An Act to amend the Federal Food, Drug, and Cosmetic Act with respect to residues of pesticide chemicals in or on raw agricultural commodities
PL 83-518 (H.R.7125), enacted 07/22/1954

68 S T A T . ] 
PUBLIC LAW 518-JULY 22, 1954 
Public Law 518 
CHAPTER 559 
AN ACT 
To amend the Federal Food, Drug, and Cosmetic Act with respect to residues of 
pesticide chemicals in or on raw agricultural commodities. 
Be it enacted hy the Senate and House of Representatives 
of the 
United States of America in Congress assemoled^ That section 201 of 
the Federal Food, Drug, and Cosmetic Act is amended by adding at 
the end thereof the following new paragraphs: 
"(q) The term 'pesticide chemical' means any substance which, 
alone, in chemical combination or in formulation with one or more 
other substances, is an 'economic poison' within the meaning of the 
Federal Insecticide, Fungicide, and Rodenticide Act (7 U. S. C, sees. 
135-135k) as now in force or as hereafter amended, and which is used 
in the production, storage, or transportation of raw agricultural 
commodities. 
"(r) The term 'raw agricultural commodity' means any food in its 
raw or natural state, including all fruits that are washed, colored, or 
otherwise treated in their unpeeled natural form prior to marketing." 
SEC. 2. Clause (2) of section 402 (a) of the Federal Food, Drug, and 
Cosmetic Act is amended to read as follows: "(2) if it bears or con-
tains any added poisonous or added deleterious substance, except a 
pesticide chemical in or on a raw agricultural commodity, which is 
unsafe within the meaning of section 406, or if it is a raw agricultural 
commodity and it bears or contains a pesticide chemical which is 
unsafe within the meaning of section 408 (a);". 
SEC. 3. Chapter IV of the Federal Food, Drug, and Cosmetic Act 
is amended by adding at the end thereof the following new section: 
511 
July 22,1954 
[H. R. 7125] 
Pesticide chem-
ical residues. 
52 Stat. 1041. 
21 use 321. 
Definitions. 
61 Stat. 1 63. 
A d u l t e r a t e d 
food. 
21 use 342. 
21 u s e 346. 
"TOLERANCES FOR PESTICIDE CHEMICALS I N OR ON RAW AGRICULTURAL 
COMMODITIES 
"SEC. 408. (a) Any poisonous or deleterious pesticide chemical, or 
any pesticide chemical w^hich is not generally recognized, among 
experts qualified by scientific training and experience to evaluate the 
safety of pesticide chemicals, as safe for use, added to a raw agri-
cultural commodity, shall be deemed unsafe for the purposes of the 
application of clause (2) of section 402 (a) unless— 
"(1) a tolerance for such pesticide chemical in or on the raw 
agricultural commodity has been prescribed by the Secretary of 
Health, Education, and Welfare under this section and the 
quantity of such pesticide chemical in or on the raw agricultural 
commodity is within the limits of the tolerance so prescribed; or 
"(2) with respect to use in or on such raw agricultural com-
modity, the pesticide chemical has been exempted from the 
requirement of a tolerance by the Secretary under this section. 
While a tolerance or exemption from tolerance is in effect for a pesti-
cide chemical with respect to any raw agricultural commodity, such 
raw agricultural commodity shall not, by reason of bearing or con-
taining any added amount of such pesticide chemical, be considered to 
be adulterated within the meaning of clause (1) of section 402 (a). 
"(b) The Secretary shall promulgate regulations establishing toler-
ances with respect to the use in or on raw agricultural commodities 
of poisonous or deleterious pesticide chemicals and of pesticide chemi-
cals which are not generally recognized, among experts qualified by 
scientific training and experience to evaluate tne safety of pesticide 
chemicals, as safe for use, to the extent necessary to protect the public 
health. In establishing any such regulation, the Secretary shall give 
appropriate consideration, among other relevant factors, (1) to the 
21 use 342. 
E stabllshment 
of tolerances. 
512 
PUBLIC LAW 518-JULY 22, 1954 
[68 
S T A T . 
Exemptions. 
P r o c e dure pur-
suant to petition. 
7 u s e 135 note. 
Petition data. 
Notice. 
Regulation. 
Exception. 
necessity for the production of an adequate, wholesome, and economi-
cal food supply; (2) to the other ways in which the consumer may be 
affected by the same pesticide chemical or by other related substances 
that are poisonous or deleterious; and (3) to the opinion of the 
Secretary of Agriculture as submitted with a certification of usefulness 
under subsection (1) of this section. Such regulations shall be pro-
mulgated in the manner prescribed in subsection (d) or (e) of this 
section. In carrying out the provisions of this section relating to the 
establishment of tolerances, the Secretary may establish the tolerance 
applicable with respect to the use of any pesticide chemical in or on 
any raw agricultural commodity at zero level if the scientific data 
before the Secretary does not justify the establishment of a greater 
tolerance. 
"(c) The Secretary shall promulgate regulations exempting any 
pesticide chemical from the necessity of a tolerance with respect to use 
in or on any or all raw agricultural commodities w hen such a tolerance 
is not necessary to protect the public health. 
Such regulations shall 
be promulgated in the manner prescribed in subsection (d) or (e) of 
this section. 
"(d) (1) Any person who has registered, or w^ho has submitted an 
application for the registration of, an economic poison under the 
Federal Insecticide, Fungicide, and Rodenticide Act may file with 
the Secretary of Health, Education, and Welfare, a petition proposing 
the issuance of a regulation establishing a tolerance for a pesticide 
chemical which constitutes, or is an ingredient of, such economic 
poison, or exempting the pesticide chemical from the requirement of a 
tolerance. 
The petition shall contain data showing— 
"(A) the name, chemical identity, and composition of the 
pesticide chemical; 
"(B) the amount, frequency, and time of application of the 
pesticide chemical; 
"(C) full reports of investigations made with respect to the 
safety of the pesticide chemical; 
"(D) the results of tests on the amount of residue remaining, 
including a description of the analytical methods used; 
"(E) practicable methods for removing residue which exceeds 
any proposed tolerance; 
"(F) proposed tolerances for the pesticide chemical if toler-
ances are proposed; and 
"(G) reasonable grounds in support of the petition. 
Samples of the pesticide chemical shall be furnished to the Secretary 
upon request. 
Notice of the filing of such petition shall be published 
in general terms by the Secretary within thirty days after filing. Such 
notice shall include the analytical methods available for the determina-
tion of the residue of the pesticide chemical for which a tolerance or 
exemption is proposed. 
"(2) Within ninety days after a certification of usefulness by the 
Secretary of Agriculture under subsection (1) with respect to the 
pesticide chemical named in the petition, the Secretary of Health, 
Education, and Welfare shall, after giving due consideration to the 
data submitted in the petition or otherwise before him, by order make 
public a regulation— 
"(A) establishing a tolerance for the pesticide chemical named 
in the petition for the purposes for which it is so certified as 
useful, or 
"(B) exempting the pesticide chemical from the necessity of a 
tolerance for such purposes, 
unless within such ninety-day period the person filing the petition 
requests that the petition be referred to an advisory committee or the 
68 S T A T . ] 
PUBLIC LAW 518-JULY 22, 1954 
513 
Secretary within such period otherwise deems such referral necessary, 
in either of which events the provisions of paragraph (3) of this 
subsection shall apply in lieu hereof. 
"(3) In the event that the person filing the petition requests, within 
ninety days after a certification of usefulness by the Secretary of 
Agriculture under subsection (1) with respect to the pesticide chemical 
named in the petition, that the petition be referred to an advisory 
committee, or in the event the Secretary of Health, Education, and 
Welfare within such period otherwise deems such referral necessary, 
the Secretary of Health, Education, and Welfare shall forthwith sub-
mit the petition and other data before him to an advisory committee to 
be appointed in accordance with subsection (g) of this section. 
As 
soon as practicable after such referral, but not later than sixty days 
thereafter, unless extended as hereinafter provided, the committee 
shall, after independent study of the data submitted to it by the Secre-
tary and other data before it, certify to the Secretary a report and 
recommendations on the proposal in the petition to the Secretary, 
together with all underlying data and a statement of the reasons or 
basis for the recommendations. 
The sixty-day period provided for 
herein may be extended by the advisory committee for an additional 
thirty days if the advisory committee deems this necessary. 
Within 
thirty days after such certification, the Secretary shall, after giving 
due consideration to all data then before him, including such report, 
recommendations, underlying data, and statement, by order make 
public a regulation— 
"(A) establishing a tolerance for the pesticide chemical named 
in the petition for the purposes for which it is so certified as use-
ful; or 
"(B) exempting the pesticide chemical from the necessity of a 
tolerance for such purposes. 
"(4) The regulations published under paragraph (2) or (3) of 
this subsection will be effective upon publication. 
"(6) Within thirty days after publication, any person adversely 
affected by a regulation published pursuant to paragraph (2) or 
(3) of this subsection, or pursuant to subsection (e), may file objec-
tions thereto with the Secretary, specifying with particularity the 
provisions of the regulation deemed objectionable, stating reasonable 
grounds therefor, and requesting a public hearing upon such objec-
tions. A copy of the objections filed by a person other than the peti-
tioner shall be served on the petitioner, if the regulation was issued 
pursuant to a petition. The petitioner shall have two weeks to make 
a written reply to the objections. The Secretary shall thereupon, after 
due notice, hold such public hearing for the purpose of receiving evi-
dence relevant and material to the issues raised by such objections. 
Any report, recommendations, underlying data, and reasons certified 
to the Secretary by an advisory committee shall be made a part of the 
record of the hearing, if relevant and material, subject to the provisions 
of section 7 (c) of the Administrative Procedure Act (5 U. S. C, 
sec. 1006 (c)). 
The National Academy of Sciences shall designate a 
member of the advisory committee to appear and testify at any such 
hearing with respect to the report and recommendations of such com-
mittee upon request of the Secretary, the petitioner, or the officer con-
ducting the hearing: Provided^ That this shall not preclude any other 
member of the advisory committee from appearing and testifying at 
such hearing. As soon as practicable after completion of the hearing, 
the Secretary shall act upon such objections and by order make public 
a regulation. Such regulation shall be based only on substantial evi-
dence of record at such hearing, including any report, recommenda-
tions, underlying data, and reasons certified to the Secretary by an 
R e f e rral to ad-
visory committee. 
Regulation* 
Effectivity. 
Hearings^ 
60 Stat. 241. 
39777 O—55—pt. 1 
35 
514 
PUBLIC LAW 518-JULY 22, 1954 
[68 S T A T . 
Secretary's 
posals, etc. 
7 u s e 135 note. 
C o n f i d e n t i a l 
data. 
A d v i 8 ory com-
mittees* 
Members. 
Compensation. 
advisory committee, and shall set forth detailed findings of fact upon 
which the regulation is based. No such order shall take effect prior 
to the ninetieth day after its j)ublication, unless the Secretary finds 
that emergency conditions exist necessitating an earlier effective 
date, in which event the Secretary shall specify in the order his find-
ings as to such conditions. 
" (e) The Secretary may at any time, upon his own initiative or upon 
the request of any interested person, propose the issuance of a regula-
tion establishing a tolerance for a pesticide chemical or exempting it 
from the necessity of a tolerance. 
Thirty days after publication of 
such a proposal, the Secretary may by order publish a regulation based 
upon the proposal which shall become effective upon publication unless 
within such thirty-day period a person who has registered, or who 
has submitted an application for the registration of, an economic 
poison under the Federal Insecticide, Fungicide, and Rodenticide Act 
containing the pesticide chemical named in the proposal, requests that 
the proposal be referred to an advisory committee. 
In the event of 
such a request, the Secretary shall forthwith submit the proposal and 
other relevant data before him to an advisory committee to be appointed 
in accordance with subsection (g) of this section. As soon as practica-
ble after such referral, but not later than sixty days thereafter, unless 
extended as hereinafter provided, the committee shall, after inde-
pendent study of the data submitted to it by the Secretary and other 
data before it, certify to the Secretary a report and recommendations 
on the proposal together with all underlying data and a statement of 
the reasons or basis for the recommendations. 
The sixty-day period 
provided for herein may be extended by the advisory committee for 
an additional thirty days if the advisory committee deems this neces-
sary. 
Within thirty days after such certification, the Secretary may, 
after giving due consideration to all data before him, including such 
report, recommendations, underlying data and statement, by order 
publish a regulation establishing a tolerance for the pesticide chemical 
named in the proposal or exempting it from the necessity of a toler-
ance which shall become effective upon publication. 
Regulations 
issued under this subsection shall upon publication be subject to para-
graph (5) of subsection (d). 
"(f) All data submitted to the Secretary or to an advisory com-
mittee in support of a petition under this section shall be considered 
confidential by the Secretary and by such advisory committee until 
publication of a regulation under paragraph (2) or (3) of subsection 
(d) of this section. 
Until such publication, such data shall not be 
revealed to any person other than those authorized by the Secretary 
or by an advisory committee in the carrying out of their official duties 
under this section. 
"(g) Whenever the referral of a petition or proposal to an advisory 
committee is requested under this section, or the Secretary otherwise 
deems such referral necessary the Secretary shall forthwith appoint 
a committee of competent experts to review the petition or proposal 
and to make a report and recommendations thereon. 
Each such 
advisory committee shall be composed of experts, qualified in the 
subject matter of the petition and of adequately diversified pro-
fessional background selected by the National Academy of Sciences 
and shall include one or more representatives from land-grant colleges. 
The size of the committee shall be determined by the Secretary. 
Members of an advisory committee shall receive as compensation for 
their services a reasonable per diem, which the Secretary shall by rules 
and regulations prescribe, for time actually spent in the work of the 
committee, and shall in addition be reimbursed for their necessary 
traveling and subsistence expenses while so serving away from their 
68 S T A T . ] 
PUBLIC LAW 518-JULY 22, 1954 
515 
places of residence. The members shall not be subject to any other 
provisions of law regarding the appointment and compensation of 
employees of the United States. 
The Secretary shall furnish the 
committee with adequate clerical and other assistance, and shall by 
rules and regulations prescribe the procedure to be followed by the 
committee. 
"(h) A person who has filed a petition or who has requested the 
referral of a proposal to an advisory committee in accordance with 
the provisions of this section, as well as representatives of the Depart-
ment of Health, Education, and Welfare, shall have the right to con-
sult with any advisory committee provided for in subsection (g) in 
connection with the petition or proposal. 
"(i) (1) In a case of actual controversy as to the validity of any 
order under subsection (d) (5), (e), or (1) any person w^ho will be 
adversely affected by such order may obtain judicial review by filing in 
the United States Court of Appeals for the circuit wherein such person 
resides or has his principal place of business, or in the United States 
Court of Appeals for the District of Columbia Circuit, within sixty 
days after the entry of such order, a petition praying that the order be 
set aside in whole or in part. 
"(2) In the case of a petition with respect to an order under sub-
section (d) (5) or (e),a copy of the petition shall be forthwith served 
upon the Secretary, or upon any officer designated by him for that 
purpose, and thereupon the Secretary shall certify and file in the court 
a transcript of the proceedings and the record on which he based his 
order. 
Upon such filing, the court shall have exclusive jurisdiction to 
affirm or set aside the order complained of in whole or in part. 
The 
findings of the Secretary with respect to questions of fact shall be 
sustained if supported by substantial evidence when considered on the 
record as a whole, including any report and recommendation of an 
advisory committee. 
"(3) In the case of a petition with respect to an order under sub-
section (1), a copy of the petition shall be forthwith served upon the 
Secretary of Agriculture, or upon any officer designated by him for 
that purpose, and thereupon the Secretary shall certify and file in the 
court a transcript of the proceedings and the record on which he based 
his order. 
Upon such filing, the court shall have exclusive jurisdiction 
to affirm or set aside the order complained of in whole or in part. 
The 
findings of the Secretary with respect to questions of fact shall be 
sustained if supported by substantial evidence when considered on the 
record as a whole. 
"(4) If application is made to the court for leave to adduce addi-
tional evidence, the court may order such additional evidence to be 
taken before the Secretary of Health, Education, and Welfare or the 
Secretary of Agriculture, as the case may be, and to be adduced upon 
the hearing in such manner and upon such terms and conditions as to 
the court may seem proper, if such evidence is material and there w^ere 
reasonable grounds for failure to adduce such evidence in the proceed-
ings below. The Secretary of Health, Education, and Welfare or the 
Secretary of Agriculture, as the case may be, may modify his findings 
as to the facts and order by reason of the additional evidence so taken, 
and shall file with the court such modified findings and order. 
"(5) The judgment of the court affirming or setting aside, in whole 
or in part, any order under this section shall be final, subject to review 
by the Supreme Court of the United States upon certiorari or certi-
fication as provided in section 1254 of title 28 of the United States 
Code. The commencement of proceedings under this section shall not, 
unless specifically ordered by the court to the contrary, operate as a 
Clerical 
ance, etc. asslst-
C o ns u l t a ti on 
right. 
Appeals. 
Judicial review. 
62 Stat. 928. 
516 
PUBLIC LAW 518-JULY 22, 1954 
[68 S T A T . 
Ten^orary toler-
ancest 
7 u s e 135 note. 
R e g u l a ti o n s 
p r i o r to J a n . 1, 
1953. 
21 u s e 346, 371. 
Authority of Sec-
retary of Agricul-
ture. 
7 u s e 135 note. 
Hearing. 
Time limitation. 
stay of an order. The courts shall advance on the docket and expedite 
the disposition of all causes filed therein pursviant to this section. 
"(j) The Secretary may, upon the request of any person who has 
obtained an experimental permit for a pesticide chemical under the 
Federal Insecticide, Fungicide, and Rodenticide Act or upon his own 
initiative, establish a temporary tolerance for the pesticide chemical 
for the uses covered by the permit whenever in his judgment such 
action is deemed necessary to protect the public health, or may tem-
porarily exempt such pesticide chemical from a tolerance. In estab-
lishing such a tolerance, the Secretary shall give due regard to the 
necessity for experimental work in developing an adequate, whole-
some, and economical food supply and to the limited hazard to the 
public health involved in such work when conducted in accordance 
with applicable regulations under the Federal Insecticide, Fungicide, 
and Rodenticide Act. 
"(k) Regulations affecting pesticide chemicals in or on raw agri-
cultural commodities which are promulgated under the authority of 
section 406 (a) upon the basis of public hearings instituted before 
January 1, 1953, in accordance with section 701 (e), shall be deemed 
to be regulations under this section and shall be subject to amendment 
or repeal as provided in subsection (m). 
"(1) The Secretary of Agriculture, upon request of any person who 
has registered, or who has submitted an application for the registration 
of, an economic poison under the Federal Insecticide, Fungicide, and 
Rodenticide Act, and whose request is accompanied by a copy of a 
petition filed by such person under subsection (d) (1) with respect 
to a pesticide chemical which constitutes, or is an ingredient of, such 
economic poison, shall, within thirty days or within sixty days if upon 
notice prior to the termination of such thirty days the Secretary 
deems it necessary to postpone action for such period, on the basis 
of data before him, either— 
"(1) certify to the Secretary of Health, Education, and Wel-
fare that such pesticide chemical is useful for the purpose for 
which a tolerance or exemption is sought; or 
"(2) notify the person recjuesting the certification of his pro-
posal to certify that the pesticide chemical does not appear to be 
useful for the purpose for which a tolerance or exemption is 
sought, or appears to be useful for only some of the purposes for 
which a tolerance or exemption is sought. 
In the event that the Secretary of Agriculture takes the action 
described in clause (2) of the preceding sentence, the person reauesting 
the certification, within one week after receiving the proposed certifi-
cation, may either (A) request the Secretary of Agriculture to certify 
to the Secretary of Health, Education, and Welfare on the basis of the 
proposed certincation; (B) request a hearing on the proposed certifica-
tion or the parts thereof objected to; or (C) request both such certifica-
tion and such hearing. 
If no such action is taken, the Secretary may 
by order make the certification as proposed. 
In the event that the 
action described in clause (A) or (C) is taken, the Secretary shall by 
order make the certification as proposed with respect to such parts 
thereof as are requested. 
It the event a hearing is requested, the 
Secretary of Agriculture shall provide opportunity for a prompt 
hearing. 
The certification of the Secretary of Agriculture as the 
result of such hearing shall be made by order and shall be based only 
on substantial evidence of record at the hearing and shall set forth 
detailed findings of fact. 
In no event shall the time elapsing between 
the making of a request for a certification under this subsection and 
68 S T A T . ] 
PUBLIC LAW 518-JULY 22, 1954 
517 
final certification by the Secretary of Agriculture exceed one hundred 
and sixty days. The Secretary shall submit to the Secretary of Health, 
Education, and Welfare with any certification of usefulness under this 
subsection an opinion, based on the data before him, whether the toler-
ance or exemption proposed by the petitioner reasonably reflects the 
amount of residue likely to result when the pesticide chemical is used 
in the manner proposed for the purpose for which the certification is 
made. The Secretary of Agriculture, after due notice and opportunity 
for public hearing, is authorized to promulgate rules and regulations 
for carrying out the provisions of this subsection. 
"(m) The Secretary of Health, Education, and Welfare shall pre-
scribe by regulations the procedure by which regulations under this 
section may be amended or repealed, and such procedure shall con-
form to the procedure provided in this section for the promulgation 
of regulations establishing tolerances, including the appointment of 
advisory committees and the procedure for referring petitions to 
such committees. 
"(n) The provisions of section 303 (c) of the Federal Food, Drug, 
and Cosmetic Act with respect to the furnishing of guaranties shall be 
applicable to raw agricultural commodities covered by this section. 
"(o) The Secretary of Health, Education, and Welfare shall by 
regulation require the payment of such fees as will in the aggregate, 
in the judgment of the Secretary, be sufficient over a reasonable term 
to provide, equip, and maintain an adequate service for the perform-
ance of the Secretary's functions under this section. Under such regu-
lations, the performance of the Secretary's services or other functions 
pursuant to this section, including any one or more of the following, 
may be conditioned upon the payment of such fees: (1) The accept-
ance of filing of a petition submitted under subsection (d) ; (2) the 
promulgation of a regulation establishing a tolerance, or an exemption 
from the necessity of a tolerance, under this section, or the amendment 
or repeal of such a regulation; (3) the referral of a petition or pro-
posal under this section to an advisory committee; (4) the acceptance 
for filing of objections under subsection (d) (5); or (5) the certifi-
cation and filing in court of a transcript of the proceedings and the 
record under subsection (i) (2). 
Such regulations may further pro-
vide for waiver or refund of fees in whole or in part when in the 
judgment of the Secretary such waiver or refund is equitable and not 
contrary to the purposes of this subsection." 
SEC. 4. There are hereby authorized to be appropriated, out of any 
moneys in the Treasury not otherwise appropriated, such sums as may 
be necessary for the purpose and administration of this Act. 
SEC. 5. This Act shall take effect upon the date of its enactment, 
except that with respect to pesticide chemicals for which tolerances or 
exemptions have not been established under section 408 of the Federal 
Food, Drug, and Cosmetic Act, the amendment to section 402 (a) 
of such Act made by section 2 of this Act shall not be effective— 
(1) for the period of one year following the date of the enact-
ment of this Act; or 
(2) for such additional period following such period of one 
year, but not extending beyond two years after the date of the 
enactment of this Act, as the Secretary of Health, Education, and 
Welfare may prescribe on the basis of a finding that conditions 
exist which necessitate the prescribing of such additional period. 
Approved July 22, 1954. 
Opinion. 
Regulations, etc. 
HEW procedure 
for 
r e g u l a t i o n 
amendment. 
Guaranties. 
21 u s e 333. 
Payment of fees. 
Waiver or refund. 
Appropriation. 
Effective dates. 
Ante. p. 511. 
21 u s e 342.