81 FR 90356 - Removal of Certain Inert Ingredients From the Approved Chemical Substance List for Pesticide Products
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 240 (December 14, 2016)
Federal Register Volume 81, Issue 240 (December 14, 2016)
| Page Range | 90356-90358 | |
| FR Document | 2016-30043 |
[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)] [Notices] [Pages 90356-90358] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-30043] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![90356 Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Notices
greenhouse gas. The Program works to ONE Future Commitment ENVIRONMENTAL PROTECTION
encourage oil and natural gas companies AGENCY
to go above and beyond existing The annual reporting forms for the
ONE Future Commitment Option are to [EPA–HQ–OPP–2014–0558; FRL–9936–80]
regulatory action and make meaningful
and transparent commitments to yield be developed but will follow the
Removal of Certain Inert Ingredients
significant methane emissions requirements set forth in the following
From the Approved Chemical
reductions in a quick, flexible, cost- document:
Substance List for Pesticide Products
effective way. Transparency in • Supplemental Technical
comprehensively tracking company Information for ONE Future AGENCY: Environmental Protection
commitments through the non- Commitment Option: EPA Form No. Agency (EPA).
confidential data reported by Methane XXXX–XXX. ACTION: Notice.
Challenge partners is a key feature of the
Program, and enables partners to Upon becoming a partner in the SUMMARY: EPA is removing certain
highlight emissions reductions achieved Methane Challenge Program, companies chemical substances from the current
through voluntary action taken. are given an opportunity to draft and listing of inert ingredients approved for
Implementation of the Methane submit a Historical Actions Fact Sheet, use in pesticide products because these
Challenge Program’s two commitment which provides information on chemical substances are no longer used
options, the Best Management Practice historical methane reduction actions as an inert ingredient in any registered
Commitment Option and the ONE taken prior to joining Methane pesticide product.
Future Emissions Intensity Commitment Challenge. A two-page fact sheet FOR FURTHER INFORMATION CONTACT: For
Option, improves operational efficiency, template is made available to partner general information contact: Cameo G.
saves partner companies money, and companies and allows entry of up to Smoot, Field and External Affairs
enhances the protection of the five key methane mitigation activities, Division, Office of Pesticide Programs,
environment. including text, photos, and graphics. Environmental Protection Agency; 1200
Form Numbers: Methane Challenge Submitting this document is not a Pennsylvania Ave. NW., Washington,
Program partners are required to sign requirement of the Methane Challenge DC 20460–0001; telephone number:
and submit to EPA a Partnership Program partnership. The fact sheet (703) 305–5454; email address:
Agreement (PA) that describes the terms covered under this ICR is: smoot.cameo@epa.gov.
of participation in the Program. The PA For listing inquiries contact: Kerry B.
forms covered under this ICR include: • Historical Actions Fact Sheet Leifer, Registration Division, Office of
• Natural Gas STAR Methane Template—EPA Form No.: XXXX–XXX Pesticide Programs, Environmental
Challenge Program—Partnership Respondents/affected entities: The Protection Agency, 1200 Pennsylvania
Agreement for Best Management Natural Gas STAR Methane Challenge Ave. NW., Washington, DC 20460–0001;
Practice Commitment: EPA Form No. Program is open to companies in the oil telephone number: (703) 308–8811;
XXXX–XXX; and, production, and production, gathering email address: leifer.kerry@epa.gov.
• Natural Gas STAR Methane and boosting, processing, transmission SUPPLEMENTARY INFORMATION:
Challenge Program—Partnership and storage, and distribution segments
Agreement for ONE Future I. General Information
of the natural gas industry.
Commitment: EPA Form No. XXXX– A. Does this action apply to me?
XXX. Respondent’s obligation to respond:
Voluntary. You may be potentially affected by
Partners must complete and submit a
this action if you engage in activities
Methane Challenge Implementation Estimated number of respondents: 58 related to the registration of pesticide
Plan within six months of signing the (total projected partners over the three- products, including but not limited to,
MOU. The Implementation Plan forms year ICR period). the use of approved inert ingredients
covered under this ICR include:
• Methane Challenge Program Frequency of response: Annual. used in registered pesticide products.
Implementation Plan Guidelines: EPA Total estimated burden: 2,978 hours Potentially affected entities may
Form No. XXXX–XXX; and (per year, averaged over the three-year include, but are not limited to, engaging
• Methane Challenge Program ICR period). Burden is defined at 5 CFR in the formulation and preparation of
Implementation Plan Template—BMP 1320.3(b). agricultural and household pest control
Commitment: EPA Form No. XXXX– chemical substances or pesticides and
Total estimated cost: $268,952 (per other agricultural and household pest
XXX.
year, averaged over the three-year ICR control chemical substances or inert
After one full calendar year of
participation in the Program, EPA period), includes $0 annualized capital ingredient manufacturers and those who
requires partners to submit a specific set or operation & maintenance costs. make proprietary inert ingredient
of data documenting the previous year’s Changes in Estimates: This is a new formulations or pesticides and other
methane emissions, activity data, and program. Therefore, this is an initial agricultural chemical substance
reduction activities. The annual burden estimate. manufacturing generally identified by
reporting forms covered under this ICR the North American Industrial
Dated: November 14, 2016. Classification System (NAICS) code
include:
Paul Gunning, 325320.
BMP Commitment This listing is not intended to be
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Director, Climate Change Division.
• Distribution Reporting Forms: EPA [FR Doc. 2016–30062 Filed 12–13–16; 8:45 am] exhaustive, but rather provides a guide
Form No. XXXX–XXX; BILLING CODE 6560–50–P
for readers to help determine whether
• Transmission and Storage this document applies to them and
Reporting Forms: EPA Form No. XXXX– which entities are likely to be affected
XXX; and by this action. Other types of entities
• Gathering and Boosting Reporting not listed in this unit could also be
Forms: EPA Form No. XXXX–XXX. affected. The NAICS code has been
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![90358 Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Notices
4. Regulation of pesticide adjuvants. products are considered on a case-by- Synopsis: The amendment deletes
Some commenters asked the Agency to case basis as part of the Agency’s Costa Rica from the geographic scope of
clarify the impact of this removal action pesticide product registration process. the Agreement, reduces the amount of
on the use of tank-mix adjuvants, As part of that evaluation, the Agency space chartered, and adjusts the
including with respect to tolerances and looks at the identity and amount of an minimum the duration of Agreement.
exemptions under the Federal Food, impurity in the product manufacturing Agreement No.: 012446.
Drug and Cosmetic Act. information, and the steps taken to limit Title: Sealand/APL Central America
An adjuvant is a chemical substance or remove impurities. Slot Charter Agreement.
separately added to a pesticide product 7. Confirming the ingredient use in Parties: Maersk Line A/S DBA
(typically as part of a spray tank current pesticide products. Some Sealand; and APL Co. Pte Ltd. and
mixture). Since pesticide adjuvant commenters suggested that EPA provide American President Lines, Ltd.
products do not make pesticidal claims, them more time to investigate whether Filing Party: Wayne Rohde; Cozen
they are not pesticides, and the any of the 72 chemical substances are O’Connor; 1200 Nineteenth Street NW.;
components of adjuvants are therefore used in currently registered products. Washington, DC 20036.
not pesticide inert ingredients. EPA records include no Confidential Synopsis: The Agreement authorizes
Adjuvants are not included in the inert Statements of Formula for any currently Sealand to charter space to APL in the
ingredient approval process and are registered pesticide product that list any trade between the U.S. East Coast and
therefore unaffected by this policy. of these chemical substances. However, ports in Panama, Costa Rica, and
While adjuvants may need tolerances or if a registrant or a producer of Colombia.
tolerance exemptions in some cases, proprietary mixtures identifies an active Agreement No.: 012447.
tolerances and exemptions are separate registration that contains one of the Title: THE Alliance/Zim MED–USEC
from the inert ingredient approval chemical substances that has now been Slot Exchange Agreement.
process. removed from the approved inert Parties: Hapag-Lloyd AG; Nippon
5. No impact to the fragrance ingredient listing, that registrant or Yusen Kaisha; Mitsui O.S.K. Lines, Ltd.;
ingredient listing. One commenter noted producer should contact the Agency Kawasaki Kisen Kaisha, Ltd.; Yang Ming
that a few inert ingredients proposed for directly, using the contact for listing Marine Transport Corp.; Zim Integrated
removal from the chemical substance inquiries that is provided under FOR Shipping Services Limited.
list appear on the EPA Fragrance FURTHER INFORMATION CONTACT. If EPA Filing Party: Joshua Stein; Cozen
Ingredient List (FIL). confirms that the chemical substance is O’Connor; 1200 Nineteenth Street NW.;
The EPA FIL comprises more than contained in a currently registered Washington, DC 20036.
1,500 fragrance component ingredients product, the Agency will restore the Synopsis: The Agreement authorizes
that have undergone Agency evaluation chemical substance to the list of the Parties to exchange slots on their
to determine their suitability for safe use approved inert ingredients. respective services in the Agreement
as components of fragrances in nonfood- Authority: 7 U.S.C. 136 et seq. trade and to enter into cooperative
use pesticide product formulations in working arrangements in connection
accordance with the Fragrance Dated: December 7, 2016. therewith.
Notification Program. Removal of an James J. Jones,
By Order of the Federal Maritime
inert ingredient from the approved inert Assistant Administrator, Office of Chemical Commission.
ingredient listing does not preclude use Safety and Pollution Prevention. Dated: December 9, 2016.
as a fragrance ingredient as part of the [FR Doc. 2016–30043 Filed 12–13–16; 8:45 am]
Rachel E. Dickon,
Fragrance Notification Program BILLING CODE 6560–50–P
Assistant Secretary.
provided that inert ingredient is listed
[FR Doc. 2016–30022 Filed 12–13–16; 8:45 am]
on the FIL and use in a pesticide
BILLING CODE 6731–AA–P
formulation is consistent with the FEDERAL MARITIME COMMISSION
Fragrance Notification Process. The
inert ingredients no longer used in Notice of Agreements Filed
registered pesticide products will be FEDERAL TRADE COMMISSION
The Commission hereby gives notice
removed from the approved inert of the filing of the following agreements Agency Information Collection
ingredient listing but these same under the Shipping Act of 1984. Activities; Submission for OMB
ingredients will not be removed from Interested parties may submit comments Review; Comment Request; Extension
the FIL. on the agreements to the Secretary,
6. Impurities. Some commenters want Federal Maritime Commission, AGENCY: Federal Trade Commission
EPA to clarify that removing the Washington, DC 20573, within twelve (‘‘FTC’’ or ‘‘Commission’’).
chemical substances from the list does days of the date this notice appears in ACTION: Notice.
not prohibit the use of these chemical the Federal Register. Copies of the
substances being classified as residual agreements are available through the SUMMARY: The information collection
impurities in approved inert Commission’s Web site (www.fmc.gov) requirements described below will be
ingredients. or by contacting the Office of submitted to the Office of Management
The definition of inert ingredient as Agreements at (202)–523–5793 or and Budget (‘‘OMB’’) for review, as
given in 40 CFR 152.3 applies to tradeanalysis@fmc.gov. required by the Paperwork Reduction
chemical substances used as inert Agreement No.: 012338–001. Act (‘‘PRA’’). The FTC is seeking public
ingredients that are ‘‘intentionally comments on its proposal to extend for
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Title: Sealand/APL Caribbean Slot
included in a pesticide product’’ and as Charter Agreement. an additional three years the current
such the removal of a chemical Parties: Maersk Line A/S DBA PRA clearance for disclosure
substance from the approved inert Sealand; and APL Co. Pte Ltd. and requirements in its Affiliate Marketing
ingredient list does not apply to American President Lines, Ltd. Rule (or ‘‘Rule’’), which applies to
circumstances where the chemical Filing Party: Wayne Rohde; Cozen certain motor vehicle dealers, and its
substance may be present as an O’Connor; 1200 Nineteenth Street NW.; shared enforcement with the Consumer
impurity. Impurities in pesticide Washington, DC 20036. Financial Protection Bureau (‘‘CFPB’’) of
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Document Created: 2016-12-14 00:48:36
Document Modified: 2016-12-14 00:48:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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 | |
| FR Citation | 81 FR 90356 |
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