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Protocol - Concentrations of Phenols and Parabens

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Description:

Urine is collected from the subject in a pre-screened 120 ml urine container and then placed in a refrigerator or on ice packs immediately after collection. Transfer to polypropylene vial. Transport or ship urine samples on dry ice. Place urine samples in a -70° C freezer and store until shipment or analysis.

Thaw sample, and perform analysis via on-line solid phase extraction-high performance liquid chromatography-isotope dilution-tandem mass spectrometry (SPE-HPLC-isotope dilution-MS/MS).

Protocol:

Sample Collection Procedures

Supplies:

  • Personal Protective Equipment (PPE) per Exposure Control Plan (e.g., gloves, lab coat, etc.)
  • One pre-labeled, prescreened, sterile 120 ml urine collection container with screw-on lid
  • Adult Urine Collection Instructions
  • Biohazard transport bag, approx. 6" x 6"
  • Absorbent pad, 100 ml
  • Kim Wipe, 14.7" x 16.6"
  • General trash bag
  • Biohazard waste bag, approx. 19" x 24"
  • Specimen collection tray
  • Hand sanitizer
  • Chux pads
  • Biospecimen transport cooler with:
  • Dry ice, a minimum of 2 pounds of dry ice is recommended
  • Dry ice gloves

Review the adult urine collection procedures with the participant using the Adult Urine Collection Instructions and demonstration supplies.

  • Emphasize to the participant how the cap of the collection container should be handled as the specimen is collected per the Adult Urine Collection Instructions.

1. If the participant does not refuse the collection, continue with the urine collection process.

  • If the participant refuses the collection, indicate that this is fine, thank the participant for his/her time, and record the refusal and the reason.
  • If the participant has a physical limitation that prevents him/her from providing a urine specimen, record "Physical limitation."
  • If participant becomes ill during the visit or has an emergency that requires termination of the visit, record "Participant ill/emergency."
  • If there was a language issue due to the participant’s primary language not being English record, "Language issue."
  • If there was not a sufficient amount of time for the urine collection, record "No time."
  • If the participant was unable to urinate, record "Unable to urinate."
  • If the participant was uncomfortable with the collection procedures, record "Uncomfortable with collection procedures."
  • If the participant refused for a reason other than those listed, record "Other" and specify.
  • If the participant was unwilling to provide a reason, record "Refused."
  • If the participant does not know why he/she did not continue with the collection, record "Don’t know."

____________________________________

2. Read the urine collection questions to the participant and record the responses.

a. "When did you last urinate?"

Record date and time. If the participant refuses to answer the question, record "Refused." If the participant does not remember, record "Don’t know." _____________________________

b. "When was the last time you had anything to eat or drink?"

Record date and time. If the participant refuses to answer the question, record "Refused." If the participant does not remember, record "Don’t know." ______________________________

c. "How much of what you ate was beef, pork, tuna, or salmon?"

Read each of the choices (none, less than one-quarter of the meal, one-quarter to one-half of the meal, more than one-half but less than three-quarters of the meal, three-quarters or more, but not all of the meal, all of the meal) and record how much was eaten.

____________________________________

If the participant refuses to answer the question, record "Refused."

If the participant does not remember or does not know, record "Don’t know."

d. "Do you take creatine supplements?"

If the participant asks, explain that creatine supplements are often taken by athletes wishing to gain muscle mass.

Record "Yes," "No," "Refused," or "Don’t Know."

3. Locate the adult urine collection supplies.

4. Verify that the Specimen ID label is affixed to the side of the urine collection container and is readable and not damaged.

5. Give the pre-labeled, unopened urine collection container, a Kim Wipe, and the Adult Urine Collection Instructions to the participant. The participant may refer to the collection instructions when collecting the urine specimen.

6. While the participant is in the bathroom collecting the urine specimen, put on a lab coat, cleanse hands, and put on gloves.

7. Place the biospecimen collection tray on a flat surface laying a Chux Pad on top of the tray.

8. When the participant returns, thank the participant for providing the urine sample (or for trying if no sample was collected) and ask him/her to place the specimen on the biospecimen collection tray.

9. Check the lid of the urine collection container to make sure it is securely closed.

10. Record the status of the urine collection as either "Collected" or "Not collected." Any amount of urine in the collection cup is considered a collected sample.

____________________________________

11. If the urine was not collected, record the reason: ____________________________________

  • If the participant has a physical limitation that prevents him/her from providing a urine specimen, record "Physical limitation."
  • If participant becomes ill during the visit or has an emergency that requires termination of the visit, record "Participant ill/Emergency."
  • If there were issues with the collection equipment, record "Collection supplies malfunctioned."
  • If there was a language issue due to the participant’s primary language being Spanish record, "Language issue, Spanish."
  • If there was a language issue due to the participant’s primary language being other than Spanish record, "Language issue, non-Spanish."
  • If the participant has a cognitive disability that prevents him/her from understanding the instructions, record "Cognitive disability."
  • If there was not a sufficient amount of time for the urine collection, record "No time."
  • If the urine specimen was not collected for a reason other than those listed, record "Other" and specify.
  • If the urine specimen was not collected because the participant refused, record "Refused."
  • If the reason the urine specimen was not collected was unknown, record "Don’t know."

12. Record the Specimen ID number on the urine collection container.

13. Place the urine specimen in the biohazard transport bag with the absorbent pad and seal the bag.

14. Put on the dry ice glove to place the sealed bag with the collection container upright on dry ice in the transport cooler. Be sure to refer to local Hazard Communication Plan for proper handling of dry ice.

15. Record the date and time the urine specimen was collected in the collection log.

16. Record where the urine collection occurred: in the participant’s home, at a clinic, at a hospital, or other location and specify.

17. Record any comments, problems, or concerns pertaining to the urine specimen collection.

Samples should be refrigerated as soon as possible. Preferably, the specimen should be transferred to specimen vials within 4 hours of collection. If at all possible, at least five milliliters of urine is collected, and can be stored frozen in polypropylene vials or specimen cups. Crimped caps with rubber stoppers should not be used because they may contain 4-tert-Octylphenol (tOP). The specimens are then labeled, frozen, and stored on dry ice for shipping. All samples should be stored frozen until analysis. The entire urine collection procedure is available here.

Analyses is by on line SPE-HPLC-Isotope dilution-MS/MS.

The complete laboratory procedure is available here.

The NHANES laboratory measures the following phenols and parabens in the urine sample.

Variable Name

SAS Label and SI Units

URXBPA

Urinary Bisphenol A (ng/mL)

URXBP3

Urinary Benzophenone-3 (ng/mL)

URXTRS

Urinary Triclosan (ng/mL)

URXBUP

Urinary Butyl paraben (ng/ml)

URXEPB

Urinary Ethyl paraben (ng/ml)

URXMPB

Urinary Methyl paraben (ng/ml)

URXPPB

URXTLC

URXDCB

URX14D

Urinary Propyl paraben (ng/ml)

Urinary Triclocarban (ng/mL)

2,4-Dichlorophenol

2,5-Dichlorophenol

2009-2010 NHANES geometric mean (in μg/L) for all age groups 6 and older

Bisphenol A 1.83

Benzophenone-3 22.3

Triclosan 14.5

Butyl paraben < LOD

Ethyl paraben < LOD

Methyl paraben 57.1

Propyl paraben 6.97

Means for triclocarban, 2,4-Dichlorophenol, and 2,5-Dichlorophenol are not available, those analytes were measured in later NHANES.

Protocol Name from Source:

National Children’s Study (NCS), Biospecimen Adult Urine Procedures: Standard Operating Procedures

National Health and Nutrition and Examination Survey (NHANES) Laboratory Procedure Manual, Bisphenol A, Other Environmental Phenols, and Parabens in Urine

Availability:

Publicly available

Personnel and Training Required

The laboratory processing and analysis procedures should be performed by a certified laboratory technician.

Equipment Needs

Highly specialized laboratory equipment is necessary to perform accurate analyses. Collection containers must be pre-screened prior to collection.

Requirements
Requirement CategoryRequired
Major equipment Yes
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Bioassay

Life Stage:

Adolescent, Adult, Pregnancy

Participants:

Ages 6 years and older, pregnant women

Specific Instructions:

Collect multiple urine specimens from the subject (e.g., three urine samples on separate days) to reduce exposure misclassification.

Selection Rationale

The National Children's Study (NCS) was one of the largest pregnancy cohort studies in the United States, and the biospecimen collection methods have been validated in other studies.

This is a sensitive assay to measure phenols and parabens in human urine. National Health and Nutrition and Examination Survey (NHANES) is a major cross-sectional study in the United States, and the methods have been validated on other studies.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Urine Phenol and Paraben Concentration in Nanograms per Milliliter Concentration 5633745 CDE Browser
Derived Variables

None

Process and Review

The Expert Review Panel has not reviewed this measure yet.

Source

Centers for Disease Control and Prevention (CDC), National Health and Nutrition and Examination Survey (NHANES), 2011-2012. (2013). CDC laboratory procedure manual, Bisphenol A, other environmental phenols, and parabens in urine. Atlanta, GA: Author.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). (2014). National Children’s Study, Biospecimen adult urine procedures: Standard operating procedures. Rockville, MD: Author.

General References

Centers for Disease Control and Prevention (CDC). (2013). Fourth national report on human exposure to environmental chemicals. Atlanta, GA: Author.

Darbre, P. D., & Harvey, P. W. (2008). Paraben esters: Review of recent studies of endocrine toxicity, absorption, esterase and human exposure, and discussion of potential human health risks. Journal of Applied Toxicology, 28(5), 561-578.

Guidry, V. T., Longnecker, M. P., Aase, H., Eggesbø, M., Zeiner, P., Reichborn-Kjennerud, T., Knudsen, G. P., Bertelsen, R. J., Ye, X., Calafat, A. M., & Engel, S. M. (2015). Measurement of total and free urinary phenol and paraben concentrations over the course of pregnancy: Assessing reliability and contamination of specimens in the Norwegian Mother and Child Cohort Study. Environmental Health Perspectives, 123, 705-711.

Philippat, C., Wolff, M. S., Calafat, A. M., Ye, X., Bausell, R., Meadows, M., Stone, J., Slama, R., & Engel, S. M. (2013). Prenatal exposure to environmental phenols: concentrations in amniotic fluid and variability in urinary concentrations during pregnancy. Environmental Health Perspectives, 121, 1225-1231.

Pycke, B. F., Geer, L. A., Dalloul, M., Abulafia, O., Jenck, A. M., & Halden, R. U. (2014). Human fetal exposure to triclosan and triclocarban in an urban population from Brooklyn, New York. Environmental Science and Technology, 48(15), 8831-8838.

Protocol ID:

240301

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
Research Domain Information
Measure Name:

Concentrations of Phenols and Parabens

Release Date:

January 31, 2017

Definition

Collect and analyze a urine sample to determine the concentrations of several phenolic compounds such as bisphenol A (BPA) used to make plastic water bottles, children’s toys, and baby bottles. This bioassay also describes analysis of parabens, which are chemicals used as preservatives in foods and beverages and in cosmetics and pharmaceuticals.

Purpose

To determine the concentrations of phenols and parabens in the subject’s urine. Some phenols and parabens are endocrine disruptors and some have been associated with adverse health effects.

Keywords

Pregnancy, urine, bisphenol A, BPA, phenol, paraben, National Children’s Study, NCS, National Health and Nutrition and Examination Survey, NHANES, Centers for Disease Control and Prevention, CDC