336, (301) 436-2098 (Updated contact number: (240) 402-2098)
Email: alex.krynitsky@fda.hhs.gov

ORA Scientific Contact:

Steve Robbs, ORO/Division of Field Science,
HFC-140, Phone: (301) 827-9555
Email: steven.robbs@fda.hhs.gov

ORO Investigational Inquiries:

Norman Fogg, ORO/ Division of Field Investigations,
HFC-130, Phone: (301) 827-5645
Email: norman.fogg@fda.hhs.gov

Priority

This assignment has high priority and to be implemented upon receipt.

Attachments

[Attachment Redacted]

Kaniz Shireen

Cc:/with Attachment

[cc List with Attachment Redacted]