Disease Associated With Exposure to Certain Herbicide Agents (Multiple Myeloma and Respiratory Cancers)

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AG73

Disease Associated With Exposure to Certain Herbicide Agents

(Multiple Myeloma and Respiratory Cancers)

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: The Department of Veterans Affairs (VA) has amended its

adjudication regulations concerning presumptive service connection for

certain diseases even though there is no record of the disease during

service. This amendment is necessary to implement a decision of the

Secretary of Veterans Affairs under the authority granted by the Agent

Orange Act of 1991 that there is a positive association between

exposure to herbicides used in the Republic of Vietnam during the

Vietnam era and the subsequent development of multiple myeloma and

respiratory cancers. The intended effect of this amendment is to

establish presumptive service connection for those conditions based on

herbicide exposure.

EFFECTIVE DATE: This amendment is effective on June 9, 1994, as

provided by Public Law 102-4.

FOR FURTHER INFORMATION CONTACT: Donald England, Chief, Regulations

Staff, Compensation and Pension Service, Veterans Benefits

Administration, Department of Veterans Affairs, 810 Vermont Avenue,

NW., Washington, DC 20420, (202) 233-3005.

SUPPLEMENTARY INFORMATION: VA published a proposal to amend 38 CFR

3.307(a) and 3.309(e) to establish presumptive service connection for

multiple myeloma and respiratory cancers based on exposure to

herbicides in the Federal Register of February 3, 1994 (59 FR 5161-63).

As explained in that notice, these presumptions of service connection,

like various others, are rebuttable under 38 U.S.C. 1113 by affirmative

evidence to the contrary; evidence establishing an intercurrent, post-

service cause of the disease; or evidence establishing that the disease

is due to the veteran's own willful misconduct. Interested persons were

invited to submit written comments, suggestions or objections

concerning the proposal on or before March 7, 1994. We received one

comment from the General Counsel and Director of Litigation for the

National Veterans Legal Services Project.

The commenter suggested changes not only to the proposed rule

concerning multiple myeloma and respiratory cancers published on

February 3, 1994, but also to the final rule effective February 3,

1994, that established presumptive service connection for Hodgkin's

disease and porphyria cutanea tarda (See 59 FR 5106-07) based on

exposure to herbicides, to the final rule published on October 15,

1991, that established service connection for soft-tissue sarcoma (See

56 FR 51651-53) based on exposure to herbicides containing dioxin, and

to the final rule published on October 21, 1991, that extended the

period during which chloracne must appear following exposure to a

herbicide containing dioxin in order to establish service connection

(See 56 FR 52473-74).

To the extent that these comments pertain to rulemaking other than

the proposed rule concerning multiple myeloma and respiratory cancers

published on February 3, 1994, the comments are beyond the scope of the

current rulemaking.

The commenter stated that the proposal concerning multiple myeloma

and respiratory cancers is in error since it specifies an effective

date that is not consistent with the Final Stipulation and Order

entered in Nehmer v. United States Veterans Administration, C.A. No. C-

86-6160 (TEH) (N.D. Cal.), and the procedural instructions contained in

Circular 21-94-1, Processing of Claims Based on Exposure to Herbicide

Agents (February 15, 1994). The commenter suggested that the final rule

should specify an effective date for the payment of benefits that

conforms with the Nehmer stipulation.

VA does not concur. 38 U.S.C. 1116(c)(2), which was added by the

Agent Orange Act of 1991, Public Law 102-4, clearly and unambiguously

requires that regulations promulgated as a result of a decision of the

Secretary of Veterans Affairs that a positive association exists

between exposure to herbicides and a specified condition or disease be

effective on the date of issuance, i.e., the date the final rule is

published in the Federal Register. The effective date for this rule

conforms to that statutory mandate.

Further, the commenter recognized that the effective date of this

regulation and the date of entitlement in an individual claim for

benefits are not synonymous. In fact, there is a specific regulatory

framework that governs the assignment of the date of entitlement (See

38 CFR 3.400 through 3.404). In addition, the Final Stipulation and

Order entered in the Nehmer case contains provisions governing

effective dates of entitlement applicable to certain groups of

claimants. VA is bound by these provisions. This notice merely

specifies the effective date of the regulatory amendment and does not

purport to modify provisions governing effective dates of entitlement

contained in regulations or in the Nehmer stipulation.

Under the Nehmer stipulation, when the Secretary of Veterans

Affairs issues regulations under Public Law 102-4 establishing a

presumption of service connection for a disease associated with

herbicide exposure, VA will review herbicide-exposure claims based on

disability or death resulting from that disease which were: (1) Denied

under regulations voided by the court in Nehmer and never finally

decided under a valid regulation, or, (2) filed after the date of the

court's decision and before issuance of the new regulations. Where

benefits are awarded under such reviews, the effective date of

entitlement will be based on the later of the date of receipt of the

claim or the date on which disability or death occurred, subject to the

provisions of 38 U.S.C. 5110 (b)(1) and (d)(1) allowing earlier

effective dates in some cases where claims are filed within one year of

service discharge or death. Under the stipulation, the date of

entitlement may be based on the date of claim, if otherwise

appropriate, without regard to whether the claim was filed prior to

September 25, 1985, the effective date of the voided regulations, if

the claim was denied under those regulations.

As to the suggestion that the regulation restate the provisions

governing effective dates of entitlement found in the Nehmer

stipulation, that stipulation applies to a specific class of claimants

whose claims for benefits based on exposure to dioxin were denied on or

after September 25, 1985, or who have claims pending at the time of

issuance of regulations under Public Law 102-4. This regulation will

apply to a broader class of veterans and dependents, including those

whose claims were denied prior to September 25, 1985, and those who

file claims in the future. Individuals will continue to have specific

rights under the terms of the Nehmer stipulation and it is not

necessary to include them in a regulation of general applicability. To

the extent that class counsel believes that class members are not

sufficiently aware of their rights under the stipulation, the

stipulation provides class counsel with a means to contact class

members concerning their rights.

For those reasons, as well as the fact that the effective date

established by this rule is in accordance with 38 U.S.C. 1116(c)(2), VA

finds that it is neither necessary nor appropriate to include

requirements affecting a specific class of claimants in a rule which is

for broader application.

VA appreciates the comment submitted in response to the proposed

rule which is now adopted without change.

The Secretary hereby certifies that this regulatory amendment will

not have a significant economic impact on a substantial number of small

entities as they are defined in the Regulatory Flexibility Act (RFA), 5

U.S.C. 601-612. The reason for this certification is that this

amendment would not directly affect any small entities. Only VA

beneficiaries could be directly affected. Therefore, pursuant to 5

U.S.C. 605(b), this amendment is exempt from the initial and final

regulatory flexibility analysis requirements of sections 603 and 604.

These regulations have been reviewed by the Office of Management

and Budget under E.O. 12866.

The Catalog of Federal Domestic Assistance program numbers are

64.109 and 64.110.

List of Subjects in 38 CFR Part 3

Administrative practice and procedure, Claims, Handicapped, Health

care, Pensions, Veterans.

Approved: April 28, 1994.

Jesse Brown,

Secretary of Veterans Affairs.

For the reasons set out in the preamble, 38 CFR part 3 is amended

as set forth below:

PART 3--ADJUDICATION

Subpart A--Pension, Compensation, and Dependency and Indemnity

Compensation

1. The authority citation for part 3, subpart A, continues to read

as follows:

Authority: 38 U.S.C. 501(a), unless otherwise noted.

2. In Sec. 3.307, paragraph (a)(6)(ii) is revised to read as

follows:

Sec. 3.307 Presumptive service connection for chronic, tropical or

prisoner-of-war related disease, or disease associated with exposure to

certain herbicide agents; wartime and service on or after January 1,

1947.

(a) * * *

(6) * * *

(ii) The diseases listed at Sec. 3.309(e) shall have become

manifest to a degree of 10 percent or more at any time after service,

except that chloracne or other acneform disease consistent with

chloracne and porphyria cutanea tarda shall have become manifest to a

degree of 10 percent or more within a year, and respiratory cancers

within 30 years, after the last date on which the veteran was exposed

to an herbicide agent during active military, naval, or air service.

* * * * *

Sec. 3.309 [Amended]

3. In Sec. 3.309(e) in the listing of diseases, after the words

``Hodgkin's disease'' and before the words ``Non-Hodgkin's lymphoma'',

add the words ``Multiple myeloma''; and after the words ``Porphyria

cutanea tarda'' and before the words ``Soft-tissue sarcoma (other than

osteosarcoma, chondrosarcoma, Kaposi's sarcoma, or mesothelioma)'', add

the words ``Respiratory cancers (cancer of the lung, bronchus, larynx,

or trachea)''.

[FR Doc. 94-14124 Filed 6-7-94; 12:16 pm]

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