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05172

Author

° Not Scanned

Hays, Harry W.

United States Department of Agriculture, Agricultural Re

RGport/APtiClB TltlO Notice to Manufacturers, Formulators, Distributors and
Registrants of Economic Poisons: Cancellation of 2,4,5T Products Bearing Certain Directions for Use

Journal/Book Title

Year

197

Month/Day

Ma 1

Color

°

v

D

o

Friday, March 01, 2002

Page 5172 of 5263

�PR Notice 70-13
UNITED STATES, DEPARTMENT OF AGRICULTURE ..
•
AGRICULTURAL RESEARCH SERVICE
PESTICIDES REGULATION DIVISION
".
' . •
WASHINGTON, D.C. 20250
May 1, 1970
;

' NOTICE TO MANUFACTURERS, FORMULATORS, DISTRIBUTORS, AND
REGISTRANTS .OF ECONOMIC POISONS •. . • ...,, ,:-, ..

'Attention: Person Responsible "for Federal Registration of
Economic Poisons
Cancellation of 2,4,5-T Products Bearing Certain Directions
for Use
'
"
'
"•• •
Recent studies by the. National Environmental Health Service of the ,•••.'
Department of Health, Education, and Welfare have shown that the subcutaneous administration of high concentrations of the purest samples of
2,4,5-T that are practical to manufacture at the present time produced
a significant number of fetal abnormalities in mice. On April 15, 1970,
.Secretary of Agriculture Clifford M. Hardin, Secretary of the Interior
Walter J. Hic'kel, and Secretary of Health, Education, and Welfare
Robert J. Finch announced the suspension of certain uses of 2,4,5-T.
The President's Science Advisory Committee Report in 1963 on "use of
pesticides" recommended continuing review of pesticide uses and, after
hazard evaluation, .restriction or disapproval on a basis of "reasonable
doubt" of safety. The Eleventh Report by the Committee on Government
Operations (House Report No. 91-637) stated "The Committee recommends
that the United States Department of Agriculture take appropriate steps
to insure that cancellation proceedings are promptly initiated whenever
a reasonable question as to the safety of a registered product becomes
apparent."
Since there are no finite tolerances established for the use of 2,4,5-T
on food crops intended for human consumption and since women of child
bearing age may be exposed to granular material for use around the
home, a reasonable doubt exists as to the safety of certain uses of this
material and, therefore, whether products registered for these uses are
in compliance with the Federal Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 135 et seq.). In accordance with the provisions of
Section 4.c. of the Act, you are, hereby notified that the registration
of all products with directions for use as listed below are hereby
cancelled effective 30 days following receipt of this notice, unless
within such time all directions for such uses are deleted from the
labeling of such products or other procedures provided for under Section
4.c. of the Act are invoked:
•.

�I.

All granular 2,4,5-T formulations for use around the home,
recreation areas and similar sites.
.'
"

II. All 2,4,5-T uses on food crops intended for human consumption.
•
Labeling for products containing 2,4,5-T that can be modified by deleting the above claims should be amended. Five copies.of the revised
label must be submitted to the Registration Branch, Pesticides Regulation Division, Agricultural Research Service, U.S. Department of Agriculture, Washington, D.C. 20250, for amended registration (PR Form
9-198).
• '
•'•
•
•
'•'•'• '• '• ' " ' ;"
.
. . .

Harry W/ /Hays
wf Has
Director :

''

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                  <text>&lt;p style="margin-top: -1em; line-height: 1.2em;"&gt;The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.&lt;/p&gt;&#13;
&lt;p&gt;For more about this collection, &lt;a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a"&gt;view the Agent Orange Exhibit.&lt;/a&gt;&lt;/p&gt;</text>
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                    <text>Item D Number

°5171

Author

Ha s Harr w

v'

D
v -

United States Department of Agriculture, Agricultural Re

RBDOrt/ArtlClB HUB Notice to Manufacturers, Formulators, Distributors and
Registrants of Economic Poisons: Suspension of 2,4,5T Products Bearing Certain Directions for Use

Journal/Book Title
Year

197

Month/Day

April 20

Color

D

Number of Images

°

°

Descrtyton Notes

Friday, March 01, 2002

Page 5171 of 5263

�.

UNITED STATES DEPARTMENT OF AGRICULTURE
AGRICULTURAL RESEARCH SERVICE
PESTICIDES REGULATION DIVISION
WASHINGTON, D. C. 202SO

ft/Uv

. NOTICE TO MANUFACTURERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS OF ECONOMIC-'POISONS
Attention:

Person Responsible for Federal Registration of
Economic Poisons
'
•

•
.

Suspension of 2,4,5-T Products Bearing Certain Directions for .Use
Recent studies by the'National Environmental Health Service of the
Department of Health, Education, and Welfare have shown that the syh._cu£aneous administration of hjyjji concentrations, of the purest samples
of 2,4*;"31^T"that are practical to manufacture at the present time
produce a significant number of fetal abnormalities in mice.
In accordance with the Interdepartmental 'Agreement for Protection of
the Public Health and the Quality of the Environment in Relation to
Pesticides, the Secretary of Health, Education, and Welfare has
advised the Secretary of Agriculture that exposure to this herbicide
may present an imminent health hazard to women of child-bearing age
and has recommended suspension of certain registered uses of 2,4,5-T.
On the basis of the above and in accordance with Section 4.c. of the
statute, it is hereby found that in order to prevent an imminent hazard
to the public it is necessary to'suspend the registration for products
containing 2,4,5-T and bearing directions for use as follows-:
I.

All uses in lakes, ponds or on ditch banks.

II. Liquid formulations for use around the home, recreation
areas, and similar sites.
Therefore, such registrations are hereby suspended and such products may
not be lawfully distributed in interstate commerce.
Labeling for products containing 2,4,5-T that can be modified by deleting
the above claims may be amended. Revocation, of these suspension orders
will be considered if 5 copies of acceptable labeling are submitted with
PR Form 9-198.

Harry«. Hays
Director ' . '

�UMT2i&gt; SVAT2S U2PARTi''-iNT Or Y,~ «.;.«~,
UNITED STATES D2PART?.2IiT OP HEALTH, EDUCATION. AND KELFAB2
Washington, April 15, 1970
^e Use of 2, 4, 5-T Suspended:
Secretary of Agriculture Clifford M. Hardin, Secretary of tho Interior.
V/alter J. Kickol, and Socrotary of Health, Education, end Kolfaro Robert H.
Finch today announced tho iezzodiate suspension by tho Department of
Agriculture o£ tho rogistrationa of liquid formulations of tho wood killer
2,4,S-T, for uses affcasd tho ho=» end on Ickes, ponds, and ditch banks.
Thoso actions ara boing taken pursuant to the "Interagoncy Agrocr.ont
*
for Protection of the Public Health and the Quality of the Environment in
Relation to Posticidop" Ezong tho three DopartnentS.
The throo Socrotaries also announced that the Departccnt of Agricultura
intends to cancel registered uses of non-liquid formulations of 2, 4, 5-T
the hoco mid CTI all food crops intended for huaan consumption (applos,
blueberries, barley, com, oats, rice, rye and sugar cane).

:

.

The suspension actions were based on the opinion of the Dopartcont of
Health, Education, and Welfare that contamination resulting frca uses of
2, 4, 5-T around tho hccie and in water areas could constitute a hazard to
huaan health.

.

New information reported to DHEW on Monday, April 13, 1970, indicates
that 2, 4, 5-T, as well as its contaminant, dioxins, may produce abnormal
development in unborn animals. Nearly pure 2, 4, 5-T was reported to cause
birth defects when injected at high doses into experimental t&gt;regnant mice
but not in jyats. No data on humans are available.
;

7197

'

.

(more ) . • ' . .
USDA 1176-70

�These actions do not eliminate registered use of 2,4,5-T for control
•
of weeds and brush on range, pasture, and forests or on rights of way
and other non-agricultural land. Users are cautioned that 2,4,5-T should
not be used near homes or recreation areas.

Registered uses are being

reviewed by the three Departments to make certain that they include adequate
precautions against grazing treated areas long enough after treatment by
2,4.,5-T so that no contaminated meat or milk results from animals grazing
the treated area.

.

While residues of. 2,4,5-T in meat and milk are very rare, such residues .
are illegal and render contaminated products subject to seizure.

There is

*

no tolerance for 2,4,5-T on meat, milk or any other"feed or food.
USDA will issue guidelines for disposal of household products containing
2,4,5-T. The chemical is biologically decomposed in a moist environment.
Background Information
Secretary Finch's Coccaission on Pesticides, which reported its findings
in November and December 1969, expressed concern that research conducted
at Bionetics Research Laboratories, under the Direction of the National
Cancer Institute, indicated that 2,4,5-T had produced a number of birth
defects when fed or injected into certain strains of mice and rats.

Because

the test material contained substantial concentrations of chemical impurities
(dioxins), the birth abnormalities could not be attributed with certainty
either to 2,4,5-T, or to the impurities known to be present.

Representatives

of the chemical industry pointed to evidence of extreme potency of the
impurities as toxic agents.

They demonstrated that 2,4,5-T now being

•marketed is of #. 'greater purity than that which had been tested in the
Bionetics experiments and urged that further testing be undertaken to clarify
the questions raised.
.

(more)

�- 3 -.

:

.',*•;.

' • ''. •'!
''
Responding to this suggestion and utilizing materials supplied by
.'•£
• • ,-;•
one of the major producers of 2,4,5-T, scientists at the National Institute .;/;
of Environmental Health Sciences promptly initiated studies to determine
whether 2,4,5-T itself, its impurities or a combination of both, had caused

:'.''&lt;

.-I.
.-' o
'*'•£

the earlier findings, and whether the 2,4,5-T now being marketed produces

.•

birth abnormalities in mice'and rats.

On Monday

j
•I
.'

and Tuesday of this week the analyses of the data were presented to the

~y

regulatory agencies of the Federal Government and to the members of the

;,;

Cabinet.

••'.

The experiments were completed last

week aid the statistical analyses performed over the weekend.

:
^

'
•

.

'. *

The dioxin impurities and the 2,4,5-T as it is now manufactured,
separately produced birth abnormalities in the experimental mice.

Because

!

absolutely pure 2,4,5-T was not available for testing, it is possible only
to infer from certain of the observations that the pure 2,4,5-T probably
would be found to be teratogenic if it were tested.

But, since pure

•

2,4,5-T is, not marketed and could not be produced in commercial quantities,
this is not a practical issue for consideration.
Believing that prudence must dictate action in these circumstances,
the regulatory agencies of the Federal, government are moving to minimize
human exposure to 2,4,5-T and its impurities. .The measures being taken
are designed to provide maximum protection to women in the childbaaring
years by eliminating formulation of 2,4,5-T from use in household, aquatic,
and recreational areas.

Its use on food crops will be cancelled, and use

on range Aind pastureland will be controlled. Maximum surveillance of water
(more)

.

:

�. - 4 •

•

.

.

supplies and marketed foods will be maintained as a measure of the

..-. % J
• 't .•
• • ' • " •:'f
:

-.•••in-

effectiveness of these controls. These measures will be announced more

'•.';.;:-;'
• • '.
r

' ' . :~!:.

specifically in the Federal Register shortly.

.j
.|

While the restriction to be imposed upon the use of this herbicide

• ,£

may cause some economic hardship, the Secretaries urged full cooperation

••/

to protect human health from potential hazards of 2,4,5-T, other pesticides

'•'•

and the dioxins.

)

The three Secretaries coircnended the chemical industry for its prompt
and willing cooperation with the NIEHS in the studies to clarify questions

:•••£

raised by the initial studies of this herbicide and for working closely with ^
'/i
the FDA in the other studies still underway. They urged the full.support
/
i
•
.
- • &gt;.
of industry, agriculture and the home gardner in insuring the safe use of
2,4,5-T and other pesticides which contribute in important ways to the
welfare of the Nation.

.

.

•

USDA 1176-70

."&gt;

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                  <text>&lt;p style="margin-top: -1em; line-height: 1.2em;"&gt;The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.&lt;/p&gt;&#13;
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