10 - Results Reporting

Attachment 10. Results Reporting and Communications

Table 1. Respondent Results Reporting Overview

Green – performed and clinically relevant (action levels and reference ranges to be reported); Pink – performed and to be reported; White-performed but not to be reported; Gray – not performed.

ANALYTES *required	MICHIGANA			MINNESOTAB			NEW YORKC
	State-Specific Action Levels for Additional Surveillance or Medical Referral
Toxic Metals (US NHANES Years and 50th% - 95th% Reference Values)	(Action Levels)		MATRIX	(Action Levels)	MATRIX		(Action Levels)	MATRIX
*Mercury (07-08) Blood: 0.89-5.32 μg/L	>15 μg/L		blood	No Tier 1 Tier 2: Female 18-44 years, >5.8 µg/L	blood		0.5 μg/dL is reportable 2.5 μg/dL is call trigger	blood
				Tier 2: All other adults, >17.4 μg/dL
				Hg speciation if Total Hg >5.8 µg/L
Mercury (07-08) Urine: 0.50-2.56 μg/g creatinine or 0.47 – 2.82 µg/L	(>20 μg/L or >35 μg/g creatinine)		urine				(2.0 μg/dL is reportable	urine
*Lead (07-08) Blood: 1.34-3.90 μg/dL	≥10 μg/dL		blood	Tier 1: >5 to ≤15 μg/dL		blood	10 μg/dL	blood
				Tier 2: >15 μg/dL
Arsenic (07-08) Urine: 7.55-59.4 μg/g creatinine	≥100 μg/L	urine
Cadmium (07-08) Urine: 0.24-1.05 μg/g creatinine Blood: 0.33-1.70 μg/L	>2 μg/L or >3 μg/g creatinine	urine		Tier 1: >1.7 to ≤5 μg/L	blood		1 μg/dL is reportable 1 μg/dL is call trigger	blood
				Tier 2: >5 μg/L

^A MICHIGAN – Heavy Metals Surveillance Program – all metals are reportable (required action levels)

^B MINNESOTA – No state heavy metals surveillance program – Action levels set at greater than the 95^th percentiles are presented in two tiers (and are detailed in Attachment 10b2).

Tier 1 Action Levels are based on the lowest identified level of statistically significant increased risk for adverse human health effects demonstrated in epidemiologic studies. These levels are not expected to result in overt symptoms of metal poisoning and are not considered an immediate hazard to health.

Tier 2 Action Levels are of greater concern for health based on effects seen on a population level in epidemiologic studies. These levels are not expected to result in overt symptoms of metal poisoning. It is anticipated that Tier 2 action levels will rarely be exceeded. Exceedences may be found in people who are occupationally exposed, eat a diet very high in fish (mercury) or organ meats (cadmium), or have contact with an uncommon source of exposure.

Blood Mercury > 5.8 µg/L will be further speciated.

^C NEW YORK – NYS Heavy Metals Registry – all blood lead levels are reportable. Blood and urine cadmium and mercury and urine arsenic are reportable for follow-up at state-determined thresholds.

ANALYTES *required	MICHIGAN		MINNESOTA		NEW YORK
	US NHANES Reference Values
Organohalides and Pesticides (US NHANES Years)	50th%-95th%	MATRIX	50th%-95th%	MATRIX	50th%-95th%	MATRIX
Total PCBs *PCB-28 *PCB-52 *PCB-101 *PCB-105 *PCB-118 *PCB-138 *PCB-153 *PCB-180	TBD	serum	TBD	serum	TBD	serum
Total Dioxin-like Compounds (Dioxins, Furans, Co-planar PCBs)	Age 18-39 years: < 18.7 pg-TEQ/g of lipid	serum
	Age 40-59 years: < 32.0 pg-TEQ/g of lipid
	Age 60 years and older: < 63.2 pg-TEQ/g of lipid
PBB-153 (03-04)	Age 18-39 yrs: 1.6 – 12.2 ng/g lipid	serum
	Age 40 -59 yrs: 2.9 – 36.9 ng/g lipid
	Age 60+ yrs: 3.4 – 52.8 ng/g lipid
PBDEs					Not reported	serum
1-Hydroxypyrene (03-04)			73.5-424 ng/g creatinine	urine
*Mirex (03-04)	<LOD -15.4 ng/g lipid	serum	<LOD-15.4 ng/g lipid	serum	<LOD –15.4 ng/g lipid		serum
*Hexachlorobenzene (03-04)	15.1-29.0 ng/g lipid	serum	15.1-29.0 ng/g lipid	serum	15.1-29.0 ng/g lipid		serum

*** No NHANES; PBB-153 based on – Sjodin A, et al. Serum concentrations of polybrominated diphenyl ethers (PBDEs) and Polybrominated Biphenyls (PBB) in the United States Population: 2003-2004. Environmental Sciences & Technology. 2008;42:1377-1384.

ANALYTES (continued) *required	MICHIGAN		MINNESOTA				NEW YORK
	US NHANES Reference Values
Organohalides and Pesticides (US NHANES Years)	50th%-95th%	MATRIX	50th%-95th%		MATRIX		50th%-95th%	MATRIX
*(p,p')-DDT (03-04)	<LOD -20.7 lipid	serum	<LOD-20.7 ng/g lipid		serum		<LOD -20.7 ng/g lipid		serum
*(o,p')-DDT (03-04)	<LOD-<LOD ng/g lipid	serum	<LOD-<LOD ng/g lipid			serum
*(p,p')-DDE (03-04)	233-1990 ng/g lipid	serum	233-1990 ng/g lipid		serum		233-1990 ng/g lipid		serum
Lindane ***	*** <0.002 μg/mL	serum
Oxychlordane (03-04)	11.4 – 39.2 ng/g lipid	serum					11.4 – 39.2 ng/g lipid		serum
Heptachlor epoxide ((03-04)	<LOD – 20.6 ng/g lipid	serum
Trans-nonachlor (03-04)	17.3 – 74.7 ng/g lipid	serum					17.3 – 74.7 ng/g lipid		serum
Toxaphene			***	serum			Not reported		serum

*** No NHANES; LINDANE based on - Aks SE, et al. Acute accidental lindane ingestion in toddlers. Ann Emerg Med. 1995 Nov;26(5):647-51.

ANALYTES	MICHIGAN		MINNESOTA			NEW YORK
	US NHANES Reference Values
Emerging and Other Exposure Biomarkers (US NHANES Years)	50th%-95th%	MATRIX	50th%-95th%	MATRIX		50th%-95th%	MATRIX
Total Perfluorinated Compounds (07-08)
PFOA			4.30-9.80 μg/L		serum	Not reported	serum
PFOS			14.0-42.8 μg/L			Not reported
PFBA			***
PFHxS			1.9-9.0 μg/L
PFBS			<LOD - <LOD μg/L
PFHxA			***
PFPeA			***
PFNA			1.5-4.1 μg/L
Bisphenol-A (07-08)			1.92-9.32 μg/g		urine
Triclosan (07-08)			12.6-484 μg/g		urine
Cotinine			***		urine

*** No NHANES; Minnesota PFC Biomonitoring Program has detected these PFCs in other community investigations.

ANALYTES † used in analyte reporting adjustment	MICHIGAN				MINNESOTA				NEW YORK
	*** Non-NHANES Clinical Reference Values
Trace Metals, Nutrients, and Lipids	Clinical References		MATRIX		Clinical References		MATRIX		Clinical References	MATRIX
Manganese	4.7-18.3 ng/mL	blood
Selenium					15-50 μg/L		urine
† Cholesterol (Fasting not required)	(Fasting) Desirable: <200 mg/dL			serum	(Fasting) Normal: <200 mg/dL			serum	(Fasting)	serum
	Borderline High: 200-239 mg/dL				Borderline High: 200-239 mg/dL				Borderline High: 200-239 mg/dL
	High: 240 mg/dL				High: ≥240 mg/dL				High: 240 mg/dL
† Triglyceride (Fasting not required)	Not reported			serum					(Fasting)	serum
									Borderline High: 150-199 mg/dL
									High: 200-499 mg/dL
A Creatinine	Not reported			urine	Not reported	urine			Not reported		urine

Manganese - http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/89120

Selenium - http://www.mayomedicallaboratories.com/test-catalog/Overview/89120

Cholesterol/Triglycerides - National Institute of Health Cholesterol Education Program

ANALYTES	MICHIGAN		MINNESOTA				NEW YORK
	US NHANES Reference Values
Additional Nutrients (NHANES Years)	2.5th%-97.5th%	MATRIX	2.5th%-97.5th%			MATRIX	2.5th%-97.5th%	MATRIX
Total Omega-3 fatty acids (03-04)
Eicosapentaenoic acid (EPA)			14.8-151 μmol/L			plasma
Docosahexaenoic acid (DHA)			54.9-323 μmol/L
Docosatetraenoic acid			12.1-47.7 μmol/L
Docosapentaenoic acid (DPA)			22.1-82.9 μmol/L
Gamma-Linoleic acid			17.1-117 μmol/L
Alpha-Linoleic acid			25.2-165 μmol/L
Homo-gamma-Linoleic acid			73.2-289 μmol/L
Arachnidonic acid (AA)			445-1320 μmol/L
Linoleic acid (LA)			2210-5410 μmol/L
ANALYTES	MICHIGAN		MINNESOTA				NEW YORK
	*** Non-NHANES Reference Values
Clinical Biomarkers	Clinical References	MATRIX	Clinical References	MATRIX			Clinical References	MATRIX
Glycohemoglobin (A1C)			Normal (<5.7%)		blood
			Pre-diabetes/or under control (≥5.7% to < 6.5%)
			Possible diabetes/Diabetes management needed (≥6.5%)

A1C - American Diabetes Association: Diagnosis and Classification of Diabetes Mellitus: Position Statement, DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012.

ANALYTES	MICHIGAN			MINNESOTA		NEW YORK
	*** Non-NHANES Reference Values
Body Measures	Clinical References		MATRIX	Clinical References	MATRIX	Clinical References	MATRIX
Body Mass Index	Not reported	body measure		Normal – (<25.0)	body measure	Not reported	body measure
				Overweight – (25.0-29.9)
				Obese – (>30.0)
Waist Circumference (in conjunction with BMI) ‡				Normal – (BMI < 25) and (WC ≤ 40 inches Male); (WC ≤ 35 inches Female)	body measure
				Increased Risk – (BMI ≥ 25) and (WC > 40 inches Male); (WC > 35 inches Female)
Blood Pressure	(Used as eligibility criterion§)	body measure		Normal – (SBP <120 and DBP<80)	body measure
				PreHBP – (SBP 120-139 or DBP 80-89)
				Stage 1 HBP – (SBP 140-159 or DBP 90-99)
				Stage 2 HBP – (SBP ≥160 or DBP ≥ 100)

^‡ MDH - National Heart, Lung, and Blood Institute classification of overweight and obesity and associated disease risk for type 2 diabetes, hypertension, and cardiovascular disease.

^§ MDCH - Blood pressure will be assessed prior to blood sample collection to ensure that participants may safely give the required volume of blood. The Certified Phlebotomy Technician or other qualified person will assess the participants’ blood pressure prior to collection of a blood sample. Blood samples will be collected from participants whose blood pressure is below 180/100 (systolic/diastolic) and above 80/50 (systolic/diastolic). Participants will be given am American Heart Association blood pressure information (Attachment 10a6) sheet with blood pressure measures recorded. Blood pressure readings will be verbally shared with participants and recorded, but will not be retained for any analytical purpose.