[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)]
[Notices]
[Pages 90356-90358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30043]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0558; FRL-9936-80]


Removal of Certain Inert Ingredients From the Approved Chemical 
Substance List for Pesticide Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is removing certain chemical substances from the current 
listing of inert ingredients approved for use in pesticide products 
because these chemical substances are no longer used as an inert 
ingredient in any registered pesticide product.

FOR FURTHER INFORMATION CONTACT: For general information contact: Cameo 
G. Smoot, Field and External Affairs Division, Office of Pesticide 
Programs, Environmental Protection Agency; 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 305-5454; email 
address: [email protected].
    For listing inquiries contact: Kerry B. Leifer, Registration 
Division, Office of Pesticide Programs, Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 
telephone number: (703) 308-8811; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you engage in 
activities related to the registration of pesticide products, including 
but not limited to, the use of approved inert ingredients used in 
registered pesticide products. Potentially affected entities may 
include, but are not limited to, engaging in the formulation and 
preparation of agricultural and household pest control chemical 
substances or pesticides and other agricultural and household pest 
control chemical substances or inert ingredient manufacturers and those 
who make proprietary inert ingredient formulations or pesticides and 
other agricultural chemical substance manufacturing generally 
identified by the North American Industrial Classification System 
(NAICS) code 325320.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers to help determine whether this document applies to 
them and which entities are likely to be affected by this action. Other 
types of entities not listed in this unit could also be affected. The 
NAICS code has been

[[Page 90357]]

provided to assist you and others in determining whether this action 
might apply to certain entities. If you have any questions regarding 
the applicability of this action to a particular entity, consult either 
person listed under FOR FURTHER INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    EPA is taking this action under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq.

C. What action is the Agency taking?

    EPA is removing 72 chemical substances from the current listing of 
inert ingredients approved for use in pesticide products because these 
chemical substances are no longer used as an inert ingredient in any 
registered pesticide product. The list of chemical substances that are 
no longer on the approved inert ingredient list is available in the 
docket for this action, under docket identifier EPA-HQ-OPP-2014-0558-
0002 at http://www.regulations.gov. A copy of the list will also be 
posted on the Agency's Web site.
    Removal of a chemical substance from the approved inert ingredient 
listing does not, by itself, restrict the use of the chemical substance 
in a pesticide product; it changes the way an application is processed. 
Once removed, the chemical substance would be considered a ``new'' 
inert ingredient. Any inert ingredient that is not on the approved list 
must be approved by EPA before the Agency will approve a registration 
for a formulation containing that chemical substance as an inert 
ingredient. EPA approval can be obtained by submitting a request, along 
with relevant data as instructed in applicable EPA guidance. The type 
of data needed to evaluate a new inert ingredient may include, among 
other things, studies to evaluate potential carcinogenicity, adverse 
reproductive effects, developmental toxicity, genotoxicity, as well as 
environmental effects associated with any chemical substance that is 
persistent or bioaccumulative. In addition, adding the chemical 
substance to the list of approved inert ingredients would also require 
payment of a fee in accordance with FIFRA section 33, 7 U.S.C. 136w-8.
    Information regarding the inert ingredient request and approval 
process is available on the Agency's Web site at http://www2.epa.gov/pesticide-registration/guidance-documents-inert-ingredients.

D. How can I access the docket for this action?

    The docket for this action, identified by docket identification 
(ID) number EPA-HQ-OPP-2014-0558, is available online at http://www.regulations.gov or in person at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is: (202) 566-1744, and the telephone number for the OPP 
Docket is: (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

II. Background

A. What did EPA propose?

    On October 22, 2014 (79 FR 63120; FRL-9916-22), EPA published for 
comment a proposal to remove from the Agency's list of inert 
ingredients approved for use in pesticide products 72 chemical 
substances that are no longer being used as inert ingredients in 
pesticide products. In response to EPA's request for comments, no 
specific information regarding those 72 chemical substances or any 
products that may include them was provided to the Agency indicating 
that these chemical substances are being used in currently approved 
pesticide product formulations.

B. What comments did EPA receive and what is EPA response?

    EPA received approximately 50 public comments on the proposal. A 
summary of the significant areas of comment and EPA's responses is 
presented in this unit.
    1. Removal of inert ingredients no longer used in pesticide 
products. Some commenters believe that EPA is banning certain chemical 
substances from pesticide products, stating that the chemical 
substances should remain on the approved list of inert ingredients 
because they are harmless.
    EPA is not banning the chemical substances. This action does not 
change the fact that the chemical substances may be part of a 
formulation for which an application for a pesticide registration is 
submitted. All that changes is the process, which will now include an 
application for approval of the inert ingredient. As before, each 
application for registration is evaluated pursuant to the unreasonable 
adverse effects on the environment standard in FIFRA section 3, which 
evaluation includes the inert ingredients in the formulation.
    Another commenter requested that seven chemical substances: methyl 
ethyl ketone (CAS Reg. No. 78-93-3), tetrahydrofuran (CAS Reg. No. 109-
99-9), 1-butanol, 3-methyl-, acetate (CAS Reg. No. 123-92-2), nitrous 
oxide (CAS Reg. No. 10024-97-2), ethane (CAS Reg. No. 74-84-0), 
turpentine oil (CAS Reg. No. 8006-64-2), and formaldehyde (CAS Reg. No. 
50-00-0) not be removed from the list, stating that the chemical 
substances are currently being used in pesticide products formulations.
    The commenter did not submit any evidence (e.g. a confidential 
statement of formula form or other record) indicating that the chemical 
substances were in fact being used as inert ingredients in currently 
approved pesticide product formulas.
    2. Inert ingredient strategy. Some commenters believe that the 
action does not improve public access to inert ingredient information 
and suggested that EPA proceed with the rest of the inert ingredient 
strategy as expressed in the EPA May 22, 2014, letter to Kamala Harris, 
Attorney General of the State of California (see document in Docket 
EPA-HQ-OPP-2014-0558-0003).
    This action is not intended to address public access to inert 
ingredient information but to facilitate EPA review of inert 
ingredients not currently used in pesticide formulations. Removing 
ingredients no longer used in pesticide products from the list of 
approved inert ingredients is one of the actions discussed in the May 
22, letter. The Agency continues to develop and implement the other 
concepts outlined in that letter.
    3. Administrative decision to remove chemical substances. Some 
commenters stated that FIFRA requires that the Agency decision to 
remove chemical substances from the approved inert ingredient list must 
be based on risk.
    FIFRA does not state a standard for approval of an inert 
ingredient, specifying only the fee category and review time. While the 
statute incorporates the risk of unreasonable adverse effects on the 
environment as one of the factors in granting a registration for an 
individual pesticide product under FIFRA section 3, no such criteria 
apply to approval of an inert ingredient. Addition of an inert 
ingredient to the approved inert list is a prerequisite to approval of 
applications for registration of specific pesticide formulations that 
contain the inert ingredient.

[[Page 90358]]

    4. Regulation of pesticide adjuvants. Some commenters asked the 
Agency to clarify the impact of this removal action on the use of tank-
mix adjuvants, including with respect to tolerances and exemptions 
under the Federal Food, Drug and Cosmetic Act.
    An adjuvant is a chemical substance separately added to a pesticide 
product (typically as part of a spray tank mixture). Since pesticide 
adjuvant products do not make pesticidal claims, they are not 
pesticides, and the components of adjuvants are therefore not pesticide 
inert ingredients. Adjuvants are not included in the inert ingredient 
approval process and are therefore unaffected by this policy. While 
adjuvants may need tolerances or tolerance exemptions in some cases, 
tolerances and exemptions are separate from the inert ingredient 
approval process.
    5. No impact to the fragrance ingredient listing. One commenter 
noted that a few inert ingredients proposed for removal from the 
chemical substance list appear on the EPA Fragrance Ingredient List 
(FIL).
    The EPA FIL comprises more than 1,500 fragrance component 
ingredients that have undergone Agency evaluation to determine their 
suitability for safe use as components of fragrances in nonfood-use 
pesticide product formulations in accordance with the Fragrance 
Notification Program. Removal of an inert ingredient from the approved 
inert ingredient listing does not preclude use as a fragrance 
ingredient as part of the Fragrance Notification Program provided that 
inert ingredient is listed on the FIL and use in a pesticide 
formulation is consistent with the Fragrance Notification Process. The 
inert ingredients no longer used in registered pesticide products will 
be removed from the approved inert ingredient listing but these same 
ingredients will not be removed from the FIL.
    6. Impurities. Some commenters want EPA to clarify that removing 
the chemical substances from the list does not prohibit the use of 
these chemical substances being classified as residual impurities in 
approved inert ingredients.
    The definition of inert ingredient as given in 40 CFR 152.3 applies 
to chemical substances used as inert ingredients that are 
``intentionally included in a pesticide product'' and as such the 
removal of a chemical substance from the approved inert ingredient list 
does not apply to circumstances where the chemical substance may be 
present as an impurity. Impurities in pesticide products are considered 
on a case-by-case basis as part of the Agency's pesticide product 
registration process. As part of that evaluation, the Agency looks at 
the identity and amount of an impurity in the product manufacturing 
information, and the steps taken to limit or remove impurities.
    7. Confirming the ingredient use in current pesticide products. 
Some commenters suggested that EPA provide them more time to 
investigate whether any of the 72 chemical substances are used in 
currently registered products.
    EPA records include no Confidential Statements of Formula for any 
currently registered pesticide product that list any of these chemical 
substances. However, if a registrant or a producer of proprietary 
mixtures identifies an active registration that contains one of the 
chemical substances that has now been removed from the approved inert 
ingredient listing, that registrant or producer should contact the 
Agency directly, using the contact for listing inquiries that is 
provided under FOR FURTHER INFORMATION CONTACT. If EPA confirms that 
the chemical substance is contained in a currently registered product, 
the Agency will restore the chemical substance to the list of approved 
inert ingredients.

    Authority: 7 U.S.C. 136 et seq.

    Dated: December 7, 2016.
James J. Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2016-30043 Filed 12-13-16; 8:45 am]
BILLING CODE 6560-50-P