Memorandum of Understanding
Between The Environmental Protection Agency
and The United States Department of Health, Education and Welfare
Food and Drug Administration
CHAPTER 55b – MOUs AND IAGs – FEDERAL
SUBJECT: MOU with EPA regarding mutual responsibilities under FFDCA and FIFRA (FDA-225-73-8010).
Reorganization Plan No. 3 of 1970 published in the Federal Register of October 6, 1970, stated in section 2, paragraph (4) that the functions vested in the Secretary of Health, Education and Welfare of establishing tolerances for pesticide chemicals under the Federal Food, Drug, and Cosmetic Act, as amended, 21 U.S.C. 346, 346a, and 348, were transferred to the Administrator of the Environmental Protection Agency effective December 2, 1970. After considering all of the various pesticide uses which have been subject to petition procedures under these three sections, and certain other pesticide uses subject both to the Federal Insecticide, Fungicide, and Rodenticide Act, 731 U.S.C. 35, and to the Federal Food, Drug, and Cosmetic Act, the Administrator of the Environmental Protection Agency and the Secretary of Health, Education and Welfare have concluded that this agreement is needed to provide for the coordination of activities pertaining to pesticides and to inform all concerned as to which agency will process the pesticide petitions for each type of use.
Reorganization Plan No. 3 also transferred to the Administrator of the Environmental Protection Agency the functions of the Secretary of Agriculture under the Federal Insecticide, Fungicide, and Rodenticide Act. There are certain products which are subject to the requirements of both the Federal, Food, Drug, and Cosmetic Act (FFDCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In the past, confusion, misunderstanding and inconvenience have resulted from procedures followed in connection with the proposed marketing of such products. The Administrator of the Environmental Protection Agency (EPA) and the Secretary of Health, Education, and Welfare are agreed that a new procedure should be followed whereby the manufacturer would be informed:
(1) of the agency exercising primary jurisdiction regarding his product,
(2) that the matter will be referred to the other agency for decision under the law of that agency, and
(3) that approval for marketing the product will not be granted unless or until each agency has approved the marketing under its respective authority.
This matter was the subject of a proposed statement of general policy and interpretation published in the Federal Register on August 5, 1970.
There are other procedures which should be established in order to facilitate the handling of matters which are of direct concern to both Agencies. These matters involve issuance of regulations under section 406 of the FFDCA, establishment of reference standards, exchange of information on certain programs, agreements with States and foreign countries on surveillance and enforcement activities on pesticide residues in food and publication of the Pesticide Analytical Manual.
The term "pesticide chemical" is defined in section 201(q) of the Federal Food, Drug, and Cosmetic Act as a substance which is a "pesticide" *** under the Federal Insecticide, Fungicide, and Rodenticide Act and which is used in the production, storage, or transportation of raw agriculture commodities. Pesticides used on food crops before or after harvest and on food animals are included in this category. Pesticides used on or concentrating in processed foods are treated in the Federal Food, Drug, and Cosmetic Act as food additives rather than pesticide chemicals.
Both agencies agree that:
1. The following petitions will be processed by the Environmental Protection Agency:
a. Petitions requesting tolerances or exemption from tolerances for residues of pesticide chemicals on raw agriculture commodities.
b. Petitions for food additive regulations required for residues of pesticide chemicals carrying over and concentrating in processed foods manufactured from treated raw agricultural commodities.
c. Petitions for regulations for residues of pesticides from direct treatment of processed foods with fumigants or insecticides.
d. Petitions for food additive regulations to permit the safe use of pesticides to impregnate food-packaging materials such as wrappers or bags to protect raw agricultural commodities from any pest or to protect processed foods from insects.
2. The following petitions will be processed by FDA:
a. Petitions for food additive regulations to permit use of sanitizers on food-contact surfaces.
b. Petitions for food additive regulations to permit the safe use of pesticides as preservatives in processed food.
c. Petitions for food additive regulations to permit the safe use of pesticides in food packaging material when such use is not covered by l.d.
3. Applications for approval of drugs under FFDCA and for registration of pesticides under FIFRA will be processed as follows:
a. Whenever a product is submitted to either FDA or EPA for approval and it is believed by either agency that the product is subject to the requirements of both the FFDCA and the FIFRA, an interagency determination will be made and an agreement reached with respect to (1) whether the product is subject to the requirements of the FFDCA and FIFRA, (2) whether particular claims are "pesticide" or "drug" representations made for the product, including the implications to be drawn therefrom, are primarily "pesticide" or "drug" representations.
b. Whenever application is made to EPA for registration of a product that is both a drug and a pesticide and determination has been made that the principal claims or representations related to a pesticide, EPA will withhold registration of the product under FIFRA until it has been informed by FDA that the product complies with the provisions of the laws administered by FDA.
c. When application is made to FDA for approval of a product that is both a drug and a pesticide and determination has been made that the principal claims or representations relate to a drug, FDA will not approve a new drug application, a new animal drug application or an antibiotic application without first being advised by EPA that the claims or representations subject to the provision of the FIFRA are warranted and that the product is eligible for registration under that act.
d. Whenever application is made to EPA for the registration of a product that is both a drug and a pesticide and determination has been made that the principal claims or representations relate to a drug, the matter will be referred by EPA to FDA and the matter will thereafter be handled as if the application had been originally made to FDA.
e. Whenever application is made to FDA for approval of a product that is both a pesticide and a drug and determination has been made that the principal claims or representations relate to a pesticide, the matter will be referred by FDA to EPA and the matter will thereafter be handled as if the application had been originally made to EPA.
f. Neither agency will approve the marketing of a product under the law administered by it if the product would not be in full compliance with the requirements of a law administered by the other.
Note: The following paragraphs (g thru n) were added by amendment effective August 28, 1973.
g. Submissions for approval will be to the agency having primary jurisdiction in the format required by that agency which will be considered acceptable by the other agency in lieu of that normally required. Where specific requirements of the two agencies conflict in matters such as manufacturing, formulation, and labeling, the requirements of the agency of primary jurisdiction will apply.
h. The application of a product for any of, but not necessarily limited to, the uses listed below is considered to be both a human drug and a pesticide. The agency for primary jurisdiction regarding such product will be FDA and secondarily EPA.
i) Pediculicides and scabicides intended to control parasites on humans.
ii) Products intended to relieve the effect of insect bites on humans which also claim to repel the insects causing such bites.
iii) Products intended to prevent diaper rash by treatment of diapers.
iv) Fungicides for human use, i.e., athlete's foot which also claim to destroy such fungus on inanimate objects.
i. The application of a product for any of, but not necessarily limited to, the uses listed below is considered to be both a pesticide and human drug. The agency for primary jurisdiction regarding such products will be EPA and secondarily FDA.
Disinfectants and sanitizers intended for use on inanimate objects but including claims for use on humans.
j. Certain pesticides subject to the laws administered by EPA are also deemed to be animal drugs and subject to the laws administered by FDA under, but not necessarily limited to, the following conditions:
i) Products for oral administration such as tablets, boluses, drinking water preparations, medicated blocks, and medicated feeds, including liquid feeds and supplements (these do not apply to articles solely for the control of fecal breeding flies, nor solely for sanitizing the drinking water of animals).
ii) Products administered parenterally.
iii) Products which are absorbed through the skin surface as in demodectic mange conditions.
iv) Products introduced into wound or body openings, except for screwworms control, including application to the ear canal, for the control of ear mites; such conditions often require supportive treatment.
v) Products applied topically for their systemic action in an animal.
k. The application of a pesticide for any of the uses listed below is considered to be both an animal drug and a pesticide. The agency for primary jurisdiction regarding such articles will be FDA, except in those cases where the drug use is regarded as not a new animal drug. In this event, since FDA has no preclearance requirements for products so considered, the submission for registration will be to EPA. However, the product will not be registered until EPA has been notified by FDA that the product is in compliance with the requirements of the FFDCA.
i) Treatments for control of horse bots.
ii) Treatments that are administered orally or parenterally for control of cattle grubs.
iii) Treatments for control of demodectic mange mites.
iv) Treatments that are administered orally or parenterally for control of fleas (or other external parasites).
v) Treatments for control of ear mites.
vi) Treatments for control of ticks if the product labeling includes claims for control of ear mites.
vii) Aquatic treatments intended to control parasites and/or disease of fish in ponds or aquariums.
viii) Animal drinking water treatments with direct or implied claims for control of animal parasites or diseases.
ix) Any other product with a mode of action similar to that under j.
l. The application of a pesticide for any of the uses listed below will be regarded solely as a pesticide usage except where it has an action described in j, in which case it is considered to be both an animal drug and a pesticide. In these cases, the agency for primary jurisdiction will be EPA.
i) Treatments that are administered topically for control of cattle grubs which include application by spray, dip, pour-on, spot-on, back rubber or dust.
ii) Treatments for control so screwworms that are administered topically.
iii) Treatments for control of wool maggots that are administered topically.
iv) Treatments for control of horn fly or face fly that are administered topically.
v) Treatments for control of sarcoptic, psoroptic, and chorioptic mange mites that are administered topically.
vi) Treatments that are administered topically, for control of ticks except as listed in item k. (vi).
vii) Treatments for control of sheep keds that are administered
viii) Treatments for control of fleas that are administered topically.
ix) Treatments that are administered orally solely for control of horn fly and/or face fly in cattle manure.
x) Aquatic treatments of ponds or aquariums soley for control of algae or bacterial slime and any other aquatic treatments solely for pest control which do not include claims for control of parasites or diseases of fish.
xi) Sanitizers intended to sanitize aquarium equipment.
xii) Sanitizers applied to inanimate surfaces and/or in drinking water of animals that do not include any direct or implied claims to control disease.
m. If a product that is subject to joint jurisdiction is deemed to be either a new human or animal drug, prior to registration by EPA, it must be in full compliance with the requirements for FDA approval of a new drug application, to include publication of its approval where required by the FFDCA (i.e., new animal drug), regardless of the agency of primary jurisdiction.
n. If a manufacturer proposing a new product is unable to determine the agency of primary jurisdiction, a presubmission inquiry may be submitted to either agency. FDA and EPA will jointly consider the inquiry and advise the manufacturer of their conclusions in this matter.
4. If the poisonous or deleterious substance referred to in section 406 of the Federal Food, Drug, and Cosmetic Act is present in food primarily as a result of its use as a pesticide chemical, or a pesticide, any regulation establishing a tolerance for such substance in food will be promulgated by the Environmental Protection Agency. Any other regulations under section 406 will be promulgated by FDA.
5. EPA will have responsibility for maintenance of an analytical reference standards repository of pesticides for which tolerances are established. FDA will transfer to EPA those samples which have been prepared for the purpose. Upon request, portions of these samples will be made available to the FDA and local enforcement authorities as needed for use in official analysis.
6. Each agency will appoint an individual and alternates who shall be responsible for interagency cooperation and coordination.
a. These representatives, with staff support as desired, shall meet regularly on a mutually agreeable schedule to discuss program and policy coordination and to establish operating procedures between the agencies. Primary functions of the representatives are:
i) To assure adherence to the general provisions of paragraphs 1-4 above, inclusive;
ii) To promote mutual concurrence on chemical, toxicologic, and pharmacologic requirements for pesticide tolerances;
iii) To provide for complete and timely exchange of information concerning proposed tolerances, administrative guidelines, methodology, research programs, monitoring, surveillance and enforcement programs, and legal action;
iv) To provide that FDA will continue responsibility for agreements with States and foreign countries on surveillance and enforcement activities on pesticide residues in food;
v) To provide that where the official U.S. delegate to international organizations is either EPA or FDA this will not automatically preclude representation by the other agency;
vi) To provide that publication of FDA's Pesticide Analytical Manual for residues in foods and other environmental substrates will be continued as joint FDA-EPA sponsorship under editorial management consisting of representatives of both agencies.
b. Issues arising out of the above provisions which are not resolved after two regularly scheduled meetings shall be submitted through the organizational structure of each agency for resolution.
c. Agency representatives may propose additional agreements concerning these and other matters affecting interagency coordination and cooperation on the health aspects of pesticides and their residues in food and drugs. These proposals may be jointly approved by the Deputy Assistant Administrator for Pesticides Programs EPA, and the Commissioner of Food Drugs, HEW.
Effective date: This agreement became effective on November 10, 1971.
Note: This Memorandum of Agreement was published in the Federal Register of December 22, 1971 and was amended effective August 28, 1973. The amendments have been included in the document as printed above and consisted of:
1. the addition of paragraphs g. thru n. under Item 3 to further detail each agency's responsibilities on the regulation of drugs and pesticides and,
2. the substitution of the word "pesticide" for the term "economic poison" wherever it appears in the agreement in order to make the agreement compatible with the amendment of the FIFRA (86 Stat. 973).
Approved and Accepted
for the Environmental Protection Agency
Signed by: William D. Ruckelshaus
Date: September 4, 1971
Approved and Accepted
for the Department of Health, Education and Welfare
Signed by: J.G. Veneman
Date: June 17, 1971
Approved and Accepted
for the Department of Health, Education and Welfare
Signed by: Charles C. Edwards
Date: May 11, 1971