AGENT ORANGE HELP!

[Federal Register: June 12, 2007 (Volume 72, Number 112)]

[Notices]              

[Page 32395-32407]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr12jn07-88]                        

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DEPARTMENT OF VETERANS AFFAIRS

Health Outcomes Not Associated With Exposure to Certain Herbicide

Agents

AGENCY: Department of Veterans Affairs.

ACTION: Notice.

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SUMMARY: As required by law, the Department of Veterans Affairs (VA)

hereby gives notice that the Secretary of Veterans Affairs, under

authority of the Veterans Education and Benefits Expansion Act of 2001,

Public Law 107-103, Section 201(d), has determined that a presumption

of service connection is not warranted based on exposure to herbicides

used in the Republic of Vietnam during the Vietnam Era for the

following health outcomes: Hepatobiliary cancers; oral, nasal, and

pharyngeal cancer; bone and joint cancer; skin cancers (melanoma,

basal, and squamous cell); breast cancer; female reproductive cancer

(cervix, uterus, and ovary); testicular cancer; urinary bladder cancer;

renal cancer; leukemia (other than chronic lymphocytic leukemia (CLL));

abnormal sperm characteristics and infertility; spontaneous abortion;

neonatal or infant death and stillbirth in offspring of exposed

individuals; low birthweight in offspring of exposed individuals;

neurobehavioral disorders (cognitive and neuropsychiatric); movement

disorders including Parkinson's disease and amyotrophic lateral

sclerosis (ALS); chronic peripheral nervous system disorders;

respiratory disorders; gastrointestinal, metabolic, and digestive

disorders (changes in liver enzymes, lipid abnormalities, ulcers);

immune system disorders (immune suppression, autoimmunity); circulatory

disorders; amyloid light-chain (AL) amyloidosis; endometriosis; effects

on thyroid homeostasis; gastrointestinal tumors (esophagus, stomach,

pancreas, colon, rectum; brain tumors; and any other condition for

which the Secretary has not specifically determined a presumption of

service connection is warranted.

    The Secretary's determinations regarding individual diseases are

based on all available evidence in a 2004 report of the National

Academy of Sciences (NAS) and prior NAS reports. This notice generally

states specific information only with respect to significant additional

studies that were first reviewed by NAS in its 2004 report. Information

regarding additional relevant studies is stated in VA's prior notices

following earlier NAS reports, and will not be repeated here.

FOR FURTHER INFORMATION CONTACT: Rhonda F. Ford, Consultant,

Regulations Staff, Compensation and Pension Service, Veterans Benefits

Administration, Department of Veterans Affairs, 810 Vermont Avenue,

NW., Washington, DC 20420, (202) 273-7210.

SUPPLEMENTARY INFORMATION: Section 3 of the Agent Orange Act of 1991,

Public Law 102-4, 105 Stat. 11, directed the Secretary to seek to enter

into an agreement with the National Academy of Sciences (NAS) to review

and summarize the scientific evidence concerning the association

between exposure to herbicides used in support of military operations

in the Republic of Vietnam during the Vietnam Era and each disease

suspected to be associated with such exposure. Congress mandated that

NAS determine, to the extent possible: (1) Whether there is a

statistical association between the suspect diseases and herbicide

exposure, taking into account the strength of the scientific evidence

and the appropriateness of the methods used to detect the association;

(2) the increased risk of disease among individuals exposed to

herbicides during service in the Republic of Vietnam during the Vietnam

Era; and (3) whether there is a plausible biological mechanism or other

evidence of a causal relationship between herbicide exposure and the

health outcome. Section 3 of Public Law 102-4 also required that NAS

submit reports on its activities every two years (as measured from the

date of the first report) for a ten-year period.

    Section 2 of Public Law 102-4, codified in pertinent part at 38

U.S.C. 1116(b) and (c), provides that whenever the Secretary

determines, based on sound medical and scientific evidence, that a

positive association (i.e. the credible evidence for the association is

equal to or outweighs the credible evidence against the association)

exists between exposure of humans to an herbicide agent (i.e. a

chemical in an herbicide used in support of the United States and

allied military operations in the Republic of Vietnam during the

Vietnam Era) and a disease, the Secretary will publish regulations

establishing presumptive service connection for that disease. If the

Secretary determines that a presumption of service connection is not

warranted, he is to publish a notice of that determination, including

an explanation of the scientific basis for that determination. The

Secretary's determination must be based on consideration of the NAS

reports and all other sound medical and scientific information and

analysis available to the Secretary.

    Section 2 of the Agent Orange Act of 1991 provided that the

Secretary's authority and duties under that section would expire 10

years after the first day of the fiscal year in which NAS transmitted

its first report to VA. The first NAS report was transmitted to VA in

July 1993, during the fiscal year that began on October 1, 1992.

Accordingly, VA's authority under section 2 of the Agent Orange Act of

1991 expired on September 30, 2002. In December 2001, however, Congress

enacted the Veterans Education and Benefits Expansion Act of 2001,

Public Law 107-103. Section 201(d) of that Act extended VA's authority

under 38 U.S.C. 1116(b)-(d) through September 30, 2015.

    Although 38 U.S.C. 1116 does not define ``credible,'' it does

instruct the Secretary to ``take into consideration whether the results

[of any study] are statistically significant, are capable of

replication, and withstand peer review.'' The Secretary reviews studies

that report a positive relative risk and studies that report a negative

relative risk of a particular health outcome. He then determines

whether the weight of evidence supports a finding that there is or is

not a positive association between herbicide exposure and the

subsequent health outcome.

    The Secretary does this by taking into account the statistical

significance, capability of replication, and whether that study will

withstand peer review. Because of differences in statistical

significance, confidence levels, control for confounding factors, bias,

and other pertinent characteristics, some studies are more credible

than others. The Secretary gives weight to more credible studies in

evaluating the overall evidence concerning specific health outcomes.

Chronology

    NAS issued its initial report, entitled ``Veterans and Agent

Orange: Health Effects of Herbicides Used in Vietnam,'' (VAO) on July

27, 1993. The Secretary subsequently determined that a positive

association exists between exposure to herbicides used in the Republic

of Vietnam and the subsequent development of Hodgkin's disease,

porphyria cutanea tarda, multiple

[[Page 32396]]

myeloma, and certain respiratory cancers. The Secretary also determined

that there was no positive association between herbicide exposure and

any other health outcome, other than chloracne, non-Hodgkin's lymphoma,

and soft-tissue sarcomas, for which presumptions already existed. A

notice of the health outcomes that the Secretary determined were not

associated with exposure to herbicides was published on January 4,

1994. (See 59 FR 341 (1994)).

    NAS issued its second report, entitled ``Veterans and Agent Orange:

Update 1996'' (Update 1996), on March 14, 1996. The Secretary

subsequently determined that a positive association exists between

exposure to herbicides used in the Republic of Vietnam and the

subsequent development of prostate cancer and acute and subacute

peripheral neuropathy in exposed persons. The Secretary further

determined that there was no positive association between herbicide

exposure and any other condition, other than those for which

presumptions already existed. A notice of the diseases that the

Secretary determined were not associated with exposure to herbicide

agents was published on August 8, 1996. (See 61 FR 41442 (1996)).

    NAS issued a third report, entitled ``Veterans and Agent Orange:

Update 1998'' (Update 1998), on February 11, 1999. The focus of this

update was new scientific studies published since the release of Update

1996 and updates of scientific studies previously reviewed. After NAS

issued Update 1998, the Secretary determined that there was no positive

association between herbicide exposure and any other condition, other

than those for which presumptions already existed. A notice of the

health outcomes that the Secretary determined were not associated with

exposure to herbicide agents was published on November 2, 1999. (See 64

FR 59232 (1999)).

    At VA's request, NAS issued a special interim report, ``Veterans

and Agent Orange: Herbicide/Dioxin Exposure and Type 2 Diabetes'' (VAO:

Diabetes) on October 11, 2000. NAS concluded that: ``there is limited/

suggestive evidence of an association between exposure to the

herbicides used in Vietnam or the contaminant dioxin and Type 2

diabetes.'' NAS based its conclusion on the conglomeration of

scientific evidence, not one particular study. (VAO: Diabetes.) After

considering all of the evidence, the Secretary determined that there is

a positive association between exposure to herbicides and Type 2

diabetes and, therefore, a presumption of service connection was

warranted. (See 66 FR 2376 (2001)).

    NAS issued a fourth report, entitled ``Veterans and Agent Orange:

Update 2000'' (Update 2000), on April 19, 2001. The focus of this

update was the new scientific studies published since the release of

Update 1998 and updates of scientific studies previously reviewed.

After NAS issued Update 2000, the Secretary determined that there was

no positive association between herbicide exposure and any other

condition, other than those for which presumptions already existed. A

notice of the health outcomes that the Secretary determined were not

associated with exposure to herbicide agents was published in June 24,

2002 (See 67 FR 42600 (2002)).

    NAS issued its fifth report, entitled ``Veterans and Agent Orange:

Update 2002'' (Update 2002) on January 23, 2003. The focus of this

update was the new scientific studies published since the release of

Update 2000 and review of the studies previously reviewed along with

the newest scientific evidence. The Secretary subsequently determined

that a positive association exists between exposure to herbicides used

in the Republic of Vietnam and the subsequent development of chronic

lymphocytic leukemia (CLL) in exposed persons. After NAS issued Update

2002, the Secretary determined that there was no positive association

between herbicide exposure and any other condition, other than those

for which presumptions already existed. A notice of the health outcomes

the Secretary determined were not associated with exposure to herbicide

agents was published on May 20, 2003 (See 68 FR 27630 (2003)).

Update 2004

    NAS issued its sixth report entitled ``Veterans and Agent Orange:

Update 2004'' (Update 2004) on March 4, 2005. Consistent with its prior

reports, NAS in Update 2004 found that there was ``sufficient evidence

of an association'' between herbicide exposure and five categories of

diseases in veterans and ``limited/suggestive evidence'' of an

association between herbicide exposure and six other categories of

diseases in veterans. VA has previously established presumptions of

service connection for each of these diseases. NAS, in Update 2004,

categorized certain health outcomes to have ``inadequate/insufficient''

evidence to determine whether an association exists. This category is

defined to mean that the available studies are of insufficient quality,

consistency, or statistical power to permit a conclusion regarding the

presence or absence of an association with herbicide exposure. Health

outcomes that met the inadequate/insufficient category include:

Hepatobiliary cancers; oral, nasal, and pharyngeal cancer; bone and

joint cancer; skin cancers (melanoma, basal, and squamous cell); breast

cancer; female reproductive system cancer (cervix, uterus, ovary);

testicular cancer; urinary bladder cancer; renal cancer; leukemia

(other than chronic lymphocytic leukemia (CLL)); abnormal sperm

characteristics and infertility; spontaneous abortion; neonatal or

infant death and stillbirth in offspring of exposed individuals; low

birthweight in offspring of exposed individuals; birth defects (other

than spina bifida) in offspring of exposed individuals; childhood

cancer (including acute myelogenous leukemia) in offspring of exposed

individuals; neurobehavioral disorders (cognitive and

neuropsychiatric); movement disorders, including Parkinson's disease

and amyotrophic lateral sclerosis (ALS); chronic peripheral nervous

system disorders; respiratory disorders; gastrointestinal, metabolic,

and digestive disorders (changes in liver enzymes, lipid abnormalities,

ulcers); immune system disorders (immune suppression, autoimmunity);

circulatory disorders; AL amyloidosis; endometriosis; and effects of

thyroid homeostasis.

    In this same report, NAS found two health outcomes that fell into

the ``limited or suggestive evidence of no association category. These

health outcomes were deemed consistent in not showing a positive

association between them and any magnitude of exposure to herbicides.

Those health outcomes that met the ``no association'' category were:

gastrointestinal tumors (esophagus, stomach, pancreas, colon, rectum),

and brain tumors.

    The Secretary's determinations regarding individual diseases are

based on all available evidence in Update 2004 and prior NAS reports.

This notice generally states specific information only with respect to

significant additional studies that were first reviewed by NAS in

Update 2004. Information regarding additional relevant studies has been

stated in VA's prior notices following earlier NAS reports, and will

not be repeated here.

Hepatobiliary Cancers